At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 500 enrolled
Drug / intervention
13 valent pneumococcal conjugate vaccine with Polysorbate 80 +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, Randomized, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine Manufactured With and Without Polysorbate 80 in Healthy Infants Given in a 2-, 3-, 4-, and 12-Month Schedule With Routine Pediatric Vaccinations
Wyeth is now a wholly owned subsidiary of Pfizer·interventional·Posted Aug 21, 2006·Updated Aug 15, 2012
In Brief
A Phase 3 clinical trial evaluating 13 valent pneumococcal conjugate vaccine with Polysorbate 80 and 13 valent pneumococcal conjugate vaccine without Polysorbate 80 for Vaccines, Pneumococcal. Completed, enrolled 500 participants across 14 sites.
Detailed Summary
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine manufactured with Polysorbate 80 compared to a 13-valent pneumococcal conjugate (13vPnC) manufactured without Polysorbate 80 when given concomitantly with routine paediatric vaccinations.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVaccines, Pneumococcal
CountriesPoland
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 2006
Enrollment StartNov 2006
Primary CompletionJun 2008
TodayJul 2026
First PostedAug 21, 2006
Enrollment StartNov 1, 2006
Primary CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 19.9 years ago
Interventions
13 valent pneumococcal conjugate vaccine with Polysorbate 80biological
13 valent pneumococcal conjugate vaccine without Polysorbate 80biological