Influenza, Myxovirus Infection, Orthomyxoviridae Infection
Conditions
Keywords
Influenza, Orthomyxoviridae Infection, Inactivated, Split-virion influenza vaccine, Intradermal injection, Adults.
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.
Interventions
0.1 mL, ID. 1 injection/year for 3 years
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 57 Years
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Belgium, Czechia, Lithuania
Outcome results
None listed