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

Influenza Clinical Trial

Official title:

Safety and Immunogenicity of Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone® 2003/2004

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00835926
• Other study ID #: GRC16
• Status: Completed
• Phase: Phase 4
• First received: January 27, 2009
• Last updated: April 12, 2016
• Start date: July 2003
• Est. completion date: September 2003

Study information

• Verified date: April 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: September 2003
• Est. primary completion date: September 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Influenza virus vaccine
0.5 mL, Intramuscular
• Influenza virus vaccine
0.5 mL, Intramuscular

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	No
Primary	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	No
Primary	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	No

External Links

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