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

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

Timeline

Start

2007-10

Primary completion

2007-12

Completion

2007-12

Outcome

Mixed primary results

paper Non-inferiority of the intradermal vaccine was demonstrated for the A/H1N1 and B strains PMID 20504306 ↗

paper but not for the A/H3N2 strain (upper bound of the 95% CI = 1.53) PMID 20504306 ↗

paper and for all three strains by the SRH method PMID 20504306 ↗

Publications

• Van Damme P, Arnou R, Kafeja F, Fiquet A, Richard P, Thomas S, Meghlaoui G, Samson SI, Ledesma E. Evaluation of non-inferiority of intradermal versus adjuvanted seasonal influenza vaccine using two serological techniques: a randomised comparative study. BMC Infect Dis. 2010 May 26;10:134. doi: 10.1186/1471-2334-10-134.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Flu-ID	Vaccine	15 ug	Other
Comparator	Inactivated adjuvanted Influenza Vaccine	Vaccine	15 ug	Intramuscular

Indications