Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06118151 | Safety and Immunogenicity of a Monovalent mRNA Vaccine Encoding Influenza Hemagglutinin in Adult Participants 18 Years of Age and Older | PHASE1 | COMPLETED | 388 | — | — | Apr 11, 2022 | Feb 17, 2023 | Nov 7, 2023 | 20 | United States |
Number of participants with unsolicited systemic immediate adverse events (AEs)
Number of participants with solicited injection site reactions
Number of participants with solicited systemic reactions
Number of participants with unsolicited AEs
Number of participants with medically attended adverse events (MAAE)s
Number of participants with serious adverse events (SAEs)
Number of participants with out-of-range biological test results
| Arm | Type | Description |
|---|---|---|
| sentinel cohort 1 | EXPERIMENTAL | 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 |
| sentinel cohort 2 | EXPERIMENTAL | 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 |
| sentinel cohort 3 | EXPERIMENTAL | 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 |
| main cohort 1 | EXPERIMENTAL | 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 |
| main cohort 2 | EXPERIMENTAL | 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 |
| main cohort 3 | EXPERIMENTAL | 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 |
| Name | Type | Description |
|---|---|---|
| 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 |
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 dur...