CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 1,200 enrolled
Drug / intervention
13-valent Pneumococcal conjugate vaccine +1 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/NCT02034877
NCT02034877Phase 4Completed
CompareCT.gov

A Phase 4/3, Open-label, Single-arm, Multicenter Study To Describe The Safety And Immunogenicity Of 13-valent Pneumococcal Conjugate Vaccine In Adults 50 To 65 Years Of Age And In Children 6 To 17 Years Of Age In India

Pfizer·interventional·Posted Jan 14, 2014·Updated Jul 1, 2016

In Brief

A Phase 4 clinical trial evaluating 13-valent Pneumococcal conjugate vaccine and Blood sample collection for Prevention of Pneumonia and Invasive Disease Caused by the Serotypes in 13vPnC. Completed, enrolled 1,200 participants across 16 sites.

Detailed Summary

This study is to describe the safety and immunogenicity of 13vPnC in Indian adults 50 to 65 years of age and in Indian children 6 to 17 years of age.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrevention of Pneumonia and Invasive Disease Caused by the Serotypes in 13vPnC
CountriesIndia
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 14, 2014
Enrollment StartAug 1, 2014
Primary CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 12.5 years ago

Interventions

13-valent Pneumococcal conjugate vaccinebiological

1 dose (0.5 mL/ pre-filed syringe) of 13vPnC administered at visit 1

Blood sample collectionprocedure

10 mL of blood will be collected just before and approximately 1 month after vaccination.