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
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: 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 July 29, 2014