CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 234 enrolled
Drug / intervention
13vPnC +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.

Search/NCT00824655
NCT00824655Phase 3Completed
CompareCT.gov

A Phase 3, Open-Label Trial, Evaluating the Safety, Tolerability, and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine in Healthy Children Previously Partially Immunized With Prevenar

Pfizer·interventional·Posted Jan 19, 2009·Updated Aug 10, 2011

In Brief

A Phase 3 clinical trial evaluating 13vPnC for Pneumococcal Vaccines. Completed, enrolled 234 participants across 7 sites.

Detailed Summary

The purposes of this study are to evaluate the safety of 13-valent pneumococcal Conjugate Vaccine (13vPnC) in children who have already been vaccinated with Prevenar. The study will also assess the immunological response (measure the amount of antibodies, i.e. proteins that fight off germs) produced by children after they have been given the 13-valent pneumococcal vaccine at 5 and 12 months or 12 months of age. In addition, reactions at the injection site will be assessed during the study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPneumococcal Vaccines
CountriesSweden
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 19, 2009
Enrollment StartMar 1, 2009
Primary CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.5 years ago

Interventions

13vPnCbiological

13vPnC will be administered by intramuscular injection at approximately 5 and 12 months of age.

13vPnCbiological

13vPnC will be administered by intramuscular injection at approximately 12 months of age.