CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 391 enrolled
Drug / intervention
GSK2202083A vaccine +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/NCT01171989
NCT01171989Phase 2Completed
CompareCT.gov

Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine Administered as a Booster Dose in 12-18 Months Old Healthy Children

GlaxoSmithKline·interventional·Posted Jul 29, 2010·Updated Jan 21, 2020

In Brief

A Phase 2 clinical trial evaluating GSK2202083A vaccine, Infanrix hexa™, and 3 other interventions for Tetanus and 6 related conditions. Completed, enrolled 391 participants across 9 sites.

Detailed Summary

The current trial will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine when administered as a booster dose following priming in the first year of life with the same vaccine. This protocol posting deals with objectives \& outcome measures of the booster phase. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00970307).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTetanus, Diphtheria, Haemophilus Influenzae Type b, Hepatitis B, Poliomyelitis, Acellular Pertussis, Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b-Neisseria Meni
CountriesPoland
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 29, 2010
Enrollment StartAug 18, 2010
Primary CompletionDec 3, 2010
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 15.9 years ago

Interventions

GSK2202083A vaccinebiological

Intramuscular, one dose.

Infanrix hexa™biological

Intramuscular, one dose.

Menjugate™biological

Intramuscular, one dose.

NeisVac-C™biological

Intramuscular, one dose.

Synflorix™biological

Intramuscular, one dose.