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

Sanofi

Status and phase

Completed

Phase 2

Conditions

Myxovirus Infection

Influenza

Orthomyxoviridae Infection

Treatments

Biological: Inactivated, split-virion influenza vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00703651

GID02

Details and patient eligibility

About

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

Full 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.

Enrollment

1,150 patients

Sex

All

Ages

18 to 57 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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)