Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
H3 mRNA/ LNP Vaccine · 1 trial · 1 indication
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: ...
The H3 mRNA/LNP Vaccine is an investigational vaccine developed by Sanofi for influenza immunization. It uses modified mRNA encoding influenza hemagglutinin delivered with a lipid nanoparticle (LNP) carrier. It is designed to protect adults against influenza and has been studied in a Phase 1 clinical trial.
The H3 mRNA/LNP Vaccine is being developed for influenza immunization in adults. Its Phase 1 trial enrolled healthy participants aged 18 to 49 years and 60 years and above. The vaccine aims to generate an immune response against influenza hemagglutinin, the viral protein it encodes.
Sanofi develops the H3 mRNA/LNP Vaccine. Sanofi trades on the New York Stock Exchange under the ticker SNY. The company is running the clinical program for this modified mRNA influenza vaccine candidate.
The H3 mRNA/LNP Vaccine is in Phase 1 clinical development. Its single Phase 1 trial, NCT05829356, has been completed. The vaccine is investigational and has not been approved by the FDA for influenza immunization.
The H3 mRNA/LNP Vaccine has been studied in one Phase 1 trial, NCT05829356, titled a substudy on safety and immunogenicity of a monovalent modified mRNA vaccine encoding influenza hemagglutinin with LNP. The completed trial enrolled 159 participants across Australia and the United Kingdom.