CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 1,806 enrolled
Drug / intervention
Pneumococcal vaccine GSK2189242A +3 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/NCT01545375
NCT01545375Phase 2Completed
CompareCT.gov

Study to Determine Protective Efficacy Against Otitis Media and Assess Safety of an Investigational Pneumococcal Vaccine 2189242A in Healthy Infants

GlaxoSmithKline·interventional·Posted Mar 6, 2012·Updated Dec 27, 2019

In Brief

A Phase 2 clinical trial evaluating Pneumococcal vaccine GSK2189242A, Placebo, and 2 other interventions for Infections, Streptococcal. Completed, enrolled 1,806 participants across 5 sites.

Detailed Summary

The purpose of this study is to 1) demonstrate the protective efficacy against acute otitis media (AOM), 2) assess safety of the GlaxoSmithKline (GSK) Biologicals' pneumococcal vaccine GSK2189242A in Native American infants aged less than 24 months, living in the southwestern US, in and around the Navajo and White Mountain Apache reservations, and 3) evaluate the impact on acute lower respiratory tract infections (ALRI) up to the second year of life.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Streptococcal
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 6, 2012
Enrollment StartMay 21, 2012
Primary CompletionJul 26, 2016
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 14.3 years ago

Interventions

Pneumococcal vaccine GSK2189242Abiological

4 doses administered intramuscularly

Placebobiological

4 doses administered intramuscularly

Prevnar 13®biological

4 doses administered intramuscularly

PedvaxHIB®biological

4 doses administered intramuscularly