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

Phase 3

Completed

• Conditions: Influenza
• Interventions: Biological: Flu-ID 15μg; Biological: Inactivated adjuvanted Influenza Vaccine

• Registration Number: NCT00554333
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-11-05
• Study First Submitted QC: 2007-11-05
• Study First Posted: 2007-11-06
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-15
• Last Update Posted: 2018-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 795

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Flu-ID 15μg	Inactivated Split-Virion Influenza Vaccine for Intradermal Route
2	Inactivated adjuvanted Influenza Vaccine	Inactivated adjuvanted Influenza Vaccine for Intramuscular Route

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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