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Study of Intradermal Quadrivalent Influenza Vaccine in Adults Aged 18 Through 64 Years

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ClinicalTrials.gov Identifier: NCT01712984
Recruitment Status : Completed
First Posted : October 24, 2012
Results First Posted : February 10, 2014
Last Update Posted : May 7, 2015
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Description
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Brief Summary:

The aim of the study is to demonstrate safety and immunogenicity of the quadrivalent influenza intradermal (QIV-ID) vaccine compared to the trivalent influenza vaccine (TIV) containing the B strain from the primary (Yamagata) lineage (TIV-ID1) and the trivalent influenza vaccine containing B strain from the alternate (Victoria) lineage (TIV-ID2) vaccines in producing protection against four strains of influenza virus.

Primary Objective:

  • To demonstrate that QIV-ID induces an immune response (as assessed by hemagglutination inhibition (HAI) geometric mean titers (GMTs) and seroconversion rates) that is non-inferior to responses induced by TIV-ID1 and TIV-ID2 for the 4 virus strains at 28 days post-vaccination.

Secondary Objectives:

  • To demonstrate that each B strain in QIV-ID induces an immune response (as assessed by HAI GMTs and seroconversion rates) that is superior to the response induced by the TIV-ID that does not contain the corresponding B strain.
  • To describe the rate of post-vaccination seroprotection induced by QIV-ID and TIV-ID.
  • To describe post-vaccination immunogenicity stratified by age (18-49 years and 50-64 years), race, ethnicity, gender, previous vaccination status, and baseline seropositivity status.
  • To describe the safety profile for subjects who receive QIV-ID and TIV-ID.

Observational Objectives:

  • To demonstrate non-inferiority of QIV-ID compared to TIV-ID in terms of all Grade 2 or Grade 3 solicited systemic reactions combined
  • To demonstrate non-inferiority of QIV-ID compared to TIV-ID in terms of all Grade 3 solicited injection site reactions combined.

Condition or disease Intervention/treatment Phase
Influenza Biological: Influenza Virus Vaccine USP Quadrivalent, (Zonal Purified Subvirion) 2012 2013 Formulation Biological: Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone® Intradermal Biological: Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone Intradermal Phase 3

Detailed Description:
All participants will receive a single dose of their assigned vaccine on Day 0. A subset of the participants will be assessed for immunologic response on Day 0 before vaccination and Day 28 after vaccination. All subjects will be monitored for safety for up to 6 months after vaccination.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety Trial of Quadrivalent Influenza Vaccine Administered by Intradermal Route in Adult Subjects Aged 18 Through 64 Years
Study Start Date : October 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: QIV ID Vaccine Group
Participants will receive the intradermal quadrivalent influenza vaccine
 Biological: Influenza Virus Vaccine USP Quadrivalent, (Zonal Purified Subvirion) 2012 2013 Formulation
0.1mL, Intradermal
Other Name: QIV ID
Active Comparator: TIV ID1 Vaccine Group
Participants will receive the trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage
 Biological: Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone® Intradermal
0.1mL, Intradermal
Other Name: Fluzone® Intradermal
Active Comparator: TIV ID2 Group
Participants will receive the intradermal trivalent influenza vaccine containing B strain from the alternate (Victoria) lineage
 Biological: Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone Intradermal
0.1mL, Intradermal
Other Name: Fluzone® Intradermal


Outcome Measures
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Primary Outcome Measures :
  1. Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route [ Time Frame: Day 28 post-vaccination ]
    Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay.

  2. Number of Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route [ Time Frame: Day 28 post-vaccination ]
    Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay. Seroconversion was defined as titer< 10 (1/dil) on Day 0 and post injection titer ≥ 40 (1/dil) on Day 28, or titer ≥10 (1/dil) on Day 0 and a ≥4 fold increase in titer (1/dil) on Day 28).


Secondary Outcome Measures :
  1. Geometric Mean Titers Against the Influenza Virus Antigens Before and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route [ Time Frame: Day 0 (pre-vaccination) and Day 28 post-vaccination ]
    Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay.

  2. Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before (Baseline) and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route [ Time Frame: Day 0 (pre-vaccination) and Day 28 post-vaccination ]
    Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay. Seroprotection was defined as titer ≥ 40 [1/dil] at baseline and 28 days after vaccination.

  3. Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route [ Time Frame: Day 0 up to Day 7 post-vaccination ]
    Solicited injection site: Pain, Erythema, Swelling, Induration, Ecchymosis, and Pruritus; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 injection site: Pain and Pruritus Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis >100 mm. Grade 3 systemic reactions: Fever ≥39˚C; Headache, Malaise, Myalgia, and Shivering Significant preventing daily activity.


Eligibility Criteria
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Information from the National Library of Medicine

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

Inclusion Criteria:

  • Aged 18 through 64 years on the day of inclusion
  • Informed consent form (ICF) has been signed and dated
  • Able to attend all scheduled visits and to comply with all trial procedures. Exclusion Criteria:
  • Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination)
  • Participation at the time of trial enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
  • Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following trial vaccination
  • Vaccination against influenza in the past 6 months
  • Receipt of immune globulins, blood or blood-derived products in the past 3 months
  • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
  • Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
  • History of thrombocytopenia
  • Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion
  • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
  • Current alcohol abuse or drug addiction
  • Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
  • Identified as an Investigator or employee of the Investigator or trial center with direct involvement in the proposed trial, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed trial
  • Personal or family history of Guillain-Barré Syndrome
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01712984


Locations
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United States, Alabama
Hoover, Alabama, United States, 35216
Huntsville, Alabama, United States, 35802
United States, Arizona
Chandler, Arizona, United States, 85224
Mesa, Arizona, United States, 85213
Phoenix, Arizona, United States, 85020
Tucson, Arizona, United States, 85704
United States, California
Chula Vista, California, United States, 91911
Sacramento, California, United States, 95816
San Diego, California, United States, 92103
United States, Connecticut
Milford, Connecticut, United States, 06460
United States, Florida
Coral Gables, Florida, United States, 33134
Melbourne, Florida, United States, 32935
Pinellas Park, Florida, United States, 33781
South Miami, Florida, United States, 33143
United States, Idaho
Boise, Idaho, United States, 83642
United States, Iowa
Iowa City, Iowa, United States, 52242
United States, Kansas
Overland Park, Kansas, United States, 66212
Wichita, Kansas, United States, 67207
United States, Missouri
Kansas City, Missouri, United States, 64114
Springfield, Missouri, United States, 65802
St. Louis, Missouri, United States, 63104
United States, Nebraska
Omaha, Nebraska, United States, 68134
United States, New York
Binghamton, New York, United States, 13901
Rochester, New York, United States, 14609
Rochester, New York, United States, 14621
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, South Dakota
Dakota Dunes, South Dakota, United States, 57049
United States, Texas
Austin, Texas, United States, 78745
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, 84109
Salt Lake City, Utah, United States, 84121
West Jordan, Utah, United States, 84088
United States, Wisconsin
Marshfield, Wisconsin, United States, 54449
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Medical Director Sanofi Pasteur Inc.
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT01712984    
Other Study ID Numbers: QID01
U1111-1124-8066 ( Other Identifier: WHO )
First Posted: October 24, 2012    Key Record Dates
Results First Posted: February 10, 2014
Last Update Posted: May 7, 2015
Last Verified: April 2015
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Influenza
Fluzone® Intradermal vaccine
Influenza Virus Vaccine USP Quadrivalent
Influenza Virus Vaccine USP Trivalent Types A and B
Additional relevant MeSH terms:
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Influenza, Human
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases
Fluconazole
Vaccines
Immunologic Factors
Physiological Effects of Drugs
 Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors