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TIV-HA Vaccine formulation 1 at low dose · 1 trial · 5 indications
Number of participants with unsolicited systemic AEs
Number of participants with solicited injection site and systemic reactions
Number of participants with unsolicited AEs
: Number of participants with SAEs and AESIs
: Number of participants with out-of-range biological tests
| Arm | Type | Description |
|---|---|---|
| Group 1 trivalent influenza vaccine-hemagglutinin (TIV-HA) formulation 1 at high dose | EXPERIMENTAL | Participants 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 dose | EXPERIMENTAL | Participants 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 dose | EXPERIMENTAL | Participants 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 dose | EXPERIMENTAL | Participants 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 dose | EXPERIMENTAL | Participants 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 dose | EXPERIMENTAL | Participants 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 dose | EXPERIMENTAL | Participants 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 dose | EXPERIMENTAL | Participants 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_COMPARATOR | Participants will receive a single IM (Intramuscular) injection on day 1 of the RIV4 vaccine according to their randomization schedule. |
| Name | Type | Description |
|---|---|---|
| TIV-HA Vaccine formulation 1 at low dose | BIOLOGICAL | Suspension for injection in a vial. Route of administration: IM injection |
| TIV-HA formulation 1 at high dose | BIOLOGICAL | Suspension for injection in a vial. Route of administration: IM injection |
| TIV-HA formulation 2 at low dose | BIOLOGICAL | Suspension for injection in a vial. Route of administration: IM injection |
| TIV-HA formulation 2 at high dose | BIOLOGICAL | Suspension for injection in a vial. Route of administration: IM injection |
| RSV/hMPV/PIV3 formulation 2 at low dose | BIOLOGICAL | Suspension for injection in a vial. Route of administration: IM injection |
| RSV/hMPV/PIV3 formulation 1 at high dose | BIOLOGICAL | Suspension for injection in a vial. Route of administration: IM injection |
| RSV/hMPV/PIV3 formulation 2 at high dose | BIOLOGICAL | Suspension for injection in a vial. Route of administration: IM injection |
| RSV/hMPV/PIV3 formulation 1 at low dose | BIOLOGICAL | Suspension for injection in a vial. Route of administration: IM injection |
| RIV4 (Supemtek®) | BIOLOGICAL | Solution for injection in a prefilled syringe. Route of administration: IM injection |
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...
TIV-HA Vaccine formulation 1 at low dose is an investigational influenza vaccine developed by Sanofi. It is a low-dose formulation of a trivalent inactivated influenza hemagglutinin vaccine, designed for influenza vaccination. It has been studied in a Phase 1 clinical trial in healthy adult volunteers.
TIV-HA Vaccine formulation 1 at low dose is being developed for influenza vaccination. Its intended use is to protect against influenza virus infection. The Phase 1 study enrolled healthy volunteers aged 18 to 49 years and evaluated safety and immune response to influenza vaccination.
TIV-HA Vaccine formulation 1 at low dose is developed by Sanofi, which trades on the New York Stock Exchange under the ticker SNY. Sanofi is the sponsor of the clinical program evaluating this low-dose trivalent inactivated influenza hemagglutinin vaccine formulation.
TIV-HA Vaccine formulation 1 at low dose is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by the FDA. The Phase 1 trial has been completed, and no active trials of this formulation are currently listed.
TIV-HA Vaccine formulation 1 at low dose was evaluated in one completed Phase 1 trial, NCT06850051. The study assessed safety and immunogenicity of influenza, respiratory syncytial virus, human metapneumovirus and parainfluenza vaccines in adults 18 to 49 years of age. It enrolled 270 participants in Australia and was randomized, double-blind and active-controlled.