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

NCT ID: NCT00743275

Last Updated: 2016-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2008-11-30

Brief Summary

To describe the safety of the inactivated, split-virion influenza vaccine, 2008-2009 formulation.

To evaluate the compliance, in terms of immunogenicity, of the inactivated, split-virion influenza vaccine 2008-2009 formulation with the requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96.

Conditions

Influenza

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Study Group

Participants received one dose of Fluzone® vaccine on Day 0.

Group Type: EXPERIMENTAL

Split, Inactivated, Trivalent Influenza vaccine (Fluzone®)

Intervention Type: BIOLOGICAL

0.5 mL, intramuscular

Interventions

Split, Inactivated, Trivalent Influenza vaccine (Fluzone®)

0.5 mL, intramuscular

Intervention Type: BIOLOGICAL

Other Intervention Names

Fluzone®

Eligibility Criteria

Inclusion Criteria

• Participant is 18 years of age or older on the day of inclusion.
• Participant willing and able to attend scheduled visits and to comply with the study procedures during the entire duration of the study.
• Participant in reasonably good health as assessed by the Investigator.
• 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 in the 72 hours preceding enrollment in the trial.
• Clinically significant findings in vital signs (including temperature ≥ 99.5°F oral) or 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 2.
• Participation in any other interventional drug or vaccine trial within the 30 days preceding or during enrollment into this study.*
• Immunocompromising condition 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 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 potential, 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.
• Current use of alcohol or recreational drugs that may interfere with the subject's ability to comply with trial procedures.
• Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
• Prior personal history of Guillain-Barré syndrome. * Subjects enrolled into this study will not be prohibited from donating blood for non-interventional studies.

• 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

GRC41

Identifier Type: -

Identifier Source: org_study_id