A Study of Different Formulations of an A/H1N1 Pandemic Vaccine in Healthy Adults and the Elderly
NCT ID: NCT00953524
Last Updated: 2014-03-10
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
849 participants
INTERVENTIONAL
2009-08-31
2010-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Primary Objectives:
* To describe the immunogenicity of the candidate vaccines after each injection.
* To describe the safety of the candidate vaccines after each injection.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Different Formulations of an Adjuvanted A/H1N1 Pandemic Vaccine in Healthy Adults and the Elderly
NCT00952276
A Study of Different Formulations of an A/H1N1 Pandemic Vaccine in Healthy Children Aged 6 Months to 9 Years
NCT00952419
A/H1N1 Immunogenicity and Safety in Adults
NCT00959465
A Study to Find and Confirm the Dose and Assess Safety, Reactogenicity and Immune Response of a Vaccine Against Pandemic H5N1 Influenza Virus in Healthy Younger and Older Adults
NCT06382311
A Study of Swine-origin A/H1N1 Influenza Vaccines in Healthy European Adults and the Elderly
NCT00954798
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A/H1N1 Vaccine Group 1
Participants will receive A/H1N1 vaccine formulation 1
Monovalent Subvirion A/H1N1 Influenza vaccine (7.5 µg of HA)
0.5 mL, Intramuscular on Day 0 and on Day 21
A/H1N1 Vaccine Group 2
Participants will receive A/H1N1 vaccine formulation 2
Monovalent Subvirion A/H1N1 Influenza vaccine (15 µg of HA)
0.5 mL, Intramuscular on Day 0 and Day 21
A/H1N1 Vaccine Group 3
Participants will receive A/H1N1 Vaccine formulation 3
Monovalent Subvirion A/H1N1 Influenza vaccine (30 µg of HA)
0.5 mL, Intramuscular on Day 0 and day 21
Placebo Group
Participants will receive a placebo vaccine
Normal saline solution (placebo)
0.5 mL, Intramuscular on Day 0 and Day 21
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Monovalent Subvirion A/H1N1 Influenza vaccine (7.5 µg of HA)
0.5 mL, Intramuscular on Day 0 and on Day 21
Monovalent Subvirion A/H1N1 Influenza vaccine (15 µg of HA)
0.5 mL, Intramuscular on Day 0 and Day 21
Monovalent Subvirion A/H1N1 Influenza vaccine (30 µg of HA)
0.5 mL, Intramuscular on Day 0 and day 21
Normal saline solution (placebo)
0.5 mL, Intramuscular on Day 0 and Day 21
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Monitor
Role: STUDY_DIRECTOR
Sanofi Pasteur Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hoover, Alabama, United States
Chandler, Arizona, United States
Phoenix, Arizona, United States
Anaheim, California, United States
South Miami, Florida, United States
Maddisonville, Kentucky, United States
Springfield, Missouri, United States
Raleigh, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Mt. Pleasant, South Carolina, United States
Knoxville, Tennessee, United States
Austin, Texas, United States
Salt Lake City, Utah, United States
Norfolk, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Plennevaux E, Sheldon E, Blatter M, Reeves-Hoche MK, Denis M. Immune response after a single vaccination against 2009 influenza A H1N1 in USA: a preliminary report of two randomised controlled phase 2 trials. Lancet. 2010 Jan 2;375(9708):41-8. doi: 10.1016/S0140-6736(09)62026-2. Epub 2009 Dec 15.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UTN: U1111-1111-4798
Identifier Type: OTHER
Identifier Source: secondary_id
FUF14
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.