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

Primary Purpose

Influenza

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Influenza virus vaccine

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza, Fluzone®

Eligibility Criteria

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

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Fluzone® Vaccine Group 1

Fluzone® Vaccine Group 2

Arm Description

Participants aged 18 to 59 years at enrollment - Fluzone® Group

Participants aged 60 years and older at enrollment - Fluzone® Group

Outcomes

Primary Outcome Measures

Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone®

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®

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®

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®

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00835926

First Posted

January 27, 2009

Last Updated

April 12, 2016

Sponsor

Sanofi Pasteur, a Sanofi Company

1. Study Identification

Unique Protocol Identification Number

NCT00835926

Brief Title

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

Official Title

Safety and Immunogenicity of Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone® 2003/2004

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

July 2003 (undefined)

Primary Completion Date

September 2003 (Actual)

Study Completion Date

September 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi Pasteur, a Sanofi Company

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

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

Influenza

Keywords

Influenza, Fluzone®

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

121 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fluzone® Vaccine Group 1

Arm Type

Experimental

Arm Description

Participants aged 18 to 59 years at enrollment - Fluzone® Group

Arm Title

Fluzone® Vaccine Group 2

Arm Type

Experimental

Arm Description

Participants aged 60 years and older at enrollment - Fluzone® Group

Intervention Type

Biological

Intervention Name(s)

Influenza virus vaccine

Other Intervention Name(s)

Fluzone®

Intervention Description

0.5 mL, Intramuscular

Intervention Type

Biological

Intervention Name(s)

Influenza virus vaccine

Other Intervention Name(s)

Fluzone®

Intervention Description

0.5 mL, Intramuscular

Primary Outcome Measure Information:

Title

Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone®

Description

Time Frame

Days 0 to 3 Post-vaccination

Title

Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Before and After Vaccination With Fluzone®

Description

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.

Time Frame

Day 0 and Day 21 Post-vaccination

Title

Percentage of Participants With a ≥ 4-Fold Rise in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone®

Description

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.

Time Frame

Day 21 Post-vaccination

Title

Percentage of Participants With Serum Hemagglutination Inhibition Antibody Titers ≥ 40 Post-Vaccination With Fluzone®

Description

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

Time Frame

Day 21 Post-vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

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

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

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