Influenza
Conditions
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
Interventions
BIOLOGICALFlu-ID 15μg
Inactivated Split-Virion Influenza Vaccine for Intradermal Route
BIOLOGICALInactivated adjuvanted Influenza Vaccine
Inactivated adjuvanted Influenza Vaccine for Intramuscular Route
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunogenicity Anti-Haemagglutinin (Anti-HA) antibody titres (1/dil) for the three strains obtained on Day 21 after vaccination. | 21 days |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Immunogenicity The derived endpoints will be: - Anti-HA individual titre ratios [Day 21 / Day 0] | 21 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 |
| 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 |
Countries
Belgium, France
Outcome results
None listed