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A Study of Different Formulations of an A/H1N1 Pandemic Vaccine in Healthy Adults and the Elderly

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00953524
First received: August 3, 2009
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

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.

Condition Intervention Phase
Influenza
Swine-origin A/H1N1 Influenza
Biological: Monovalent Subvirion A/H1N1 Influenza vaccine (7.5 µg of HA)
Biological: Monovalent Subvirion A/H1N1 Influenza vaccine (15 µg of HA)
Biological: Monovalent Subvirion A/H1N1 Influenza vaccine (30 µg of HA)
Biological: Normal saline solution (placebo)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of Multiple Formulations of an A/H1N1 Pandemic Vaccine in Healthy Adult and Elderly Subjects

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.

  • 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 ] [ Designated as safety issue: No ]
    Seroprotection: Antibody titer ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.

  • 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 ] [ Designated as safety issue: No ]
    Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.

  • 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 ] [ Designated as safety issue: No ]
    Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.

  • 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 ] [ Designated as safety issue: No ]
    Seroprotection: Antibody titer ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.

  • 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 ] [ Designated as safety issue: No ]
    Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.

  • 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 ] [ Designated as safety issue: No ]
    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).

  • Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years [ Time Frame: Days 0 to 7 post-vaccination ] [ Designated as safety issue: No ]
    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).


Enrollment: 849
Study Start Date: August 2009
Study Completion Date: December 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A/H1N1 Vaccine Group 1
Participants will receive A/H1N1 vaccine formulation 1
Biological: Monovalent Subvirion A/H1N1 Influenza vaccine (7.5 µg of HA)
0.5 mL, Intramuscular on Day 0 and on Day 21
Experimental: A/H1N1 Vaccine Group 2
Participants will receive A/H1N1 vaccine formulation 2
Biological: Monovalent Subvirion A/H1N1 Influenza vaccine (15 µg of HA)
0.5 mL, Intramuscular on Day 0 and Day 21
Experimental: A/H1N1 Vaccine Group 3
Participants will receive A/H1N1 Vaccine formulation 3
Biological: Monovalent Subvirion A/H1N1 Influenza vaccine (30 µg of HA)
0.5 mL, Intramuscular on Day 0 and day 21
Placebo Comparator: Placebo Group
Participants will receive a placebo vaccine
Biological: Normal saline solution (placebo)
0.5 mL, Intramuscular on Day 0 and Day 21

Detailed Description:

Participants will receive two injections of their randomized vaccine on Day 0 and Day 21, respectively.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00953524

Locations
United States, Alabama
Hoover, Alabama, United States, 35216
United States, Arizona
Chandler, Arizona, United States, 85224
Phoenix, Arizona, United States, 85020
United States, California
Anaheim, California, United States
United States, Florida
South Miami, Florida, United States, 33143
United States, Kentucky
Maddisonville, Kentucky, United States, 42431
United States, Missouri
Springfield, Missouri, United States, 65802
United States, North Carolina
Raleigh, North Carolina, United States, 27612
United States, Ohio
Cincinnati, Ohio, United States, 45227
Cleveland, Ohio, United States, 44122
United States, South Carolina
Mt. Pleasant, South Carolina, United States, 29464
United States, Tennessee
Knoxville, Tennessee, United States, 37920
United States, Texas
Austin, Texas, United States, 78705
United States, Utah
Salt Lake City, Utah, United States, 84124
United States, Virginia
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Monitor Sanofi Pasteur Inc.
  More Information

Additional Information:
Publications:
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00953524     History of Changes
Other Study ID Numbers: FUF14, UTN: U1111-1111-4798
Study First Received: August 3, 2009
Results First Received: June 8, 2011
Last Updated: February 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Influenza
Pandemic Flu
Swine-origin A/H1N1 Influenza
Adult

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 25, 2014