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Evaluate Safety & Immunogenicity of a Pandemic Influenza Vaccine (GSK1562902A) in Adults Over 60 Years of Age

NCT00397215 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 437

Last updated 2019-06-10

Study results available
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Summary

The present study is designed to evaluate the immunogenicity and safety of a single or double dose of the pandemic influenza candidate vaccine (GSK1562902A), administered following a two-administration schedule (21 days apart) in adults over 60 years of age. The persistence of influenza antibodies will also be evaluated 24 months after vaccination.

Conditions

Interventions

BIOLOGICAL

Pandemic influenza vaccine (GSK1562902A) (adjuvanted or not)

intramuscular injection

BIOLOGICAL

Fluarix

Intramuscular injection. All subjects not vaccinated with an influenza vaccine for the 2006-2007 season received Fluarix NH 2006/2007 (i.e. interpandemic GSK's influenza vaccine) at least 3 weeks before administration of the first dose of H5N1 vaccine.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-11-17
Primary Completion
2009-09-14
Completion
2009-09-14

Countries

  • Belgium
  • Italy

Study Locations

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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 NCT00397215 on ClinicalTrials.gov