A Study of the Immunogenicity of Swine-origin A/H1N1 Influenza Vaccine in Healthy Adults
Primary Purpose
Influenza, Swine-origin A/H1N1 Influenza
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Swine A/H1N1 influenza vaccine (split virion, inactivated)
Swine A/H1N1 influenza vaccine (split virion, inactivated)
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Influenza, Pandemic Flu, Swine-origin Influenza, Inactivated split-virion vaccine
Eligibility Criteria
Inclusion Criteria :
- Aged 18 to 60 years on the day of inclusion
- Informed consent form has been signed and dated
- Able to attend all scheduled visits and to comply with all trial procedures
- For a woman of childbearing potential, use of an effective method of contraception from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination
- Entitled to national social security
Exclusion Criteria :
- Known pregnancy, or a positive urine pregnancy test
- Currently breastfeeding a child
- Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial vaccination
- Planned participation in another clinical trial during the present trial period
- Receipt of any vaccine in the 4 weeks preceding the trial vaccination
- Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- Self-reported seropositivity for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
- Self-reported thrombocytopenia, contraindicating intramuscular (IM) vaccination
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination
- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
- Employee of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator
- Participant previously vaccinated with an A/H1N1 pandemic influenza vaccine during vaccination campaign or in a clinical trial
- Personal history of influenza infection since May 2009
- Febrile illness (temperature ≥ 38.0°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Study Group 1
Study Group 2
Arm Description
Swine-origin A/H1N1 Vaccine Low-dose
Swine-origin A/H1N1 Vaccine High-dose
Outcomes
Primary Outcome Measures
To provide information concerning the immunogenicity in terms of anti-hemagglutinin (HA) antibody titers against non-adjuvanted pandemic A/H1N1 influenza vaccine.
Secondary Outcome Measures
Full Information
NCT ID
NCT01089660
First Posted
March 17, 2010
Last Updated
January 10, 2014
Sponsor
Sanofi Pasteur, a Sanofi Company
1. Study Identification
Unique Protocol Identification Number
NCT01089660
Brief Title
A Study of the Immunogenicity of Swine-origin A/H1N1 Influenza Vaccine in Healthy Adults
Official Title
Immunogenicity of the Intramuscular Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine Without Adjuvant in Healthy Adult Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
December 2010 (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 describe the immunogenicity of a pandemic A/H1N1 influenza vaccine in healthy adults given a lower vaccine dose and in a similar group given a full dose of the vaccine.
The primary objective is to describe describe the immune response of the inactivated, split-virion swine-origin A/H1N1 influenza vaccine without adjuvant.
Detailed Description
All participants will receive a single dose of study vaccine and will also be monitored for serious adverse events and adverse events of special interest occurring from Days 0 to 21 and at 6 months post-vaccination.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Swine-origin A/H1N1 Influenza
Keywords
Influenza, Pandemic Flu, Swine-origin Influenza, Inactivated split-virion vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
202 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study Group 1
Arm Type
Experimental
Arm Description
Swine-origin A/H1N1 Vaccine Low-dose
Arm Title
Study Group 2
Arm Type
Experimental
Arm Description
Swine-origin A/H1N1 Vaccine High-dose
Intervention Type
Biological
Intervention Name(s)
Swine A/H1N1 influenza vaccine (split virion, inactivated)
Intervention Description
0.3 mL, Intramuscular (IM)
Intervention Type
Biological
Intervention Name(s)
Swine A/H1N1 influenza vaccine (split virion, inactivated)
Intervention Description
0.5 mL, Intramuscular (IM)
Primary Outcome Measure Information:
Title
To provide information concerning the immunogenicity in terms of anti-hemagglutinin (HA) antibody titers against non-adjuvanted pandemic A/H1N1 influenza vaccine.
Time Frame
21 days post-vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria :
Aged 18 to 60 years on the day of inclusion
Informed consent form has been signed and dated
Able to attend all scheduled visits and to comply with all trial procedures
For a woman of childbearing potential, use of an effective method of contraception from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination
Entitled to national social security
Exclusion Criteria :
Known pregnancy, or a positive urine pregnancy test
Currently breastfeeding a child
Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial vaccination
Planned participation in another clinical trial during the present trial period
Receipt of any vaccine in the 4 weeks preceding the trial vaccination
Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
Self-reported seropositivity for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
Self-reported thrombocytopenia, contraindicating intramuscular (IM) vaccination
Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination
Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
Employee of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator
Participant previously vaccinated with an A/H1N1 pandemic influenza vaccine during vaccination campaign or in a clinical trial
Personal history of influenza infection since May 2009
Febrile illness (temperature ≥ 38.0°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment.
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
Rennes
ZIP/Postal Code
35000
Country
France
City
Rueil Malmaison
ZIP/Postal Code
92502
Country
France
12. IPD Sharing Statement
Links:
URL
http://www.sanofipasteur.com
Description
Related Info
Learn more about this trial
A Study of the Immunogenicity of Swine-origin A/H1N1 Influenza Vaccine in Healthy Adults
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