A Study of Fluzone® High-Dose Vaccine Compared With Fluzone® Vaccine In Elderly Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01427309
First received: August 30, 2011
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

The aim of this study is to determine the efficacy of Fluzone High-Dose compared to standard dose Fluzone for laboratory-confirmed or culture-confirmed influenza caused by influenza types/subtypes that are similar (for laboratory-confirmed) or antigenically similar (for culture-confirmed) to those contained in the respective annual vaccine formulations.

Primary Objective:

  • To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly adults, with respect to laboratory-confirmed influenza caused by any influenza viral types/subtypes, associated with the occurrence of a protocol-defined influenza-like-illnesses (ILI).

Secondary Objectives:

  • To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly adults, with respect to laboratory-confirmed influenza, caused by any influenza viral types/subtypes, associated with the occurrence of a protocol-defined ILI.
  • To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly adults, with respect to culture-confirmed influenza, caused by any influenza viral types/subtypes, associated with the occurrence of a protocol-defined ILI.
  • To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly adults, with respect to culture-confirmed influenza caused by viral types/subtypes antigenically similar to those contained in the respective annual vaccine formulations, associated with the occurrence of a modified Centers for Disease Control and Prevention (CDC)-defined ILI.
  • To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly adults, with respect to culture-confirmed influenza caused by any influenza viral types/subtypes, associated with the occurrence of a modified CDC-defined ILI.
  • To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly adults, with respect to culture-confirmed influenza caused by viral types/subtypes antigenically similar to those contained in the respective annual vaccine formulations, associated with the occurrence of a respiratory illness.
  • To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly adults, with respect to culture-confirmed influenza caused by any influenza viral types/subtypes, associated with the occurrence of a respiratory illness.

Condition Intervention Phase
Influenza
Biological: High Dose Trivalent Inactivated Influenza Vaccine
Biological: Trivalent Inactivated Influenza Vaccine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy Study of Fluzone® High-Dose Vaccine Compared With Fluzone® Vaccine In Elderly Adults

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Occurrences of culture- or polymerase chain reaction (PCR)-confirmed influenza caused by any influenza viral types/subtypes, in association with a protocol-defined Influenza like illness (ILI). [ Time Frame: ≥ 14 days post-vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrences of culture-confirmed influenza caused by influenza viral types/subtypes that are antigenically similar to those contained in the vaccine formulations, in association with a protocol-defined ILI. [ Time Frame: ≥ 14 days post-vaccination ] [ Designated as safety issue: No ]
  • Occurrences of culture-confirmed influenza caused by any influenza viral types/subtypes, in association with a protocol-defined ILI. [ Time Frame: ≥ 14 days post-vaccination ] [ Designated as safety issue: No ]
  • Occurrences of culture-confirmed influenza caused by influenza viral types/subtypes that are antigenically similar to those contained in the vaccine formulations, in association with a modified CDC-defined ILI. [ Time Frame: ≥ 14 days post-vaccination ] [ Designated as safety issue: No ]
  • Occurrences of culture-confirmed influenza caused by any influenza viral types/subtypes, in association with a modified CDC-defined ILI. [ Time Frame: ≥ 14 days post-vaccination ] [ Designated as safety issue: No ]
  • Occurrences of culture-confirmed influenza caused by influenza viral types/subtypes that are antigenically similar to those contained in the vaccine formulations, in association with a respiratory illness. [ Time Frame: ≥ 14 days post-vaccination ] [ Designated as safety issue: No ]
  • Occurrences of culture-confirmed influenza caused by any influenza viral types/subtypes, in association with a respiratory illness. [ Time Frame: ≥ 14 days post-vaccination ] [ Designated as safety issue: No ]

Enrollment: 31989
Study Start Date: September 2011
Study Completion Date: November 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High Dose Trivalent Inactivated Influenza Vaccine
Participants will receive an injection of High Dose Trivalent Inactivated Influenza Vaccine
Biological: High Dose Trivalent Inactivated Influenza Vaccine
0.5 mL Intramuscular
Other Name: Fluzone® High Dose
Active Comparator: Trivalent Inactivated Influenza Vaccine
Participants will receive an injection of the Trivalent Inactivated Influenza vaccine
Biological: Trivalent Inactivated Influenza Vaccine
0.5 mL, Intramuscular
Other Name: Fluzone®

Detailed Description:

The trial will span 2 influenza seasons. Each study year, participants will be randomized to receive one dose of either Fluzone® High-Dose or Fluzone® vaccine prior to the start of the influenza season and will be followed until the end of each season.

The duration of each participant's participation in the respective study year will be 6 to 8 months, depending on the time of enrollment.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged ≥ 65 years on the day of vaccination
  • Informed consent form signed and dated
  • Able to attend all scheduled visits and to comply with all trial procedures.

Exclusion Criteria:

  • Participation at the time of study enrollment (or in the 4 weeks preceding the trial vaccination), or planned participation during each year of the trial period, in another clinical trial investigating a vaccine, drug, medical device, or medical procedure (Note: Concomitant participation in an observational trial is acceptable)
  • Vaccination against influenza in the 6 months preceding the trial vaccination
  • Systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a history of a life-threatening reaction to Fluzone High-Dose or Fluzone vaccine or to a vaccine containing any of the same substances
  • Personal history of Guillain-Barré Syndrome
  • Dementia or any other cognitive condition at a stage that could interfere with following the trial procedures
  • Thrombocytopenia contraindicating intramuscular (IM) vaccination, as judged by the investigator
  • Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination, as judged by the investigator
  • Current alcohol abuse or drug addiction
  • Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
  • Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study
  • Moderate or severe acute illness with or without fever (oral temperature > 99.0ºF [> 37.2ºC]). If this contraindication exists, vaccination will be deferred until the individual has been medically stable and/or afebrile (temperature ≤ 99.0 ºF [≤ 37.2ºC]) for at least 24 hours
  • Signs and symptoms of an acute infectious respiratory illness. If this exists, vaccination will be deferred until the symptoms resolve.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01427309

  Show 113 Study Locations
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01427309     History of Changes
Other Study ID Numbers: FIM12, U1111-1120-1300
Study First Received: August 30, 2011
Last Updated: December 5, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Sanofi:
Influenza
Trivalent Inactivated Influenza Vaccine
High-Dose Trivalent Inactivated Influenza Vaccine
Fluzone® High-Dose
Influenza vaccines

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 31, 2014