At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,712 enrolled
Drug / intervention
13-valent Pneumococcal Conjugate Vaccine +1 morebiological
Likely dose
13-valent Pneumococcal Conjugate Vaccine 0.5 mLfrom 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, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of Three Lots of 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in the United States
Wyeth is now a wholly owned subsidiary of Pfizer·interventional·Posted Mar 7, 2007·Updated Oct 15, 2012
In Brief
A Phase 3 clinical trial evaluating 13-valent Pneumococcal Conjugate Vaccine and 7vPnC for Vaccines, Pneumococcal. Completed, enrolled 1,712 participants across 78 sites.
Detailed Summary
The purpose of this study will be to evaluate safety, tolerability and immunogenicity of three lots of 13-valent pneumococcal vaccine given to healthy infants. Lots will be studied for consistency of the immune response, as well as for non-inferiority and safety as compared to 7-valent Pneumococcal Conjugate Vaccine.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVaccines, Pneumococcal
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 2007
Enrollment StartMay 2007
Primary CompletionJun 2009
TodayJul 2026
First PostedMar 7, 2007
Enrollment StartMay 1, 2007
Primary CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 19.3 years ago
Interventions
13-valent Pneumococcal Conjugate Vaccinebiological
0.5 mL of study vaccine administered IM at 2, 4, 6, and 12 months of age.
7vPnCbiological
0.5 mL of study vaccine administered IM at 2, 4, 6, and 12 months of age.