Safety and Immunogenicity of the 2005-2006 Fluzone® Vaccine

NCT00258830 | Completed Phase 4 Results

• 1 other identifier: GRC25
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

To describe the safety during Days 0 to 21 following injection of the 2005-2006 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 (antibodies to hemagglutinin) 21 days following injection of the 2005-2006 formulation of the inactivated, split-virion influenza vaccine Fluzone, in subjects aged 18-59 years and subjects aged ≥ 60 years. To submit remaining available sera to the Center for Biologics Evaluation and Research (CBER) for further analysis by the Food and Drug Administration (FDA), Center for Disease Control and Prevention (CDC) and the World Health Organization (WHO) to support selection and recommendation of antigen strains for subsequent influenza vaccines.

Conditions

Influenza

Keywords

Influenza vaccine

Outcome Measures

Primary Outcomes (2)

• Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Fluzone® Vaccination

  Day 0 to 3 post-vaccination

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

  GMTs and their 95% Confidence Intervals are presented for each of the 3 antigens in Fluzone® vaccine (2005-2006 Formulation)

  21 days post-vaccination

Other Outcomes (2)

• Percentage of Participants With ≥ 40 Serum Hemagglutination Inhibition Antibody Titers Post-vaccination.

  21 Days post-vaccination

• Percentage of Participants With a ≥ 4-fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-vaccination

  Day 21 post-vaccination

Study Arms (2)

Age 18 to 59 years

EXPERIMENTAL

Participants aged 18 to 59 years at enrollment.

Biological: Fluzone®: Influenza Virus Vaccine

Age 60 years and older

EXPERIMENTAL

Participants aged 60 years and older at enrollment.

Biological: Fluzone®: Influenza Virus Vaccine

Interventions

Fluzone®: Influenza Virus Vaccine BIOLOGICAL

0.5 mL, Intramuscular

Also known as: Fluzone®

Age 18 to 59 years

Eligibility Criteria

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

You may qualify if:

• 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.
• 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 (temperature ≥ 99.5°F oral) in the 72 hours preceding enrollment in the trial.
• Clinically significant findings in vital signs (including temperature ≥ 99.5°F oral) on 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 3.
• Vaccination planned in the 4 weeks following any trial vaccination.
• Participation in any other interventional drug or vaccine trial within the 30 days preceding or during enrollment into this study.
• Immunocompromising 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 posed a health risk to the subject if enrolled or interfered 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 form of contraception for the duration of the trial.
• Current abuse of alcohol or drug addiction that interfered with the subject's ability to comply with trial procedures.

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: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2005
• First Posted: November 28, 2005
• Study Start: September 1, 2005
• Primary Completion: February 1, 2006
• Study Completion: March 1, 2007
• Last Updated: April 14, 2016
• Results First Posted: June 3, 2009

Record last verified: 2016-04

Locations

US (1)