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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 19, 2014