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.

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2006-002366-18-LT
• Date of registration: 28/06/2006
• Prospective Registration: Yes
• Primary sponsor: Sanofi Pasteur SA
• 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.
• 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.
• Date of first enrolment: 25/09/2006
• 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) yes
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 = 37.5°C or rectal equivalent temperature = 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 influenza vaccine administered by the intradermal route using Vaxigrip® as IM reference vaccine.

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)
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: not less then
Concentration number: 150-
Other descriptive name: Inactivated, split-virion, influenza vaccine (H1N1 strain)
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: not less then
Concentration number: 150-
Other descriptive name: Inactivated, slit-virion, influenza vaccine (B strain)
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: not less then
Concentration number: 150-

Trade Name: VAXIGRIP
Pharmaceutical Form: Suspension for injection
Other descriptive name: Inactivated, split-virion, influenza vaccine (H3N2 strain)
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: not less then
Concentration number: 30-
Other descriptive name: Inactivated, split-virion, influenza vaccine (H1N1 strain)
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: not less then
Concentration number: 30-
Other descriptive name: Inactivated, split-virion, influenza vaccine (B strain)
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: not less then
Concentration number: 30-

Primary Outcome(s)

Secondary Objective: Immunogenicity:
-To describe the antibody persistence induced by both vaccines at 3, 6 and 12 months after the 1st vaccination in a subset of subjects.
-To describe the immunogenicity of the ID investigational vaccine after each vaccination using parameters defined in the 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.

Comfort of the vaccination assessment

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 = 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 ID(s)

GID17