A Study of the Immunogenicity and Safety of the 2006-2007 Influenza Vaccine
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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. |
ClinicalTrials.gov Identifier: NCT00343681 |
Recruitment Status :
Completed
First Posted : June 23, 2006
Last Update Posted : January 17, 2014
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Influenza Orthomyxoviridae Infections | Biological: Inactivated influenza vaccine (split virion) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 120 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Immunogenicity and Safety of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2006-2007 Formulation (Intramuscular Route) |
Study Start Date : | July 2006 |
Actual Primary Completion Date : | August 2007 |
Actual Study Completion Date : | August 2007 |

Arm | Intervention/treatment |
---|---|
Experimental: 1 |
Biological: Inactivated influenza vaccine (split virion)
0.5 mL, Intramuscular |
- To provide information concerning the immunogenicity of inactivated influenza vaccine (split virion) [ Time Frame: 21 Days post-vaccination ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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 ClinicalTrials.gov identifier (NCT number): NCT00343681
Switzerland | |
Allschwil, Switzerland | |
United Kingdom | |
Edinburgh, United Kingdom |
Study Director: | Medical Monitor | Sanofi Pasteur Inc |
Responsible Party: | Sanofi Pasteur, a Sanofi Company |
ClinicalTrials.gov Identifier: | NCT00343681 |
Other Study ID Numbers: |
GRT63 |
First Posted: | June 23, 2006 Key Record Dates |
Last Update Posted: | January 17, 2014 |
Last Verified: | January 2014 |
Influenza Orthomyxoviridae Infections Orthomyxoviruses Split-virion influenza vaccine |
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |