Immunogenicity of the Investigational Inactivated, Split-Virion Influenza Vaccine Administered by the Intradermal Route in Comparison with the Intramuscular Reference Vaccine Vaxigrip in the Elderly - ND

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2006-002366-18-IT
• Date of registration: 18/10/2006
• Prospective Registration: No
• Primary sponsor: SANOFI PASTEUR
• Public title: Immunogenicity of the Investigational Inactivated, Split-Virion Influenza Vaccine Administered by the Intradermal Route in Comparison with the Intramuscular Reference Vaccine Vaxigrip in the Elderly - ND
• Scientific title: Immunogenicity of the Investigational Inactivated, Split-Virion Influenza Vaccine Administered by the Intradermal Route in Comparison with the Intramuscular Reference Vaccine Vaxigrip in the Elderly - ND
• Date of first enrolment: 07/07/2006
• Target sample size: 3655
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-002366-18
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Italy, Lithuania

Key inclusion & exclusion criteria

Inclusion criteria:
1 Aged over 60 years on the day of inclusion 2 Informed Consent Form signed 3 Able to attend all scheduled visits and to comply with all trial procedures
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1 Systemic hypersensitivity to egg proteins, chick proteins, or any of the vaccine components, in particular, neomycin, formaldehyde, and octoxinol 9, or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances 2 Febrile illness oral temperature 8805; 37.5 C or rectal equivalent temperature 8805; 38.0 C on the day of inclusion 3 Participation in another clinical trial in the four weeks preceding the first trial vaccination 4 Planned participation in another clinical trial during the present trial period 5 Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy 6 Unstable chronic illness defined as illness requiring hospitalization or a clinically significant change in medication in the 12 weeks prior to inclusion at a stage that could interfere with trial conduct or completion 7 Current abuse of alcohol or drug addiction that may interfere with the subject s ability to comply with trial procedures 8 Blood or blood-derived products received in the past 3 months 9 Any vaccination in the 4 weeks preceding the first trial vaccination 10 Vaccination planned in the 4 weeks following the first trial vaccination 11 Previous vaccination against influenza in the previous 6 months with the trial vaccine or another vaccine 12 Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination 13 Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Vaccination of elderly subjects aged 60 years and over with inactivated, split-virion inf luenza vaccine administered by the intradermal route using Vaxigrip as IM reference vaccine
MedDRA version: 6.1 Level: SOC Classification code 10021881

Intervention(s)

Product Name: Intradermal Influenza Vaccine
Product Code: 333
Pharmaceutical Form: Suspension for injection
Other descriptive name: Inactivated, split-virion, influenza vaccine H3N2 strain, H1N1 strain, B strain
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 150-

Trade Name: VAXIGRIP*1SIR 0,5ML 05-06 C/CA

Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Influenza, purified antigen
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 30-

Primary Outcome(s)

Primary end point(s): Anti-hemagglutinin HA antibody titers for the three strains, 21 days D21 after the first vaccination. Seroprotection status anti-HA antibody individual titer 8805; 40 1/dil , 21 days D21 after the first vaccination

Main Objective: To demonstrate that the intradermal ID investigational vaccine induces a better immunogenicity than the intramuscular IM reference vaccine in terms of seroprotection rate after the first vaccination.

Secondary Objective: Immunogenicity To describe the antibody persistence induced by both vaccines at 3 months, 6 months, and 12 months after the first vaccination in a subset of subjects. To describe the immunogenicity of the ID investigational vaccine after each vaccination using parameters defined in the European Medicines Agency EMEA Note for Guidance CPMP/BWP/214/96 specific to elderly subjects. Safety To demonstrate that the ID investigational vaccine is at least as well tolerated as the IM reference vaccine, after the first vaccination, in terms of proportions of subjects with any moderate or severe solicited systemic reaction. To describe the safety profile after each vaccination. To describe the effect of repetitive ID injections on the safety profile. To assess the pain felt at the time of the injection, immediately after each injection via the ID and IM routes using a Verbal Rating Scale VRS . To describe the vaccination comfort after each injection via the ID and IM

Secondary ID(s)

2006-002366-18-LT

GID17