Study of Swine-Origin A/H1N1 Influenza Non-Adjuvanted Vaccine in Healthy Adults in India
Primary Purpose
Influenza, Pandemic Influenza, Influenza A Virus, H1N1 Subtype
Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
A/H1N1 pandemic influenza vaccine (non- adjuvanted)
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Influenza, Pandemic Influenza, Swine-Origin Influenza A/H1N1 Non-adjuvanted Vaccine, Influenza A Virus, H1N1 subtype, Adults
Eligibility Criteria
Inclusion Criteria :
- 18 years of age and above on the day of inclusion
- Provision of informed consent form signed by the participant. If the participant is illiterate, an independent witness is required to sign the consent form.
- Participant able to attend all scheduled visits and comply with all trial procedures
- For a female, if sexually active, use of an effective method of contraception or abstinence for at least 4 weeks prior to the first vaccination, until at least 4 weeks after the last vaccination.
Exclusion Criteria :
- 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
- Planned receipt of any vaccine during the study period (except 6 months follow up)
- 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)
- Known seropositivity for human immunodeficiency virus, hepatitis B, or hepatitis C as reported by the participant / parent or legal representative and/or based on medical history
- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
- Known thrombocytopenia, contraindicating intramuscular vaccination
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- 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
- Previous participation in a trial investigating a vaccine with the swine-origin A/H1N1 influenza strain
- History of influenza infection in 2009-2010
- Receipt of any allergy shots and/or seasonal allergy medication in the 7-day period prior to enrollment (vaccination), or scheduled to receive any allergy shots and/or seasonal allergy medication in the 7-day period after enrollment (vaccination)
- Known pregnancy, or a positive urine pregnancy
- Currently breastfeeding a child
- Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
Temporary contraindication to be resolved before vaccination:
- Febrile illness (temperature ≥38.0°C) or moderate or severe acute illness/infection on the day of vaccination.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study Group
Arm Description
Participants aged 18 years and older at enrollment.
Outcomes
Primary Outcome Measures
To provide information concerning the safety profile in terms of solicited injection site reactions, systemic events, and serious adverse events after administration of A/H1N1 pandemic influenza vaccine.
Secondary Outcome Measures
To provide information concerning the immune response to A/H1N1 pandemic influenza vaccine.
To provide information concerning antibody persistence 6 months after vaccination with A/H1N1 pandemic influenza vaccine.
Full Information
NCT ID
NCT01053143
First Posted
January 19, 2010
Last Updated
January 10, 2014
Sponsor
Sanofi Pasteur, a Sanofi Company
1. Study Identification
Unique Protocol Identification Number
NCT01053143
Brief Title
Study of Swine-Origin A/H1N1 Influenza Non-Adjuvanted Vaccine in Healthy Adults in India
Official Title
Bridging Study on Safety and Immunogenicity of an Intramuscular Inactivated, Split Virion Swine-Origin A/H1N1 Influenza Non-Adjuvanted Vaccine in Healthy Adults in India
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
September 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
The purpose of this study is to assess the safety and immunogenicity of one dose of A/H1N1 non-adjuvanted pandemic vaccine to support registration of the vaccine in India.
Primary Objective:
To describe the safety profile (injection site reactions and systemic events) of the vaccine within 21 days following vaccination, and serious adverse events throughout the study in all subjects
Secondary Objectives:
To describe the immune response to the vaccine 21 days after vaccination by hemagglutination inhibition (HAI) testing in all subjects
To describe the antibody persistence 6 months after vaccination by HAI testing in all subjects.
Detailed Description
Each study participant will receive one dose of the study vaccine on Day 0, provide pre- and post-vaccination blood samples at 21 and 180 days for immunogenicity testing and undergo safety follow-up for 6 months post-vaccination.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Pandemic Influenza, Influenza A Virus, H1N1 Subtype
Keywords
Influenza, Pandemic Influenza, Swine-Origin Influenza A/H1N1 Non-adjuvanted Vaccine, Influenza A Virus, H1N1 subtype, Adults
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study Group
Arm Type
Experimental
Arm Description
Participants aged 18 years and older at enrollment.
Intervention Type
Biological
Intervention Name(s)
A/H1N1 pandemic influenza vaccine (non- adjuvanted)
Intervention Description
0.5 mL, Intramuscular
Primary Outcome Measure Information:
Title
To provide information concerning the safety profile in terms of solicited injection site reactions, systemic events, and serious adverse events after administration of A/H1N1 pandemic influenza vaccine.
Time Frame
7 days post-vaccination and entire study duration
Secondary Outcome Measure Information:
Title
To provide information concerning the immune response to A/H1N1 pandemic influenza vaccine.
Time Frame
21 days post-vaccination
Title
To provide information concerning antibody persistence 6 months after vaccination with A/H1N1 pandemic influenza vaccine.
Time Frame
6 months post-vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria :
18 years of age and above on the day of inclusion
Provision of informed consent form signed by the participant. If the participant is illiterate, an independent witness is required to sign the consent form.
Participant able to attend all scheduled visits and comply with all trial procedures
For a female, if sexually active, use of an effective method of contraception or abstinence for at least 4 weeks prior to the first vaccination, until at least 4 weeks after the last vaccination.
Exclusion Criteria :
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
Planned receipt of any vaccine during the study period (except 6 months follow up)
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)
Known seropositivity for human immunodeficiency virus, hepatitis B, or hepatitis C as reported by the participant / parent or legal representative and/or based on medical history
Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
Known thrombocytopenia, contraindicating intramuscular vaccination
Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
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
Previous participation in a trial investigating a vaccine with the swine-origin A/H1N1 influenza strain
History of influenza infection in 2009-2010
Receipt of any allergy shots and/or seasonal allergy medication in the 7-day period prior to enrollment (vaccination), or scheduled to receive any allergy shots and/or seasonal allergy medication in the 7-day period after enrollment (vaccination)
Known pregnancy, or a positive urine pregnancy
Currently breastfeeding a child
Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
Temporary contraindication to be resolved before vaccination:
- Febrile illness (temperature ≥38.0°C) or moderate or severe acute illness/infection on the day of vaccination.
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
Chandigarh
ZIP/Postal Code
160012
Country
India
City
New Delhi
ZIP/Postal Code
110001
Country
India
City
Pune
ZIP/Postal Code
411043
Country
India
12. IPD Sharing Statement
Links:
URL
http://www.sanofipasteur.com
Description
Related Info
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Study of Swine-Origin A/H1N1 Influenza Non-Adjuvanted Vaccine in Healthy Adults in India
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