CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 286 enrolled
Drug / intervention
13-valent Pneumococcal Conjugate Vaccine +4 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/NCT00384059
NCT00384059Phase 3Completed

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 the United Kingdom

Wyeth is now a wholly owned subsidiary of Pfizer·interventional·Posted Oct 4, 2006·Updated Jan 24, 2013

In Brief

A Phase 3 clinical trial evaluating 13-valent Pneumococcal Conjugate Vaccine, 7vPnC, and 3 other interventions for Vaccines, Pneumococcal. Completed, enrolled 286 participants across 11 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 paediatric vaccines in the United Kingdom.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 4, 2006
Enrollment StartOct 1, 2006
Primary CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 19.7 years ago

Interventions

13-valent Pneumococcal Conjugate Vaccinebiological

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

7vPnCbiological

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

Pediacelbiological

concommitant vaccine, both at arm 1 and at arm 2, at 2 months, 3 months and 4 months of age

NeisVac-Cbiological

concomittant vaccine, both at arm 1 and at arm 2, at 2 months and 4 months of age

Menitorixbiological

concomitant vaccine, both at arm 1 and at arm 2, at 12 months of age