An Open-label, Multi-centre, Randomised, Comparative Study of the Immunogenicity and Safety of an Inactivated Split-Virion Influenza Vaccine Administered by Intradermal Route (Flu-ID 15μg) Versus an Inactivated Adjuvanted Influenza Vaccine Administered by Intramuscular Route in Subjects 65 Years of Age or Older

Sanofi Pasteur, a Sanofi Company0 sites795 target enrollmentOctober 2007

ConditionsInfluenza

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Influenza
Sponsor: Sanofi Pasteur, a Sanofi Company
Enrollment: 795
Primary Endpoint: Immunogenicity Anti-Haemagglutinin (Anti-HA) antibody titres (1/dil) for the three strains obtained on Day 21 after vaccination.
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

Primary objective:

* Immunogenicity To demonstrate that the influenza vaccine administered by intradermal route at least as immunogenic as the adjuvanted influenza vaccine administered by intramuscular route at the same dosage in term of HA antibody titres

Secondary objectives

Immunogenicity
- To describe the immune response 21 days after vaccination with the influenza vaccine administered by ID route versus the adjuvanted influenza vaccine administered by IM route..
- To describe the compliance of both vaccines administered with the European Medicine Agency (EMEA) Note for Guidance immunogenicity criteria, specific for elderly subjects
Safety
- To describe the safety profile after vaccination in each group
Acceptability
- To describe the pain at the injection site
- To describe the comfort of the injection

Registry

clinicaltrials.gov

Start Date

October 2007

End Date

December 2007

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sanofi Pasteur, a Sanofi Company

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Aged 65 years or older on the day of inclusion

Exclusion Criteria

•Febrile illness (oral temperature ≥37.5°C) on the day of inclusion
•Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination
•Unstable chronic illness
•Congenital or acquired immunodeficiency,
•Any blood or blood-derived product in the past 3 months
•Current abuse of alcohol or drug addiction
•Any vaccination in the past 4 weeks or planned in the 4 weeks following study vaccination
•Any vaccination against influenza in the past 6 months
•Subjects who previously received a vaccination against influenza by intradermal route

Outcomes

Primary Outcomes

Immunogenicity Anti-Haemagglutinin (Anti-HA) antibody titres (1/dil) for the three strains obtained on Day 21 after vaccination.

Time Frame: 21 days

Secondary Outcomes

Immunogenicity The derived endpoints will be: - Anti-HA individual titre ratios [Day 21 / Day 0](21 days)
Occurrence of some solicited adverse reactions occurring from D0 to D3 after vaccination as defined by the EMEA Note for Guidance [CPMP/BWP/214/96](3 days)
Immunogenicity The derived endpoints will be: - Seroprotection status [anti-HA individual titre ≥40 (1/dil)] on Day 21(21 days)
Seroconversion or significant increase status at Day 21:anti-HA individual post-vaccination titre ≥40 (1/dil) on D21 for subjects with a pre-vaccination anti-HA individual titre <10 (1/dil) on D0(21 days)
Seroconversion or significant increase status at D21: ≥4-fold increase from pre- to post-vaccination anti-HA individual titre on D21 for subjects with a pre-vaccination anti-HA individual titre ≥10 (1/dil)(21 days)
Occurrence, time to onset, number of days of occurrence, and intensity of solicited injection site adverse reactions and systemic adverse reactions occurring from D0 to D7 after vaccination(7 days)
Occurrence, nature (MedDRA PT), time to onset, duration, intensity, and relationship to vaccination (only for systemic adverse events) of unsolicited (spontaneously reported) adverse events (injection site and systemic) occurring from D0 to visit 2(21 days (plus or minus 3 days))
Occurrence, nature (MedDRA PT), time to onset, duration, intensity, and relationship to vaccination (only for systemic adverse events) of serious adverse events occurring from D0 to visit 2(21 days (plus or minus 3 days))
Intensity of pain at the time of injection evaluated just after vaccination on D0 using a Verbal Rating Scale(1 day (day of vaccination))
Answers to the Vaccination Comfort Questionnaire completed on D21(21 days)