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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00289783




Registration number
NCT00289783
Ethics application status
Date submitted
9/02/2006
Date registered
10/02/2006

Titles & IDs
Public title
Safety and Immunogenicity Study of Hib-MenCY-TT Vaccine Compared to Licensed Hib Conjugate Vaccine
Scientific title
A Phase III, Randomized, Multinational Study, Double-blinded for the Immunogenicity and Consistency Evaluation of 3 Hib-MenCY-TT Vaccine Lots and Single-blinded and Controlled for the Evaluation of Safety and Immunogenicity of GSK Biologicals' Haemophilus Influenzae Type b and Neisseria Meningitidis Serogroups C and Y-tetanus Toxoid Conjugate Vaccine Combined (Hib-MenCY-TT) Compared to Monovalent Hib Vaccine in Healthy Infants at 2, 4, 6, and 12 to 15 Months of Age.
Secondary ID [1] 0 0
105067
Secondary ID [2] 0 0
103813
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Haemophilus Influenzae Type b 0 0
Neisseria Meningitidis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis 792014 vaccine
Treatment: Other - ActHIB
Treatment: Other - PedvaxHIB
Treatment: Other - Pediarix
Treatment: Other - Prevnar
Treatment: Other - M-M-R II
Treatment: Other - Varivax

Experimental: Menhibrix A Group - Subjects were primed with 3 doses of Menhibrix vaccine Lot A co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.

Experimental: Menhibrix B Group - Subjects were primed with 3 doses of Menhibrix vaccine Lot B co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.

Experimental: Menhibrix C Group - Subjects were primed with 3 doses of Menhibrix vaccine Lot C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.

Experimental: Menhibrix Group - Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.

Active comparator: ActHIB Group - Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.


Treatment: Other: GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis 792014 vaccine
3-dose intramuscular injection at 2, 4 and 6 months of age, and 1 booster dose by intramuscular injection at 12 to 15 months of age.

Treatment: Other: ActHIB
3-dose intramuscular injection at 2, 4 and 6 months of age.

Treatment: Other: PedvaxHIB
1 booster dose by intramuscular injection at 12 to 15 months of age.

Treatment: Other: Pediarix
3-dose intramuscular injection at 2, 4 and 6 months of age.

Treatment: Other: Prevnar
3-dose intramuscular injection at 2, 4 and 6 months of age, and 1 booster dose by intramuscular injection at 12 to 15 months of age.

Treatment: Other: M-M-R II
1 booster dose by subcutaneous injection at 12 to 15 months of age.

Treatment: Other: Varivax
1 booster dose by subcutaneous injection at 12 to 15 months of age
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Anti-Polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations
Timepoint [1] 0 0
One month after primary vaccination
Primary outcome [2] 0 0
Neisseria Meningitidis Serogroup C (MenC) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers
Timepoint [2] 0 0
One month after primary vaccination
Primary outcome [3] 0 0
Neisseria Meningitidis Serogroup Y (MenY) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers
Timepoint [3] 0 0
One month after primary vaccination
Primary outcome [4] 0 0
hSBA-MenC Antibody Titers
Timepoint [4] 0 0
Prior to the fourth dose vaccination and 42 days after the fourth dose
Primary outcome [5] 0 0
hSBA-MenY Antibody Titers
Timepoint [5] 0 0
Prior to the fourth dose vaccination and 42 days after the fourth dose
Primary outcome [6] 0 0
Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL)
Timepoint [6] 0 0
One month after primary vaccination
Primary outcome [7] 0 0
Number of Subjects With hSBA-MenC Titer Equal to or Above 1:8
Timepoint [7] 0 0
42 days after the fourth dose
Primary outcome [8] 0 0
Number of Subjects With hSBA-MenY Titer Equal to or Above 1:8
Timepoint [8] 0 0
42 days after the fourth dose
Primary outcome [9] 0 0
Number of Subjects With Anti-measles Antibody Concentrations Equal to or Above 150 Milli-international Units Per Milli-liter (mIU/ML)
Timepoint [9] 0 0
42 days after the fourth dose
Primary outcome [10] 0 0
Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter
Timepoint [10] 0 0
42 days after the fourth dose
Primary outcome [11] 0 0
Number of Subjects With Anti-mumps Titer Equal to or Above 28 Estimated Dose 50 (ED50)
Timepoint [11] 0 0
42 days after the fourth dose
Primary outcome [12] 0 0
Number of Subjects With Anti-rubella Antibody Concentrations Equal to or Above 10 International Units Per Milli-litre (IU/mL)
Timepoint [12] 0 0
42 days after the fourth dose
Primary outcome [13] 0 0
Number of Subjects With Anti-varicella Titer Equal to or Above 1:5
Timepoint [13] 0 0
42 days after the fourth dose
Secondary outcome [1] 0 0
Number of Subjects With Anti-tetanus (Anti-T) and Anti-diphtheria Toxoid (Anti-D) Antibody Concentrations Equal to or Above 0.1 International Units Per Millilitre (IU/mL)
Timepoint [1] 0 0
One month after primary vaccination
Secondary outcome [2] 0 0
Anti-D and Anti-T Antibody Concentrations
Timepoint [2] 0 0
One month after primary vaccination
Secondary outcome [3] 0 0
Number of Subjects With Anti Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above 10.0 Milli-international Units Per Millilitre (mIU/mL)
Timepoint [3] 0 0
One month after primary vaccination
Secondary outcome [4] 0 0
Anti-HBS Antibody Concentrations
Timepoint [4] 0 0
One month after primary vaccination
Secondary outcome [5] 0 0
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5 ELISA Units Per Millilitre (EL.U/mL)
Timepoint [5] 0 0
One month after primary vaccination
Secondary outcome [6] 0 0
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Timepoint [6] 0 0
One month after primary vaccination
Secondary outcome [7] 0 0
Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Equal to or Above 8 Estimated Dose 50 (ED50)
Timepoint [7] 0 0
One month after primary vaccination
Secondary outcome [8] 0 0
Anti-poliovirus Types 1, 2 and 3 Titers
Timepoint [8] 0 0
One month after primary vaccination
Secondary outcome [9] 0 0
Number of Subjects With Antibodies to Neisseria Meningitidis Serogroup C and Y Polysaccharide Capsule (Anti-PSC and Anti-PSY) Concentrations Equal to or Above the Cut-off Values
Timepoint [9] 0 0
One month after primary vaccination
Secondary outcome [10] 0 0
Anti-PSC and Anti-PSY Antibody Concentrations
Timepoint [10] 0 0
One month after primary vaccination
Secondary outcome [11] 0 0
Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Values
Timepoint [11] 0 0
One month after the primary vaccination course
Secondary outcome [12] 0 0
Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Values
Timepoint [12] 0 0
Prior to the fourth dose vaccination and one month after fourth dose vaccination
Secondary outcome [13] 0 0
Anti-PRP Antibody Concentrations
Timepoint [13] 0 0
One month after the primary vaccination course
Secondary outcome [14] 0 0
Anti-PRP Antibody Concentrations
Timepoint [14] 0 0
Prior to the fourth dose vaccination and one month after fourth dose vaccination
Secondary outcome [15] 0 0
Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values
Timepoint [15] 0 0
One month after the primary vaccination course
Secondary outcome [16] 0 0
Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values
Timepoint [16] 0 0
Prior to the fourth dose vaccination and one month after fourth dose vaccination
Secondary outcome [17] 0 0
hSBA-MenC and hSBA-MenY Antibody Titers
Timepoint [17] 0 0
One month after the primary vaccination course
Secondary outcome [18] 0 0
hSBA-MenC and hSBA-MenY Antibody Titers
Timepoint [18] 0 0
Prior to the fourth dose vaccination and one month after fourth dose vaccination
Secondary outcome [19] 0 0
Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values
Timepoint [19] 0 0
One month after the primary vaccination course
Secondary outcome [20] 0 0
Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values
Timepoint [20] 0 0
Prior to the fourth dose vaccination and one month after fourth dose vaccination
Secondary outcome [21] 0 0
Anti-PSC and Anti-PSY Antibodies Concentrations
Timepoint [21] 0 0
One month after the primary vaccination course
Secondary outcome [22] 0 0
Anti-PSC and Anti-PSY Antibody Concentrations
Timepoint [22] 0 0
Prior to the fourth dose vaccination and one month after fourth dose vaccination
Secondary outcome [23] 0 0
Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Value
Timepoint [23] 0 0
One month after the primary vaccination course
Secondary outcome [24] 0 0
Anti-PRP Antibody Concentrations
Timepoint [24] 0 0
One month after the primary vaccination course and prior to the fourth dose vaccination
Secondary outcome [25] 0 0
Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values
Timepoint [25] 0 0
One month after the primary vaccination course
Secondary outcome [26] 0 0
Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values
Timepoint [26] 0 0
Prior to the fourth dose vaccination and 42 days after fourth dose vaccination
Secondary outcome [27] 0 0
Anti-PSC and Anti-PSY Antibody Concentrations
Timepoint [27] 0 0
Prior to the fourth dose vaccination and 42 days after fourth dose vaccination
Secondary outcome [28] 0 0
Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above 0.15 Microgram Per Milliliter (µg/mL)
Timepoint [28] 0 0
Prior to the fourth dose vaccination and 42 days after fourth vaccination
Secondary outcome [29] 0 0
Anti-PRP Antibody Concentrations
Timepoint [29] 0 0
Prior to the fourth vaccination and 42 days after fourth vaccination
Secondary outcome [30] 0 0
Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Concentrations Equal to or Above 1:4
Timepoint [30] 0 0
Prior to the fourth dose vaccination and 42 days after fourth vaccination
Secondary outcome [31] 0 0
Number of Subjects With Anti-measles Antibody Concentrations Equal to or Above 200 Milli-international Units Per Millilitre (mIU/mL)
Timepoint [31] 0 0
42 days after fourth vaccination
Secondary outcome [32] 0 0
Anti-measles Antibody Concentrations
Timepoint [32] 0 0
42 days after fourth vaccination
Secondary outcome [33] 0 0
Number of Subjects With Anti-mumps Titer Equal to or Above the Cut-off Values
Timepoint [33] 0 0
42 days after fourth vaccination
Secondary outcome [34] 0 0
Anti-mumps Antibody Titers
Timepoint [34] 0 0
42 days after fourth vaccination
Secondary outcome [35] 0 0
Number of Subjects With Anti-rubella Antibody Concentrations Equal to or Above 4 International Units Per Millilitre (IU/mL)
Timepoint [35] 0 0
42 days after fourth vaccination
Secondary outcome [36] 0 0
Anti-rubella Antibody Concentrations
Timepoint [36] 0 0
42 days after fourth vaccination
Secondary outcome [37] 0 0
Number of Subjects With Anti-varicella Titer Equal to or Above 1:40
Timepoint [37] 0 0
42 days after fourth vaccination
Secondary outcome [38] 0 0
Anti-varicella Antibody Titers
Timepoint [38] 0 0
42 days after fourth vaccination
Secondary outcome [39] 0 0
Number of Subjects With Anti-H1N1, Anti-H3N2 and Anti-influenza-B (Anti B) Antibody Titers Equal to or Above 1:40
Timepoint [39] 0 0
Prior to the fourth dose vaccination and one month after the fourth dose vaccination
Secondary outcome [40] 0 0
Number of Subjects Reporting Fever Above 39.5 Degrees Celsius/103.1 Degrees Fahrenheit
Timepoint [40] 0 0
In the 4-day (Day 0-3) follow-up period after primary vaccination course
Secondary outcome [41] 0 0
Number of Subjects Reporting Fever Above 39.5 Degrees Celsius/103.1 Degrees Fahrenheit
Timepoint [41] 0 0
In the 4-day (Day0-3) follow-up period after the fourth dose
Secondary outcome [42] 0 0
Number of Subjects Reporting Solicited Local and General Symptoms
Timepoint [42] 0 0
Within the 4 days (Day 0-3) following each dose of the primary vaccination course
Secondary outcome [43] 0 0
Number of Subjects Reporting Solicited Local and General Symptoms
Timepoint [43] 0 0
Within the 4 days (Day 0-3) post-vaccination period following the fourth dose
Secondary outcome [44] 0 0
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Timepoint [44] 0 0
Within 31 days (Day 0-30) following the primary vaccination course
Secondary outcome [45] 0 0
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Timepoint [45] 0 0
Within 31 days (Day 0-30) following the fourth dose
Secondary outcome [46] 0 0
Number of Subjects Reporting Increased Circumferential Swelling at the Injection Limb(s)
Timepoint [46] 0 0
Within 4 days (Day 0 to Day 3) after fourth dose vaccination
Secondary outcome [47] 0 0
Number of Subjects Reporting General Symptoms Specific to Measles, Mumps, Rubella and Varicella Vaccination
Timepoint [47] 0 0
Within 43 days (Day 0 through Day 42) after vaccination
Secondary outcome [48] 0 0
Number of Subjects Reporting Serious Adverse Events (SAEs)
Timepoint [48] 0 0
From Dose 0 through 6 months after the last primary dose or untill administration of the fourth dose
Secondary outcome [49] 0 0
Number of Subjects Reporting Serious Adverse Events (SAEs)
Timepoint [49] 0 0
From the fourth dose through the end of the 6-month safety follow-up
Secondary outcome [50] 0 0
Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCDs)
Timepoint [50] 0 0
From Dose 0 through 6 months after the last primary dose or until administration of the fourth dose
Secondary outcome [51] 0 0
Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCDs)
Timepoint [51] 0 0
From the fourth dose through the end of the 6-month safety follow-up
Secondary outcome [52] 0 0
Number of Subjects Reporting Rash
Timepoint [52] 0 0
From Dose 0 through 6 months after the last primary dose or until administration of the fourth dose
Secondary outcome [53] 0 0
Number of Subjects Reporting Rash
Timepoint [53] 0 0
From the fourth dose through the end of the 6-month safety follow-up
Secondary outcome [54] 0 0
Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits
Timepoint [54] 0 0
From Dose 0 through 6 months after the last primary dose or until administration of the fourth dose
Secondary outcome [55] 0 0
Number of Subjects Reporting Adverse Events Resulting in Physicians (MD) Office Visits.
Timepoint [55] 0 0
From Dose 0 through 6 months after the last primary dose or until administration of the fourth dose
Secondary outcome [56] 0 0
Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits
Timepoint [56] 0 0
From the fourth dose through the end of the 6-month safety follow-up
Secondary outcome [57] 0 0
Number of Subjects Reporting Adverse Events Resulting in Physicians (MD) Office Visits
Timepoint [57] 0 0
From the fourth dose through the end of the 6-month safety follow-up
Secondary outcome [58] 0 0
Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL).
Timepoint [58] 0 0
Prior to the fourth dose vaccination
Secondary outcome [59] 0 0
Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titer Equal to or Above 1:8.
Timepoint [59] 0 0
Prior to the fourth dose vaccination

Eligibility
Key inclusion criteria
* Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol
* A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.
* Written informed consent obtained from the parent or guardian of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Born after 36 weeks gestation.
* Infants who have not received a previous dose of hepatitis B vaccine or those who have received only 1 dose of hepatitis B vaccine administered at least 30 days prior to enrollment.
* Infants may have received a birth dose of Bacillus Calmette-Guérin (BCG) vaccine.
Minimum age
6 Weeks
Maximum age
15 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
* Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine(s). (Synagis® [palivizumab, MedImmune], Prevnar (Prevenar), rotavirus vaccine, and influenza vaccine are allowed.
* Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, and/or poliovirus; more than one previous dose of hepatitis B vaccine.
* History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, hepatitis B, and/or poliovirus disease.
* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including dry natural latex rubber.
* Major congenital defects or serious chronic illness.
* History of any neurologic disorders or seizures.
* Acute disease at time of enrollment.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
* Concurrent participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).

Additional specific criteria for the US subjects in Cohort 1. In addition, for Cohorts 2 and 3, subjects should not be administered M-M-R II and Varivax if any of these criteria apply:

* History of measles, mumps, rubella or varicella.
* Previous vaccination against measles, mumps, rubella or varicella.
* Hypersensitivity to any component of the vaccines, including gelatin or neomycin.
* Patients receiving immunosuppressive therapy.
* Individuals with blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems.
* Individuals with primary and acquired immunodeficiency states.
* Individuals with a family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
* Individuals with active tuberculosis.
* Acute disease at time of booster vaccination.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/02/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/02/2008
Sample size
Target
Accrual to date
Final
4441
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Randwick
Recruitment hospital [2] 0 0
GSK Investigational Site - Herston
Recruitment hospital [3] 0 0
GSK Investigational Site - South Brisbane
Recruitment hospital [4] 0 0
GSK Investigational Site - Carlton
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
3053 - Carlton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Idaho
Country [9] 0 0
United States of America
State/province [9] 0 0
Iowa
Country [10] 0 0
United States of America
State/province [10] 0 0
Kansas
Country [11] 0 0
United States of America
State/province [11] 0 0
Kentucky
Country [12] 0 0
United States of America
State/province [12] 0 0
Louisiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Maryland
Country [14] 0 0
United States of America
State/province [14] 0 0
Massachusetts
Country [15] 0 0
United States of America
State/province [15] 0 0
Michigan
Country [16] 0 0
United States of America
State/province [16] 0 0
Minnesota
Country [17] 0 0
United States of America
State/province [17] 0 0
Nebraska
Country [18] 0 0
United States of America
State/province [18] 0 0
Nevada
Country [19] 0 0
United States of America
State/province [19] 0 0
New York
Country [20] 0 0
United States of America
State/province [20] 0 0
North Carolina
Country [21] 0 0
United States of America
State/province [21] 0 0
Ohio
Country [22] 0 0
United States of America
State/province [22] 0 0
Oklahoma
Country [23] 0 0
United States of America
State/province [23] 0 0
Oregon
Country [24] 0 0
United States of America
State/province [24] 0 0
Pennsylvania
Country [25] 0 0
United States of America
State/province [25] 0 0
Rhode Island
Country [26] 0 0
United States of America
State/province [26] 0 0
South Carolina
Country [27] 0 0
United States of America
State/province [27] 0 0
Texas
Country [28] 0 0
United States of America
State/province [28] 0 0
Utah
Country [29] 0 0
United States of America
State/province [29] 0 0
Virginia
Country [30] 0 0
United States of America
State/province [30] 0 0
Washington
Country [31] 0 0
United States of America
State/province [31] 0 0
Wisconsin
Country [32] 0 0
Mexico
State/province [32] 0 0
Mexico, D.F.

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


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/NCT00289783