CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 373 enrolled
Drug / intervention
13-valent Pneumococcal Conjugate Vaccine +4 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/NCT00743652
NCT00743652Phase 3Completed
CompareCT.gov

A Phase 3, Open Label Trial Evaluating the Safety, Immunogenicity and Impact of 13-valent Pneumococcal Conjugate Vaccine in Alaskan Native Children.

Pfizer·interventional·Posted Aug 29, 2008·Updated Mar 15, 2012

In Brief

A Phase 3 clinical trial evaluating 13-valent Pneumococcal Conjugate Vaccine for Pneumococcal Disease and 13-valent Pneumococcal Vaccine. Completed, enrolled 373 participants across 21 sites.

Detailed Summary

This study is to evaluate the safety, immunogenicity and impact of 13-valent Pneumococcal conjugate vaccine in Alaskan Native Children.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPneumococcal Disease, 13-valent Pneumococcal Vaccine
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 29, 2008
Enrollment StartJan 1, 2009
Primary CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 17.8 years ago

Interventions

13-valent Pneumococcal Conjugate Vaccinebiological

4 doses of 13vPnC (0.5ml, IM) will be administered. (3 doses infant series, and 1 toddler dose)

13-valent Pneumococcal Conjugate Vaccinebiological

3 doses of 13vPnC (0.5ml, IM) will be administered. (2 doses for infant series catch-up, and 1 toddler dose)

13-valent Pneumococcal Conjugate Vaccinebiological

2 doses of 13vPnC (0.5ml, IM) will be administered. (1 dose infant series catch-up, and 1 toddler dose)

13-valent Pneumococcal Conjugate Vaccinebiological

2 doses of 13vPnC (0.5ml, IM) will be administered. (2 catch-up dose(s) greater than 60 days apart )

13-valent Pneumococcal Conjugate Vaccinebiological

1 dose of 13vPnC (0.5ml, IM) will be administered. (1 catch-up dose)