CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 403 enrolled
Drug / intervention
Infanrix Hexabiological
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/NCT00627458
NCT00627458Phase 2Completed
CompareCT.gov

Immunogenicity and Reactogenicity of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine When Given as a Booster Dose

GlaxoSmithKline·interventional·Posted Mar 3, 2008·Updated Jun 6, 2018

In Brief

A Phase 2 clinical trial evaluating Infanrix Hexa for Acellular Pertussis and 5 related conditions. Completed, enrolled 403 participants across 6 sites.

Detailed Summary

The purpose of this booster study is to evaluate, in subjects primed in the primary study 106786, the persistence, at the time of the booster vaccination, of antibodies elicited by the different formulation of DTPa-HBV-IPV/ Hib vaccine (Infanrix Hexa TM). The study will also evaluate the immune response of these subjects to a DTPa-HBV-IPV/Hib booster. This protocol posting deals with the objectives and outcome measures of the booster phase. The objectives and outcomes measures of the primary phase are presented in a separate protocol posting (NCT = 00376779).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcellular Pertussis, Diphtheria, Poliomyelitis, Haemophilus Influenzae Type b, Tetanus, Hepatitis B
CountriesFinland
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 3, 2008
Enrollment StartFeb 1, 2008
Primary CompletionAug 18, 2008
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 18.3 years ago

Interventions

Infanrix Hexabiological

Vaccine administered as a booster dose at 16-20 months of age