A Study of High-Dose Trivalent Inactivated Influenza Vaccine in Adults 50 to 64 Years of Age

NCT01258595 | Completed Phase 2 Results

• 2 other identifiers: FIM09UTN: U1111-1113-3648
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 5

Brief Summary

The aim of the study is to generate data on key parameters associated with assessment of influenza vaccines in individuals 50-64 years of age Primary Objective:

• To describe the immunogenicity of High-Dose Trivalent Inactivated Influenza Vaccine (TIV) compared to TIV.
• To describe the safety profile of High-Dose Trivalent Inactivated Influenza Vaccine, as assessed by solicited adverse reactions collected for 7 days post-vaccination, and unsolicited adverse events (including Serious Adverse Events and Adverse Events of Special Interests) collected between Visit 1 and Visit 2

Conditions

Influenza

Keywords

Influenza; Trivalent Inactivated Influenza Vaccine; High-Dose Trivalent Inactivated Influenza Vaccine; Influenza vaccines

Outcome Measures

Primary Outcomes (4)

• Geometric Mean Titers (GMTs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine.

  Serum antibody titers to vaccine antigens were assessed by means of the hemagglutination inhibition (HAI) assay method.

  Day 0 and Day 28 post-vaccination

• Geometric Mean of Individual Titer Ratios (GMTRs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine

  Serum antibody titers to vaccine antigens were assessed by means of the hemagglutination inhibition (HAI) assay method.

  Day 0 and Day 28 Post-vaccination

• Percentage of Participants With Seroconversion After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine

  Seroconversion: For participants with a Day 0 (pre-vaccination) titer \< 10 (1/dilution \[1/dil\]) a titer ≥ 40 (1/dil), and for participants with a Day 0 titer ≥ 10 (1/dil) a ≥ 4 fold increase of titer on Day 28. Serum antibody titers were assessed by means of the hemagglutination inhibition (HAI) assay method.

  Day 0 and Day 28 post-vaccination

• Percentage of Participants With Seroprotection Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine

  Seroprotection was defined as a titer ≥ 40 (1/dilution \[1/dil\]). Serum antibody titers were assessed by means of the hemagglutination inhibition (HAI) assay method.

  Day 0 and Day 28 post vaccination

Secondary Outcomes (1)

• Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine

  Day 0 through Day 7 post-vaccination

Study Arms (2)

High-Dose Trivalent Inactivated Influenza Vaccine

EXPERIMENTAL

Biological: High-Dose Trivalent Inactivated Influenza Vaccine

Trivalent Inactivated Influenza Vaccine

ACTIVE COMPARATOR

Biological: Trivalent Inactivated Influenza Vaccine

Interventions

High-Dose Trivalent Inactivated Influenza Vaccine BIOLOGICAL

0.5 mL Intramuscular

Also known as: Fluzone® High-Dose

High-Dose Trivalent Inactivated Influenza Vaccine

Trivalent Inactivated Influenza Vaccine BIOLOGICAL

0.5 mL, Intramuscular

Also known as: Fluzone®

Trivalent Inactivated Influenza Vaccine

Eligibility Criteria

• Age: 50 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 50 to 64 years (inclusive) on the day of vaccination
• Informed consent form has been signed and dated
• Medically stable
• Able to attend all scheduled visits and to comply with all trial procedures
• For a woman of childbearing potential, use of an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination

You may not qualify if:

• Known pregnancy, or a positive urine pregnancy test
• Currently breastfeeding a child
• Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial vaccination
• Planned participation in another clinical trial during the present trial period
• Planned receipt of any vaccine in the 4 weeks following the trial vaccination (prior to the Visit 2 blood draw)
• Receipt of seasonal or pandemic influenza vaccine in the past 6 months
• Receipt of blood or blood-derived products in the past 3 months
• Systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a history of a life-threatening reaction to the standard-dose Trivalent Inactivated Influenza Vaccine or a vaccine containing any of the same substances
• Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy
• Neoplastic disease or any hematologic malignancy
• Personal history of Guillain-Barré Syndrome
• Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C
• Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
• Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
• Identified as 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 (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (5)

Unknown Facility

Idaho Falls, Idaho, 83404, United States

Location

Unknown Facility

Columbia, Maryland, 21045, United States

Location

Unknown Facility

Ellicott City, Maryland, 21042, United States

Location

Unknown Facility

Missoula, Montana, 59802, United States

Location

Unknown Facility

Cleveland, Ohio, 44122, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

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

RegistryContactUs@sanofipasteur.com

Study Officials

• Medical Director

  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: December 10, 2010
• First Posted: December 13, 2010
• Study Start: November 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: April 1, 2011
• Last Updated: May 16, 2016
• Results First Posted: October 27, 2011

Record last verified: 2016-04

Locations

US (5)