Safety and Immunogenicity of an Intramuscular Pandemic Influenza Vaccine in Adults and the Elderly

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00415129
First received: December 21, 2006
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

Based on the results from a previous formulation/dosage ranging trial, this phase II multicenter, open trial was designed to determine the safety and immunogenicity of two vaccine formulation/dosages with and without adjuvant 21 days after each vaccination in adults (18 to 60 years and in the elderly (> 60 years) as required by the European Medicines Agency (EMEA) guideline. The antibody persistence until the booster vaccination at 6 or 12 months will also be evaluated.


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

Study Type: Interventional
Study Design: Allocation: 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 safety of an A/H5N1 inactivated, split-virion influenza virus vaccine [ Time Frame: 21 Days post-vaccination ] [ Designated as safety issue: Yes ]

Enrollment: 600
Study Start Date: June 2006
Study Completion Date: March 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study Group 1
Vaccine with adjuvant
Biological: A/H5N1 inactivated, split-virion influenza virus
0.5mL, Intramuscular
Experimental: Study Group 2
Vaccine without adjuvant
Biological: A/H5N1 inactivated, split-virion influenza virus
0.5mL, Intramuscular

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria :

  • Aged over 18 years on the 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 and at least 4 weeks after to 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
  • 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 within the past 3 months
  • Any vaccination within 4 weeks prior to the first trial vaccination
  • Vaccination planned within 4 weeks after 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: NCT00415129

Locations
Belgium
Ghent, Belgium
Leuven, Belgium
Wilrijk, Belgium
United Kingdom
Oxford, United Kingdom
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: NCT00415129     History of Changes
Other Study ID Numbers: GPA02
Study First Received: December 21, 2006
Last Updated: January 10, 2014
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

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 22, 2014