Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in India
A Phase 3, Randomised, Active-Controlled, Double-Blind Trial Evaluating the Safety, Tolerability and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Paediatric Vaccinations in India
1 other identifier
interventional
708
1 country
12
Brief Summary
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC) compared to Prevenar (7vPnC), when given concomitantly with routine paediatric vaccinations in India.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2007
Typical duration for phase_3
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2007
CompletedFirst Posted
Study publicly available on registry
March 27, 2007
CompletedStudy Start
First participant enrolled
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedResults Posted
Study results publicly available
November 15, 2010
CompletedMarch 24, 2011
March 1, 2011
2.3 years
March 23, 2007
October 13, 2010
March 22, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (Mcg)/mL, 1 Month After the Infant Series.
Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding O'Brien-Fleming-adjusted, exact, 2-sided 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F and 19 A) are presented.
1 month after the infant series (18 weeks of age)
Percentage of Participants Achieving a Predefined Antibody Level for Concomitant Vaccine Pertussis Antigens (Pertussis Toxoid [PT], Filamentous Hemagglutinin [FHA], Pertactin [PRN]), 1 Month After the Infant Series.
Percentage of participants achieving a predefined antibody level (measured in enzyme-linked immunosorbent assay \[ELISA\] units per mL \[EU/mL\]) along with the corresponding O'Brien-Fleming-adjusted, exact, 2-sided 95% CI for concomitant antigens pertussis (PT, FHA and PRN) are presented.
1 month after the infant series (18 weeks of age)
Secondary Outcomes (1)
Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Mcg/mL, 1 Month After the Toddler Dose.
1 month after the toddler dose (13 months of age)
Other Outcomes (10)
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the 3-Dose Infant Series
1 month after the 3-dose infant series (18 weeks of age)
GMC for Serotype-specific Pneumococcal IgG Antibody, 1 Month After the Toddler Dose
1 month after toddler dose (13 months of age)
Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (6 Weeks of Age)
Within 4 days after the dose 1 of the infant series (6 weeks of age)
- +7 more other outcomes
Study Arms (2)
A
EXPERIMENTALB
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Healthy infants aged 6 weeks (42-72 days) at time of enrolment
- Available for the entire study period
You may not qualify if:
- Previous vaccination with pneumococcal, diphtheria, tetanus, pertussis or Hib vaccines
- A previous anaphylactic reaction to any vaccine or vaccine-related component
- Contraindication to vaccination with pneumococcal, Hib, diphtheria, tetanus, pertussis, polio, hepatitis B or measles vaccines
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Unknown Facility
Sector-12, Chandigarh, 160 012, India
Unknown Facility
Sector-32 B, Chandigarh, 160031, India
Unknown Facility
Bangalore, Karnataka, 560 034, India
Unknown Facility
Bangalore, Karnataka, 560017, India
Unknown Facility
Mumbai, Maharashtra, 400 026, India
Unknown Facility
Pune, Maharashtra, 411 043, India
Unknown Facility
Pune, Maharashtra, 411001, India
Unknown Facility
Pune, Maharashtra, 411011, India
Unknown Facility
Rajinder Nagar, New Delhi, 110 060, India
Unknown Facility
Ludhiana, Punjab, 141008, India
Unknown Facility
Chennai, Tamil Nadu, 600034, India
Unknown Facility
Vellore, Tamil Nadu, 632 004, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Geometric Mean Concentration Outcome Measures were identified as secondary analysis in the study protocol, but are included to maintain consistency with other postings for this program.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 23, 2007
First Posted
March 27, 2007
Study Start
June 1, 2007
Primary Completion
October 1, 2009
Study Completion
February 1, 2010
Last Updated
March 24, 2011
Results First Posted
November 15, 2010
Record last verified: 2011-03