CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 466 enrolled
Drug / intervention
Pneumococcal conjugate vaccine GSK1024850A (different lots) +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/NCT00808444
NCT00808444Phase 3Completed
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Non-inferiority of a Commercial Lot of the Pneumococcal Vaccine GSK1024850A Compared to a Clinical Lot.

GlaxoSmithKline·interventional·Posted Dec 15, 2008·Updated Aug 17, 2018

In Brief

A Phase 3 clinical trial evaluating Pneumococcal conjugate vaccine GSK1024850A (different lots), Infanrix hexa, and 2 other interventions for Infections, Streptococcal. Completed, enrolled 466 participants across 5 sites in 2 countries.

Detailed Summary

The purpose of the present study is to demonstrate that the changes in the manufacturing process for the commercial lot of the pneumococcal conjugate vaccine GSK1024850A have no clinical impact and that the immune responses are non-inferior to the immune responses induced by the clinical lot. The study will be conducted in Singapore and Malaysia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Streptococcal
CountriesMalaysia, Singapore
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 15, 2008
Enrollment StartJan 5, 2009
Primary CompletionNov 2, 2009
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 17.5 years ago

Interventions

Pneumococcal conjugate vaccine GSK1024850A (different lots)biological

Intramuscular injection, 3 doses

Infanrix hexabiological

Intramuscular injection, 3 doses in Malaysia and 2 doses in Singapore

Infanrix-IPV/Hibbiological

Intramuscular injection, only for Visit 2 in Singapore

Rotarixbiological

Oral, 2 doses