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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Influenza
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Enrollment
- 388
- Locations
- 20
- Primary Endpoint
- Presence of unsolicited AEs reported up to 28 days after injection
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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
Detailed Description
Approximately 6 months
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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
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)
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
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)
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
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
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
Secondary Outcomes
- Individual HAI Ab titer ratio D29/D01, D91/D01, D91/D29, D181/D01, and D181/D29(From baseline up to 6 months)
- Hemagglutination inhibition (HAI) antibody (Ab) titers to homologous H3 strain at D29, D91, and D181(At Day 29, Day 91, and Day 181)
- 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)
- 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)
- Neutralizing Ab titers to homologous H3 strain at D29, D91, and D181(At Day 29, Day 91, and Day 181)
- Individual neutralizing Ab titer ratio D29/D01, D91/D01, D91/D29, D181/D01, and D181/D29(From baseline up to 6 months)
- HAI Ab titer ≥ 40 [1/dil] at D29, D91, and D181(At Day 29, Day 91 and Day 181)
- HAI Ab titers to selected heterologous H3 strains at D01, D29, D91, and D181(At Day 01, Day 29, D91 and D181)
- Neutralizing Ab titers to selected heterologous H3 strains at D01, D29, D91, and D181(At Day 01, Day 29, Day 91, and Day 181)