NCT00814489

Evaluation of Non-typable Haemophilus Influenzae and Pneumococcal Protein Vaccine Formulations in Young Adults

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Detailed description

This Protocol Posting has been updated following amendment of the Protocol, January 2010. The sections impacted are: study design and study endpoints.

Conditions

• Streptococcus Pneumoniae
• Haemophilus Influenzae

Interventions

Type	Name	Description
BIOLOGICAL	GSK2231395A	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.
BIOLOGICAL	Engerix-B	Two doses will be administered intramuscularly; one dose at Month 0 and the second dose a Month 2.

Timeline

• Start date: 2009-01-08
• Primary completion: 2009-05-04
• Completion: 2010-06-10
• First posted: 2008-12-25
• Last updated: 2018-08-08
• Results posted: 2013-01-25

Locations

1 site across 1 country: Sweden