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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 )

Tracking Information
First Submitted Date  ICMJE October 22, 2012
First Posted Date  ICMJE October 24, 2012
Results First Submitted Date  ICMJE December 15, 2013
Results First Posted Date  ICMJE February 10, 2014
Last Update Posted Date May 7, 2015
Study Start Date  ICMJE October 2012
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2014)
  • 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.
  • 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).
Original Primary Outcome Measures  ICMJE
 (submitted: October 22, 2012)
  • Percentages of Participants with Seroconversion after Vaccination with Fluzone® Intradermal Vaccine (QIV-ID) or a Fluzone Intradermal Investigational Formulation Vaccine (TIV-ID) 2012 to 2013 Formulation. [ Time Frame: Day 0 (Pre-vaccination) and Day 28 Post-vaccination ]
    Immunogenicity endpoints on serum bactericidal antibody titers for each influenza virus strain will be measured using hemagglutination inhibition assay
  • Geometric mean titers following vaccination with Fluzone® Intradermal Vaccine (QIV-ID) or a Fluzone Intradermal Investigational Formulation Vaccine (TIV-ID) 2012 to 2013 Formulation. [ Time Frame: Day 0 (Pre-vaccination) and Day 28 Post-vaccination ]
    Immunogenicity endpoints on serum bactericidal antibody titers for each influenza virus strain will be measured using hemagglutination inhibition assay
Change History Complete list of historical versions of study NCT01712984 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2014)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2012)
  • Percentages of Participants with Seroprotection after Vaccination with Fluzone® Intradermal Vaccine (QIV-ID) or a Fluzone Intradermal Investigational Formulation Vaccine (TIV-ID) 2012 to 2013 Formulation. [ Time Frame: Day 0 (pre-vaccination) and Day 28 post-vaccination ]
    Immunogenicity endpoints on serum bactericidal antibody titers for each influenza virus strain will be measured using hemagglutination inhibition assay
  • Number of Participants Reporting Solicited Injection Site Reactions, Solicited Systemic Reactions, Unsolicited Systemic Reactions, and Serious Adverse Events Occurring Throughout the Trial [ Time Frame: Day 0 to 28 post-vaccination ]
    Solicited injection site reactions: Pain, Erythema, Swelling, Induration, Ecchymosis, and Pruritus. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Intradermal Quadrivalent Influenza Vaccine in Adults Aged 18 Through 64 Years
Official Title  ICMJE Immunogenicity and Safety Trial of Quadrivalent Influenza Vaccine Administered by Intradermal Route in Adult Subjects Aged 18 Through 64 Years
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Influenza
Intervention  ICMJE
  • Biological: Influenza Virus Vaccine USP Quadrivalent, (Zonal Purified Subvirion) 2012 2013 Formulation
    0.1mL, Intradermal
    Other Name: QIV ID
  • Biological: Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone® Intradermal
    0.1mL, Intradermal
    Other Name: Fluzone® Intradermal
  • Biological: Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone Intradermal
    0.1mL, Intradermal
    Other Name: Fluzone® Intradermal
Study Arms  ICMJE
  • Experimental: QIV ID Vaccine Group
    Participants will receive the intradermal quadrivalent influenza vaccine
    Intervention: Biological: Influenza Virus Vaccine USP Quadrivalent, (Zonal Purified Subvirion) 2012 2013 Formulation
  • Active Comparator: TIV ID1 Vaccine Group
    Participants will receive the trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage
    Intervention: Biological: Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone® Intradermal
  • Active Comparator: TIV ID2 Group
    Participants will receive the intradermal trivalent influenza vaccine containing B strain from the alternate (Victoria) lineage
    Intervention: Biological: Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone Intradermal
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 7, 2013)
3360
Original Estimated Enrollment  ICMJE
 (submitted: October 22, 2012)
3348
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01712984
Other Study ID Numbers  ICMJE QID01
U1111-1124-8066 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi ( Sanofi Pasteur, a Sanofi Company )
Study Sponsor  ICMJE Sanofi Pasteur, a Sanofi Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Sanofi Pasteur Inc.
PRS Account Sanofi
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP