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

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Sanofi

Status and phase

Completed
Phase 3

Conditions

Influenza

Treatments

Biological: Flu-ID 15μg
Biological: Inactivated adjuvanted Influenza Vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00554333
FID01C

Details and patient eligibility

About

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

Enrollment

795 patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

795 participants in 2 patient groups

1
Experimental group
Description:
Inactivated Split-Virion Influenza Vaccine for Intradermal Route
Treatment:
Biological: Flu-ID 15μg
2
Active Comparator group
Description:
Inactivated adjuvanted Influenza Vaccine for Intramuscular Route
Treatment:
Biological: Inactivated adjuvanted Influenza Vaccine

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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