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

• ClinicalTrials.gov Identifier: NCT00953524
• Recruitment Status: Completed
• First Posted: August 6, 2009
• Results First Posted: July 11, 2011
• Last Update Posted: March 10, 2014
• Sponsor: Sanofi Pasteur, a Sanofi Company
• Information provided by (Responsible Party): Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Description

Brief Summary:

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 or disease	Intervention/treatment	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

Detailed Description:

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 849 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, 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
• Study Start Date: August 2009
• Actual Primary Completion Date: March 2010
• Actual Study Completion Date: December 2010

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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 ]
   Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
2. 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 ]
   Seroprotection: Antibody titer ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.
3. 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 ]
   Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
4. 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 ]
   Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
5. 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 ]
   Seroprotection: Antibody titer ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.
6. 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 ]
   Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
7. 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 ]
   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).
8. Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years [ Time Frame: Days 0 to 7 post-vaccination ]
   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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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:

Related Info 

Related Info 

Publications of Results:

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. doi: 10.1016/S0140-6736(09)62026-2. Epub 2009 Dec 15.

• Responsible Party: Sanofi Pasteur, a Sanofi Company
• ClinicalTrials.gov Identifier: NCT00953524
• Other Study ID Numbers: FUF14; UTN: U1111-1111-4798 ( Other Identifier: WHO )
• First Posted: August 6, 2009
• Results First Posted: July 11, 2011
• Last Update Posted: March 10, 2014
• Last Verified: February 2014

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):

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; Vaccines; Immunologic Factors; Physiological Effects of Drugs