Clinical trial NCT00703651: Study of Inactivated, Split-Virion Influenza Vaccine Administered by Intradermal Route Versus Vaxigrip® in Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Orthomyxoviridae Infection
Myxovirus Infection
Keywords: Influenza
Orthomyxoviridae Infection
Inactivated, Split-virion influenza vaccine
Intradermal injection
Adults.
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-06-23
Enrollment: 1150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 57
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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

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 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)

Primary outcomes:
measure: To provide information concerning the immunogenicity of Inactivated, Split-Virion Influenza Vaccine.
timeFrame: 21days post-vaccination
measure: To provide information concerning the safety of Inactivated, Split-Virion Influenza Vaccine
timeFrame: 21 days post-vaccination and entire study duration
Secondary outcomes:
Other outcomes:
Locations:
city: Gribomont
country: Belgium
city: Kraainem
country: Belgium
city: Linkebeek
country: Belgium
city: Molenbeek
country: Belgium
city: Thuin
country: Belgium
city: Hradec Kralove
country: Czech Republic
city: Kaunas
country: Lithuania
city: Vilnius
country: Lithuania
Study officials:
affiliation: Sanofi Pasterur Inc
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1186/1741-7015-7-13.