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OpenTrials
Completed

NCT Number: NCT06118151

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

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

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Key information

Conditions

Influenza Infections Influenza Immunization Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Peninsula Research Associates Site Number : 8400013, Rolling Hills Estates, California, United States

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About this study

Approximately 6 months

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Influenza Hemagglutinin mRNA vaccine

Biological

Pharmaceutical form:Solution for injection-Route of administration:IM injection

Quadrivalent Recombinant Influenza Vaccine

Biological

Pharmaceutical form:Solution for injection-Route of administration:IM injection

Other names: RIV4, Flublok Quadrivalent®

Primary outcomes

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Up to 28 days after injection

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

Secondary outcomes

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: From baseline up to 6 months

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

    Time frame: 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

    Time frame: At Day 01, Day 29, D91 and D181

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

    Time frame: At Day 01, Day 29, Day 91, and Day 181

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 7, 2023
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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