Immunogenicity and Safety of the Investigational Inactivated, Split-Virion Influenza Vaccine 15 µg Administered by the Intradermal Route in Comparison with the Intramuscular Reference Vaccine Vaxigrip® in 50 to 59 Years old Adults

Phase 1

• Conditions: Vaccination of adults subjects aged 50 to 59 years with inactivated, split-virion influenza vaccine administered by the intradermal route using Vaxigrip® as IM reference vaccine.

• Registration Number: EUCTR2008-001219-39-NL
• Lead Sponsor: Sanofi Pasteur SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-06-02
• Study Completion: 2008-06-20
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2740

Inclusion Criteria

1) Aged 50 (from the 50th birthday) to 59 years old (day before the 60th birthday) on the day of inclusion.
2) Informed Consent Form signed.
3) Able to attend all scheduled visits and to comply with all trial procedures.
4) For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) observed for at least 4 weeks prior to the vaccination and at least 4 weeks after the vaccination.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test.
2) Breast-feeding woman.
3) Systemic hypersensitivity to egg proteins, chick proteins, or any of the vaccine components, in particular, neomycin, formaldehyde, and octoxinol 9, or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
4) Febrile illness, i.e. oral temperature = 37.5°C (>37.0°C for Czech) or rectal equivalent temperature =38.0°C (>37.5°C for Czech), on the day of inclusion.
5) Participation in another clinical trial in the 4 weeks preceding the trial vaccination.
6) Planned participation in another clinical trial during the present trial period.
7) Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.
8) Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
9) Current abuse of alcohol or drug addiction that may interfere with the subject’s ability to comply with trial procedures.
10) Receipt of blood or blood-derived products in the past 3 months.
11) Any vaccine in the 4 weeks preceding the trial vaccination.
12) Planned receipt of any vaccine in the 4 weeks following the trial vaccination.
13) Previous vaccination against seasonal or pandemic influenza (in the previous 6 months).
14) Previous vaccination with inactivated, split-virion influenza vaccine administered by intradermal route.
15) Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
16) Known Human Immunodeficiency Virus (HIV), HBs antigen or Hepatitis C seropositivity.
17) Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified