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Safety and Immunogenicity of the 2005-2006 Fluzone® Vaccine

Primary Purpose

Influenza

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Fluzone®: Influenza Virus Vaccine
Fluzone®: Influenza Virus Vaccine
Sponsored by
Sanofi Pasteur, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza vaccine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Participant aged 18 years or older on the day of inclusion. Participant able to attend scheduled visits and to comply with the study procedures during the entire duration of the study. Participant is in reasonably good health as assessed by the investigator. Participant willing and able to meet protocol requirements. Participant willing and able to give informed consent. For a woman, inability to bear a child or negative serum/urine pregnancy test. 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 ≥ 99.5°F oral) in the 72 hours preceding enrollment in the trial. Clinically significant findings in vital signs (including temperature ≥ 99.5°F oral) on review of systems. Self-reported history of severe adverse event to any influenza vaccine. Laboratory-confirmed influenza infection or 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. Vaccination planned in the 4 weeks following any trial vaccination. Participation in any other interventional drug or vaccine trial within the 30 days preceding or during enrollment into this study. Immunocompromising or immunosuppressive therapy (including systemic steroid use for 2 weeks or more), cancer chemotherapy, or radiation therapy at the time of enrollment, planned during the period of this study, or at any time within the past 6 months. Receipt of blood or blood products within the 3 months preceding enrollment in the study. Diabetes mellitus requiring pharmacological control. Any condition that in the opinion of the Investigator posed a health risk to the subject if enrolled or interfered with the evaluation of the vaccine. Person deprived of freedom by an administrative or court order (having legal or medical guardian). For women of childbearing potential, a positive urine pregnancy test, breast feeding, or not using a medically approved form of contraception for the duration of the trial. Current abuse of alcohol or drug addiction that interfered with the subject's ability to comply with trial procedures. Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Age 18 to 59 years

Age 60 years and older

Arm Description

Participants aged 18 to 59 years at enrollment.

Participants aged 60 years and older at enrollment.

Outcomes

Primary Outcome Measures

Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Fluzone® Vaccination
Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Before and After Fluzone® Vaccination
GMTs and their 95% Confidence Intervals are presented for each of the 3 antigens in Fluzone® vaccine (2005-2006 Formulation)

Secondary Outcome Measures

Full Information

First Posted
November 24, 2005
Last Updated
April 12, 2016
Sponsor
Sanofi Pasteur, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00258830
Brief Title
Safety and Immunogenicity of the 2005-2006 Fluzone® Vaccine
Official Title
Annual Study of Safety and Immunogenicity of Fluzone® Influenza Virus Vaccine (2005-2006 Formulation)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To describe the safety during Days 0 to 21 following injection of the 2005-2006 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 (antibodies to hemagglutinin) 21 days following injection of the 2005-2006 formulation of the inactivated, split-virion influenza vaccine Fluzone, in subjects aged 18-59 years and subjects aged ≥ 60 years. To submit remaining available sera to the Center for Biologics Evaluation and Research (CBER) for further analysis by the Food and Drug Administration (FDA), Center for Disease Control and Prevention (CDC) and the World Health Organization (WHO) to support selection and recommendation of antigen strains for subsequent influenza vaccines.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Age 18 to 59 years
Arm Type
Experimental
Arm Description
Participants aged 18 to 59 years at enrollment.
Arm Title
Age 60 years and older
Arm Type
Experimental
Arm Description
Participants aged 60 years and older at enrollment.
Intervention Type
Biological
Intervention Name(s)
Fluzone®: Influenza Virus Vaccine
Other Intervention Name(s)
Fluzone®
Intervention Description
0.5 mL, Intramuscular
Intervention Type
Biological
Intervention Name(s)
Fluzone®: Influenza Virus Vaccine
Other Intervention Name(s)
Fluzone®
Intervention Description
0.5 mL, Intramuscular
Primary Outcome Measure Information:
Title
Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Fluzone® Vaccination
Time Frame
Day 0 to 3 post-vaccination
Title
Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Before and After Fluzone® Vaccination
Description
GMTs and their 95% Confidence Intervals are presented for each of the 3 antigens in Fluzone® vaccine (2005-2006 Formulation)
Time Frame
21 days post-vaccination
Other Pre-specified Outcome Measures:
Title
Percentage of Participants With ≥ 40 Serum Hemagglutination Inhibition Antibody Titers Post-vaccination.
Description
Seroprotection: Percentage of participants with ≥ 40 serum hemagglutination inhibition antibody titers 21 days post-vaccination.
Time Frame
21 Days post-vaccination
Title
Percentage of Participants With a ≥ 4-fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-vaccination
Description
Seroconversion: percentage of participants with at least a 4-fold increase in serum hemagglutination inhibition antibody titers at 21 days post-vaccination.
Time Frame
Day 21 post-vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participant aged 18 years or older on the day of inclusion. Participant able to attend scheduled visits and to comply with the study procedures during the entire duration of the study. Participant is in reasonably good health as assessed by the investigator. Participant willing and able to meet protocol requirements. Participant willing and able to give informed consent. For a woman, inability to bear a child or negative serum/urine pregnancy test. 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 ≥ 99.5°F oral) in the 72 hours preceding enrollment in the trial. Clinically significant findings in vital signs (including temperature ≥ 99.5°F oral) on review of systems. Self-reported history of severe adverse event to any influenza vaccine. Laboratory-confirmed influenza infection or 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. Vaccination planned in the 4 weeks following any trial vaccination. Participation in any other interventional drug or vaccine trial within the 30 days preceding or during enrollment into this study. Immunocompromising or immunosuppressive therapy (including systemic steroid use for 2 weeks or more), cancer chemotherapy, or radiation therapy at the time of enrollment, planned during the period of this study, or at any time within the past 6 months. Receipt of blood or blood products within the 3 months preceding enrollment in the study. Diabetes mellitus requiring pharmacological control. Any condition that in the opinion of the Investigator posed a health risk to the subject if enrolled or interfered with the evaluation of the vaccine. Person deprived of freedom by an administrative or court order (having legal or medical guardian). For women of childbearing potential, a positive urine pregnancy test, breast feeding, or not using a medically approved form of contraception for the duration of the trial. Current abuse of alcohol or drug addiction that interfered with the subject's ability to comply with trial procedures. Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Sanofi Pasteur Inc.
Official's Role
Study Director
Facility Information:
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.sanofipasteur.com
Description
Related Info

Learn more about this trial

Safety and Immunogenicity of the 2005-2006 Fluzone® Vaccine

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