MedTrace Logo

Study to Evaluate Immunological Equivalence Between Two Investigational Influenza Vaccines in Adults (H1N1)

NCT00979407 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 336

Last updated 2018-08-06

Study results available
· View outcomes & findings →

Summary

The primary purpose of the study is to assess the equivalence of the immune response elicited by two GSK Biologicals' adjuvanted influenza investigational vaccines (GSK2340272A and GSK2340274A) in adults aged 18 to 60 years. The second purpose of the study is to evaluate the safety and reactogenicity of these two vaccines.

Conditions

Interventions

BIOLOGICAL

Influenza vaccine GSK2340272A

Two intramuscular injections at Day 0 and Day 21

BIOLOGICAL

Influenza vaccine GSK2340274A

Two intramuscular injections at Day 0 and Day 21

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-10-12
Primary Completion
2009-11-09
Completion
2010-11-04

Countries

  • France
  • Germany

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 NCT00979407 on ClinicalTrials.gov