CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 613 enrolled
Drug / intervention
13-valent pneumococcal conjugate vaccine +2 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.

Search/NCT00366678
NCT00366678Phase 3Completed
CompareCT.gov

A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in France.

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, 7-valent pneumococcal conjugate vaccine, and 1 other intervention for Vaccines, Pneumococcal. Completed, enrolled 613 participants across 45 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 Prevenar (7vPnC), when given concomitantly with routine pediatric vaccines in France.

Study Details

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

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 21, 2006
Enrollment StartOct 1, 2006
Primary CompletionNov 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 19.9 years ago

Interventions

13-valent pneumococcal conjugate vaccinebiological

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

7-valent pneumococcal conjugate vaccinebiological

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

Pentavacdrug

The Pentavac was administered by intramuscular injection 0.5 ml into the anterolateral thigh muscle of the right leg at 2, 3, and 4 months (infant series) and 12 months of age (toddler dose).