CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 604 enrolled
Drug / intervention
13-valent pneumococcal conjugate vaccine +1 morebiological
Likely dose
13-valent pneumococcal conjugate vaccine 0.5mLfrom 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.

Search/NCT00366340
NCT00366340Phase 3Completed
CompareCT.gov

A Phase 3, Randomized, Active-Controlled, Double-blind Trial of the Safety, Tolerability, and Immunologic Non-Inferiority of a 13-valent Pneumococcal Conjugate Vaccine Compared to a 7-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in Germany.

Wyeth is now a wholly owned subsidiary of Pfizer·interventional·Posted Aug 21, 2006·Updated Aug 8, 2012

In Brief

A Phase 3 clinical trial evaluating 13-valent pneumococcal conjugate vaccine and 7-valent pneumococcal conjugate vaccine for Vaccines, Pneumococcal. Completed, enrolled 604 participants across 51 sites.

Detailed Summary

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to 7-valent pneumococcal conjugate (Prevenar/Prevenar®, 7vPnC), when given concomitantly with Infanrix hexa at 2, 3, 4, months (infant series) and at 11-12 months of age (toddler dose) in Germany.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVaccines, Pneumococcal
CountriesGermany
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 21, 2006
Enrollment StartOct 1, 2006
Primary CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 19.9 years ago

Interventions

13-valent pneumococcal conjugate vaccinebiological

Single 0.5mL dose given at 2, 3, 4 and 11 to 12 months of age

7-valent pneumococcal conjugate vaccinebiological

Single 0.5mL dose given at 2, 3, 4 and 11 to 12 months of age