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A Study of the Immunogenicity and Safety of the 2006-2007 Influenza Vaccine

Primary Purpose

Influenza, Orthomyxoviridae Infections

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Inactivated influenza vaccine (split virion)
Sponsored by
Sanofi Pasteur, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza, Orthomyxoviridae Infections, Orthomyxoviruses, Split-virion influenza vaccine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

To provide information concerning the immunogenicity of inactivated influenza vaccine (split virion)

Secondary Outcome Measures

Full Information

First Posted
June 21, 2006
Last Updated
January 16, 2014
Sponsor
Sanofi Pasteur, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00343681
Brief Title
A Study of the Immunogenicity and Safety of the 2006-2007 Influenza Vaccine
Official Title
Immunogenicity and Safety of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2006-2007 Formulation (Intramuscular Route)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Orthomyxoviridae Infections
Keywords
Influenza, Orthomyxoviridae Infections, Orthomyxoviruses, Split-virion influenza vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Inactivated influenza vaccine (split virion)
Intervention Description
0.5 mL, Intramuscular
Primary Outcome Measure Information:
Title
To provide information concerning the immunogenicity of inactivated influenza vaccine (split virion)
Time Frame
21 Days post-vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Sanofi Pasteur Inc
Official's Role
Study Director
Facility Information:
City
Allschwil
Country
Switzerland
City
Edinburgh
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.sanofipasteur.com
Description
Related Info

Learn more about this trial

A Study of the Immunogenicity and Safety of the 2006-2007 Influenza Vaccine

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