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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00224484
Registration number
NCT00224484
Ethics application status
Date submitted
21/09/2005
Date registered
23/09/2005
Titles & IDs
Public title
Safety Study of Herpes Simplex Vaccine in HSV Seronegative and Seropositive Females Between 10 and 17 Years Old
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Scientific title
A Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline Biologicals' Herpes Simplex Candidate Vaccine (gD2-AS04) in Healthy HSV Seronegative and Seropositive Female Subjects Aged 10-17 Years.
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Secondary ID [1]
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0
208141/040
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Herpes Simplex
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0
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Condition category
Condition code
Infection
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Other infectious diseases
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Skin
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0
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0
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - GSK208141
Treatment: Other - Havrix (investigational formulation)
Treatment: Other - Placebo
Experimental: GD2-AS04 GROUP - Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Active comparator: HAVRIX GROUP - Female subjects aged 10-17 years, who received 3 doses of Havrix, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Placebo comparator: SALINE GROUP - Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Treatment: Other: GSK208141
3 intramuscular doses
Treatment: Other: Havrix (investigational formulation)
3 intramuscular doses
Treatment: Other: Placebo
3 intramuscular doses
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Subjects With Serious Adverse Events (SAEs)
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Assessment method [1]
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Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
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Timepoint [1]
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From Month 0 to Month 12
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Secondary outcome [1]
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Number of Subjects With Any and Grade 3 Solicited Local Symptoms
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Assessment method [1]
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Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activities. Grade 3 redness/swelling = greater than (\>) 30mm diameter and persisting more than 24 hours.
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Timepoint [1]
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Within 7 days (Days 0-6) after each and any vaccination
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Secondary outcome [2]
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Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
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Assessment method [2]
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Assessed solicited general symptoms were arthralgia, fatigue, headache, malaise, rash, temperature \[defined as oral temperature equal to or above (=) 37.5 degrees Celsius (°C)\] and urticaria. Any = occurrence of any general symptom regardless of intensity grade or relation to vaccination. Grade 3 arthralgia, fatigue, headache, malaise, rash = general symptom that prevented normal activity. Grade 3 temperature = greater than 39 degrees Celsius (°C). Grade 3 urticaria = urticaria distributed on at least 4 body areas. Related = general symptom assessed by the investigator as causally related to the study vaccination.
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Timepoint [2]
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Within 7 days (Days 0-6) after each and any vaccination
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Secondary outcome [3]
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Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
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Assessment method [3]
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An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 = event which prevented normal, everyday activities. In adults/ adolescents, such an AE would, for example, prevent attendance at work/ school and would necessitate the administration of corrective therapy. Related = event assessed by the investigator as causally related to study vaccination.
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Timepoint [3]
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Within 30 days (Day 0-29) after any vaccination
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Secondary outcome [4]
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Number of Subjects With Unsolicited Adverse Events (AEs) With Medically Attended Visits
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Assessment method [4]
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An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. A medically attended visit is an event which prompted the subject to seek medical advice.
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Timepoint [4]
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Within the 30 Day (Day 0-29) post-vaccination period
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Secondary outcome [5]
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Number of Subjects With New Onset Chronic Diseases (NOCD)
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Assessment method [5]
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NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.
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Timepoint [5]
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During the active phase (up to Month 12)
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Secondary outcome [6]
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Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed
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Assessment method [6]
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Assessed parameters were alanine aminotransferase (ALT), creatinine (CREA), haematocrit (Hct), platelets (PLA), red blood cells (RBC), urea and white blood cells (WBC). A subset of subjects was formed for these analyses. Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range at other timepoints. This outcome presents ALT results.
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Timepoint [6]
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At months 7 and 12
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Secondary outcome [7]
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Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed
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Assessment method [7]
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Assessed parameters were alanine aminotransferase (ALT), creatinine (CREA), haematocrit (Hct), platelets (PLA), red blood cells (RBC), urea and white blood cells (WBC). A subset of subjects was formed for these analyses. Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range at other timepoints. This outcome presents CREA results.
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Timepoint [7]
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At months 7 and 12
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Secondary outcome [8]
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Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed
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Assessment method [8]
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Assessed parameters were alanine aminotransferase (ALT), creatinine (CREA), haematocrit (Hct), platelets (PLA), red blood cells (RBC), urea and white blood cells (WBC). A subset of subjects was formed for these analyses. Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range at other timepoints. This outcome presents Hct results.
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Timepoint [8]
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At months 7 and 12
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Secondary outcome [9]
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Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed
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Assessment method [9]
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Assessed parameters were alanine aminotransferase (ALT), creatinine (CREA), haematocrit (Hct), platelets (PLA), red blood cells (RBC), urea and white blood cells (WBC). A subset of subjects was formed for these analyses. Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range at other timepoints. This outcome presents PLA results.
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Timepoint [9]
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At months 7 and 12
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Secondary outcome [10]
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Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed
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Assessment method [10]
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Assessed parameters were alanine aminotransferase (ALT), creatinine (CREA), haematocrit (Hct), platelets (PLA), red blood cells (RBC), urea and white blood cells (WBC). A subset of subjects was formed for these analyses. Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range at other timepoints. This outcome presents RBC results.
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Timepoint [10]
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At months 7 and 12
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Secondary outcome [11]
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Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed
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Assessment method [11]
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Assessed parameters were alanine aminotransferase (ALT), creatinine (CREA), haematocrit (Hct), platelets (PLA), red blood cells (RBC), urea and white blood cells (WBC). A subset of subjects was formed for these analyses. Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range at other timepoints. This outcome presents UREA results.
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Timepoint [11]
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At months 7 and 12
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Secondary outcome [12]
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Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed
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Assessment method [12]
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Assessed parameters were alanine aminotransferase (ALT), creatinine (CREA), haematocrit (Hct), platelets (PLA), red blood cells (RBC), urea and white blood cells (WBC). A subset of subjects was formed for these analyses. Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range at other timepoints. This outcome presents WBC results.
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Timepoint [12]
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At months 7 and 12
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Secondary outcome [13]
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Number of Subjects With Unsolicited Adverse Events (AEs) With Medically Attended Visits
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Assessment method [13]
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An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. A medically attended visit is an event which prompted the subject to seek medical advice.
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Timepoint [13]
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Starting from Day 30 until the end of study (Month 18)
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Secondary outcome [14]
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Number of Subjects With Medically Significant Conditions (MSC)
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Assessment method [14]
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MSCs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury. For outcomes covering the ESFU period, the Havrix Group and Saline Group were pooled.
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Timepoint [14]
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During the Extended Safety Follow Up (ESFU) period (Month 12 to Month 18)
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Secondary outcome [15]
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Number of Subjects With New Onset Chronic Diseases (NOCD)
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Assessment method [15]
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NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. For outcomes covering the ESFU period, the Havrix Group and Saline Group were pooled.
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Timepoint [15]
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During the Extended Safety Follow Up (ESFU) period (Month 12 to Month 18)
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Secondary outcome [16]
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Number of Subjects With Serious Adverse Events (SAEs)
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Assessment method [16]
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Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. For outcomes covering the ESFU period, the Havrix Group and Saline Group were pooled.
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Timepoint [16]
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Up to month 18 (during active phase and ESFU period)
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Secondary outcome [17]
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Anti-glycoprotein D (Anti-gD) Antibody Concentrations
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Assessment method [17]
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Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EU/mL). Analysis was based on an immunogenicity subset, stratified by initial serostatus: HSV seronegative (-)/ seropositive (+), this included gD2-AS04 vaccine recipients, as follows: HSV 1 and HSV 2 seronegative (HSV1-/2-) and HSV 1 seropositive and HSV 2 seronegative (HSV1+/2-)
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Timepoint [17]
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At months 0, 7 and 12
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Secondary outcome [18]
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Anti-deacylated Monophosphoryl Lipid A (Anti-MPL) Antibody Concentrations
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Assessment method [18]
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Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EU/mL). The subset of subjects used for this analysis was 50% of the pre-defined subset of subjects that underwent assessment of biochemical and hematological parameters.
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Timepoint [18]
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At months 0, 7 and 12
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Eligibility
Key inclusion criteria
* Subjects who the investigator believes that can and will comply with the requirements of the protocol should be enrolled in the study.
* Healthy female between, and including, 10 and 17 years of age at the time of the first vaccination.
* Written informed assent obtained from the subject and written informed consent obtained from a parent or legal guardian of the subject prior to enrolment. If the subject is above the legal age of consent in her country, written informed consent will only be obtained from the subject.
* Subjects must have a negative urine pregnancy test.
* Subjects of childbearing potential at the time of study entry must be abstinent or must be using an effective method of birth control for 30 days prior to vaccination and must agree to continue such precautions for two months after completion of the vaccination series. Subjects who reach menarche during the study and therefore are of childbearing potential must agree to follow the same precautions.
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Minimum age
10
Years
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Maximum age
17
Years
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Pregnant or lactating female.
* Female planning to become pregnant or likely to become pregnant during the first eight months of the study (months 0-8).
* Any previous confirmed history of, or current clinical signs or symptoms of, oro labial herpes (cold sores), herpetic whitlow or genital herpes disease, such as swelling, papules, vesicles, pustules, ulcers, crusts, fissures, erythema, discharge, dysuria or pain, burning, itching, tingling in the ano-genital area.
* History of previous or planned vaccination against hepatitis A or a history of hepatitis A infection.
* Previous vaccination against herpes.
* History of herpetic keratitis.
* History of multiform erythema.
* Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after the first dose of study vaccine with the following exceptions: administration of routine meningococcal, hepatitis B, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccine up to 8 days before and 30 days after the first dose of study vaccine.
* History of allergic disease or reactions likely to be exacerbated by any component of the study vaccines
* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination
* History of a current acute or chronic autoimmune disease.
* History of any neurological disorders or seizures, with the exception of a single febrile seizure during childhood.
* Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality
* Acute disease at the time of enrolment
* Oral temperature >= 37.5°C (99.5°F) / axillary temperature >= 37.5°C (99.5°F) at the time of enrolment.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
* Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
7/04/2004
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
24/07/2007
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Sample size
Target
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Accrual to date
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Final
5960
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,TAS,VIC
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Recruitment hospital [1]
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GSK Investigational Site - Garran
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Recruitment hospital [2]
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GSK Investigational Site - Westmead
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Recruitment hospital [3]
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GSK Investigational Site - South Brisbane
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Recruitment hospital [4]
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GSK Investigational Site - Hobart
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Recruitment hospital [5]
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GSK Investigational Site - Carlton
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Recruitment postcode(s) [1]
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2606 - Garran
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Recruitment postcode(s) [2]
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2145 - Westmead
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Recruitment postcode(s) [3]
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4101 - South Brisbane
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Recruitment postcode(s) [4]
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- Hobart
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Recruitment postcode(s) [5]
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3053 - Carlton
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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Country [2]
0
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United States of America
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State/province [2]
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Arizona
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Country [3]
0
0
United States of America
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State/province [3]
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California
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Country [4]
0
0
United States of America
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State/province [4]
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Colorado
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Country [5]
0
0
United States of America
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State/province [5]
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Connecticut
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Country [6]
0
0
United States of America
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State/province [6]
0
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Florida
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Country [7]
0
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United States of America
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State/province [7]
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Illinois
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Country [8]
0
0
United States of America
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State/province [8]
0
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Kansas
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Country [9]
0
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United States of America
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State/province [9]
0
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Maryland
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Minnesota
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Country [11]
0
0
United States of America
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State/province [11]
0
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Missouri
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Country [12]
0
0
United States of America
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State/province [12]
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New Jersey
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Country [13]
0
0
United States of America
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State/province [13]
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New Mexico
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Country [14]
0
0
United States of America
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State/province [14]
0
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New York
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Country [15]
0
0
United States of America
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State/province [15]
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North Carolina
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Country [16]
0
0
United States of America
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State/province [16]
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Ohio
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Country [17]
0
0
United States of America
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State/province [17]
0
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Oregon
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Country [18]
0
0
United States of America
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State/province [18]
0
0
Pennsylvania
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Country [19]
0
0
United States of America
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State/province [19]
0
0
Tennessee
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Country [20]
0
0
United States of America
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State/province [20]
0
0
Texas
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Country [21]
0
0
United States of America
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State/province [21]
0
0
Utah
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Country [22]
0
0
United States of America
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State/province [22]
0
0
Virginia
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Country [23]
0
0
United States of America
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State/province [23]
0
0
Wisconsin
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Country [24]
0
0
Belgium
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State/province [24]
0
0
Gent
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Country [25]
0
0
Belgium
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State/province [25]
0
0
Wilrijk
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Country [26]
0
0
Canada
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State/province [26]
0
0
Alberta
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Country [27]
0
0
Canada
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State/province [27]
0
0
British Columbia
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Country [28]
0
0
Canada
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State/province [28]
0
0
Ontario
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Country [29]
0
0
Canada
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State/province [29]
0
0
Quebec
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Country [30]
0
0
Denmark
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State/province [30]
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0
Aarhus N
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Country [31]
0
0
Estonia
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State/province [31]
0
0
Tallinn
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Country [32]
0
0
Estonia
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State/province [32]
0
0
Tartu
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Country [33]
0
0
France
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State/province [33]
0
0
Château Renault
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Country [34]
0
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France
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State/province [34]
0
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Derval
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Country [35]
0
0
France
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State/province [35]
0
0
Evreux
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Country [36]
0
0
France
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State/province [36]
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0
Haute Goulaine
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Country [37]
0
0
France
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State/province [37]
0
0
La Chapelle sur Erdre
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Country [38]
0
0
France
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State/province [38]
0
0
Le Temple De Bretagne
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Country [39]
0
0
France
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State/province [39]
0
0
Luynes
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Country [40]
0
0
France
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State/province [40]
0
0
Nantes
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Country [41]
0
0
France
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State/province [41]
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0
Nort sur Erdre
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Country [42]
0
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France
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State/province [42]
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Paris
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Country [43]
0
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France
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State/province [43]
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Pont de L'Arche
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Country [44]
0
0
France
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State/province [44]
0
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Saint Aubin des Chateaux
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Country [45]
0
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France
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State/province [45]
0
0
Saint Avertin
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Country [46]
0
0
France
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State/province [46]
0
0
Saint Sebastien sur Loire
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Country [47]
0
0
France
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State/province [47]
0
0
Tours
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Country [48]
0
0
Greece
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State/province [48]
0
0
Athens
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Country [49]
0
0
Greece
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State/province [49]
0
0
Komotini
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Country [50]
0
0
Greece
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State/province [50]
0
0
Thessaloniki
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Country [51]
0
0
Hungary
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State/province [51]
0
0
Bordány
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Country [52]
0
0
Hungary
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State/province [52]
0
0
Budapest
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Country [53]
0
0
Hungary
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State/province [53]
0
0
Gyor
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Country [54]
0
0
Hungary
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State/province [54]
0
0
Hódmezovásárhely
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Country [55]
0
0
Hungary
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Szeged
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Hungary
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Zsombó
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Iceland
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Gardabaer
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Iceland
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Kopavogur
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Iceland
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Reykjavik
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Lithuania
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Kaunas
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Lithuania
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Panevezys
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Lithuania
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Vilnius
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Netherlands
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Rotterdam
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New Zealand
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Christchurch
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Norway
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Bergen
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Norway
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Oslo
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Romania
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Bucharest
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Romania
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Bucuresti
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Spain
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Blanes
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Spain
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Castellon
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Spain
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Madrid
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Spain
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Montgat/Barcelona
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Spain
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Valencia
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Sweden
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Göteborg
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Sweden
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Karlskrona
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Sweden
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Linköping
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Sweden
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Malmö
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Sweden
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Umeå
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Sweden
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Örebro
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United Kingdom
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Hampshire
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United Kingdom
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Lancashire
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United Kingdom
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Warwickshire
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United Kingdom
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West Midlands
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United Kingdom
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Bradford
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United Kingdom
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Doncaster
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United Kingdom
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Leeds
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United Kingdom
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London
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United Kingdom
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Sheffield
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
GlaxoSmithKline
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Ethics approval
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Summary
Brief summary
Main goal of this study is to compare the occurrence of serious adverse events (SAEs) between the herpes simplex (gD2-AS04) vaccine group and the Saline control group throughout the study period (up to month 12). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
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Trial website
https://clinicaltrials.gov/study/NCT00224484
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Trial related presentations / publications
Tavares F, Cheuvart B, Heineman T, Arellano F, Dubin G. Meta-analysis of pregnancy outcomes in pooled randomized trials on a prophylactic adjuvanted glycoprotein D subunit herpes simplex virus vaccine. Vaccine. 2013 Mar 25;31(13):1759-64. doi: 10.1016/j.vaccine.2013.01.002. Epub 2013 Jan 10. HSV-040 Study Group; Abu-Elyazeed RR, Heineman T, Dubin G, Fourneau M, Leroux-Roels I, Leroux-Roels G, Richardus JH, Ostergaard L, Diez-Domingo J, Poder A, Van Damme P, Romanowski B, Blatter M, Silfverdal SA, Berglund J, Josefsson A, Cunningham AL, Flodmark CE, Tragiannidis A, Dobson S, Olafsson J, Puig-Barbera J, Mendez M, Barton S, Bernstein D, Mares J, Ratner P. Safety and immunogenicity of a glycoprotein D genital herpes vaccine in healthy girls 10-17 years of age: results from a randomised, controlled, double-blind trial. Vaccine. 2013 Dec 9;31(51):6136-43. doi: 10.1016/j.vaccine.2013.06.081. Epub 2013 Jul 9. Verstraeten T, Descamps D, David MP, Zahaf T, Hardt K, Izurieta P, Dubin G, Breuer T. Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 2008 Dec 2;26(51):6630-8. doi: 10.1016/j.vaccine.2008.09.049.
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Public notes
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Contacts
Principal investigator
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GSK Clinical Trials
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GlaxoSmithKline
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00224484