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

• ClinicalTrials.gov Identifier: NCT01011049
• Recruitment Status: Completed
• First Posted: November 11, 2009
• Results First Posted: August 11, 2011
• Last Update Posted: April 14, 2016
• Sponsor: Sanofi Pasteur, a Sanofi Company
• Information provided by (Responsible Party): Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Influenza	Biological: Influenza Virus Vaccine USP Trivalent Types A and B	Phase 2

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1250 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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
• Study Start Date: September 2009
• Actual Primary Completion Date: May 2010
• Actual Study Completion Date: October 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: Group 1: Fluzone ID After Fluzone ID; Participants will receive Fluzone intradermal (ID) following Fluzone ID in Study FID31	Biological: Influenza Virus Vaccine USP Trivalent Types A and B; 0.1 mL, Intradermal
Experimental: Group 2: Fluzone IM After Fluzone ID; Participants will receive Fluzone intramuscular (IM) following Fluzone ID in Study FID31	Biological: Influenza Virus Vaccine USP Trivalent Types A and B; 0.5 mL, Intramuscular; Other Name: Fluzone® 2009/2010 Northern Hemisphere Formulation
Experimental: Group 3: Fluzone IM After Fluzone IM; Participants will receive Fluzone intramuscular (IM) following Fluzone IM in Study FID31	Biological: Influenza Virus Vaccine USP Trivalent Types A and B; 0.5 mL, Intramuscular; Other Name: Fluzone® 2009/2010 Northern Hemisphere Formulation
Experimental: Group 4: Fluzone ID After Fluzone IM; Participants will receive Fluzone intradermal (ID) following Fluzone intramuscular (IM) in Study FID31	Biological: Influenza Virus Vaccine USP Trivalent Types A and B; 0.1 mL, Intradermal

Outcome Measures

Primary Outcome Measures :

1. Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine [ Time Frame: Day 0 through Day 7 post-vaccination ]
   Solicited injection site reactions: Erythema (redness), Swelling, Induration, Pain, Pruritus, Ecchymosis. Solicited systemic reactions: Headache, Myalgia, Malaise, Shivering, Fever (temperature).

Secondary Outcome Measures :

1. Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine [ Time Frame: Day 0 and Day 28 post-vaccination ]
   Serum antibody titers for influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by the hemagglutinin inhibition (HAI) assay.
2. Percentage of Participants Who Achieved Seroprotection Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine. [ Time Frame: Day 28 post-vaccination ]
   Seroprotection was defined as a hemagglutinin inhibition (HAI) titer ≥ 1:40 at Day 28 post-vaccination.
3. Percentage of Subjects Who Achieved Seroconversion After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine [ Time Frame: Day 28 post vaccination ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 64 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

United States, Alabama

Hoover, Alabama, United States, 35216

Huntsville, Alabama, United States, 35802

Mobile, Alabama, United States, 36608

United States, Arizona

Chandler, Arizona, United States, 85224

Mesa, Arizona, United States, 85213

Tempe, Arizona, United States, 85282

Tucson, Arizona, United States, 85711

United States, California

Fountain Valley, California, United States, 92708

San Diego, California, United States, 92103

United States, Connecticut

Milford, Connecticut, United States, 06460

United States, Florida

Melbourne, Florida, United States, 32935

Pembroke Pines, Florida, United States, 33024

Pinellas Park, Florida, United States, 33781

United States, Idaho

Boise, Idaho, United States, 83642

United States, Illinois

Chicago, Illinois, United States, 60610

United States, Iowa

Iowa City, Iowa, United States, 52242

United States, Kansas

Wichita, Kansas, United States, 67207

United States, Kentucky

Lexington, Kentucky, United States, 40509

Madisonville, Kentucky, United States, 42431

United States, Maryland

Rockville, Maryland, United States, 20850

United States, Missouri

Kansas City, Missouri, United States, 64114

Springfield, Missouri, United States, 65802

St. Louis, Missouri, United States, 63104

United States, New Mexico

Albuquerque, New Mexico, United States, 87108

United States, New York

Binghamton, New York, United States, 13901

Endwell, New York, United States, 13760

Rochester, New York, United States, 14609

Rochester, New York, United States, 14621

United States, North Carolina

Cary, North Carolina, United States, 27518

Raleigh, North Carolina, United States, 27609

United States, Ohio

Cincinnati, Ohio, United States, 45249

United States, Pennsylvania

Allentown, Pennsylvania, United States, 18102

Bensalem, Pennsylvania, United States, 19020

United States, Rhode Island

Warwick, Rhode Island, United States, 02886

United States, South Carolina

Mt. Pleasant, South Carolina, United States, 29464

United States, Tennessee

Nashville, Tennessee, United States, 37203

United States, Texas

Austin, Texas, United States, 78705

Fort Worth, Texas, United States, 76107

Fort Worth, Texas, United States, 76135

San Angelo, Texas, United States, 76904

United States, Utah

Salt Lake City, Utah, United States, 84121

Salt Lake, Utah, United States, 84109

West Jordan, Utah, United States, 84088

United States, Wisconsin

Marshfield, Wisconsin, United States, 54449

Puerto Rico

San Juan, Puerto Rico, 00918

Sponsors and Collaborators

Sanofi Pasteur, a Sanofi Company

Investigators

• Study Director: Medical Director; Sanofi Pasteur Inc.

More Information

Additional Information:

Related Info 

• Responsible Party: Sanofi Pasteur, a Sanofi Company
• ClinicalTrials.gov Identifier: NCT01011049
• Other Study ID Numbers: FID33; UTN: U1111-1111-5095 ( Other Identifier: WHO )
• First Posted: November 11, 2009
• Results First Posted: August 11, 2011
• Last Update Posted: April 14, 2016
• Last Verified: April 2016

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):

Influenza; Fluzone Vaccine; Intradermal Injections; Adults

Additional relevant MeSH terms:

Influenza, Human; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Vaccines; Immunologic Factors; Physiological Effects of Drugs