Comparative Study of Immunogenicity and Safety of Flu-ID Vaccine Versus Flu-IM Vaccine

Sanofi Pasteur, a Sanofi Company795 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

795

Conditions

Influenza

Interventions

Eligibility

Sex: ALLMin age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (8)

Unnamed facility

Antwerp, Belgium

Unnamed facility

Massemen, Belgium

Unnamed facility

Wilrijk, Belgium

Unnamed facility

Angers, France

Unnamed facility

Cherbourg, France

Unnamed facility

Laval, France

Unnamed facility

Seysses, France

Unnamed facility

Tiercé, France

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]

Time frame: 21 days

Immunogenicity The derived endpoints will be: - Seroprotection status [anti-HA individual titre ≥40 (1/dil)] on Day 21

Time frame: 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

Time frame: 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)

Time frame: 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

Time frame: 7 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]

Time frame: 3 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

Time frame: 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

Time frame: 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

Time frame: 1 day (day of vaccination)

Answers to the Vaccination Comfort Questionnaire completed on D21

Time frame: 21 days