Study of Influenza Vaccine Revaccination in Healthy Adults Previously Vaccinated With Fluzone ID or Fluzone IM

Influenza Clinical Trial

Official title:

Safety and Immunogenicity of Revaccination With Influenza Vaccine in Healthy Adult Subjects Aged 18 to 64 Years Who Were Previously Vaccinated With Fluzone ID or Fluzone IM

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01011049
• Other study ID #: FID33
• Secondary ID: UTN: U1111-1111-
• Status: Completed
• Phase: Phase 2
• First received: November 9, 2009
• Last updated: April 12, 2016
• Start date: September 2009
• Est. completion date: October 2010

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

The purpose of this study is to generate additional data on the immunogenicity and safety of revaccination with Fluzone Intradermal (ID) or Fluzone Intramuscular (IM) vaccine.

Primary Objective:

• To evaluate and describe the safety profile of revaccination with Fluzone ID for all participants.

Secondary Objective:

• To describe immunogenicity following revaccination with Fluzone ID or Fluzone IM.

Description:

All participants, who previously received either Fluzone ID or Fluzone IM in Study FID31 (NCT 00772109), will receive one dose of either the same or the alternative vaccine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1250
• Est. completion date: October 2010
• Est. primary completion date: May 2010
• 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 in study FID33

• Enrolled in and completed study FID31 (NCT 00772109) and received the correct vaccine (Fluzone ID or Fluzone® IM) for the group to which they were randomized

• Informed consent form signed and dated

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

• For a woman 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 (observational trials will be allowed)

• 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

• Known human immunodeficiency virus (HIV), hepatitis B surface (HBs) antigen, or Hepatitis C seropositivity.

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

• Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination

• 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, (those who have localized skin or prostate cancer that is stable at the time of vaccination in the absence of therapy, as well as subjects who have a history of neoplastic disease and who have been disease free for = 5 years will not be excluded).

• Personal or family history of Guillain-Barré Syndrome

Temporary Exclusion Criteria:

A prospective subject should not be included in the study until the following conditions and/or symptoms are resolved:

• Febrile illness (temperature = 37.5°C [or = 99.5°F]) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment

• Signs and symptoms of an acute infectious respiratory illness.

Study Design

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

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	Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine	Solicited injection site reactions: Erythema (redness), Swelling, Induration, Pain, Pruritus, Ecchymosis. Solicited systemic reactions: Headache, Myalgia, Malaise, Shivering, Fever (temperature).	Day 0 through Day 7 post-vaccination	No
Secondary	Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine	Serum antibody titers for influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by the hemagglutinin inhibition (HAI) assay.	Day 0 and Day 28 post-vaccination	No
Secondary	Percentage of Participants Who Achieved Seroprotection Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine.	Seroprotection was defined as a hemagglutinin inhibition (HAI) titer = 1:40 at Day 28 post-vaccination.	Day 28 post-vaccination	No
Secondary	Percentage of Subjects Who Achieved Seroconversion After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine	Seroconversion was defined as either a pre vaccination hemagglutinin inhibition (HAI) titer < 1:10 and a post vaccination titer = 1:40 or a pre-vaccination titer = 1:10 and a minimum 4 fold increase at 28 days post-vaccination.	Day 28 post vaccination	No

External Links

•   Link
•   Link