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

Immunogenicity and Safety of Multiple Formulations of an Adjuvanted A/H1N1 Pandemic Vaccine in Healthy Adult and Elderly Subjects

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.

Study Overview

• Status: Completed
• Conditions: Influenza; Swine-origin A/H1N1 Influenza
• Intervention / Treatment: Biological: Monovalent Subvirion A/H1N1 influenza vaccine with adjuvant; Biological: Monovalent Subvirion A/H1N1 influenza vaccine; Biological: Normal saline solution

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 548
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
    • Fountain Valley, California, United States, 92708
  • Florida
    • South Miami, Florida, United States, 33143
  • Missouri
    • Springfield, Missouri, United States, 65802
  • New York
    • Rochester, New York, United States, 14609
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
  • Ohio
    • Cincinnati, Ohio, United States, 45227
    • Cleveland, Ohio, United States, 44122
  • Pennsylvania
    • Grove City, Pennsylvania, United States, 16127
    • Jefferson Hills, Pennsylvania, United States, 15025
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
  • Tennessee
    • Jackson, Tennessee, United States, 38305
  • Utah
    • Salt Lake City, Utah, United States, 84109
    • Salt Lake City, Utah, United States, 84124
    • Springville, Utah, United States, 84663

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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	Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (1/dil).	Day 0 and Day 21 post-vaccination
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	Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay.	Day 0 and Day 21 post-vaccination
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	Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Detectable anti-HA antibody titer was defined as titers ≥ 10 (1/dil).	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 ≥ 65 Years	Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (1/dil).	Day 0 and Day 21 post-vaccination
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	Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay.	Day 0 and Day 21 post-vaccination
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	Solicited Injections Site Reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering	Day 0 up to Day 7 post-vaccination
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	Solicited Injections Site Reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering.	Day 0 up to Day 7 post-vaccination

Collaborators and Investigators

• Sponsor: Sanofi

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: August 3, 2009
• First Submitted That Met QC Criteria: August 3, 2009
• First Posted (Estimate): August 6, 2009

Study Record Updates

• Last Update Posted (Estimate): October 3, 2011
• Last Update Submitted That Met QC Criteria: August 26, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: Influenza Pandemic Flu Swine-origin A/H1N1 Influenza Adults
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: FUF16; UTN: U1111-1111-4882