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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05829356 | Substudy 01 - Safety and Immunogenicity of One Monovalent Modified mRNA Vaccine Encoding Influenza Hemagglutinin With LNP, in Adult Participants Aged 18 to 49 Years and 60 Years and Above | PHASE1 | COMPLETED | 159 | — | — | Apr 12, 2023 | Mar 14, 2024 | Sep 12, 2025 | 8 | Australia, United Kingdom |
Unsolicited systemic AEs that occur within 30 minutes after vaccination
Number of participants reporting Adverse reactions pre-listed in the protocol and case report form (CRF) * Injection site reactions: pain, redness, swelling * Systemic reactions: fever, headache, malaise, myalgia, arthralgia, chills
Unsolicited (spontaneously reported) adverse events not fulfilling criteria for solicited reactions
Number of participants with biological safety assessment values out of normal range (as per the laboratory performing the test)
Number of participants experiencing SAEs
Number of participants experiencing AESIs
Antibody are expressed as geometric mean titers (GMTs) at baseline and post-baseline
Antibody titers are expressed as GMTs at baseline and post-baseline
Antibody titers are expressed as GMTs at baseline and post-baseline
Individual HAI Ab titer ratio will be calculated as: D29/D01
Seroconversion (HAI Ab titer \< 10 \[1/dil\] at D01 and post-injection titer ≥ 40 \[1/dil\] at D29, or titer ≥ 10 \[1/dil\] at D01 and a ≥ 4-fold increase in titer \[1/dil\] at D29)
Expressed as percentage post-baseline
Nab titers at Day 1
Nab titers at Day 29
Individual nab titer ratio will be calculated as: D29/D01
Expressed as percentage post-baseline
| Arm | Type | Description |
|---|---|---|
| Group 1: H3 mRNA /LNP dose 1 | EXPERIMENTAL | Participants will receive one intramuscular (IM) dose of H3 mRNA/LNP at Day 01 |
| Group 2: H3 mRNA /LNP dose 2 | EXPERIMENTAL | Participants will receive one IM dose of H3 mRNA/LNP at Day 01 |
| Group 3: H3 mRNA /LNP dose 3 | EXPERIMENTAL | Participants will receive one IM dose of H3 mRNA/LNP at Day 01 |
| Group 4: H3 mRNA /LNP dose 4 | EXPERIMENTAL | Participants will receive one IM dose of H3 mRNA/LNP at Day 01 |
| Group 5: H3 mRNA /LNP dose 5 | EXPERIMENTAL | Participants will receive one IM dose of H3 mRNA/LNP at Day 01 |
| Group 6 (Control Group): RIV4 dose | ACTIVE_COMPARATOR | Participants will receive one IM dose of RIV4 at Day 01 |
| Name | Type | Description |
|---|---|---|
| H3 mRNA / LNP Vaccine | BIOLOGICAL | Pharmaceutical Form: Suspension for injection Route of Administration: Intra-Muscular |
| Quadrivalent recombinant influenza Vaccine (RIV4) | BIOLOGICAL | Pharmaceutical Form: Solution for injection in a pre-filled syringe Route of Administration: Intra-Muscular |
Inclusion Criteria: * Aged 18 years and above on the day of inclusion \*Aged 18 years to 49 years or 60 years and above on the day of inclusion (substudy 01) * A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: ...