Study of Recombinant Influenza Vaccine Containing Different H3 Antigens Without or With Adjuvant in Healthy Adult Subjects
NCT ID: NCT04451954
Last Updated: 2025-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
210 participants
INTERVENTIONAL
2020-07-02
2021-09-20
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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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
Quadrivalent RIV with H3 strain 1
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
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
Quadrivalent RIV with H3 strain 1 and adjuvant
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
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
Quadrivalent RIV with H3 strain 2
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
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
Quadrivalent RIV with H3 strain 2 and adjuvant
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
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
Quadrivalent RIV with 2018-2019 NH H3 strain
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
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
Quadrivalent RIV with 2018-2019 NH H3 strain and adjuvant
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
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
Quadrivalent RIV with 2018-2019 NH H3 strain
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Interventions
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Quadrivalent RIV with H3 strain 1
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Quadrivalent RIV with H3 strain 1 and adjuvant
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Quadrivalent RIV with H3 strain 2
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Quadrivalent RIV with H3 strain 2 and adjuvant
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Quadrivalent RIV with 2018-2019 NH H3 strain
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Quadrivalent RIV with 2018-2019 NH H3 strain and adjuvant
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Eligibility Criteria
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Inclusion Criteria
* Informed consent form has been signed and dated
* Able to attend all scheduled visits and to comply with all trial procedures
Exclusion Criteria
* 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.
18 Years
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi Pasteur, a Sanofi Company
Locations
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Investigational Site Number 8400003
San Diego, California, United States
Investigational Site Number 8400002
Melbourne, Florida, United States
Investigational Site Number 8400004
Orlando, Florida, United States
Investigational Site Number 8400001
Peoria, Illinois, United States
Investigational Site Number 8400005
Rockville, Maryland, United States
Countries
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Related Links
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FBP00004 Plain Language Results Summary
Other Identifiers
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U1111-1239-0391
Identifier Type: OTHER
Identifier Source: secondary_id
FBP00004
Identifier Type: -
Identifier Source: org_study_id
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