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Safety and Immunogenicity of a Monovalent mRNA Vaccine Encoding Influenza Hemagglutinin in Adult Participants 18 Years of Age and Older

Sponsor
Sanofi Pasteur, a Sanofi Company (Industry)
Overall Status
Completed
CT.gov ID
NCT06118151
Collaborator
(none)
388
Enrollment
20
Locations
6
Arms
10.3
Actual Duration (Months)
19.4
Patients Per Site
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular (IM) injection of different dose levels of messenger ribonucleic acid (mRNA) vaccine encoding influenza hemagglutinin compared to an active control quadrivalent recombinant influenza vaccine (RIV4) in adults 18 years of age and older. Study details include:

Study Duration: approximately 6 months Treatment Duration: 1 injection of mRNA vaccine encoding influenza hemagglutinin encoding influenza hemagglutinin or control.

Visit Frequency: Screening visit, Day 01, Day 02, Day 03, Day 09, Day 29, Day 91, Day 181

Condition or Disease Intervention/Treatment Phase
  • Biological: Influenza Hemagglutinin mRNA vaccine
  • Biological: Quadrivalent Recombinant Influenza Vaccine
 Phase 1

Detailed Description

Approximately 6 months

Study Design

Study Type:
Interventional
Actual Enrollment :
388 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Open label (Sponsor) Blinded (Sites, except for those preparing/administering study intervention)
Primary Purpose:
Prevention
Official Title:
A Phase I, Parallel, Randomized, Active-controlled, Multi-center, Dose-escalation Study With Early Safety Data Reviews to Assess Safety and Immunogenicity of a Monovalent mRNA Vaccine Encoding Influenza Hemagglutinin in Adults 18 Years of Age and Older
Actual Study Start Date :
Apr 11, 2022
Actual Primary Completion Date :
Feb 17, 2023
Actual Study Completion Date :
Feb 17, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: sentinel cohort 1

20 Participants in each age group will receive either Influenza hemagglutinin mRNA vaccine candidate dose 1 or dose 2 and half number of the participants in each age group also receiving the RIV4 control

Biological: Influenza Hemagglutinin mRNA vaccine
Pharmaceutical form:Solution for injection-Route of administration:IM injection

Biological: Quadrivalent Recombinant Influenza Vaccine
Pharmaceutical form:Solution for injection-Route of administration:IM injection
Other Names:
  • RIV4
  • Flublok Quadrivalent®

    		•
    Experimental: sentinel cohort 2

    20 Participants in each age group will receive either Influenza hemagglutinin mRNA vaccine candidate dose 3 or dose 4 and half number of the participants in each age group also receiving the RIV4 control

    Biological: Influenza Hemagglutinin mRNA vaccine
    Pharmaceutical form:Solution for injection-Route of administration:IM injection

    Biological: Quadrivalent Recombinant Influenza Vaccine
    Pharmaceutical form:Solution for injection-Route of administration:IM injection
    Other Names:
  • RIV4
  • Flublok Quadrivalent®

    		•
    Experimental: sentinel cohort 3

    10 Participants in each age group will receive Influenza hemagglutinin mRNA vaccine candidate dose 5 with half of the participants in each age group also receiving the RIV4 control

    Biological: Influenza Hemagglutinin mRNA vaccine
    Pharmaceutical form:Solution for injection-Route of administration:IM injection

    Biological: Quadrivalent Recombinant Influenza Vaccine
    Pharmaceutical form:Solution for injection-Route of administration:IM injection
    Other Names:
  • RIV4
  • Flublok Quadrivalent®

    		•
    Experimental: main cohort 1

    40 Participants in each age group will receive either Influenza hemagglutinin mRNA vaccine candidate dose 1 or dose 2 and half number of the participants in each age group also receiving the RIV4 control

    Biological: Influenza Hemagglutinin mRNA vaccine
    Pharmaceutical form:Solution for injection-Route of administration:IM injection

    Biological: Quadrivalent Recombinant Influenza Vaccine
    Pharmaceutical form:Solution for injection-Route of administration:IM injection
    Other Names:
  • RIV4
  • Flublok Quadrivalent®

    		•
    Experimental: main cohort 2

    40 Participants in each age group will receive either Influenza hemagglutinin mRNA vaccine candidate dose 3 or dose 4 and half number of the participants in each age group also receiving the RIV4 control

    Biological: Influenza Hemagglutinin mRNA vaccine
    Pharmaceutical form:Solution for injection-Route of administration:IM injection

    Biological: Quadrivalent Recombinant Influenza Vaccine
    Pharmaceutical form:Solution for injection-Route of administration:IM injection
    Other Names:
  • RIV4
  • Flublok Quadrivalent®

    		•
    Experimental: main cohort 3

    20 Participants in each age group will receive Influenza hemagglutinin mRNA vaccine candidate dose 5, and half number of the participants in each age group also receiving the RIV4 control

    Biological: Influenza Hemagglutinin mRNA vaccine
    Pharmaceutical form:Solution for injection-Route of administration:IM injection

    Biological: Quadrivalent Recombinant Influenza Vaccine
    Pharmaceutical form:Solution for injection-Route of administration:IM injection
    Other Names:
  • RIV4
  • Flublok Quadrivalent®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Presence of any unsolicited systemic adverse events (AEs) reported in the 30 minutes after injection [Within 30 minutes after injection]

      Number of participants with unsolicited systemic immediate adverse events (AEs)

    2. Presence of solicited injection site reactions (ie, pre listed in the participant's diary card [DC] and in the electronic case report form [eCRF]) occurring up to 7 days after injection [Up to 7 days after injection]

      Number of participants with solicited injection site reactions

    3. Presence of solicited systemic reactions (ie, pre-listed in the participant's DC and in the eCRF) occurring up to 7 days after injection [Up to 7 days after injection]

      Number of participants with solicited systemic reactions

    4. Presence of unsolicited AEs reported up to 28 days after injection [Up to 28 days after injection]

      Number of participants with unsolicited AEs

    5. Presence of medically attended AEs (MAAEs) reported up to 28 days after injection [Up to 28 days after injection]

      Number of participants with medically attended adverse events (MAAE)s

    6. Presence of serious adverse events (SAEs) and adverse events of special interest (AESIs) throughout the study [From baseline up to 6 months]

      Number of participants with serious adverse events (SAEs)

    7. Presence of out-of-range biological test results (including shift from baseline values) up to 28 days after injection [Up to 28 days after injection]

      Number of participants with out-of-range biological test results

    Secondary Outcome Measures

    1. Hemagglutination inhibition (HAI) antibody (Ab) titers to homologous H3 strain at D29, D91, and D181 [At Day 29, Day 91, and Day 181]

      Antibody titers are expressed as Geometric Mean Titers (GMTs)

    2. Individual HAI Ab titer ratio D29/D01, D91/D01, D91/D29, D181/D01, and D181/D29 [From baseline up to 6 months]

      Ratios of antibody titers measured by HAI in each group before and after vaccination

    3. HAI Ab titer ≥ 40 [1/dil] at D29, D91, and D181 [At Day 29, Day 91 and Day 181]

    4. 2-fold and 4-fold rise in HAI titers from D01 to D91 and D01 to D181 [From Day 01 through Day 91 and Day 01 through Day 181]

    5. Neutralizing Ab titers to homologous H3 strain at D29, D91, and D181 [At Day 29, Day 91, and Day 181]

    6. Individual neutralizing Ab titer ratio D29/D01, D91/D01, D91/D29, D181/D01, and D181/D29 [From baseline up to 6 months]

    7. 2-fold and 4-fold rise in neutralizing titers from D01 to D91 and D01 to D181 [From Day 01 through Day 29 and Day 01 through Day 181]

    8. HAI Ab titers to selected heterologous H3 strains at D01, D29, D91, and D181 [At Day 01, Day 29, D91 and D181]

    9. Neutralizing Ab titers to selected heterologous H3 strains at D01, D29, D91, and D181 [At Day 01, Day 29, Day 91, and Day 181]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Having given written informed consent prior to undertaking any study-related procedure. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply:

    • Any subject who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peninsula Research Associates Site Number : 8400013 Rolling Hills Estates California United States 90274
    2 Optimal Research Site Number : 8400026 San Diego California United States 92108
    3 AMR Coral Gables/Miami, Formerly Clinical Research of South Florida, an AMR company (Clinic) Site Number : 8400004 Coral Gables Florida United States 33134
    4 Research Centers of America Site Number : 8400003 Hollywood Florida United States 33024
    5 Meridian Clinical Research, LLC Site Number : 8400016 Savannah Georgia United States 31406
    6 AES Peoria Site Number : 8400017 Peoria Illinois United States 61614
    7 AMR El Dorado Site Number : 8400009 El Dorado Kansas United States 67042
    8 AMR - Newton Site Number : 8400005 Newton Kansas United States 67114
    9 AMR Wichita West Site Number : 8400030 Wichita Kansas United States 67205
    10 AMR Lexington Site Number : 8400014 Lexington Kentucky United States 40509
    11 Benchmark Research Site Number : 8400010 Metairie Louisiana United States 70006
    12 Quality Clinical Research Site Number : 8400018 Omaha Nebraska United States 68112
    13 Velocity Clinical Research, Omaha Site Number : 8400007 Omaha Nebraska United States 68134
    14 Velocity Clinical Research Vestal Site Number : 8400033 Vestal New York United States 13850
    15 Coastal Carolina Research Center - N Charleston Site Number : 8400008 North Charleston South Carolina United States 29405
    16 AMR Knoxville Site Number : 8400027 Knoxville Tennessee United States 37920
    17 Elligo Health Research, Inc. Site Number : 8400035 Austin Texas United States 78704
    18 Benchmark Research - Austin Site Number : 8400006 Austin Texas United States 78705
    19 AES Austin Site Number : 8400021 Austin Texas United States 78744
    20 Clinical Trials of Texas, Inc. Site Number : 8400012 San Antonio Texas United States 78229

    Sponsors and Collaborators

    • Sanofi Pasteur, a Sanofi Company

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sanofi Pasteur, a Sanofi Company
    ClinicalTrials.gov Identifier:
    NCT06118151
    Other Study ID Numbers:
    • VAV00018
    • U1111-1271-2001
    First Posted:
    Nov 7, 2023
    Last Update Posted:
    Nov 7, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Influenza, Human
    Hemagglutinins
    Vaccines

    Study Results

    No Results Posted as of Nov 7, 2023