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Study of Recombinant Influenza Vaccine Containing Different H3 Antigens Without or With Adjuvant in Healthy Adult Subjects (FBP00004)

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ClinicalTrials.gov Identifier: NCT04451954
Recruitment Status : Recruiting
First Posted : June 30, 2020
Last Update Posted : November 17, 2020
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Brief Summary:

The primary objectives of the study are:

  • To describe the safety profile of the different formulations in all participants
  • To describe the hemagglutinin inhibition (HAI) and seroneutralization (SN) antibody responses against hemagglutinin (H1, H3, B/Victoria, and B/Yamagata) antigens present in the control vaccine in all groups at all timepoints.

The secondary objectives are:

  • To describe antigenic coverage in each group by assessing the HAI and SN antibody responses against a panel of H3 antigens (not present in any of the vaccine formulations).
  • To describe SN antibody responses in each group against each of the H3 antigens.
  • To compare H3 HAI and SN antibody responses for the groups with quadrivalent recombinant influenza vaccine (RIV) formulations with H3 antigens to those of the quadrivalent RIV control group.
  • To compare the HAI and SN antibody responses for the groups with quadrivalent RIV formulation with adjuvant to the group without adjuvant.

Condition or disease Intervention/treatment Phase
Influenza Biological: Quadrivalent RIV with H3 strain 1 Biological: Quadrivalent RIV with H3 strain 1 and adjuvant Biological: Quadrivalent RIV with H3 strain 2 Biological: Quadrivalent RIV with H3 strain 2 and adjuvant Biological: Quadrivalent RIV with 2018-2019 NH H3 strain Biological: Quadrivalent RIV with 2018-2019 NH H3 strain and adjuvant Phase 1

Detailed Description:
Study duration per participant is approximately 1 year

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity of Quadrivalent Recombinant Influenza Vaccine Formulations Containing Different H3 Hemagglutinin Antigens Without or With Adjuvant in Healthy Adult Subjects
Actual Study Start Date : July 2, 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: Group 1: Quadrivalent RIV with H3 strain 1, without adjuvant
1 injection of quadrivalent RIV containing H3 strain 1, without adjuvant, in participants ≥ 50 years old
Biological: Quadrivalent RIV with H3 strain 1
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

Experimental: Group 2: Quadrivalent RIV with H3 strain 1, with adjuvant
1 injection of quadrivalent RIV containing H3 strain 1, with adjuvant, in participants ≥ 50 years old
Biological: Quadrivalent RIV with H3 strain 1 and adjuvant
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

Experimental: Group 3: Quadrivalent RIV with H3 strain 2, without adjuvant
1 injection of quadrivalent RIV containing H3 strain 2, without adjuvant, in participants ≥ 50 years old
Biological: Quadrivalent RIV with H3 strain 2
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

Experimental: Group 4: Quadrivalent RIV with H3 strain 2, with adjuvant
1 injection of quadrivalent RIV containing H3 strain 2, with adjuvant, in participants ≥ 50 years old
Biological: Quadrivalent RIV with H3 strain 2 and adjuvant
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

Active Comparator: Group 5: Quadrivalent RIV Control, without adjuvant
1 injection of quadrivalent RIV containing 2018-19 Northern Hemisphere (NH) recommended H3 strain, without adjuvant, in participants ≥ 50 years old
Biological: Quadrivalent RIV with 2018-2019 NH H3 strain
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

Active Comparator: Group 6: Quadrivalent RIV Control, with adjuvant
1 injection of quadrivalent RIV containing 2018-19 NH recommended H3 strain, with adjuvant, in participants ≥ 50 years old
Biological: Quadrivalent RIV with 2018-2019 NH H3 strain and adjuvant
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

Active Comparator: Group 7: Quadrivalent RIV Control, without adjuvant
1 injection of quadrivalent RIV containing 2018-19 NH recommended H3 strain, without adjuvant, in participants 18-30 years old
Biological: Quadrivalent RIV with 2018-2019 NH H3 strain
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular




Primary Outcome Measures :
  1. Number of participants with immediate adverse events [ Time Frame: Within 30 minutes after vaccination ]
    Immediate adverse events are unsolicited systemic adverse events reported in the 30 minutes after vaccination

  2. Number of participants with solicited injection site or systemic reactions [ Time Frame: From Day 0 to Day 7 ]
    Solicited injection site reactions: injection site pain, erythema, swelling, induration and bruising; solicited systemic reactions: fever, headache, malaise, and myalgia

  3. Number of participants with unsolicited adverse events [ Time Frame: From Day 0 to Day 28 ]
    Unsolicited (spontaneously reported) adverse events not not fulfilling criteria for solicited reactions

  4. Number of participants with serious adverse events [ Time Frame: From Day 0 to Day 365 ]
    Serious adverse events are collected throughout the study

  5. Number of participants with adverse events of special interest [ Time Frame: From Day 0 to Day 365 ]
    Adverse events of special interest are collected throughout the study

  6. Clinical safety laboratory test results [ Time Frame: From Day 0 to Day 7 ]
    Laboratory tests include complete blood count (CBC), platelet count, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, serum creatinine, serum lipase, and serum amylase)

  7. HAI and SN antibody titers against influenza antigens in the quadrivalent RIV control vaccine [ Time Frame: From Day 0 to Day 365 ]
    Influenza antibody titers are measured by HAI and SN assays

  8. Individual HAI and SN titers ratio against influenza antigens in the quadrivalent RIV control vaccine [ Time Frame: From Day 0 to Day 90 ]
    Titers ratio is calculated for the following time points: Day 7/Day 0, Day 28/Day 0, and Day 90/Day 0

  9. Number of participants with seroconversion to influenza antigens in the quadrivalent RIV control vaccine [ Time Frame: From Day 0 to Day 28 ]
    Seroconversion is defined as HAI antibody titer < 10 [1/dil] at Day 0 and post-injection titer ≥ 40 [1/dil] at Day 28, or titer ≥ 10 [1/dil] at Day 0 and a ≥ 4-fold increase in titer [1/dil] at Day 28)

  10. HAI Ab titer ≥ 40 [1/dil] [ Time Frame: From Day 0 to Day 365 ]
    Influenza vaccine antibody titers are measured by HAI assay

  11. 2-fold and 4-fold increase in SN titers [ Time Frame: From Day 0 to Day 28 ]
    Influenza vaccine antibody titers are measured by SN assay


Secondary Outcome Measures :
  1. HAI antibody titers against influenza H3 antigens not present in the vaccine formulations and the SN antibody titers against each of the H3 antigens [ Time Frame: Day 0, Day 7, Day 28, Day 90, Day 180, and Day 365 ]
    Influenza vaccine antibody titers are measured by HAI and SN assays

  2. Individual HAI titer ratios against influenza H3 antigens not present in the vaccine formulations and individual SN titer ratio against each of the H3 antigens [ Time Frame: From Day 0 to Day 90 ]
    Titer ratio is calculated for the following time points: Day 7/Day 0, Day 28/Day 0, Day 90/Day 0

  3. Number of participants with seroconversion to influenza H3 antigens not present in the vaccine formulations [ Time Frame: Day 0 and Day 28 ]
    Seroconversion is defined as HAI antibody titer < 10 [1/dil] at Day 0 and post-injection titer ≥ 40 [1/dil] at Day 28, or titer ≥ 10 [1/dil] at Day 0 and a ≥ 4-fold increase in titer [1/dil] at Day 28)

  4. 2-fold and 4-fold rise in SN antibody titers against each of the H3 antigens [ Time Frame: Day 0, Day 7, Day 28, Day 90, Day 180, and Day 365 ]
    Influenza vaccine antibody titers a are measured by SN assay



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria :

  • Older adults: Aged 50 years and older on the day of inclusion Young adults: Aged 18 to 30 years on the day of inclusion
  • Informed consent form has been signed and dated
  • Able to attend all scheduled visits and to comply with all trial procedures

Exclusion criteria:

  • Participant is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 12 weeks postvaccination. To be considered of non-childbearing potential, a female must be premenarche, or postmenopausal for at least 1 year, or surgically sterile
  • Participation at the time of study enrollment (or in the 4 weeks preceding the study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
  • Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned receipt of any vaccine in the 4 weeks following study vaccination
  • Previous vaccination against influenza during either of the previous 2 influenza seasons (2018-2019 and 2019-2020) with any licensed or investigational influenza vaccine
  • Receipt of immune globulins, blood, or blood-derived products in the past 3 months
  • Known or suspected congenital or acquired immunodeficiency; immunosuppressive therapy (such as anticancer 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) or receipt of hydroxychloroquine within the preceding 4 weeks
  • Dementia or any other cognitive condition at a stage that could interfere with following the trial procedures
  • Have known active or recently active (12 months) neoplastic disease or a history of any hematologic malignancy
  • History of influenza infection during either of the previous 2 influenza seasons (2018- 2019 or 2019-2020), confirmed by laboratory tests (including rapid tests) at that time
  • History of laboratory confirmed coronavirus disease 2019 (COVID-19), confirmed with a nucleic acid amplification test on a respiratory specimen, or known exposure to severe acute respiratory syndrome coronavirus (SARS-CoV-2) positive confirmed close contact (eg, family member, housemate, daycare provider, aged parent requiring care), in the 30 days preceding vaccination, at the discretion of the investigator
  • Self-reported or documented seropositivity for human immunodeficiency virus, hepatitis B, or hepatitis C
  • Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances
  • Have any diagnosis, current or past, of an autoimmune disease
  • Thrombocytopenia or bleeding disorder, contraindicating intramuscular vaccination based on investigator's judgment
  • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
  • Any change in chronic prescription medication or change in medication dose or dosage in the 60 days prior to enrollment
  • Alcohol abuse or substance abuse that, in the opinion of the investigator, might interfere with the study conduct or completion
  • Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
  • Any current or past diagnosis of chronic pulmonary disease including asthma (history of childhood asthma is allowed), cystic fibrosis and chronic pulmonary obstructive disease
  • Have taken a high-dose inhaled corticosteroid within 6 months prior to study vaccination
  • Body mass index of 40 or higher
  • Any current or past diagnosis of cardiac disease (eg, coronary artery disease, heart failure, or valvular heart disease [mild mitral valve prolapse allowed]). Participants with isolated primary (essential) hypertension are allowed
  • Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (oral temperature ≥100.4 F [≥38.0 C]). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
  • Identified as an investigator or employee of the investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the investigator or employee with direct involvement in the proposed study
  • Personal or family history of Guillain-Barré syndrome
  • History of chronic kidney disease
  • Current or past diagnosis of thyroid disease (eg, thyroiditis [including Hashimoto's thyroiditis], hyperthyroidism, and hypothyroidism)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.


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): NCT04451954


Contacts
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Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext option 6 Contact-US@sanofi.com

Locations
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United States, California
Investigational Site Number 8400003 Recruiting
San Diego, California, United States, 92108
United States, Florida
Investigational Site Number 8400002 Recruiting
Melbourne, Florida, United States, 32934
Investigational Site Number 8400004 Recruiting
Orlando, Florida, United States, 32806
United States, Illinois
Investigational Site Number 8400001 Recruiting
Peoria, Illinois, United States, 61614
United States, Maryland
Investigational Site Number 8400005 Recruiting
Rockville, Maryland, United States, 20850
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Clinical Sciences & Operations Sanofi Pasteur, a Sanofi Company
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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT04451954    
Other Study ID Numbers: FBP00004
U1111-1239-0391 ( Other Identifier: UTN )
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases