- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00953524
A Study of Different Formulations of an A/H1N1 Pandemic Vaccine in Healthy Adults and the Elderly
February 6, 2014 updated by: Sanofi Pasteur, a Sanofi Company
Immunogenicity and Safety of Multiple Formulations of an A/H1N1 Pandemic Vaccine in Healthy Adult and Elderly Subjects
The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic vaccine.
Primary Objectives:
- To describe the immunogenicity of the candidate vaccines after each injection.
- To describe the safety of the candidate vaccines after each injection.
Study Overview
Status
Completed
Conditions
Detailed Description
Participants will receive two injections of their randomized vaccine on Day 0 and Day 21, respectively.
Study Type
Interventional
Enrollment (Actual)
849
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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Alabama
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Hoover, Alabama, United States, 35216
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Arizona
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Chandler, Arizona, United States, 85224
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Phoenix, Arizona, United States, 85020
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California
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Anaheim, California, United States
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Florida
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South Miami, Florida, United States, 33143
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Kentucky
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Maddisonville, Kentucky, United States, 42431
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Missouri
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Springfield, Missouri, United States, 65802
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North Carolina
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Raleigh, North Carolina, United States, 27612
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Ohio
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Cincinnati, Ohio, United States, 45227
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Cleveland, Ohio, United States, 44122
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South Carolina
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Mt. Pleasant, South Carolina, United States, 29464
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Tennessee
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Knoxville, Tennessee, United States, 37920
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Texas
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Austin, Texas, United States, 78705
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Utah
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Salt Lake City, Utah, United States, 84124
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Virginia
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Norfolk, Virginia, United States, 23507
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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 :
- Healthy adults aged 18 years or older on the day of inclusion
- Informed consent has been signed and dated
- Able to attend all scheduled visits and comply with all trial procedures
- For a woman of child-bearing 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 last vaccination.
Exclusion Criteria :
- Known pregnancy or positive urine pregnancy test
- Currently breastfeeding a child
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a 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 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 the assessment of immune response
- Known or suspected congenital or acquired immunodeficiency, 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 antigen, 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 may interfere with the subject's 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
- Employees 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 swine-origin H1N1 pandemic flu trial except if performed in 1976
- Any confirmed case of influenza (including swine-origin A/H1N1 Influenza) since March 2009
- Febrile illness (temperature ≥ 100.4°F [≥ 38.0°C]) or moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination
- Personal or family history of Guillain-Barré syndrome
- Active neoplastic disease or a history of any hematologic malignancy
- Known seizure/epilepsy history and/or taking anti-seizure medication
- Receipt of psychiatric drugs. Subjects receiving a single antidepressant drug and stable for at least 3 months prior to enrollment, without decompensating symptoms will be allowed to enroll in the study
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 Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A/H1N1 Vaccine Group 1
Participants will receive A/H1N1 vaccine formulation 1
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0.5 mL, Intramuscular on Day 0 and on Day 21
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Experimental: A/H1N1 Vaccine Group 2
Participants will receive A/H1N1 vaccine formulation 2
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0.5 mL, Intramuscular on Day 0 and Day 21
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Placebo Comparator: Placebo Group
Participants will receive a placebo vaccine
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years
Time Frame: Pre-vaccination (Day 0) and day 21 post-vaccination
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Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
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Pre-vaccination (Day 0) and day 21 post-vaccination
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Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years
Time Frame: Pre-vaccination (Day 0) and Day 21 post-vaccination
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Seroprotection: Antibody titer ≥ 40 1/dil.
Antibody titers were determined by the hemagglutination inhibition (HAI) test.
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Pre-vaccination (Day 0) and Day 21 post-vaccination
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Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years
Time Frame: Pre-vaccination (Day 0) and 21 days post-vaccination
|
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
|
Pre-vaccination (Day 0) and 21 days post-vaccination
|
Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1) Strain - Age ≥ 65 Years
Time Frame: Pre-vaccination (Day 0) and 21 days post-vaccination
|
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
|
Pre-vaccination (Day 0) and 21 days post-vaccination
|
Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years
Time Frame: Pre-vaccination (Day 0) and 21 days post-vaccination
|
Seroprotection: Antibody titer ≥ 40 1/dil.
Antibody titers were determined by the hemagglutination inhibition (HAI) test.
|
Pre-vaccination (Day 0) and 21 days post-vaccination
|
Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years
Time Frame: Pre-vaccination (Day 0) and 21 days post-vaccination
|
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
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Pre-vaccination (Day 0) and 21 days post-vaccination
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Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years
Time Frame: Days 0 to 7 post-vaccination
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Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising).
Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering (chills).
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Days 0 to 7 post-vaccination
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Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years
Time Frame: Days 0 to 7 post-vaccination
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Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising).
Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering (chills).
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Days 0 to 7 post-vaccination
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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)
March 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
August 3, 2009
First Submitted That Met QC Criteria
August 4, 2009
First Posted (Estimate)
August 6, 2009
Study Record Updates
Last Update Posted (Estimate)
March 10, 2014
Last Update Submitted That Met QC Criteria
February 6, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FUF14
- UTN: U1111-1111-4798 (Other Identifier: WHO)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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