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TIV-HA Vaccine formulation 1 at low dose

Phase 1

Healthy Volunteers | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Jan 16, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment270
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06850051A Study on the Safety and Immunogenicity of Influenza, Respiratory Syncytial Virus, Human Metapneumovirus and Parainfluenza Vaccines in Adults 18 to 49 Years of Age.PHASE1 COMPLETED 270 — — Mar 19, 2025Dec 11, 2025Jan 16, 20266 Australia
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Study Endpoints
Primary Endpoints
Presence of any unsolicited systemic Adverse Events (AEs) reported within 30 minutes after vaccination
Within 30 minutes after each vaccination

Number of participants with unsolicited systemic AEs

Presence of solicited injection site and systemic reactions (ie, pre-listed in the participant's diary and in the eCRF (electronic case report form) occurring through 7 days after vaccination
Through 7 days after each vaccination

Number of participants with solicited injection site and systemic reactions

Presence of unsolicited AEs reported through 28 days after vaccination
Through 28 days after each vaccination

Number of participants with unsolicited AEs

Presence of SAEs (Serious Adverse Events) and AESIs (Adverse Events of Special Interest) throughout the study
Throughout study, approximately 6 months

: Number of participants with SAEs and AESIs

Presence of out-of-range biological test results (including shift from baseline values) through 7 days after vaccination
Through 7 days after vaccination

: Number of participants with out-of-range biological tests

Hemagglutinin Inhibition Assay (HAI) antibody (Ab) response to each homologous influenza strain at Day 1 and Day 29
Day 1 and Day 29
RSV A, hMPV A and PIV3 serum neutralizing antibodies (nAb) titers at Day 1 and Day 29
Day 1 and Day 29
Secondary Endpoints
RSV B and hMPV A nAb titers at Day 1 and Day 29
Day 1 and Day 29
Neutralization Test (NT) Ab response to each homologous influenza strain at Day 29
Day 29
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Group 1 trivalent influenza vaccine-hemagglutinin (TIV-HA) formulation 1 at high doseEXPERIMENTALParticipants will receive a single IM (Intramuscular) injection on day 1 of the TIV-HA vaccines according to their randomization schedule.
Group 2 TIV-HA formulation 2 at high doseEXPERIMENTALParticipants will receive a single IM (Intramuscular) injection on day 1 of the TIV-HA vaccines according to their randomization schedule.
Group 3 TIV-HA formulation 1 at low doseEXPERIMENTALParticipants will receive a single IM (Intramuscular) injection on day 1 of the TIV-HA vaccines according to their randomization schedule.
Group 4 TIV-HA formulation 2 at low doseEXPERIMENTALParticipants will receive a single IM (Intramuscular) injection on day 1 of the TIV-HA vaccines according to their randomization schedule.
Group 5 RSV/hMPV/PIV3 formulation 1 at high doseEXPERIMENTALParticipants will receive a single IM (Intramuscular) injection on day 1 of the RSV/hMPV/PIV3 vaccines according to their randomization schedule.
Group 6 RSV/hMPV/PIV3 formulation 2 at high doseEXPERIMENTALParticipants will receive a single IM (Intramuscular) injection on day 1 of the RSV/hMPV/PIV3 vaccines according to their randomization schedule.
Group 7 RSV/hMPV/PIV3 formulation 1 at low doseEXPERIMENTALParticipants will receive a single IM (Intramuscular) injection on day 1 of the RSV/hMPV/PIV3 vaccines according to their randomization schedule.
Group 8 RSV/hMPV/PIV3 formulation 2 at low doseEXPERIMENTALParticipants will receive a single IM (Intramuscular) injection on day 1 of the RSV/hMPV/PIV3 vaccines according to their randomization schedule.
Group 9 recombinant influenza vaccine quadrivalent (RIV4)ACTIVE_COMPARATORParticipants will receive a single IM (Intramuscular) injection on day 1 of the RIV4 vaccine according to their randomization schedule.
Interventions
NameTypeDescription
TIV-HA Vaccine formulation 1 at low doseBIOLOGICALSuspension for injection in a vial. Route of administration: IM injection
TIV-HA formulation 1 at high doseBIOLOGICALSuspension for injection in a vial. Route of administration: IM injection
TIV-HA formulation 2 at low doseBIOLOGICALSuspension for injection in a vial. Route of administration: IM injection
TIV-HA formulation 2 at high doseBIOLOGICALSuspension for injection in a vial. Route of administration: IM injection
RSV/hMPV/PIV3 formulation 2 at low doseBIOLOGICALSuspension for injection in a vial. Route of administration: IM injection
RSV/hMPV/PIV3 formulation 1 at high doseBIOLOGICALSuspension for injection in a vial. Route of administration: IM injection
RSV/hMPV/PIV3 formulation 2 at high doseBIOLOGICALSuspension for injection in a vial. Route of administration: IM injection
RSV/hMPV/PIV3 formulation 1 at low doseBIOLOGICALSuspension for injection in a vial. Route of administration: IM injection
RIV4 (Supemtek®)BIOLOGICALSolution for injection in a prefilled syringe. Route of administration: IM injection
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Eligibility Criteria
Age Range18 Years — 49 Years
SexALL
Healthy VolunteersYes
Study Sites6

Inclusion Criteria: * Aged 18 to 49 years on the day of inclusion * A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: * Is of non-childbearing potential. To be considered of non-childbearing potential, a female mu...

Countries:Australia
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