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

NCT00743275 | Completed Phase 4 Results

• 1 other identifier: GRC41
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

Influenza

Outcome Measures

Primary Outcomes (4)

• Number of Participants With at Least 1 Solicited Injection Site Solicited Systemic Reactions Post-vaccination With Fluzone® Vaccine.

  Solicited Injection Site Reaction: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reaction: Fever (temperature), Headache, Malaise, Myalgia, and Shivering

  Days 0-3 post-vaccination

• Geometric Mean Titers (GMTs) for the 3 Influenza Strains Pre- and Post-vaccination With Fluzone® Vaccine 2008-2009 Formulation

  Day 0 and 21 days post-vaccination

• Percentage of Participants With at Least 1:40 Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone® Vaccine (Seroprotection)

  Seroprotection was defined as post-vaccination titer value of ≥ 1:40.

  21 days post-vaccination

• Percentage of Participants With at Least a 4-Fold Rise in Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone Vaccine (Seroconversion)

  Seroconversion was defined as a four-fold rise in titers or greater from baseline. If the baseline titer value is \< 10, then 10 is used as the baseline value for the purposes of this calculation

  21 days post-vaccination

Study Arms (1)

Study Group

EXPERIMENTAL

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

Biological: Split, Inactivated, Trivalent Influenza vaccine (Fluzone®)

Interventions

Split, Inactivated, Trivalent Influenza vaccine (Fluzone®) BIOLOGICAL

0.5 mL, intramuscular

Also known as: Fluzone®

Study Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (1)

Unknown Facility

Norfolk, Virginia, 23507, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Medical Director
• Organization: Sanofi Pasteur Inc.

RegistryContactUs@sanofipasteur.com

Study Officials

• Medical Director

  Sanofi Pasteur Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2008
• First Posted: August 28, 2008
• Study Start: August 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: May 16, 2016
• Results First Posted: February 23, 2010

Record last verified: 2016-04

Locations

US (1)