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Immunogenicity Study of the Influenza Vaccine in Adults

Primary Purpose

Orthomyxoviridae Infections, Influenza

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

About this trial

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

Eligibility Criteria

18 Years - 57 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Aged 18 to 57 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 V01 For a woman of child-bearing potential: use of an effective method of contraception or abstinence for at least 4 weeks prior to, and at least four weeks after, the first vaccination. At Year 1 (Visit 05): -Addendum to the informed consent form signed and dated by the subject prior to vaccination at Visit 05 At Year 2 (Visit 07): -Addendum to the informed consent form signed and dated by the subject prior to vaccination at Visit 07 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 (rectal equivalent temperature >= 38.0°C) on the day of inclusion Breast-feeding 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 corticosteroid 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 Any vaccination in the four weeks preceding the first trial vaccination 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 IM 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 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

To provide information concerning the immunogenicity of influenza vaccination.

Secondary Outcome Measures

Full Information

First Posted
November 24, 2005
Last Updated
January 10, 2014
Sponsor
Sanofi Pasteur, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00258934
Brief Title
Immunogenicity Study of the Influenza Vaccine in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
All marketed influenza vaccines are injected by the intramuscular (IM) route. This study will test whether an influenza vaccine is effective when injected by a route other 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). In addition, the safety of both influenza vaccines administered by different routes will be tested by evaluating all adverse events and especially all serious reactions. Primary Objective: To demonstrate and compare the immune response of an influenza vaccine after a single dose when administered by different routes. Secondary Objectives: To describe the compliance of the immunogenicity of the vaccine with the European Medicine Agency (EMEA) after the first injection.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
978 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Inactivated, split-virion influenza vaccine
Intervention Description
0.1 mL single annual dose
Intervention Type
Biological
Intervention Name(s)
Inactivated, split-virion, influenza virus
Other Intervention Name(s)
Vaxigrip®
Intervention Description
0.5 mL single annual dose
Primary Outcome Measure Information:
Title
To provide information concerning the immunogenicity of influenza vaccination.
Time Frame
21 Days and 2 Years post-vaccination 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
57 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged 18 to 57 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 V01 For a woman of child-bearing potential: use of an effective method of contraception or abstinence for at least 4 weeks prior to, and at least four weeks after, the first vaccination. At Year 1 (Visit 05): -Addendum to the informed consent form signed and dated by the subject prior to vaccination at Visit 05 At Year 2 (Visit 07): -Addendum to the informed consent form signed and dated by the subject prior to vaccination at Visit 07 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 (rectal equivalent temperature >= 38.0°C) on the day of inclusion Breast-feeding 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 corticosteroid 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 Any vaccination in the four weeks preceding the first trial vaccination 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 IM 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 Director
Organizational Affiliation
Sanofi Pasteur Inc.
Official's Role
Study Director
Facility Information:
City
Antwerpen
Country
Belgium
City
Ghent
Country
Belgium
City
Hamburg
Country
Germany
City
Allschwil
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
19261173
Citation
Chevat C, Viala-Danten M, Dias-Barbosa C, Nguyen VH. Development and psychometric validation of a self-administered questionnaire assessing the acceptance of influenza vaccination: the Vaccinees' Perception of Injection (VAPI) questionnaire. Health Qual Life Outcomes. 2009 Mar 4;7:21. doi: 10.1186/1477-7525-7-21.
Results Reference
derived
Links:
URL
http://www.sanofipasteur.com
Description
Related Info

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Immunogenicity Study of the Influenza Vaccine in Adults

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