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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00296829
Recruitment Status : Completed
First Posted : February 27, 2006
Last Update Posted : January 14, 2014
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1080 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Study Start Date : January 2006
Primary Completion Date : February 2007
Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Senior)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00296829

Adelaide, Australia, 5000
Carina Heights, Australia, QLD 4152
Inala, Australia, QLD 4077
Kippa-Ring, Australia, QLD 4021
Victoria, Australia, 3079
Victoria, Australia, 3128
Victoria, Australia, 3144
Westmead, Australia, NSW 2145
New Zealand
Auckland, New Zealand
Dunedin, New Zealand
Hamilton, New Zealand
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Study Director: Clinical Trials Sanofi Pasteur, a Sanofi Company

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sanofi Pasteur, a Sanofi Company Identifier: NCT00296829     History of Changes
Other Study ID Numbers: GID16
First Posted: February 27, 2006    Key Record Dates
Last Update Posted: January 14, 2014
Last Verified: January 2014

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Inactivated Split-virion influenza vaccine;

Additional relevant MeSH terms:
Communicable Diseases
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs