Study of Fluzone Vaccine Administered by Intradermal Route in Comparison With Standard Fluzone® in Adults

Influenza Clinical Trial

Official title:

Lot Consistency, Immunogenicity, and Safety Study of Three Lots of Fluzone Vaccine Administered by Intradermal Route in Comparison With Standard Fluzone® Administered Intramuscularly in Adult Subjects Aged 18 to 64 Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00772109
• Other study ID #: FID31
• Status: Completed
• Phase: Phase 3
• First received: October 13, 2008
• Last updated: April 12, 2016
• Start date: October 2008
• Est. completion date: July 2009

Study information

• Verified date: April 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is designed to test lot consistency of three different manufacturing lots and to generate safety and immunogenicity data of the investigational vaccine administered via the ID route.

Primary Objective:

• To demonstrate lot consistency of the Fluzone ID manufacturing process.

• To provide information concerning the immune response of Fluzone ID.

Secondary Objectives:

Safety

• To describe the safety profile of subjects who receive of Fluzone ID.

Description:

Three lots of the investigational Fluzone vaccine with the 2008/2009 Northern Hemisphere formulation will be administered intradermally (ID) using the Becton Dickinson Micro Injection System.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4292
• Est. completion date: July 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria :

• Aged 18 to 64 years on the day of vaccination.

• Informed consent form signed and dated.

• Able to attend all scheduled visits and to comply with all trial procedures.

• For women of child bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to vaccination, until at least 4 weeks after vaccination.

Exclusion Criteria :

• Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances.

• For a woman of child-bearing potential: known pregnancy or positive serum/urine pregnancy test.

• Breast-feeding woman.

• Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the four weeks preceding the trial vaccination.

• Planned participation in another clinical trial during the present trial period.

• Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy

• Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator.

• Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures.

• Receipt of blood or blood-derived products in the past 3 months that might interfere with the assessment of immune response.

• Receipt of any vaccination in the 4 weeks preceding the trial vaccination.

• Planned receipt of any vaccine in the 4 weeks following the trial vaccination.

• Previous vaccination against influenza in the past 6 months with the trial vaccine or another vaccine.

• Thrombocytopenia or bleeding disorder in the 3 weeks preceding inclusion.

• Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.

• Neoplastic disease or any hematologic malignancy, (except localized skin or prostate cancer that is stable at the time of vaccination in the absence of therapy, and subjects who have a history of neoplastic disease and who have been disease free for >=5 years).

• Personal or family history of Guillain-Barré Syndrome.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infection
• Influenza
• Myxovirus Infection
• Orthomyxoviridae Infection
• Orthomyxoviridae Infections

Intervention

Biological:
• Influenza Virus Vaccine USP Trivalent Types A and B
0.1 mL, Intradermal
• Influenza Virus Vaccine USP Trivalent Types A and B
0.1 mL, Intradermal
• Influenza Virus Vaccine USP Trivalent Types A and B
0.1 mL, Intradermal
• Influenza Virus Vaccine USP Trivalent Types A and B
0.5 mL, Intramuscular

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines	The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay	Baseline (Day 0) and 28 Days post-vaccination	No
Primary	Percentage of Participants Who Achieved Seroconversion Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine	The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay.; Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and post-vaccination titer of = 1:40, or a pre-vaccination titer = 1:10 and a minimum of four-fold increase 28 days post-vaccination.	28 Days post-vaccination	No
Secondary	Percentage of Participants Who Achieved Seroprotection Pre- and Post-vaccination With Either Fluzone ID or Fluzone IM	The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay.; Seroprotection was defined as a HAI antibody titer = 1:40.	Before and 28 Days post-vaccination	No
Secondary	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine	Solicited injection site reactions: Ecchymosis, Erythema, Induration, Pain, Pruritus, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering.	Day 0 up to 7 Days post vaccination	No

External Links

•   Link
•   Link