A Study to Evaluate the Safety and Immune Responses to Fluzone® Vaccination

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00835926
First received: January 27, 2009
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

To describe the safety during days 0 to 21 following injection of the 2003-2004 formulation of the inactivated, split-virion influenza vaccine Fluzone® in subjects aged 18-59 years and subjects aged ≥ 60 years.

To describe the immune response at 21 days following injection of the 2003-2004 formulation of the inactivated, split-virion influenza vaccine Fluzone®, in subjects aged 18-59 years and subjects aged ≥ 60 years.


Condition Intervention Phase
Influenza
Biological: Influenza virus vaccine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity of Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone® 2003/2004

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® [ Time Frame: Days 0 to 3 Post-vaccination ] [ Designated as safety issue: Yes ]

    Solicited injection site reactions: Erythema, bruising, induration, and Pain at injection site.

    Solicited systemic reaction: Fever (temperature), chills, rash, headache, cough, runny nose, nausea, vomiting, diarrhea, malaise, myalgia, and arthralgia


  • Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Before and After Vaccination With Fluzone® [ Time Frame: Day 0 and Day 21 Post-vaccination ] [ Designated as safety issue: No ]
    Hemagglutination inhibition antibodies is a measure of the serum antibody to the influenza virus in the vaccine as determined by the hemagglutinin inhibition (HAI) assay.

  • Percentage of Participants With a ≥ 4-Fold Rise in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone® [ Time Frame: Day 21 Post-vaccination ] [ Designated as safety issue: No ]
    Hemagglutination inhibition antibodies is a measure of the serum antibody to the influenza virus in the vaccine as determined by the hemagglutinin inhibition (HAI) assay.

  • Percentage of Participants With Serum Hemagglutination Inhibition Antibody Titers ≥ 40 Post-Vaccination With Fluzone® [ Time Frame: Day 21 Post-vaccination ] [ Designated as safety issue: No ]
    Hemagglutination inhibition antibodies is a measure of the serum antibody to the influenza virus in the vaccine as determined by the hemagglutinin inhibition (HAI) assay


Enrollment: 121
Study Start Date: July 2003
Study Completion Date: September 2003
Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fluzone® Vaccine Group 1
Participants aged 18 to 59 years at enrollment - Fluzone® Group
Biological: Influenza virus vaccine
0.5 mL, Intramuscular
Other Name: Fluzone®
Experimental: Fluzone® Vaccine Group 2
Participants aged 60 years and older at enrollment - Fluzone® Group
Biological: Influenza virus vaccine
0.5 mL, Intramuscular
Other Name: Fluzone®

Detailed Description:

Safety will be assessed throughout the trial period. Using antigens provided by Aventis Pasteur Inc., pre- and post-vaccination serum antibody titers for each of the three vaccine strains will be measured.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria :

  • Age of 18 years or greater.
  • Ambulatory.
  • In reasonably good health as assessed by the investigator.
  • Available for duration of the study (21 days + 2d).
  • Willing and able to meet protocol requirements.
  • Willing and able to give informed consent.

Exclusion Criteria :

  • Self-reported allergy to egg proteins, chicken proteins, or one of the constituents of the vaccine, such as thimerosal or formaldehyde.
  • An acute illness with or without fever (temperature >100.4°F) in the 72 hours preceding enrollment in the trial.
  • Clinically significant findings in vital signs (including temperature >100.4°F) or review of systems.
  • Self-reported history of severe adverse event to any influenza vaccine.
  • Vaccination against influenza in the 6 months preceding enrollment in the study.
  • Any vaccination in the 14 days preceding enrollment in the study or scheduled between Visit 1 and Visit 3.
  • Participation in any other experimental drug or vaccine trial within the 30 days preceding enrollment into the study.
  • Immunosuppressive therapy including long-term (> 2 weeks) systemic corticosteroids or cancer therapy within the past 3 months or ongoing.
  • Receipt of blood or blood products within the 3 months preceding enrollment in the study.
  • Diabetes
  • Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine (e.g., existing severe chronic illness such as pulmonary disorders, cardiovascular disorders, chronic blood disorders, etc.).
  • Person deprived of freedom by an administrative or court order (having legal or medical guardian).
  • For women of childbearing age, a positive urine pregnancy test, breast feeding, or not using a medically approved and reliable form of contraception (oral contraceptives or double barrier method) for the duration of the trial.
  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: NCT00835926

Locations
United States, Virginia
Norfolk, Virginia, United States, 23507
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: NCT00835926     History of Changes
Other Study ID Numbers: GRC16
Study First Received: January 27, 2009
Results First Received: September 23, 2009
Last Updated: January 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Sanofi:
Influenza
Fluzone®

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 September 11, 2014