A Study of Swine-origin A/H1N1 Influenza Vaccines in Healthy European Adults and the Elderly
January 10, 2014 updated by: Sanofi Pasteur, a Sanofi Company
Immunogenicity and Safety of Multiple Formulations of an Intramuscular Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With and Without Adjuvant in Healthy European Adult and Elderly Subjects
The purpose of this study is to generate data on immunogenicity and safety of the monovalent H1N1 vaccine in support of the development and registration.
Primary objectives:
- To describe the immune response to study vaccine 21 days after each vaccination.
- To describe the antibody persistence 8 months after the first vaccine administration using hemagglutination inhibition (HAI) method in a randomized subset of adult subjects who received two injections.
- To describe the immune response against the A/H1N1 strain using HAI method 21 days after a vaccination with the 2010-2011 Northern Hemisphere (NH) seasonal trivalent influenza vaccine (TIV) administered 13 months after the first vaccination in a subset subjects who received the A/H1N1 influenza vaccine and in subjects naïve to the swine origin A/H1N1 strain.
- To describe the safety profiles of study vaccines in all participants.
Study Overview
Status
Completed
Conditions
Detailed Description
All participants will receive two injections of their randomized vaccine on Day 0 and Day 21, respectively.
A subset of the participants will receive a third vaccine injection (2010-2011 Northern Hemisphere [NH] seasonal trivalent influenza vaccine [TIV]) approximately 13 months after the first vaccination; additionally, a subset of participants' naïve to the swine-origin A/H1N1 strain will also receive one vaccine injection of the 2010-2011 NH seasonal TIV.
Study Type
Interventional
Enrollment (Actual)
450
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Angers, France, 49000
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Chateau Gontier, France, 53200
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Cherbourg, France, 50100
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Equeurdreville, France, 50120
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Laval, France, 53000
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Tierce, France, 49125
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria :
- Aged 18 years or over 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 or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks after the last vaccination
- Entitled to national social security
At Visit 05, for antibody persistence assessment:
- Addendum 1 to Informed Consent Form has been signed and dated
- Having received two vaccinations with the vaccine formulation 1 or 2.
At Month 13, for trivalent influenza vaccine (TIV) administration in subjects who received the A/H1N1 influenza vaccine:
- Addendum 2 to Informed Consent Form has been signed and dated
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 first trial vaccination
- Planned participation in another clinical trial during the present trial period
- Receipt of any vaccine in the 4 weeks preceding the first trial vaccination
- Planned receipt of any vaccine prior to the Day 42 blood sample
- 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(s) 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
- Previous participation in a trial investigating a vaccine with the swine-origin A/H1N1 influenza strain
- Confirmed infection with the swine-origin A/H1N1 influenza strain (different from the seasonal strain) in 2009
- Febrile illness (temperature ≥ 38.0°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment
- 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)
At Month 8, for antibody persistence assessment:
- Subjects who received, in the context of a pandemic immunization program, another A/H1N1 pandemic influenza vaccine than the Investigational Medicinal Products.
Additional criteria for subset to receive only the TIV:
- History of pandemic A/H1N1 influenza vaccination
- History of clinically or laboratory confirmed pandemic A/H1N1 influenza infection
- Receipt of an adjuvanted influenza vaccine in a clinical trial within the previous 12 months
- Planned receipt of any vaccine during the present trial period.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: A/H1N1 Vaccine Group 1
All participants will receive A/H1N1 vaccine formulation 1 at Visits 1 and 2; a subset will receive a trivalent influenza vaccine (TIV) at Month 13.
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0.5 mL, Intramuscular on Day 0 and day 21 (all participants); and 0.5 mL of trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset)
0.5 mL, Intramuscular on Day 0 and day 21 (all participants), and 0.5 mL of trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset).
0.5 mL, Intramuscular on Day 0 and Day 21
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EXPERIMENTAL: A/H1N1 Vaccine Group 2
All participants will receive A/H1N1 vaccine formulation 2 at Visits 1 and 2; a subset will receive a trivalent influenza vaccine (TIV) at Month 13.
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0.5 mL, Intramuscular on Day 0 and day 21 (all participants); and 0.5 mL of trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset)
0.5 mL, Intramuscular on Day 0 and day 21 (all participants), and 0.5 mL of trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset).
0.5 mL, Intramuscular on Day 0 and Day 21
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EXPERIMENTAL: A/H1N1 Vaccine Group 3
Participants will receive A/H1N1 vaccine formulation 3
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0.5 mL, Intramuscular on Day 0 and day 21 (all participants); and 0.5 mL of trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset)
0.5 mL, Intramuscular on Day 0 and day 21 (all participants), and 0.5 mL of trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset).
0.5 mL, Intramuscular on Day 0 and Day 21
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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To provide information concerning the immunogenicity of Swine A/H1N1 influenza vaccine
Time Frame: 21 days post-vaccination
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21 days post-vaccination
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To provide information concerning the safety in terms of solicited injection site and systemic reactions following vaccination with Swine A/H1N1 influenza vaccine
Time Frame: 0 to7 days post-vaccination and entire study duration
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0 to7 days post-vaccination and entire study duration
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2009
Primary Completion (ACTUAL)
December 1, 2010
Study Completion (ACTUAL)
March 1, 2011
Study Registration Dates
First Submitted
August 3, 2009
First Submitted That Met QC Criteria
August 6, 2009
First Posted (ESTIMATE)
August 7, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
January 14, 2014
Last Update Submitted That Met QC Criteria
January 10, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GPF07
- UTN: U1111-1111-4918
- 2009-013344-37 (EUDRACT_NUMBER)
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