CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 40 enrolled
Drug / intervention
GSK2231395A +1 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/NCT00814489
NCT00814489Phase 1Completed

A Study to Evaluate GlaxoSmithKline (GSK) Biologicals' Investigational Vaccination Regimen in Healthy Young Adults

GlaxoSmithKline·interventional·Posted Dec 25, 2008·Updated Aug 8, 2018

In Brief

A Phase 1 clinical trial evaluating GSK2231395A and Engerix-B for Streptococcus Pneumoniae and Haemophilus Influenzae. Completed, enrolled 40 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of 2 formulations of a non-typable Haemophilus influenzae and pneumococcal candidate vaccine in young adults. Subjects will be vaccinated 2 times in an observer-blind manner with an interval of 2 months. The subjects receiving Engerix-B will receive in an open-manner a third dose of the vaccine at Month 6. The protocol posting has been updated following a protocol amendment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSweden
Collaborators--

Timeline

Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 25, 2008
Enrollment StartJan 8, 2009
Primary CompletionMay 4, 2009
Study CompletionJun 10, 2010
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 17.5 years ago

Interventions

GSK2231395Abiological

Two doses will be administered intramuscularly; one dose at Month 0 and the second dose a Month 2. Two different formulations of this vaccine will be tested.

Engerix-Bbiological

Two doses will be administered intramuscularly; one dose at Month 0 and the second dose a Month 2.