A Study of the Immunogenicity and Safety of the 2006-2007 Influenza Vaccine
This study has been completed.
Sponsor:
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00343681
First received: June 21, 2006
Last updated: January 16, 2014
Last verified: January 2014
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Purpose
This study is designed to generate clinical data as outlined in the Note for Guidance on harmonization requirements for influenza vaccine marketing authorization by the European Medicines Agency.
The objectives of the trial are:
- To evaluate the compliance, in terms of immunogenicity, of the inactivated, split-virion influenza vaccine Northern Hemisphere 2006-2007 formulation with the requirements of the European Medicines Agency
- To describe the safety of the inactivated, split-virion influenza vaccine, Northern Hemisphere 2006-2007 formulation.
| Condition | Intervention | Phase |
|---|---|---|
|
Influenza Orthomyxoviridae Infections |
Biological: Inactivated influenza vaccine (split virion) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Immunogenicity and Safety of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2006-2007 Formulation (Intramuscular Route) |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- To provide information concerning the immunogenicity of inactivated influenza vaccine (split virion) [ Time Frame: 21 Days post-vaccination ] [ Designated as safety issue: No ]
| Enrollment: | 120 |
| Study Start Date: | July 2006 |
| Study Completion Date: | August 2007 |
| Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Biological: Inactivated influenza vaccine (split virion)
0.5 mL, Intramuscular
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Aged at least 18 years on the day of inclusion
- Informed consent form signed
- Able to attend all scheduled visits and to comply with all trial procedures
- For a woman, inability to bear a child or negative urine pregnancy test at Visit 1
- For a woman of child-bearing potential: use of an effective method of contraception or abstinence for at least four weeks prior to vaccination and at least three weeks after vaccination.
Exclusion Criteria:
- Febrile illness (oral temperature >=37.5°C) on the day of vaccination
- Breast-feeding
- Participation in another clinical trial in the four weeks preceding the 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
- Systemic hypersensitivity to egg proteins, chick proteins, or to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances
- 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
- Any vaccination in the four weeks preceding the trial vaccination
- Vaccination planned in the three weeks following the trial vaccination
- Vaccination against influenza in the previous six months
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00343681
Please refer to this study by its ClinicalTrials.gov identifier: NCT00343681
Locations
| Switzerland | |
| Allschwil, Switzerland | |
| United Kingdom | |
| Edinburgh, United Kingdom | |
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
| Study Director: | Medical Monitor | Sanofi Pasteur Inc |
More Information
Additional Information:
| Responsible Party: | Sanofi Pasteur, a Sanofi Company |
| ClinicalTrials.gov Identifier: | NCT00343681 History of Changes |
| Other Study ID Numbers: | GRT63 |
| Study First Received: | June 21, 2006 |
| Last Updated: | January 16, 2014 |
| Health Authority: | Switzerland: Swissmedic United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Sanofi:
|
Influenza Orthomyxoviridae Infections Orthomyxoviruses Split-virion influenza vaccine |
Additional relevant MeSH terms:
|
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Virus Diseases Respiratory Tract Infections |
Respiratory Tract Diseases Vaccines Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 30, 2016