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Evaluate Reactogenicity & Immunogenicity of an Influenza Pandemic Candidate Vaccine (GSK1562902A) in Primed Adults

NCT00506350 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2017-10-04

Study results available
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Summary

The present study is designed to evaluate the reactogenicity and immunogenicity of one or two booster administrations of an influenza pandemic candidate vaccine (GSK1562902A) in adults aged between 19 and 61 years, previously vaccinated with 2 doses of a pandemic candidate vaccine. Fifty new subjects who did not participate in a primary study (106750, NCT00309634) will be recruited. 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 (NCT00309634)

Conditions

Interventions

BIOLOGICAL

Pandemic influenza candidate vaccine (GSK1562902A) - 1 dose

A single dose of Pandemic influenza candidate vaccine (GSK1562902A) administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.

BIOLOGICAL

Pandemic influenza candidate vaccine (GSK1562902A) - 2 doses

Two doses of Pandemic influenza candidate vaccine (GSK1562902A) administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
61 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-08-01
Primary Completion
2009-10-12
Completion
2009-10-12

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00506350 on ClinicalTrials.gov