Study of Inactivated, Split-Virion Influenza Vaccine Administered by Intradermal Route Versus Vaxigrip® in Adults - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00703651

Purpose

This is a follow-up of a previous dose-ranging study aimed at investigating 2 doses of the trivalent inactivated split virion influenza vaccine when administered by intradermal route with that of the current pharmaceutical presentation administered by intramuscular route.

Primary Objective:

To assess the immunogenicity of two pharmaceutical presentations of the trivalent inactivated split virion influenza vaccine 21 days after a single injection in subjects aged 18 to 57 years.

Secondary Objective:

To evaluate the safety profile during the 21-day period following each vaccination in each study group

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

MedlinePlus related topics: Flu

Drug Information available for: Fluvirin Influenza Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Immunogenicity of Two Dosages of Inactivated, Split-Virion Influenza Vaccine Administered by Intradermal Route in Comparison With Intramuscular Vaccination With Vaxigrip® in Adults

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

To provide information concerning the immunogenicity of Inactivated, Split-Virion Influenza Vaccine. [ Time Frame: 21days post-vaccination ] [ Designated as safety issue: No ]
To provide information concerning the safety of Inactivated, Split-Virion Influenza Vaccine [ Time Frame: 21 days post-vaccination and entire study duration ] [ Designated as safety issue: Yes ]

Enrollment:	1150
Study Start Date:	September 2003
Study Completion Date:	July 2006
Primary Completion Date:	May 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Biological: Inactivated, split-virion influenza vaccine 0.1 mL, ID. 1 injection/year for 3 years
2: Experimental	Biological: Inactivated, split-virion influenza vaccine 0.1 mL, ID. 1 injection/year for 3 years.
3: Active Comparator	Biological: Inactivated, split-virion influenza vaccine 0.5 mL, IM. 1 injection/year for 3 years

Detailed Description:

This is an open (for the administration route) and double-blind (only for the two dosages administered at year 0 by using the investigational administration route) randomized trial conducted in subjects aged 18 to 60 years. The subjects will receive three vaccine injections at 1-year interval.

Eligibility

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

Criteria

Inclusion Criteria :

Subject aged between 18 and 57 years (i.e., less than 60 at the last vaccination)
For woman of child-bearing potential, negative urine pregnancy test at V#01
Use of effective contraception prior to and during the trial
Subject available during the trial period
Subject able to read and understand the informed consent form
Informed consent form signed and dated by the subject prior to any protocol-required intervention (and Visit 05 and Visit 07, respectively).

Exclusion Criteria :

Self-reported allergy to egg proteins, chick proteins, or any of the constituents of the vaccine, in particular, neomycin, formaldehyde, and octoxinol 9
Acute febrile disease within the 72 hours preceding V#01, or axillary temperature >37.5°C the day of inclusion, prior to vaccination (>37.0°C Czech Republic)
Subject with an aggravation of existing chronic illness (heart disease, respiratory disease, etc.)
Vaccination against influenza within the 6 months preceding V#01
Any vaccination within the 28 days preceding V#01 or scheduled between V#01 and V#02
Breast-feeding
Immunosuppressive therapy including long term systemic corticotherapy (20 mg/day of prednisolone or equivalent for >2 weeks) or cancer therapy within the month preceding V#01 or ongoing
Immunoglobulin injection within the 3 months preceding V#01
Subject taking part or planned to take part in another clinical trial (3 months before and through the trial duration)
Subject having received extracted pituitary hormones
Subjects who participated in the GID01 study (Lithuanian centers)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00703651

Locations

Belgium

Linkebeek, Belgium

Molenbeek, Belgium

Gribomont, Belgium

Thuin, Belgium

Kraainem, Belgium
Czech Republic

Hradec Kralove, Czech Republic
Lithuania

Vilnius, Lithuania

Kaunas, Lithuania

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Medical Monitor

Sanofi Pasterur Inc

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided by Sanofi-Aventis

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Beran J, Ambrozaitis A, Laiskonis A, Mickuviene N, Bacart P, Calozet Y, Demanet E, Heijmans S, Van Belle P, Weber F, Salamand C. Intradermal influenza vaccination of healthy adults using a new microinjection system: a 3-year randomised controlled safety and immunogenicity trial. BMC Med. 2009 Apr 2;7:13.

Responsible Party:	Sanofi Pasteur Inc. ( Medical Monitor )
Study ID Numbers:	GID02
Study First Received:	June 19, 2008
Last Updated:	June 20, 2008
ClinicalTrials.gov Identifier:	NCT00703651 History of Changes
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products; Czech Republic: State Institute for Drug Control; Lithuania: State Medicine Control Agency - Ministry of Health

Keywords provided by Sanofi-Aventis:

Influenza
Orthomyxoviridae Infection
Inactivated, Split-virion influenza vaccine
Intradermal injection
Adults.

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
Communicable Diseases
RNA Virus Infections
Respiratory Tract Diseases

Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections
Infection

ClinicalTrials.gov processed this record on May 07, 2009