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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01712984
First received: October 22, 2012
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 3360
Study Start Date: October 2012
Study Completion Date: October 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01712984

  Show 38 Study Locations
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01712984     History of Changes
Other Study ID Numbers: QID01, U1111-1124-8066
Study First Received: October 22, 2012
Results First Received: December 15, 2013
Last Updated: January 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Influenza
Fluzone® Intradermal vaccine
Influenza Virus Vaccine USP Quadrivalent
Influenza Virus Vaccine USP Trivalent Types A and B

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
Respiratory Tract Diseases
Respiratory Tract Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 22, 2014