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

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00953524

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:

MedlinePlus related topics: Flu

Drug Information available for: Influenza Vaccines

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

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

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-Aventis

Investigators

Study Director:

Medical Monitor

Sanofi Pasteur Inc.

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

Publications:

Plennevaux E, Sheldon E, Blatter M, Reeves-Hoché 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. Epub 2009 Dec 15.

Responsible Party:	Medical Monitor, Sanofi Pasteur Inc.
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:	July 8, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

Influenza
Pandemic Flu
Swine-origin A/H1N1 Influenza
Adult

Additional relevant MeSH terms:

Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections

Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2012