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

NCT00835926 | Completed Phase 4 Results

• 1 other identifier: GRC16
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza

Keywords

Influenza; Fluzone®

Outcome Measures

Primary Outcomes (4)

• Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone®

  Solicited injection site reactions: Erythema, bruising, induration, and Pain at injection site. Solicited systemic reaction: Fever (temperature), chills, rash, headache, cough, runny nose, nausea, vomiting, diarrhea, malaise, myalgia, and arthralgia

  Days 0 to 3 Post-vaccination

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

  Hemagglutination inhibition antibodies is a measure of the serum antibody to the influenza virus in the vaccine as determined by the hemagglutinin inhibition (HAI) assay.

  Day 0 and Day 21 Post-vaccination

• Percentage of Participants With a ≥ 4-Fold Rise in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone®

  Hemagglutination inhibition antibodies is a measure of the serum antibody to the influenza virus in the vaccine as determined by the hemagglutinin inhibition (HAI) assay.

  Day 21 Post-vaccination

• Percentage of Participants With Serum Hemagglutination Inhibition Antibody Titers ≥ 40 Post-Vaccination With Fluzone®

  Hemagglutination inhibition antibodies is a measure of the serum antibody to the influenza virus in the vaccine as determined by the hemagglutinin inhibition (HAI) assay

  Day 21 Post-vaccination

Study Arms (2)

Fluzone® Vaccine Group 1

EXPERIMENTAL

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

Biological: Influenza virus vaccine

Fluzone® Vaccine Group 2

EXPERIMENTAL

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

Biological: Influenza virus vaccine

Interventions

Influenza virus vaccine BIOLOGICAL

0.5 mL, Intramuscular

Also known as: Fluzone®

Fluzone® Vaccine Group 1

Eligibility Criteria

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

You may qualify if:

• 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.

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 \>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.

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: January 27, 2009
• First Posted: February 4, 2009
• Study Start: July 1, 2003
• Primary Completion: September 1, 2003
• Study Completion: September 1, 2003
• Last Updated: April 14, 2016
• Results First Posted: October 26, 2009

Record last verified: 2016-04

Locations

US (1)