At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 708 enrolled
Drug / intervention
13-valent Pneumococcal Conjugate Vaccine +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
Wyeth is now a wholly owned subsidiary of Pfizer·interventional·Posted Mar 27, 2007·Updated Mar 24, 2011
In Brief
A Phase 3 clinical trial evaluating 13-valent Pneumococcal Conjugate Vaccine and 7 valent pneumococcal conjugate vaccine for Pneumococcal Infections. Completed, enrolled 708 participants across 12 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPneumococcal Infections
CountriesIndia
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 2007
Enrollment StartJun 2007
Primary CompletionOct 2009
Study CompletionFeb 2010
TodayJul 2026
First PostedMar 27, 2007
Enrollment StartJun 1, 2007
Primary CompletionOct 1, 2009
Study CompletionFeb 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 19.3 years ago
Interventions
13-valent Pneumococcal Conjugate Vaccinebiological
1 dose at 6, 10, 14 weeks and 12 months of age
7 valent pneumococcal conjugate vaccinebiological
1 dose at 6, 10, 14 weeks and 12 months of age