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Influenza Hemagglutinin mRNA vaccine

Phase 1

Influenza | Vaccine | Infectious Disease |Sanofi|Trials Updated: Nov 7, 2023

Influenza Hemagglutinin mRNA vaccine development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Nov 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment388

FDA Designations

No designations recorded

Influenza Hemagglutinin mRNA vaccine clinical trials

Influenza Hemagglutinin mRNA vaccine · 1 trial · 2 indications

Phase 1 1
NCT06118151Safety and Immunogenicity of a Monovalent mRNA Vaccine Encoding Influenza Hemagglutinin in Adult Participants 18 Years of Age and OlderInfluenza
COMPLETED388 Analytics
PHASE1COMPLETED
Safety and Immunogenicity of a Monovalent mRNA Vaccine Encoding Influenza Hemagglutinin in Adult Participants 18 Years of Age and Older
InfluenzaUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Number of participants with unsolicited systemic immediate adverse events (AEs)

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
Up to 7 days after injection

Number of participants with solicited injection site reactions

Presence of solicited systemic reactions (ie, pre-listed in the participant's DC and in the eCRF) occurring up to 7 days after injection
Up to 7 days after injection

Number of participants with solicited systemic reactions

Presence of unsolicited AEs reported up to 28 days after injection
Up to 28 days after injection

Number of participants with unsolicited AEs

Presence of medically attended AEs (MAAEs) reported up to 28 days after injection
Up to 28 days after injection

Number of participants with medically attended adverse events (MAAE)s

Presence of serious adverse events (SAEs) and adverse events of special interest (AESIs) throughout the study
From baseline up to 6 months

Number of participants with serious adverse events (SAEs)

Presence of out-of-range biological test results (including shift from baseline values) up to 28 days after injection
Up to 28 days after injection

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

Secondary Endpoints

Hemagglutination inhibition (HAI) antibody (Ab) titers to homologous H3 strain at D29, D91, and D181
At Day 29, Day 91, and Day 181
Individual HAI 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
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
sentinel cohort 1EXPERIMENTAL20 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 2EXPERIMENTAL20 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 3EXPERIMENTAL10 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 1EXPERIMENTAL40 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 2EXPERIMENTAL40 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 3EXPERIMENTAL20 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

Interventions

NameTypeDescription
Influenza Hemagglutinin mRNA vaccineBIOLOGICALPharmaceutical form:Solution for injection-Route of administration:IM injection
Quadrivalent Recombinant Influenza VaccineBIOLOGICALPharmaceutical form:Solution for injection-Route of administration:IM injection
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites20

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...

Countries:United States
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Frequently asked questions about Influenza Hemagglutinin mRNA vaccine

What is the Influenza Hemagglutinin mRNA vaccine?

The Influenza Hemagglutinin mRNA vaccine is an investigational vaccine developed by Sanofi for the prevention of influenza. It uses mRNA to encode influenza hemagglutinin, the viral protein that the immune system recognizes. It is in Phase 1 clinical development and is not approved for use.

What is the Influenza Hemagglutinin mRNA vaccine used for?

The Influenza Hemagglutinin mRNA vaccine is being developed for influenza immunization, meaning prevention of influenza infection. It is an investigational vaccine in Phase 1 testing and has not been approved for any indication.

Who makes the Influenza Hemagglutinin mRNA vaccine?

The Influenza Hemagglutinin mRNA vaccine is developed by Sanofi, which trades under the ticker SNY. Sanofi is the sponsor of the clinical program evaluating this mRNA-based influenza vaccine candidate.

What phase is the Influenza Hemagglutinin mRNA vaccine in?

The Influenza Hemagglutinin mRNA vaccine is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by the FDA or any other regulatory agency.

What clinical trials is the Influenza Hemagglutinin mRNA vaccine in?

The Influenza Hemagglutinin mRNA vaccine has been studied in one Phase 1 trial, NCT06118151, titled Safety and Immunogenicity of a Monovalent mRNA Vaccine Encoding Influenza Hemagglutinin in Adult Participants 18 Years of Age and Older. The trial enrolled 388 participants in the United States and is completed.

How was the Influenza Hemagglutinin mRNA vaccine trial designed?

The Phase 1 trial NCT06118151 was a randomized, double-blind, controlled study of the monovalent mRNA vaccine encoding influenza hemagglutinin. It enrolled 388 adults aged 18 years and older, including healthy volunteers, and was conducted in the United States. The trial is completed.