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Safety and Immunogenicity of H5N1 Adjuvanted, Inactivated, Split-Virion Pandemic Influenza Vaccine in Healthy Adults

NCT00457509 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 251

Last updated 2014-01-14

No results posted yet for this study

Summary

The purpose of this study is to test different adjuvanted vaccine formulations as a two-dose schedule in immunologically naïve adults against one vaccine formulation without adjuvant in terms of tolerance and immunogenicity

Primary Objective:

To describe the safety profile and immunogenicity following each injection.

Conditions

  • Pandemic Influenza
  • Influenza A Virus Infection
  • Orthomyxoviridae Infections

Interventions

BIOLOGICAL

A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant

0.5 mL, Intramuscular

BIOLOGICAL

A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant

0.5 mL, Intramuscular

BIOLOGICAL

A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant

0.5 mL, Intramuscular

BIOLOGICAL

A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant

0.5 mL, Intramuscular

BIOLOGICAL

A/H5N1 inactivated, split-virion influenza vaccine

0.5 mL, Intramuscular

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Sanofi Pasteur Inc

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2009-11-30
Completion
2010-09-30

Countries

  • Belgium

Study Locations

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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 NCT00457509 on ClinicalTrials.gov