Study of Recombinant Influenza Vaccine Containing Different H3 Antigens Without or With Adjuvant in Healthy Adult Subjects
FBP00004
Safety and Immunogenicity of Quadrivalent Recombinant Influenza Vaccine Formulations Containing Different H3 Hemagglutinin Antigens Without or With Adjuvant in Healthy Adult Subjects
2 other identifiers
interventional
210
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2020
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2020
CompletedFirst Posted
Study publicly available on registry
June 30, 2020
CompletedStudy Start
First participant enrolled
July 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 20, 2021
CompletedSeptember 17, 2025
September 1, 2025
1.2 years
June 25, 2020
September 11, 2025
Conditions
Outcome Measures
Primary Outcomes (11)
Number of participants with immediate adverse events
Immediate adverse events are unsolicited systemic adverse events reported in the 30 minutes after vaccination
Within 30 minutes after vaccination
Number of participants with solicited injection site or systemic reactions
Solicited injection site reactions: injection site pain, erythema, swelling, induration and bruising; solicited systemic reactions: fever, headache, malaise, and myalgia
From Day 0 to Day 7
Number of participants with unsolicited adverse events
Unsolicited (spontaneously reported) adverse events not not fulfilling criteria for solicited reactions
From Day 0 to Day 28
Number of participants with serious adverse events
Serious adverse events are collected throughout the study
From Day 0 to Day 365
Number of participants with adverse events of special interest
Adverse events of special interest are collected throughout the study
From Day 0 to Day 365
Clinical safety laboratory test results
Laboratory tests include complete blood count (CBC), platelet count, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, serum creatinine, serum lipase, and serum amylase)
From Day 0 to Day 7
HAI and SN antibody titers against influenza antigens in the quadrivalent RIV control vaccine
Influenza antibody titers are measured by HAI and SN assays
From Day 0 to Day 365
Individual HAI and SN titers ratio against influenza antigens in the quadrivalent RIV control vaccine
Titers ratio is calculated for the following time points: Day 7/Day 0, Day 28/Day 0, and Day 90/Day 0
From Day 0 to Day 90
Number of participants with seroconversion to influenza antigens in the quadrivalent RIV control vaccine
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)
From Day 0 to Day 28
HAI Ab titer ≥ 40 [1/dil]
Influenza vaccine antibody titers are measured by HAI assay
From Day 0 to Day 365
2-fold and 4-fold increase in SN titers
Influenza vaccine antibody titers are measured by SN assay
From Day 0 to Day 28
Secondary Outcomes (4)
HAI antibody titers against influenza H3 antigens not present in the vaccine formulations and the SN antibody titers against each of the H3 antigens
Day 0, Day 7, Day 28, Day 90, Day 180, and Day 365
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
From Day 0 to Day 90
Number of participants with seroconversion to influenza H3 antigens not present in the vaccine formulations
Day 0 and Day 28
2-fold and 4-fold rise in SN antibody titers against each of the H3 antigens
Day 0, Day 7, Day 28, Day 90, Day 180, and Day 365
Study Arms (7)
Group 1: Quadrivalent RIV with H3 strain 1, without adjuvant
EXPERIMENTAL1 injection of quadrivalent RIV containing H3 strain 1, without adjuvant, in participants ≥ 50 years old
Group 2: Quadrivalent RIV with H3 strain 1, with adjuvant
EXPERIMENTAL1 injection of quadrivalent RIV containing H3 strain 1, with adjuvant, in participants ≥ 50 years old
Group 3: Quadrivalent RIV with H3 strain 2, without adjuvant
EXPERIMENTAL1 injection of quadrivalent RIV containing H3 strain 2, without adjuvant, in participants ≥ 50 years old
Group 4: Quadrivalent RIV with H3 strain 2, with adjuvant
EXPERIMENTAL1 injection of quadrivalent RIV containing H3 strain 2, with adjuvant, in participants ≥ 50 years old
Group 5: Quadrivalent RIV Control, without adjuvant
ACTIVE COMPARATOR1 injection of quadrivalent RIV containing 2018-19 Northern Hemisphere (NH) recommended H3 strain, without adjuvant, in participants ≥ 50 years old
Group 6: Quadrivalent RIV Control, with adjuvant
ACTIVE COMPARATOR1 injection of quadrivalent RIV containing 2018-19 NH recommended H3 strain, with adjuvant, in participants ≥ 50 years old
Group 7: Quadrivalent RIV Control, without adjuvant
ACTIVE COMPARATOR1 injection of quadrivalent RIV containing 2018-19 NH recommended H3 strain, without adjuvant, in participants 18-30 years old
Interventions
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Eligibility Criteria
You may qualify if:
- Informed consent form has been signed and dated
- Able to attend all scheduled visits and to comply with all trial procedures
You may not qualify if:
- 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
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Investigational Site Number 8400003
San Diego, California, 92108, United States
Investigational Site Number 8400002
Melbourne, Florida, 32934, United States
Investigational Site Number 8400004
Orlando, Florida, 32806, United States
Investigational Site Number 8400001
Peoria, Illinois, 61614, United States
Investigational Site Number 8400005
Rockville, Maryland, 20850, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Sciences & Operations
Sanofi Pasteur, a Sanofi Company
Study Design
- Study Type
- interventional
- Phase
- phase 1
- 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
June 25, 2020
First Posted
June 30, 2020
Study Start
July 2, 2020
Primary Completion
September 20, 2021
Study Completion
September 20, 2021
Last Updated
September 17, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
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://vivli.org