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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

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment270

FDA Designations

No designations recorded

Clinical trial landscape

TIV-HA Vaccine formulation 1 at low dose · 1 trial · 5 indications

Phase 1 1
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.Healthy Volunteers
COMPLETED270 Analytics
PHASE1COMPLETED
A Study on the Safety and Immunogenicity of Influenza, Respiratory Syncytial Virus, Human Metapneumovirus and Parainfluenza Vaccines in Adults 18 to 49 Years of Age.
Healthy Volunteers
NCT06850051270
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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 to 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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Frequently asked questions about TIV-HA Vaccine formulation 1 at low dose

What is TIV-HA Vaccine formulation 1 at low dose used for?

TIV-HA Vaccine formulation 1 at low dose is an investigational vaccine being studied for use in healthy volunteers, specifically in the context of influenza vaccination. It is being evaluated in a Phase 1 clinical trial to assess its safety and immunogenicity in adults aged 18 to 49 years.

Who makes TIV-HA Vaccine formulation 1 at low dose?

TIV-HA Vaccine formulation 1 at low dose is being developed by Sanofi, a biopharmaceutical company traded on the stock exchange under the ticker symbol SNY. The company is conducting clinical research on this vaccine candidate.

What phase is TIV-HA Vaccine formulation 1 at low dose in?

TIV-HA Vaccine formulation 1 at low dose is in Phase 1 clinical development. It is an investigational vaccine that has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the vaccine remains under clinical investigation.

What clinical trials is TIV-HA Vaccine formulation 1 at low dose in?

TIV-HA Vaccine formulation 1 at low dose is associated with one completed Phase 1 clinical trial, identified as NCT06850051. This study evaluated the safety and immunogenicity of the vaccine in healthy adults aged 18 to 49 years in Australia, enrolling 270 participants.

Is TIV-HA Vaccine formulation 1 at low dose the same as other influenza vaccines?

TIV-HA Vaccine formulation 1 at low dose is a specific investigational vaccine formulation being studied by Sanofi. It is part of a broader study that also evaluates vaccines for respiratory syncytial virus, human metapneumovirus, and parainfluenza, but it is a distinct candidate.