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

NCT ID: NCT00835926

Last Updated: 2016-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-07-31
• Study Completion Date: 2003-09-30

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.

Conditions

Influenza

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Fluzone® Vaccine Group 1

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

Group Type: EXPERIMENTAL

Influenza virus vaccine

Intervention Type: BIOLOGICAL

0.5 mL, Intramuscular

Fluzone® Vaccine Group 2

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

Group Type: EXPERIMENTAL

Influenza virus vaccine

Intervention Type: BIOLOGICAL

0.5 mL, Intramuscular

Interventions

Influenza virus vaccine

0.5 mL, Intramuscular

Intervention Type: BIOLOGICAL

Influenza virus vaccine

0.5 mL, Intramuscular

Intervention Type: BIOLOGICAL

Other Intervention Names

Fluzone®; Fluzone®

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Sanofi Pasteur Inc.

Locations

Norfolk, Virginia, United States

Countries

United States

Related Links

http://www.sanofipasteur.com

Related Info

Other Identifiers

GRC16

Identifier Type: -

Identifier Source: org_study_id