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

Sponsor

Sanofi Pasteur, a Sanofi Company (Industry)

Overall Status

Completed

CT.gov ID

NCT00703651

Collaborator

(none)

1,150

Enrollment

Locations

Arms

Duration (Months)

143.8

Patients Per Site

4.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Influenza Orthomyxoviridae Infection Myxovirus Infection	Biological: Inactivated, split-virion influenza vaccine Biological: Inactivated, split-virion influenza vaccine Biological: Inactivated, split-virion influenza vaccine	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

1150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

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 Start Date :

Sep 1, 2003

Actual Primary Completion Date :

May 1, 2006

Actual Study Completion Date :

Jul 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Biological: Inactivated, split-virion influenza vaccine 0.1 mL, ID. 1 injection/year for 3 years
Experimental: 2	Biological: Inactivated, split-virion influenza vaccine 0.1 mL, ID. 1 injection/year for 3 years.
Active Comparator: 3	Biological: Inactivated, split-virion influenza vaccine 0.5 mL, IM. 1 injection/year for 3 years Other Names: Vaxigrip®

Arm

Intervention/Treatment

Experimental: 1

Biological: Inactivated, split-virion influenza vaccine

0.1 mL, ID. 1 injection/year for 3 years

Experimental: 2

Biological: Inactivated, split-virion influenza vaccine

0.1 mL, ID. 1 injection/year for 3 years.

Active Comparator: 3

Biological: Inactivated, split-virion influenza vaccine

0.5 mL, IM. 1 injection/year for 3 years

Other Names:

Vaxigrip®

Outcome Measures

Primary Outcome Measures

To provide information concerning the immunogenicity of Inactivated, Split-Virion Influenza Vaccine. [21days post-vaccination]
To provide information concerning the safety of Inactivated, Split-Virion Influenza Vaccine [21 days post-vaccination and entire study duration]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 57 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)