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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00457509
First received: April 5, 2007
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Pandemic Influenza
Influenza A Virus Infection
Orthomyxoviridae Infections
Biological: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant
Biological: A/H5N1 inactivated, split-virion influenza vaccine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • To provide information concerning the safety of A/H5N1 Inactivated split influenza virus vaccine [ Time Frame: Entire study period ] [ Designated as safety issue: Yes ]

Enrollment: 251
Study Start Date: January 2007
Study Completion Date: September 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Dose 1 with Adjuvant
Biological: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant
0.5 mL, Intramuscular
Experimental: Group 2
Dose 2 with adjuvant
Biological: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant
0.5 mL, Intramuscular
Experimental: Group 3
Dose 3 with adjuvant
Biological: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant
0.5 mL, Intramuscular
Experimental: Group 4
Dose 4 with adjuvant
Biological: A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant
0.5 mL, Intramuscular
Active Comparator: Group 5
Control
Biological: A/H5N1 inactivated, split-virion influenza vaccine
0.5 mL, Intramuscular

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria :

  • Aged 18 to 40 years on day of inclusion
  • Informed consent form signed
  • Able to attend all scheduled visits and to comply with all trial procedures
  • For a woman, inability to bear a child or negative urine pregnancy test.

Exclusion Criteria :

  • Participation in another clinical trial in the 4 weeks preceding the first trial vaccination.
  • Planned participation in another clinical trial during the present trial period.
  • Previous participation in a clinical trial involving an investigational flu pandemic vaccine.
  • Vaccination with an influenza vaccine during the past 6 months
  • Any vaccination in the 4 weeks preceding the first trial vaccination
  • Vaccination planned in the 4 weeks following any trial vaccination
  • Breast-feeding.
  • For a woman of child-bearing potential, the absence of an effective method of contraception or abstinence non observed for at least 4 weeks prior to the first vaccination and at least 4 weeks after the last vaccination.
  • Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy.
  • Known human immunodeficiency virus (HIV), hepatitis B (AgHBs) or hepatitis C seropositivity.
  • Known systemic hypersensitivity to egg proteins, chick proteins, or to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
  • Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
  • Chronic illness at a stage that could interfere with trial conduct or completion.
  • Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures.
  • Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
  • Blood or blood-derived products received in the past 3 months.
  • Febrile illness (temperature ≥ 37.5°C) on the day of inclusion.
  • Laboratory abnormalities considered clinically significant upon the Investigator's judgment in blood sample taken at screening (for Step 1 only)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00457509

Locations
Belgium
Brussels, Belgium
Gent, Belgium
Leuven, Belgium
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Monitor Sanofi Pasteur Inc
  More Information

Additional Information:
No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00457509     History of Changes
Other Study ID Numbers: GPF01
Study First Received: April 5, 2007
Last Updated: January 10, 2014
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

Keywords provided by Sanofi:
Pandemic influenza
Avian influenza
Orthomyxoviridae Infections
A/H5N1

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
Virus Diseases
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 15, 2014