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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

795 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2007-12-31

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

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Detailed Description

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Conditions

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Inactivated Split-Virion Influenza Vaccine for Intradermal Route

Group Type EXPERIMENTAL

Flu-ID 15μg

Intervention Type BIOLOGICAL

Inactivated Split-Virion Influenza Vaccine for Intradermal Route

2

Inactivated adjuvanted Influenza Vaccine for Intramuscular Route

Group Type ACTIVE_COMPARATOR

Inactivated adjuvanted Influenza Vaccine

Intervention Type BIOLOGICAL

Inactivated adjuvanted Influenza Vaccine for Intramuscular Route

Interventions

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Flu-ID 15μg

Inactivated Split-Virion Influenza Vaccine for Intradermal Route

Intervention Type BIOLOGICAL

Inactivated adjuvanted Influenza Vaccine

Inactivated adjuvanted Influenza Vaccine for Intramuscular Route

Intervention Type BIOLOGICAL

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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes