Safety and Immunogenicity of an Intramuscular Pandemic Influenza Vaccine in Adults and the Elderly - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00415129

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 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 II

MedlinePlus related topics: Bird Flu Flu

Drug Information available for: Influenza Vaccines Fluvirin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Further study details as provided by Sanofi-Aventis:

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 ]

Estimated Enrollment:	600
Study Start Date:	June 2006
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Vaccine with adjuvant	Biological: A/H5N1 inactivated, split-virion influenza virus 0.5mL, Intramuscular
2: Experimental 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

Leuven, Belgium

Wilrijk, Belgium

Ghent, Belgium
United Kingdom

Oxford, United Kingdom

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Medical Monitor

Sanofi Pasteur Inc

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Sanofi Pasteur Inc. ( Medical Director )
Study ID Numbers:	GPA02
Study First Received:	December 21, 2006
Last Updated:	September 22, 2008
ClinicalTrials.gov Identifier:	NCT00415129
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Sanofi-Aventis:

Influenza
Orthomyxoviridae Infections
Influenza Pandemics
A/H5N1 strain

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

Influenza, Human
Influenza in Birds
Orthomyxoviridae Infections

Additional relevant MeSH terms:

RNA Virus Infections
Infection

ClinicalTrials.gov processed this record on January 16, 2009