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

NCT01712984 | Completed Phase 3 Results

• 2 other identifiers: QID01U1111-1124-8066
• Study Type: interventional
• Target: 3,360
• Locations: 1 country
• Sites: 38

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.

Conditions

Influenza

Keywords

Influenza; Fluzone® Intradermal vaccine; Influenza Virus Vaccine USP Quadrivalent; Influenza Virus Vaccine USP Trivalent Types A and B

Outcome Measures

Primary Outcomes (2)

• 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

  Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay.

  Day 28 post-vaccination

• 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

  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).

  Day 28 post-vaccination

Secondary Outcomes (3)

• 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

  Day 0 (pre-vaccination) and Day 28 post-vaccination

• 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

  Day 0 (pre-vaccination) and Day 28 post-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

  Day 0 up to Day 7 post-vaccination

Study Arms (3)

QIV ID Vaccine Group

EXPERIMENTAL

Participants will receive the intradermal quadrivalent influenza vaccine

Biological: Influenza Virus Vaccine USP Quadrivalent, (Zonal Purified Subvirion) 2012 2013 Formulation

TIV ID1 Vaccine Group

ACTIVE COMPARATOR

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

TIV ID2 Group

ACTIVE COMPARATOR

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

Interventions

Influenza Virus Vaccine USP Quadrivalent, (Zonal Purified Subvirion) 2012 2013 Formulation BIOLOGICAL

0.1mL, Intradermal

Also known as: QIV ID

QIV ID Vaccine Group

Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone Intradermal BIOLOGICAL

0.1mL, Intradermal

Also known as: Fluzone® Intradermal

TIV ID2 Group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Informed consent form (ICF) has been signed and dated

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (38)

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Hoover, Alabama, 35216, United States

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Huntsville, Alabama, 35802, United States

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Chandler, Arizona, 85224, United States

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Mesa, Arizona, 85213, United States

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Phoenix, Arizona, 85020, United States

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Tucson, Arizona, 85704, United States

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Chula Vista, California, 91911, United States

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Sacramento, California, 95816, United States

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San Diego, California, 92103, United States

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Milford, Connecticut, 06460, United States

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Coral Gables, Florida, 33134, United States

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Melbourne, Florida, 32935, United States

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Pinellas Park, Florida, 33781, United States

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South Miami, Florida, 33143, United States

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Boise, Idaho, 83642, United States

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Iowa City, Iowa, 52242, United States

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Overland Park, Kansas, 66212, United States

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Wichita, Kansas, 67207, United States

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Kansas City, Missouri, 64114, United States

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Springfield, Missouri, 65802, United States

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St Louis, Missouri, 63104, United States

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Omaha, Nebraska, 68134, United States

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Binghamton, New York, 13901, United States

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Rochester, New York, 14609, United States

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Rochester, New York, 14621, United States

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Allentown, Pennsylvania, 18102, United States

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Bensalem, Pennsylvania, 19020, United States

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Warwick, Rhode Island, 02886, United States

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Mt. Pleasant, South Carolina, 29464, United States

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Dakota Dunes, South Dakota, 57049, United States

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Austin, Texas, 78745, United States

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Fort Worth, Texas, 76107, United States

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Fort Worth, Texas, 76135, United States

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San Angelo, Texas, 76904, United States

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Salt Lake City, Utah, 84109, United States

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Salt Lake City, Utah, 84121, United States

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West Jordan, Utah, 84088, United States

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Marshfield, Wisconsin, 54449, United States

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Related Publications (2)

• Gorse GJ, Falsey AR, Ozol-Godfrey A, Landolfi V, Tsang PH. Safety and immunogenicity of a quadrivalent intradermal influenza vaccine in adults. Vaccine. 2015 Feb 25;33(9):1151-9. doi: 10.1016/j.vaccine.2015.01.025. Epub 2015 Jan 19.

  PMID: 25613721 BACKGROUND

• Small RD, Ozol-Godfrey A, Yan L. On the use of nonparametric tests for comparing immunological Reverse Cumulative distribution curves (RCDCs). Vaccine. 2019 Oct 16;37(44):6737-6742. doi: 10.1016/j.vaccine.2019.09.007. Epub 2019 Sep 16.

  PMID: 31537446 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Medical Director
• Organization: Sanofi Pasteur Inc.

RegistryContactUs@sanofipasteur.com

Study Officials

• Medical Director

  Sanofi Pasteur Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2012
• First Posted: October 24, 2012
• Study Start: October 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: October 1, 2013
• Last Updated: May 7, 2015
• Results First Posted: February 10, 2014

Record last verified: 2015-04

Locations

US (38)