Clinical trial NCT00554333: Comparative Study of Immunogenicity and Safety of Flu-ID Vaccine Versus Flu-IM Vaccine
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-11-06
Enrollment: 795
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: 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

Primary outcomes:
measure: Immunogenicity Anti-Haemagglutinin (Anti-HA) antibody titres (1/dil) for the three strains obtained on Day 21 after vaccination.
timeFrame: 21 days
Secondary outcomes:
measure: Immunogenicity The derived endpoints will be: - Anti-HA individual titre ratios [Day 21 / Day 0]
timeFrame: 21 days
measure: Immunogenicity The derived endpoints will be: - Seroprotection status [anti-HA individual titre ≥40 (1/dil)] on Day 21
timeFrame: 21 days
measure: 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
timeFrame: 21 days
measure: 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)
timeFrame: 21 days
measure: 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
timeFrame: 7 days
measure: 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]
timeFrame: 3 days
measure: 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
timeFrame: 21 days (plus or minus 3 days)
measure: 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
timeFrame: 21 days (plus or minus 3 days)
measure: Intensity of pain at the time of injection evaluated just after vaccination on D0 using a Verbal Rating Scale
timeFrame: 1 day (day of vaccination)
measure: Answers to the Vaccination Comfort Questionnaire completed on D21
timeFrame: 21 days
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
city: Massemen
country: Belgium
city: Wilrijk
country: Belgium
city: Angers
country: France
city: Cherbourg
country: France
city: Laval
country: France
city: Seysses
country: France
city: Tierce
country: France
Study officials:
affiliation: Sanofi Pasteur, a Sanofi Company
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.