A Study of the Immunogenicity and Safety of the 2007-2008 Influenza Vaccine - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00491257

Purpose

This study is designed to generate clinical data as outlined in the Note for Guidance on harmonization requirements for influenza vaccine marketing authorization by the European Medicines Agency.

The objectives of the trial are:

To determine immunogenicity, of the inactivated, split-virion influenza vaccine Northern Hemisphere (NH) 2007-2008 formulation in terms of the requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96.
To describe the safety of the inactivated, split-virion influenza vaccine, NH 2007-2008 formulation.

Condition	Intervention	Phase
Influenza Orthomyxoviridae Infections	Biological: Inactivated influenza vaccine (split virion)	Phase II

MedlinePlus related topics: Flu

Drug Information available for: Fluvirin Influenza Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Immunogenicity and Safety of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2007-2008 Formulation (Intramuscular Route)

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

To provide information concerning the immunogenicity of 2007-2008 Influenza vaccine (split virion, inactivated). [ Time Frame: 21 Days post-vaccination ] [ Designated as safety issue: No ]

Enrollment:	130
Study Start Date:	June 2007
Study Completion Date:	July 2007
Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

Intervention Details:

0.5 mL, IM

Eligibility

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

Criteria

Inclusion Criteria :

Aged 18 to 60 years (i.e. to the day before the 61st birthday) or 61 years or above (from the day of the 61st birthday) on the day of inclusion
Provision of a signed informed consent
Able to attend all scheduled visits and comply with all trial procedures
For a woman of child-bearing potential: avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to vaccination, until at least 4 weeks after vaccination

Exclusion Criteria :

For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test at Visit 1
Febrile illness (temperature >= 37.5°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment
Breast-feeding woman
Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial vaccination
Planned participation in another clinical trial during the present trial period
Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
Known systemic hypersensitivity to egg proteins, chicken proteins, or to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing any of the same substances
Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator
Current alcohol abuse or drug addiction 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 trial vaccination
Planned receipt of any vaccine in the 3 weeks following the trial vaccination
Previous vaccination against influenza in the previous 6 months
Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination
Known Human Immunodeficiency Virus (HIV), Hepatitis B surface antigen or Hepatitis C seropositivity
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: NCT00491257

Locations

United Kingdom

Edinburgh, United Kingdom

London, United Kingdom

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Clinical Trials

sanofi pasteur

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Sanofi Pasteur Inc. ( Medical Director )
Study ID Numbers:	GRT82
Study First Received:	June 25, 2007
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00491257 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Sanofi-Aventis:

Influenza
Orthomyxoviridae Infections
Orthomyxoviruses
Split-virion influenza vaccine

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

Additional relevant MeSH terms:

Virus Diseases
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections

Influenza, Human
Orthomyxoviridae Infections
Infection

ClinicalTrials.gov processed this record on May 07, 2009