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Safety and Immunogenicity of the World Health Organization (WHO) Formulation of the 2004-2005 Fluzone® Vaccine

Primary Purpose

Influenza

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Fluzone®: Influenza virus vaccine 2004-2005 formulation

About this trial

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

Eligibility Criteria

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

Inclusion Criteria :

Participant aged 18 years or older.
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.

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) on 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.
Immunogenicity 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 3 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 would pose a health risk to the subject if enrolled, or could interfere 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 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 - Age 18-59 Years

Fluzone® Vaccine Group - Age ≥ 60 Years

Arm Description

Participants aged 18 to 59 years at enrollment and received 1 dose of Fluzone® Vaccine

Participants aged at least 60 years or older at enrollment and received 1 dose of Fluzone® Vaccine

Outcomes

Primary Outcome Measures

Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination

Solicited local reactions: Erythema (redness), Induration, Bruising, and Pain at the injection site. Solicited systemic events: Fever (temperature), Chills, Rash, Headache, Cough, Runny nose, Nausea, Vomiting, Diarrhea, Malaise, Myalgia, and Arthralgia

Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine

GMTs and their 95% Confidence Intervals for each of the 3 antigens pre- and post-vaccination with Fluzone® 2004-2005 formulation.

Percentage of Participants With at Least 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination

Percentage of Participants With at Least a 4-Fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination

Secondary Outcome Measures

Full Information

NCT ID

NCT00831987

First Posted

January 28, 2009

Last Updated

April 12, 2016

Sponsor

Sanofi Pasteur, a Sanofi Company

1. Study Identification

Unique Protocol Identification Number

NCT00831987

Brief Title

Safety and Immunogenicity of the World Health Organization (WHO) Formulation of the 2004-2005 Fluzone® Vaccine

Official Title

Annual Study of Safety and Immunogenicity of Influenza Virus Vaccine Fluzone® 2004-2005

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

August 2004 (undefined)

Primary Completion Date

February 2006 (Actual)

Study Completion Date

February 2006 (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 observe and to describe the safety during Days 0 to 21 following injection of the 2004-2005 formulation of the inactivated, split-virion influenza vaccine Fluzone® in subjects aged 18-59 years and subjects aged ≥ 60 years. To measure and to describe the immune response (antibodies to hemagglutinin) 21 days following injection of the 2004-2005 formulation of the inactivated, split-virion influenza vaccine Fluzone®, in subjects aged 18-59 years and subjects aged ≥ 60 years.

Detailed Description

The time of onset and duration of local and systemic solicited reactions will be assessed and reported. Unsolicited adverse events (including serious adverse events) will be collected and categorized throughout the study period. Antibody levels will be evaluated by hemagglutination inhibition (HI) assay from sera obtained pre-vaccination (Day 0) and 21 days post-vaccination, for antigens from the 2004-2005 influenza virus strains: A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2), and B/Jiangsu/10/2003.

6. Conditions and Keywords

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

Influenza

Keywords

Fluzone®, Influenza, Adults

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

Fluzone® Vaccine Group - Age 18-59 Years

Arm Type

Experimental

Arm Description

Participants aged 18 to 59 years at enrollment and received 1 dose of Fluzone® Vaccine

Arm Title

Fluzone® Vaccine Group - Age ≥ 60 Years

Arm Type

Experimental

Arm Description

Participants aged at least 60 years or older at enrollment and received 1 dose of Fluzone® Vaccine

Intervention Type

Biological

Intervention Name(s)

Fluzone®: Influenza virus vaccine 2004-2005 formulation

Other Intervention Name(s)

Fluzone®

Intervention Description

0.5 mL, Intramuscular

Intervention Type

Biological

Intervention Name(s)

Fluzone®: Influenza virus vaccine 2004-2005 formulation

Other Intervention Name(s)

Fluzone®

Intervention Description

0.5 mL, Intramuscular

Primary Outcome Measure Information:

Title

Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination

Description

Time Frame

0 to 3 days post-vaccination

Title

Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine

Description

GMTs and their 95% Confidence Intervals for each of the 3 antigens pre- and post-vaccination with Fluzone® 2004-2005 formulation.

Time Frame

Day 0 and Day 21 Post-Vaccination

Title

Percentage of Participants With at Least 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination

Time Frame

21 Days post-vaccination

Title

Percentage of Participants With at Least a 4-Fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination

Time Frame

Day 21 post-vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria : Participant aged 18 years or older. 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. 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) on 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. Immunogenicity 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 3 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 would pose a health risk to the subject if enrolled, or could interfere 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 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

Learn more about this trial

Safety and Immunogenicity of the World Health Organization (WHO) Formulation of the 2004-2005 Fluzone® Vaccine

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