CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 953 enrolled
Drug / intervention
Pneumococcal conjugate vaccine GSK2830929A +4 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/NCT01616459
NCT01616459Phase 2Completed
CompareCT.gov

Immunogenicity and Safety Study of Two Formulations of GlaxoSmithKline (GSK) Biologicals' Pneumococcal Vaccine (2830929A and 2830930A) When Administered in Healthy Infants

GlaxoSmithKline·interventional·Posted Jun 11, 2012·Updated Jul 16, 2019

In Brief

A Phase 2 clinical trial evaluating Pneumococcal conjugate vaccine GSK2830929A, Pneumococcal conjugate vaccine GSK2830930A, and 3 other interventions for Infections, Streptococcal. Completed, enrolled 953 participants across 42 sites in 4 countries.

Detailed Summary

The purpose of this study is to assess the immunogenicity, reactogenicity and safety of two formulations of GSK Biologicals' pneumococcal vaccine (2830929A and 2830930A) administered as 3-dose primary vaccination during the first 6 months of life followed by a booster dose in the second year of life. To comply with the routine infant immunisation program, the licensed GSK Biologicals DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine will be co-administered in infants with the pneumococcal study vaccines.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Streptococcal
CountriesCzechia, Germany, Poland, Spain
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 11, 2012
Enrollment StartJul 11, 2012
Primary CompletionApr 25, 2013
Study CompletionJan 22, 2014
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 14.1 years ago

Interventions

Pneumococcal conjugate vaccine GSK2830929Abiological

Intramuscular injection

Pneumococcal conjugate vaccine GSK2830930Abiological

Intramuscular injection

Synflorix™biological

Intramuscular injection

Prevnar 13™biological

Intramuscular injection

Infanrix hexa™biological

Intramuscular injection