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History of Changes for Study: NCT00952276
A Study of Different Formulations of an Adjuvanted A/H1N1 Pandemic Vaccine in Healthy Adults and the Elderly
Latest version (submitted August 26, 2011) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 3, 2009 None (earliest Version on record)
2 August 6, 2009 Oversight and Study Status
3 August 7, 2009 Study Status
4 October 29, 2009 Recruitment Status, Study Status, Arms and Interventions, Contacts/Locations, Eligibility and Study Design
5 November 16, 2009 Arms and Interventions, Study Status, Study Description and Outcome Measures
6 January 4, 2010 Recruitment Status, Study Status and Contacts/Locations
7 April 15, 2011 Recruitment Status, Study Status and Study Design
8 August 26, 2011 Study Status, Contacts/Locations, Outcome Measures, Sponsor/Collaborators and Results
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Study NCT00952276
Submitted Date:  August 3, 2009 (v1)

Open or close this module Study Identification
Unique Protocol ID: FUF16
Brief Title: A Study of Different Formulations of an Adjuvanted A/H1N1 Pandemic Vaccine in Healthy Adults and the Elderly
Official Title: Immunogenicity and Safety of Multiple Formulations of an Adjuvanted A/H1N1 Pandemic Vaccine in Healthy Adult and Elderly Subjects
Secondary IDs: UTN: U1111-1111-4882
Open or close this module Study Status
Record Verification: August 2009
Overall Status: Not yet recruiting
Study Start: August 2009
Primary Completion: October 2010 [Anticipated]
Study Completion: January 2011 [Anticipated]
First Submitted: August 3, 2009
First Submitted that
Met QC Criteria:
August 3, 2009
First Posted: August 6, 2009 [Estimate]
Last Update Submitted that
Met QC Criteria:
August 3, 2009
Last Update Posted: August 6, 2009 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Sanofi
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary:

The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic vaccine in adults and the elderly.

Primary Objectives:

  • To describe the immunogenicity of the candidate vaccines after each injection.
  • To describe the safety of the candidate vaccines after each injection.
Detailed Description: Participants will receive two injections of their randomized vaccine on Day 0 and Day 21, respectively.
Open or close this module Conditions
Conditions: Influenza
Swine-origin A/H1N1 Influenza
Keywords: Influenza Pandemic Flu Swine-origin A/H1N1 Influenza Adults
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 4
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 650 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: A/H1N1 Vaccine Group 1
Participants will receive A/H1N1 vaccine formulation 1
Biological: Monovalent Subvirion A/H1N1 influenza vaccine with adjuvant
0.5 mL, Intramuscular on Day 0 and Day 21
Experimental: A/H1N1 Vaccine Group 2
Participants will receive A/H1N1 vaccine formulation 2
Biological: Monovalent Subvirion A/H1N1 influenza vaccine with adjuvant
0.5 mL, Intramuscular on day 0 and Day 21
Active Comparator: A/H1N1 Vaccine Group 3
Participants will receive A/H1N1 vaccine formulation 3
Biological: Monovalent Subvirion A/H1N1 influenza vaccine
0.5 mL, Intramuscular on Day 0 and Day 21
Placebo Comparator: Placebo Group
Participants will receive a placebo vaccine
Biological: Normal saline solution
0.5 mL, Intramuscular on Day 0 and Day 21
Open or close this module Outcome Measures
Primary Outcome Measures:
1. To provide information concerning the immunogenicity of influenza A/H1N1 vaccine after primary vaccination.
[ Time Frame: 21 days post-vaccination ]

2. To provide information concerning the safety after primary administration of influenza A/H1N1 vaccine.
[ Time Frame: 0-7 days post-vaccination and entire study duration ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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 A/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
  • Out-of-range liver function values (Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), and Alkaline phosphatase) observed in blood sample taken at Screening
  • Clinically significant laboratory abnormalities (as determined by the Investigator) in blood sample taken at Screening
Open or close this module Contacts/Locations
Central Contact Person: Public Registry Sanofi Pasteur
Email: RegistryContactUs@sanofipasteur.com
Study Officials: Medical Monitor
Study Director
Sanofi Pasteur Inc.
Locations: United States, California
Anaheim, California, United States, 92801
Fountain Valley, California, United States, 92708
United States, Florida
South Miami, Florida, United States, 33143
United States, Missouri
Springfield, Missouri, United States, 65802
United States, New York
Rochester, New York, United States, 14609
United States, North Carolina
Raleigh, North Carolina, United States, 27612
United States, Ohio
Cincinnati, Ohio, United States, 45206
Cleveland, Ohio, United States, 44122
United States, Pennsylvania
Grove City, Pennsylvania, United States, 16127
Pittsburgh, Pennsylvania, United States, 15217
United States, Rhode Island
Warwick, Rhode Island, United States, 02886
United States, Tennessee
Jackson, Tennessee, United States, 38305
United States, Utah
Salt Lake City, Utah, United States, 84109
Salt Lake City, Utah, United States, 84124
Spanish Fork, Utah, United States, 84660
Open or close this module IPDSharing
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Open or close this module References
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