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

NCT06118151
clinicaltrials.gov
Phase
Phase 1
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Recruitment status
Completed
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Participants
388
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Lead sponsor
Sanofi Pasteur, a Sanofi Company
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Start date
2022-04-11
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Number of sites
20
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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
clinicaltrials.gov
Short title
Safety and Immunogenicity of a Monovalent mRNA Vaccine Encoding Influenza Hemagglutinin in Adult Participants 18 Years of Age and Older
clinicaltrials.gov
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
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Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 1
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Study type
Interventional
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Completion date
2023-02-17
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First posted
2023-11-07
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Registry last updated
2023-11-07
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Primary completion date
2023-02-17
clinicaltrials.gov
Start date
2022-04-11
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Actual participants
388
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Participants
388
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Participant count basis
Actual
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Protocol amendments
0
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Number of sites
20
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Sanofi Pasteur, a Sanofi Company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06118151
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ClinicalTrials.gov ID
NCT06118151
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
Quadruple masking
Masking description
Open label (Sponsor) Blinded (Sites, except for those preparing/administering study intervention)
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

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

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

    Timeframe: Up to 28 days after injection

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

  1. Hemagglutination inhibition (HAI) antibody (Ab) titers to homologous H3 strain at D29, D91, and D181

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

    Timeframe: From baseline up to 6 months

  7. 2-fold and 4-fold rise in neutralizing titers from D01 to D91 and D01 to D181

    Timeframe: 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

    Timeframe: At Day 01, Day 29, D91 and D181

  9. Neutralizing Ab titers to selected heterologous H3 strains at D01, D29, D91, and D181

    Timeframe: At Day 01, Day 29, Day 91, and Day 181

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
Yes

  • 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.

Sources for eligibility
clinicaltrials.gov

  • Peninsula Research Associates Site Number : 8400013Rolling Hills Estates, United States
  • Optimal Research Site Number : 8400026San Diego, United States
  • AMR Coral Gables/Miami, Formerly Clinical Research of South Florida, an AMR company (Clinic) Site Number : 8400004Coral Gables, United States
  • Research Centers of America Site Number : 8400003Hollywood, United States
  • Meridian Clinical Research, LLC Site Number : 8400016Savannah, United States
  • AES Peoria Site Number : 8400017Peoria, United States
  • AMR El Dorado Site Number : 8400009El Dorado, United States
  • AMR - Newton Site Number : 8400005Newton, United States
  • AMR Wichita West Site Number : 8400030Wichita, United States
  • AMR Lexington Site Number : 8400014Lexington, United States
  • Benchmark Research Site Number : 8400010Metairie, United States
  • Quality Clinical Research Site Number : 8400018Omaha, United States
  • Velocity Clinical Research, Omaha Site Number : 8400007Omaha, United States
  • Velocity Clinical Research Vestal Site Number : 8400033Vestal, United States
  • Coastal Carolina Research Center - N Charleston Site Number : 8400008North Charleston, United States
  • AMR Knoxville Site Number : 8400027Knoxville, United States
  • Elligo Health Research, Inc. Site Number : 8400035Austin, United States
  • Benchmark Research - Austin Site Number : 8400006Austin, United States
  • AES Austin Site Number : 8400021Austin, United States
  • Clinical Trials of Texas, Inc. Site Number : 8400012San Antonio, United States
Sources for sites
clinicaltrials.gov

Other registry identifiers

  • U1111-1271-2001
Sources for references
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (1)

Targets (2)