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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Influenza

Intervention / Treatment
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* Biological: Flu-ID 15μg
* Biological: Inactivated adjuvanted Influenza Vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Inactivated Split-Virion Influenza Vaccine for Intradermal Route | Biological: Flu-ID 15μg<br>* Inactivated Split-Virion Influenza Vaccine for Intradermal Route<br>|
| Active Comparator: 2<br>Inactivated adjuvanted Influenza Vaccine for Intramuscular Route | Biological: Inactivated adjuvanted Influenza Vaccine<br>* Inactivated adjuvanted Influenza Vaccine for Intramuscular Route<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity Anti-Haemagglutinin (Anti-HA) antibody titres (1/dil) for the three strains obtained on Day 21 after vaccination. |  | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity The derived endpoints will be: - Anti-HA individual titre ratios [Day 21 / Day 0] |  | 21 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 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 | 
| 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 |