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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01000311
Registration number
NCT01000311
Ethics application status
Date submitted
22/10/2009
Date registered
23/10/2009
Date last updated
21/04/2014
Titles & IDs
Public title
A Study to Evaluate the Safety and Immunogenicity of 4 Doses of MenACWY Conjugate Vaccine, Administered Concomitantly With Routine Vaccines, Among Infants Aged 2 Months
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Scientific title
A Phase 3, Randomized, Open Label, Controlled Multicenter Study to Evaluate the Safety and Immunogenicity of 4 Doses of MenACWY Conjugate Vaccine, Administered Concomitantly With Routine Vaccines, Among Infants Aged 2 Months
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Secondary ID [1]
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V59_33
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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:
Meningococcal Disease
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Condition category
Condition code
Infection
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Other infectious diseases
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Infection
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Studies of infection and infectious agents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - MenACWY-CRM
Treatment: Other - DTaP-IPV/Hib
Treatment: Other - HBV
Treatment: Other - PCV
Treatment: Other - MMR
Experimental: MenACWY-CRM + Routine Vaccines - Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
Experimental: Routine Vaccines - Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
In addition subjects were offered a dose of MenACWY-CRM at 18 months as a benefit of participating in this study. However, blood was not drawn for immunogenicity analysis after this dose.
Treatment: Other: MenACWY-CRM
One dose (0.5 mL) of MenACWY conjugate vaccine supplied as an extemporaneous mixing just before injection of the lyophilized component (MenA) reconstituted with the liquid component (MenCWY) was administered at 2, 4, 6 and 12 months of age as IM injections in the anterolateral area of the thigh.
Treatment: Other: DTaP-IPV/Hib
IM injections of 3 doses of 0.5 mL each of DTaP-IPV/Hib supplied in prefilled vial were administered at 2, 4 and 6 months of age in the anterolateral area of the thigh.
Treatment: Other: HBV
IM injections of 3 doses of 0.5 mL each of HBV supplied in prefilled vial were administered at 2, 4 and 6 months of age in the anterolateral area of the thigh.
Treatment: Other: PCV
IM injections of 4 doses of 0.5 mL each of PCV supplied in prefilled vial were administered at 2, 4, 6 and 12 months of age in the anterolateral area of the thigh.
Treatment: Other: MMR
Subcutaneous (SC) injection of 1 dose of 0.5 mL of MMR obtained by extemporaneous mixing just before injection of powder and the solvent for solution was administered at 12 months of age in the anterolateral area of the thigh.
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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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Percentage of Subjects With hSBA Titer =1:8 Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM
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Assessment method [1]
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Immunogenicity was measured as the percentage of subjects who achieved hSBA titer =1:8 against meningococcal serogroup A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), at baseline and one month after toddler dose of MenACWY-CRM administered at 12 months of age.
The immune response was considered sufficient if the lower limit of the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer =1:8, at one month after toddler vaccination, was greater than 85% for the serogroup C, W, or Y and greater than 80% for the serogroup A.
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Timepoint [1]
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Baseline and one month after fourth-dose of MenACWY-CRM
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Secondary outcome [1]
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hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM
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Assessment method [1]
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Immunogenicity was measured as the hSBA geometric mean titers (GMTs) directed against meningococcal serogroup A, C, W and Y, at baseline and one month after toddler dose of MenACWY-CRM administered at 12 months of age.
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Timepoint [1]
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Baseline and one month after fourth-dose of MenACWY-CRM
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Secondary outcome [2]
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Percentage of Subjects With hSBA Titers =1:8, and Four-Fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM
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Assessment method [2]
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Immunogenicity was measured as the percentage of subjects with hSBA titers =1:8 against meningococcal serogroup A, C, W and Y, before (baseline) and one month after 3 infant doses of MenACWY-CRM administered at 2, 4 and 6 months of age.
Percentage of subjects who achieved at least four-fold rise in hSBA titers against serogroup A, C, W and Y was measured one month after 3 infant doses of MenACWY-CRM.
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Timepoint [2]
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Baseline and one month after third infant dose of MenACWY-CRM
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Secondary outcome [3]
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hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM
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Assessment method [3]
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Immunogenicity was measured as the hSBA GMTs directed against meningococcal serogroups A, C, W and Y before (baseline) and one month after 3 infants doses of MenACWY-CRM administered at 2, 4 and 6 months of age.
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Timepoint [3]
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Baseline and one month after third infant dose of MenACWY-CRM
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Secondary outcome [4]
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Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone
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Assessment method [4]
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The immune seroresponse to routine concomitant vaccination was measured as the percentages of subjects with pre-specified cut-off limit of =0.1 IU/mL (Diphtheria and Tetanus); =0.15 µg/mL (Hib); =0.35 µg/mL (Pneumococcal antigens, PnC); and =10 mIU/mL (Hepatitis B), evaluated using enzyme-linked immunosorbent assay (ELISA) at one month after 3 doses of infant series vaccination administered at 2, 4 and 6 months of age.
The immune response to pertussis antigens (PT, FHA, Pertactin, FIM) was measured as percentage of subjects with seroresponse (in initially seronegative infants, =4 times the lower limit of quantification (LLQ); in initially seropositive infants, at least 4 times prevaccination concentration) by ELISA and percentage of subjects with titer =1:8 (Polio types 1, 2, and 3) by neutralization test (NT) one month after 3 doses of infant series vaccination administered at 2, 4 and 6 months of age.
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Timepoint [4]
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One month after third dose of routine infant series vaccination
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Secondary outcome [5]
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Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone
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Assessment method [5]
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The immune response was measured as the geometric mean concentrations (GMCs) of antibodies directed against diphtheria, tetanus, pertussis (PT, FHA, Pertactin, FIM), hepatitis B, Hib, polio (type 1, 2 and 3) and pneumococcal (PnC 4, 6B, 9V, 14, 18C, 19F and 23F) antigens when routine vaccines are administered concomitantly with MenACWY-CRM compared with when routine vaccines are given alone, one month after 3 doses of infant series vaccination at 2, 4 and 6 months of age.
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Timepoint [5]
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One month after third dose of routine infant series vaccination
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Secondary outcome [6]
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Geometric Mean Concentrations Of Antibodies Against Pneumococcal Antigens One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone
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Assessment method [6]
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Immunogenicity was measured as the GMCs of anti-pneumococcal antibodies against pneumococcal antigens PnC 4, 6B, 9V, 14, 18C, 19F and 23F, one month after toddler dose of PCV at 12 months of age administered concomitantly with MenACWY-CRM compared with PCV given alone.
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Timepoint [6]
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One month after PCV toddler vaccination
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Secondary outcome [7]
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Percentage of Subjects With Anti-pneumococcal Antigen Antibodies =0.35 µg/mL One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone
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Assessment method [7]
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The immune seroresponse was measured as the percentage of subjects with anti-pneumococcal antigen antibodies =0.35 µg/mL against pneumococcal antigens PnC 4, 6B, 9V, 14, 18C, 19F and 23F, one month after toddler dose of PCV at 12 months of age when administered concomitantly with MenACWY-CRM compared with PCV given alone.
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Timepoint [7]
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One month after PCV toddler vaccination
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Secondary outcome [8]
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Antibody Persistence by Percentage of Subjects With hSBA Titers =1:8 Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination
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Assessment method [8]
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The antibody persistence was measured as the percentage of subjects with hSBA titers =1:8 against meningococcal serogroup A, C, W and Y, at baseline and six months after third infant dose of MenACWY-CRM administered at 6 months (12 months of age), before administration of the toddler dose of MenACWY-CRM.
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Timepoint [8]
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Baseline and Six months after third infant dose of MenACWY-CRM
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Secondary outcome [9]
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Persistence of hSBA Geometric Mean Titers Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination
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Assessment method [9]
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The antibody persistence was measured as the hSBA GMTs directed against meningococcal serogroup A, C, W and Y, at baseline and six months after third infant dose of MenACWY-CRM administered at 6 months (12 months of age), before administration of the toddler dose of MenACWY-CRM.
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Timepoint [9]
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Baseline and Six months after third infant dose of MenACWY-CRM
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Secondary outcome [10]
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Percentage of Subjects With Four-fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM
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Assessment method [10]
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The immune response was measured as the percentage of subjects who achieved four-fold increase in hSBA titers against meningococcal serogroup A, C, W and Y one month after toddler dose of MenACWY-CRM administered at 12 months of age as compared to hSBA titers before the toddler vaccination.
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Timepoint [10]
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One month after MenACWY-CRM toddler vaccination
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Secondary outcome [11]
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Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations
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Assessment method [11]
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Safety of the study vaccines (MenACWY-CRM and other routine vaccines) was assessed in terms of the number of subjects who reported adverse events (AEs) and/or serious AEs per vaccine group at the following time points: entire study period, after infants vaccination (up to 7 months), between 2- and 4-months, between 4- and 6-months, between 6- and 12-months, between 7- and 12-months, 28 days after 12-month vaccination, and between 29 days after 12-month vaccination and study termination.
Solicited reactions were not collected during this study. The safety analyses also included any AEs observed by study personnel within 15 minutes following vaccination. All AEs and SAEs were judged by the investigator as whether probably related, possibly related, or not related to vaccine.
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Timepoint [11]
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From day 1 to 18 months
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Eligibility
Key inclusion criteria
1. Two month-old infants, born after a full-term pregnancy with an estimated gestational age =37 weeks and a birth weight =2.5 kg.
2. Documented written informed consent provided by the parent/legal representative after the nature of the study had been explained.
3. Parent/legal representative was available for all visits scheduled in the study.
4. Subjects were in good health as determined by:
1. medical history
2. physical assessment
3. clinical judgment of the investigator
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Minimum age
55
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Maximum age
89
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
1. Subjects who previously received any meningococcal vaccines or vaccines against diphtheria, tetanus, pertussis, polio (IPV or OPV), H. influenzae type b (Hib) or pneumococcus. Exceptions: prior doses HBV vaccination (one or two doses) are permitted.
2. Subjects who had a previous confirmed or suspected disease caused by N. meningitidis, C. diphtheriae, C. tetani, poliovirus, Hepatitis B, Hib, pneumococcus or B. pertussis (history of laboratory confirmed, or clinical condition of paroxysmal cough for a period of longer than or equal to 2 weeks associated with apnea or whooping).
3. Subjects who had household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis, B. pertussis, Hib, C. diphtheriae, polio, or pneumococcal infection at any time since birth.
4. Subjects who had a history of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component.
5. Subjects who had experienced significant acute or chronic infection within the previous 7 days or have experienced fever (temperature = 38.0°C [100.4°F]) within the previous 3 days.
6. Subjects who had any serious acute or chronic disease, neurological disease including seizures, congenital defects, or cytogenic disorders (e.g., Down syndrome).
7. Subjects who had a known or suspected autoimmune disease or persistent impairment/alteration of immune function.
8. Subjects who had a suspected or known HIV infection or were born to a mother known to be HIV positive.
9. Subjects who had ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation (including Hepatitis B immune globulin).
10. Subjects who had a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
11. Subjects who with their parents/legal representatives were planning to leave the area of the study site before the end of the study period.
12. Subjects who had any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
13. Subjects who received any investigational agents or vaccines since birth or who expect to receive an investigational agent or vaccine prior to the completion of the study.
14. Subjects who were relatives of site research staff working on this study.
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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
Open (masking not used)
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Who is / are masked / blinded?
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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
1/11/2009
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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
1/11/2011
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Sample size
Target
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Accrual to date
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Final
529
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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3 Sydney Children's Hospital Strasser Lab. Level 3 High Street - Randwick
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Recruitment hospital [2]
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2 Royal Children's Hospital Herston Road - Herston
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Recruitment hospital [3]
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1 Murdoch Childrens Research Institute C/- School of Population Health The University of Melbourne - Carlton
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Recruitment postcode(s) [1]
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2031 - Randwick
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Recruitment postcode(s) [2]
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4029 - Herston
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Recruitment postcode(s) [3]
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3010 - Carlton
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Recruitment outside Australia
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Alabama
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Arkansas
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Louisiana
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Michigan
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Oklahoma
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Ontario
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novartis Vaccines
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Ethics approval
Ethics application status
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Summary
Brief summary
This Phase 3 study is designed to demonstrate the safety and immunogenicity of MenACWY and non-interference of concomitant routine vaccines by MenACWY in an infant age group.
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Trial website
https://clinicaltrials.gov/study/NCT01000311
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Public notes
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Contacts
Principal investigator
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Contact person for scientific queries
No information has been provided regarding IPD availability
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/NCT01000311
Download to PDF