Immunogenicity Study of the Influenza Vaccine in Adults - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00258934

Purpose

All marketed influenza vaccines are injected by the intramuscular (IM) route. This study will test whether an influenza vaccine is effective when injected by a route other than into the muscle. In order to prove this, the amount of antibodies in the blood will be measured before and after vaccination. In addition, the safety of both influenza vaccines will be tested by evaluating all serious reactions occurring after vaccination. The vaccine injected in this study is similar to the sponsor's marketed intramuscular influenza vaccine (Vaxigrip). In addition, the safety of both influenza vaccines administered by different routes will be tested by evaluating all adverse events and especially all serious reactions.

Primary Objective: To demonstrate and compare the immune response of an influenza vaccine after a single dose when administered by different routes.

Secondary Objectives: To describe the compliance of the immunogenicity of the vaccine with the European Medicine Agency (EMEA) after the first injection.

Condition	Intervention	Phase
Orthomyxoviridae Infections Influenza	Biological: Inactivated, split-virion influenza vaccine Biological: Inactivated, split-virion, influenza virus	Phase II

MedlinePlus related topics: Flu

Drug Information available for: Influenza Vaccines Fluvirin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

To provide information concerning the immunogenicity of influenza vaccination. [ Time Frame: 21 Days and 2 Years post-vaccination 1 ] [ Designated as safety issue: No ]

Estimated Enrollment:	1000
Study Start Date:	September 2005
Estimated Study Completion Date:	May 2008
Estimated Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Biological: Inactivated, split-virion influenza vaccine 0.1 mL single annual dose
2: Active Comparator	Biological: Inactivated, split-virion, influenza virus 0.5 mL single annual dose

Eligibility

Ages Eligible for Study:	18 Years to 57 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Aged 18 to 57 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 at V01
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 four weeks after, the first vaccination.

At Year 1 (Visit 05):

-Addendum to the informed consent form signed and dated by the subject prior to vaccination at Visit 05

At Year 2 (Visit 07):

-Addendum to the informed consent form signed and dated by the subject prior to vaccination at Visit 07

Exclusion Criteria:

Systemic hypersensitivity to egg proteins, chick proteins, or any of the vaccine components; in particular, neomycin, formaldehyde, and octoxinol 9, or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
Febrile illness (rectal equivalent temperature >= 38.0°C) on the day of inclusion
Breast-feeding
Participation in another clinical trial in the four weeks preceding the first trial vaccination
Planned participation in another clinical trial during the present trial period
Congenital or acquired immunodeficiency; immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding six months; or long-term systemic corticosteroid therapy.
Chronic illness at a stage that could interfere with trial conduct or completion
Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures
Blood or blood-derived products received in the past three months
Any vaccination in the four weeks preceding the first trial vaccination
Vaccination planned in the four weeks following the first trial vaccination
Previous vaccination against influenza (in the previous six months) with the trial vaccine or another vaccine
Thrombocytopenia or bleeding disorder contraindicating IM 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: NCT00258934

Locations

Belgium

Ghent, Belgium

Antwerpen, Belgium
Germany

Hamburg, Germany
Switzerland

Allschwil, Switzerland

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Clinical Trials

sanofi pasteur

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Sanofi Pasteur, Inc ( Medical Monitor )
Study ID Numbers:	GID15
Study First Received:	November 24, 2005
Last Updated:	February 12, 2008
ClinicalTrials.gov Identifier:	NCT00258934
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines; Germany: Federal Institute for Drugs and Medical Devices; Switzerland: Swissmedic

Keywords provided by Sanofi-Aventis:

Influenza
Orthomyxoviruses
Inactivated
Split-virion influenza vaccine

adults
Myxovirus Infection
Orthomyxovirus Infection

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

RNA Virus Infections
Infection

ClinicalTrials.gov processed this record on January 14, 2009