Status:
COMPLETED
Study of Inactivated, Split-Virion Influenza Vaccine Administered by Intradermal Route Versus Vaxigrip® in Adults
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Influenza
Orthomyxoviridae Infection
Eligibility:
All Genders
18-57 years
Phase:
PHASE2
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 ...
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 subjec...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
1150 Patients enrolled
Trial Details
Trial ID
NCT00703651
Start Date
September 1 2003
End Date
July 1 2006
Last Update
January 13 2014
Active Locations (8)
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1
Gribomont, Belgium
2
Kraainem, Belgium
3
Linkebeek, Belgium
4
Molenbeek, Belgium