NCT00554333

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 795 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

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

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Flu-ID 15μg	Inactivated Split-Virion Influenza Vaccine for Intradermal Route
BIOLOGICAL	Inactivated adjuvanted Influenza Vaccine	Inactivated adjuvanted Influenza Vaccine for Intramuscular Route

Timeline

• Start date: 2007-10-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2007-11-06
• Last updated: 2018-03-16

Locations

8 sites across 2 countries: Belgium, France