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

Sponsor:	Sanofi-Aventis
Information provided by (Responsible Party):	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00952276

Purpose

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 a single injection.
To describe the safety of the candidate vaccines after a single injection.

Condition	Intervention	Phase
Influenza Swine-origin A/H1N1 Influenza	Biological: Monovalent Subvirion A/H1N1 influenza vaccine with adjuvant Biological: Monovalent Subvirion A/H1N1 influenza vaccine Biological: Normal saline solution	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 Adjuvanted 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 Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years [ Time Frame: Day 0 and Day 21 post-vaccination ] [ Designated as safety issue: No ]
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Detectable anti HA antibody titer was defined as titers ≥ 10 (1/dilution) on Day 0 and Day 21 post-vaccination.
Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years [ Time Frame: Day 0 and Day 21 post-vaccination ] [ Designated as safety issue: No ]
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (1/dil).
Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years [ Time Frame: Day 0 and Day 21 post-vaccination ] [ Designated as safety issue: No ]
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay.
Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years [ Time Frame: Day 0 and Day 21 post-vaccination ] [ Designated as safety issue: No ]
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Detectable anti-HA antibody titer was defined as titers ≥ 10 (1/dil).
Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years [ Time Frame: Day 0 and Day 21 post-vaccination ] [ Designated as safety issue: No ]
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (1/dil).
Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years [ Time Frame: Day 0 and Day 21 post-vaccination ] [ Designated as safety issue: No ]
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay.
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years [ Time Frame: Day 0 up to Day 7 post-vaccination ] [ Designated as safety issue: No ]
Solicited Injections Site Reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years [ Time Frame: Day 0 up to Day 7 post-vaccination ] [ Designated as safety issue: No ]
Solicited Injections Site Reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering.

Enrollment:	548
Study Start Date:	October 2009
Study Completion Date:	March 2011
Primary Completion Date:	December 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 (with adjuvant)	Biological: Monovalent Subvirion A/H1N1 influenza vaccine with adjuvant 0.5 mL, Intramuscular on Day 0
Experimental: A/H1N1 Vaccine Group 2 Participants will receive A/H1N1 vaccine formulation 2 (with adjuvant)	Biological: Monovalent Subvirion A/H1N1 influenza vaccine with adjuvant 0.5 mL, Intramuscular on Day 0
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
Active Comparator: A/H1N1 Vaccine Group 4 Participants will receive A/H1N1 vaccine formulation 4	Biological: Monovalent Subvirion A/H1N1 influenza vaccine 0.5 mL, Intramuscular on Day 0
Placebo Comparator: Placebo Group 5 Participants will receive a placebo vaccine	Biological: Normal saline solution 0.5 mL, Intramuscular on Day 0 Other Name: Normal saline solution

Detailed Description:

Participants will receive a single injection of their randomized vaccine on Day 0.

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, except for the inactivated seasonal influenza vaccine, within two weeks preceding 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
Any Grade 1, 2, or 3 liver function values (Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), and Alkaline phosphatase) observed in blood sample taken at Screening
Any Grade 2 or Grade 3 laboratory abnormalities in blood sample taken at Screening
Receipt of any monovalent 2009 pandemic H1N1 vaccine.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00952276

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, 45227

Cleveland, Ohio, United States, 44122
United States, Pennsylvania

Grove City, Pennsylvania, United States, 16127

Jefferson Hills, Pennsylvania, United States, 15025
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

Springville, Utah, United States, 84663

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

No publications provided

Responsible Party:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00952276 History of Changes
Other Study ID Numbers:	FUF16, UTN: U1111-1111-4882
Study First Received:	August 3, 2009
Results First Received:	August 26, 2011
Last Updated:	August 26, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

Influenza Pandemic Flu Swine-origin A/H1N1 Influenza Adults

Additional relevant MeSH terms:

Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections

Respiratory Tract Diseases
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2012