Immunogenicity of Two Dosages of Inactivated, Split-Virion Influenza Vaccine Given by an Alternate Route in the Elderly

Sponsor

Sanofi Pasteur, a Sanofi Company (Industry)

Overall Status

Completed

CT.gov ID

NCT00296829

Collaborator

(none)

1,080

Enrollment

Locations

Duration (Months)

98.2

Patients Per Site

7.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

All marketed influenza vaccines are injected by the intramuscular route. This study will test whether an influenza vaccine is effective when injected by other route than into the muscle. In order to prove this, the amount of antibodies in the blood will be measured before and after vaccination. In addition, the safety of both influenza vaccines will be tested by evaluating all serious reactions occurring after vaccination. The vaccine injected in this study is similar to the sponsor's marketed intramuscular influenza vaccine (Vaxigrip).

Primary Objective:

To demonstrate and compare the immune response of two dosages of influenza vaccine administered by an alternate route to the intramuscular administration of the vaccine.

Secondary Objectives:

To compare the immune response 21 days after vaccination between each investigational group versus intramuscular group for each influenza strain.
To describe the safety profile after the vaccination in each study group
To describe the compliance of the two dosages of the vaccine administered by the alternate route with the European Medicine Agency.

Observational Objectives:

To describe the safety profile during the 21-day period following an intramuscular revaccination in each group and the possibility of any reaction at the first injection site.
To describe the pain at the injection site with a Visual Analog Scale and the acceptability of the injection using a questionnaire in each group.
To describe the leakage appearing at the injection site immediately after the alternate route injection and to explore the relationship with immunogenicity.
To evaluate the cellular mediated immune response in a subset of subjects.

Condition or Disease	Intervention/Treatment	Phase
Orthomyxoviridae Infection Influenza Myxovirus Infection	Biological: Inactivated, split-virion influenza vaccine	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Prevention

Study Start Date :

Jan 1, 2006

Actual Primary Completion Date :

Feb 1, 2007

Actual Study Completion Date :

Feb 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Aged 60 to 85 years on the day of inclusion
Informed consent form signed
Able to attend all scheduled visits and to comply with all trial procedures.

Exclusion Criteria:

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
Febrile illness (oral temperature >= 37.5°C equivalent rectal temperature >= 38.0°C) on the day of inclusion
Any vaccination or participation in another clinical trial in the four weeks preceding the first trial vaccination
Planned participation in another clinical trial during the present trial period
Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding six months, or long-term systemic corticosteroids therapy
Chronic illness at a stage that could interfere with trial conduct or completion
Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures
Blood or blood-derived products received in the past three months
Vaccination planned in the four weeks following the first trial vaccination
Previous vaccination against influenza (in the previous six months) with the trial vaccine or another vaccine
Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination
Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.

Contacts and Locations

Locations

	City	Country	Postal Code
1	Adelaide	Australia	5000
2	Carina Heights	Australia	QLD 4152
3	Inala	Australia	QLD 4077
4	Kippa-Ring	Australia	QLD 4021
5	Victoria	Australia	3079
6	Victoria	Australia	3128
7	Victoria	Australia	3144
8	Westmead	Australia	NSW 2145
9	Auckland	New Zealand
10	Dunedin	New Zealand
11	Hamilton	New Zealand