Immunogenicity of Two Dosages of Inactivated, Split-Virion Influenza Vaccine Given by an Alternate Route in the Elderly - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00296829

Purpose

All marketed influenza vaccines are injected by the intramuscular route. This study will test whether an influenza vaccine is effective when injected by other route 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).

Primary Objective:

To demonstrate and compare the immune response of two dosages of influenza vaccine administered by an alternate route to the intramuscular administration of the vaccine.

Secondary Objectives:

To compare the immune response 21 days after vaccination between each investigational group versus intramuscular group for each influenza strain.
To describe the safety profile after the vaccination in each study group
To describe the compliance of the two dosages of the vaccine administered by the alternate route with the European Medicine Agency.

Observational Objectives:

To describe the safety profile during the 21-day period following an intramuscular revaccination in each group and the possibility of any reaction at the first injection site.
To describe the pain at the injection site with a Visual Analog Scale and the acceptability of the injection using a questionnaire in each group.
To describe the leakage appearing at the injection site immediately after the alternate route injection and to explore the relationship with immunogenicity.
To evaluate the cellular mediated immune response in a subset of subjects.

Condition	Intervention	Phase
Orthomyxoviridae Infection Influenza Myxovirus Infection	Biological: Inactivated, split-virion influenza vaccine	Phase II

MedlinePlus related topics: Flu

Drug Information available for: Influenza Vaccines Fluvirin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Sanofi-Aventis:

Estimated Enrollment:	1080
Study Start Date:	January 2006
Study Completion Date:	February 2007
Primary Completion Date:	February 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	60 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Aged 60 to 85 years on the day of inclusion
Informed consent form signed
Able to attend all scheduled visits and to comply with all trial procedures.

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 (oral temperature >= 37.5°C equivalent rectal temperature >= 38.0°C) on the day of inclusion
Any vaccination or 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 corticosteroids 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
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 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: NCT00296829

Locations

Australia

Westmead, Australia, NSW 2145

Inala, Australia, QLD 4077

Victoria, Australia, 3079

Victoria, Australia, 3144

Kippa-Ring, Australia, QLD 4021

Carina Heights, Australia, QLD 4152

Adelaide, Australia, 5000

Victoria, Australia, 3128
New Zealand

Auckland, New Zealand

Hamilton, New Zealand

Dunedin, New Zealand

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Clinical Trials

sanofi pasteur

More Information

Related Info This link exits the ClinicalTrials.gov site

Publications indexed to this study:

Holland D, Booy R, De Looze F, Eizenberg P, McDonald J, Karrasch J, McKeirnan M, Salem H, Mills G, Reid J, Weber F, Saville M. Intradermal influenza vaccine administered using a new microinjection system produces superior immunogenicity in elderly adults: a randomized controlled trial. J Infect Dis. 2008 Sep 1;198(5):650-8.

Responsible Party:	Sanofi Pasteur, Inc. ( Medical Monitor )
Study ID Numbers:	GID16
Study First Received:	February 24, 2006
Last Updated:	March 31, 2008
ClinicalTrials.gov Identifier:	NCT00296829
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration; New Zealand: Health Research Council

Keywords provided by Sanofi-Aventis:

Influenza;
Orthomyxoviruses;
Inactivated Split-virion influenza vaccine;
Elderly.

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

Communicable Diseases
RNA Virus Infections
Infection

ClinicalTrials.gov processed this record on January 15, 2009