CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 360 enrolled
Drug / intervention
Pneumococcal conjugate vaccine GSK1024850A +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/NCT00814710
NCT00814710Phase 3Completed
CompareCT.gov

Primary Vaccination Course in Healthy Children Receiving the Pneumococcal Vaccine GSK 1024850A Co-administered With Tritanrix™-HepB/Hib at 6, 10 and 14 Weeks of Age

GlaxoSmithKline·interventional·Posted Dec 25, 2008·Updated Jan 3, 2020

In Brief

A Phase 3 clinical trial evaluating Pneumococcal conjugate vaccine GSK1024850A, Tritanrix-HepB/Hib, and 2 other interventions for Infections, Streptococcal and Streptococcus Pneumoniae. Completed, enrolled 360 participants across 4 sites.

Detailed Summary

The purpose of this study is to assess the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of Indian infants with pneumococcal conjugate vaccine GSK1024850A co-administered with a diphtheria, tetanus, whole cell pertussis (DTPw)-combined vaccine during the first 4 months of life. The study will be conducted in India.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Streptococcal, Streptococcus Pneumoniae
CountriesIndia
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 25, 2008
Enrollment StartMar 7, 2009
Primary CompletionNov 13, 2009
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 17.5 years ago

Interventions

Pneumococcal conjugate vaccine GSK1024850Abiological

Intramuscular injection, 3 doses

Tritanrix-HepB/Hibbiological

Intramuscular injection, 3 doses

Hiberixbiological

Intramuscular injection, 3 doses

Tritanrix-HepBbiological

Intramuscular injection, 3 doses