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

NCT00952276 | Completed Phase 2 Results

• 2 other identifiers: FUF16UTN: U1111-1111-4882
• Study Type: interventional
• Target: 548
• Locations: 1 country
• Sites: 15

Brief Summary

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.

Conditions

Influenza; Swine-origin A/H1N1 Influenza

Keywords

Influenza Pandemic Flu Swine-origin A/H1N1 Influenza Adults

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (5)

A/H1N1 Vaccine Group 1

EXPERIMENTAL

Participants will receive A/H1N1 vaccine formulation 1 (with adjuvant)

Biological: Monovalent Subvirion A/H1N1 influenza vaccine with adjuvant

A/H1N1 Vaccine Group 2

EXPERIMENTAL

Participants will receive A/H1N1 vaccine formulation 2 (with adjuvant)

Biological: Monovalent Subvirion A/H1N1 influenza vaccine with adjuvant

A/H1N1 Vaccine Group 3

ACTIVE COMPARATOR

Participants will receive A/H1N1 vaccine formulation 3

Biological: Monovalent Subvirion A/H1N1 influenza vaccine

A/H1N1 Vaccine Group 4

ACTIVE COMPARATOR

Participants will receive A/H1N1 vaccine formulation 4

Biological: Monovalent Subvirion A/H1N1 influenza vaccine

Placebo Group 5

PLACEBO COMPARATOR

Participants will receive a placebo vaccine

Biological: Normal saline solution

Interventions

Monovalent Subvirion A/H1N1 influenza vaccine with adjuvant BIOLOGICAL

0.5 mL, Intramuscular on Day 0

A/H1N1 Vaccine Group 1

Monovalent Subvirion A/H1N1 influenza vaccine BIOLOGICAL

0.5 mL, Intramuscular on Day 0

A/H1N1 Vaccine Group 3

Normal saline solution BIOLOGICAL

0.5 mL, Intramuscular on Day 0

Placebo Group 5

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, 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
• 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: lead

Study Sites (15)

Unknown Facility

Anaheim, California, 92801, United States

Location

Unknown Facility

Fountain Valley, California, 92708, United States

Location

Unknown Facility

South Miami, Florida, 33143, United States

Location

Unknown Facility

Springfield, Missouri, 65802, United States

Location

Unknown Facility

Rochester, New York, 14609, 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

Grove City, Pennsylvania, 16127, United States

Location

Unknown Facility

Jefferson Hills, Pennsylvania, 15025, United States

Location

Unknown Facility

Warwick, Rhode Island, 02886, United States

Location

Unknown Facility

Jackson, Tennessee, 38305, United States

Location

Unknown Facility

Salt Lake City, Utah, 84109, United States

Location

Unknown Facility

Salt Lake City, Utah, 84124, United States

Location

Unknown Facility

Springville, Utah, 84663, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Influenza, Human

Interventions

Adjuvants, Pharmaceutic; Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pharmaceutic Aids; Pharmaceutical Preparations; Specialty Uses of Chemicals; Chemical Actions and Uses; Crystalloid Solutions; Isotonic Solutions; Solutions

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: October 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: March 1, 2011
• Last Updated: October 3, 2011
• Results First Posted: October 3, 2011

Record last verified: 2011-08

Locations

US (15)