Immunogenicity and Safety of an Intramuscular A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00545701
First received: October 15, 2007
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

The trial is a Phase II, open-label trial in healthy subjects aged 18 to 60 years to support the immunogenicity data from previous clinical studies.

Objectives:

  • To describe the immune response 21 days after each vaccination.
  • To describe the safety profiles following each vaccination.

Condition Intervention Phase
Influenza
Orthomyxoviridae Infections
Biological: A/H5N1 inactivated, split-virion influenza virus
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • To provide information concerning the immunogenicity of A/H5N1 inactivated, split-virion influenza virus vaccine [ Time Frame: Day 42 post-vaccination 1 ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: October 2007
Study Completion Date: September 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: A/H5N1 inactivated, split-virion influenza virus
0.5 mL, Intramuscular

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 18 to 60 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.
  • For a woman of child-bearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior to and at least 4 weeks after each vaccination.

Exclusion Criteria:

  • Systemic hypersensitivity to any component of the vaccine or a life-threatening reaction after previous administration of a vaccine containing the same substances (egg proteins, chick proteins, thimerosal, aluminum, neomycin, formaldehyde, and octoxinol 9).
  • Febrile illness (oral temperature >= 37.5°C) on the day of inclusion.
  • Breast-feeding.
  • Previous vaccination with an avian flu vaccine.
  • Participation in a clinical trial (drug, device, or medical procedure) within 4 weeks prior to the first vaccination.
  • Planned participation in another clinical trial during the present trial period.
  • Congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy.
  • Chronic illness that could interfere with trial conduct or completion (e.g. cardiac, renal, diabetes, or auto-immune disorders).
  • Current alcohol or drug abuse that may interfere with the subject's ability to comply with trial procedures.
  • Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response.
  • Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
  • Planned receipt of any vaccine in the 4 weeks following any trial vaccination.
  • Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
  • Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00545701

Locations
Australia
Adelaide, Australia
Queensland, Australia
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Monitor Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00545701     History of Changes
Other Study ID Numbers: GPA11
Study First Received: October 15, 2007
Last Updated: January 10, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Sanofi:
Influenza
A/H5N1 strain
Orthomyxoviridae Infections
Influenza Pandemics

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

ClinicalTrials.gov processed this record on April 17, 2014