Immunogenicity of Two Dosages of Inactivated, Split-Virion Influenza Vaccine Given by an Alternate Route in the Elderly
1 other identifier
interventional
1,080
2 countries
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2006
Shorter than P25 for phase_2
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 24, 2006
CompletedFirst Posted
Study publicly available on registry
February 27, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2007
CompletedJanuary 14, 2014
January 1, 2014
1.1 years
February 24, 2006
January 10, 2014
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Informed consent form signed
- Able to attend all scheduled visits and to comply with all trial procedures.
You may not qualify if:
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Unknown Facility
Adelaide, 5000, Australia
Unknown Facility
Carina Heights, QLD 4152, Australia
Unknown Facility
Inala, QLD 4077, Australia
Unknown Facility
Kippa-Ring, QLD 4021, Australia
Unknown Facility
Victoria, 3079, Australia
Unknown Facility
Victoria, 3128, Australia
Unknown Facility
Victoria, 3144, Australia
Unknown Facility
Westmead, NSW 2145, Australia
Unknown Facility
Auckland, New Zealand
Unknown Facility
Dunedin, New Zealand
Unknown Facility
Hamilton, New Zealand
Related Publications (1)
Holland D, Booy R, De Looze F, Eizenberg P, McDonald J, Karrasch J, McKeirnan M, Salem H, Mills G, Reid J, Weber F, Saville M. Intradermal influenza vaccine administered using a new microinjection system produces superior immunogenicity in elderly adults: a randomized controlled trial. J Infect Dis. 2008 Sep 1;198(5):650-8. doi: 10.1086/590434.
PMID: 18652550DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Sanofi Pasteur, a Sanofi Company
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2006
First Posted
February 27, 2006
Study Start
January 1, 2006
Primary Completion
February 1, 2007
Study Completion
February 1, 2007
Last Updated
January 14, 2014
Record last verified: 2014-01