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

NCT00953524 | Completed Phase 2 Results

• 2 other identifiers: FUF14UTN: U1111-1111-4798
• Study Type: interventional
• Target: 849
• Locations: 1 country
• Sites: 15

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.

Conditions

Influenza; Swine-origin A/H1N1 Influenza

Keywords

Influenza; Pandemic Flu; Swine-origin A/H1N1 Influenza; Adult

Outcome Measures

Primary Outcomes (8)

• Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years

  Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.

  Pre-vaccination (Day 0) and day 21 post-vaccination

• Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years

  Seroprotection: Antibody titer ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.

  Pre-vaccination (Day 0) and Day 21 post-vaccination

• Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years

  Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.

  Pre-vaccination (Day 0) and 21 days post-vaccination

• Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1) Strain - Age ≥ 65 Years

  Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.

  Pre-vaccination (Day 0) and 21 days post-vaccination

• Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years

  Seroprotection: Antibody titer ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.

  Pre-vaccination (Day 0) and 21 days post-vaccination

• Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years

  Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.

  Pre-vaccination (Day 0) and 21 days post-vaccination

• Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years

  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).

  Days 0 to 7 post-vaccination

• Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years

  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).

  Days 0 to 7 post-vaccination

Study Arms (4)

A/H1N1 Vaccine Group 1

EXPERIMENTAL

Participants will receive A/H1N1 vaccine formulation 1

Biological: Monovalent Subvirion A/H1N1 Influenza vaccine (7.5 µg of HA)

A/H1N1 Vaccine Group 2

EXPERIMENTAL

Participants will receive A/H1N1 vaccine formulation 2

Biological: Monovalent Subvirion A/H1N1 Influenza vaccine (15 µg of HA)

A/H1N1 Vaccine Group 3

EXPERIMENTAL

Participants will receive A/H1N1 Vaccine formulation 3

Biological: Monovalent Subvirion A/H1N1 Influenza vaccine (30 µg of HA)

Placebo Group

PLACEBO COMPARATOR

Participants will receive a placebo vaccine

Biological: Normal saline solution (placebo)

Interventions

Monovalent Subvirion A/H1N1 Influenza vaccine (7.5 µg of HA) BIOLOGICAL

0.5 mL, Intramuscular on Day 0 and on Day 21

A/H1N1 Vaccine Group 1

Monovalent Subvirion A/H1N1 Influenza vaccine (15 µg of HA) BIOLOGICAL

0.5 mL, Intramuscular on Day 0 and Day 21

A/H1N1 Vaccine Group 2

Monovalent Subvirion A/H1N1 Influenza vaccine (30 µg of HA) BIOLOGICAL

0.5 mL, Intramuscular on Day 0 and day 21

A/H1N1 Vaccine Group 3

Normal saline solution (placebo) BIOLOGICAL

0.5 mL, Intramuscular on Day 0 and Day 21

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (15)

Unknown Facility

Hoover, Alabama, 35216, United States

Location

Unknown Facility

Chandler, Arizona, 85224, United States

Location

Unknown Facility

Phoenix, Arizona, 85020, United States

Location

Unknown Facility

Anaheim, California, United States

Location

Unknown Facility

South Miami, Florida, 33143, United States

Location

Unknown Facility

Maddisonville, Kentucky, 42431, United States

Location

Unknown Facility

Springfield, Missouri, 65802, United States

Location

Unknown Facility

Raleigh, North Carolina, 27612, United States

Location

Unknown Facility

Cincinnati, Ohio, 45227, United States

Location

Unknown Facility

Cleveland, Ohio, 44122, United States

Location

Unknown Facility

Mt. Pleasant, South Carolina, 29464, United States

Location

Unknown Facility

Knoxville, Tennessee, 37920, United States

Location

Unknown Facility

Austin, Texas, 78705, United States

Location

Unknown Facility

Salt Lake City, Utah, 84124, United States

Location

Unknown Facility

Norfolk, Virginia, 23507, United States

Location

Related Publications (1)

• Plennevaux E, Sheldon E, Blatter M, Reeves-Hoche 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.

  PMID: 20018365 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Medical Director
• Organization: Sanofi Pasteur Inc.

RegistryContactUs@sanofipasteur.com

Study Officials

• Medical Monitor

  Sanofi Pasteur Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2009
• First Posted: August 6, 2009
• Study Start: August 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 10, 2014
• Results First Posted: July 11, 2011

Record last verified: 2014-02

Locations

US (15)