Approval Probability
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Adjusted LOA
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Also known as H5 Flu Investigational Medical Product (IMP) 1
H5 Flu Investigational Medical Product 1 · 1 trial · 2 indications
Ratio of post-vaccination to pre-vaccination hemagglutination inhibition (HAI) antibody titers, calculated as Day 22/Day 1 and Day 43/Day 1.
| Arm | Type | Description |
|---|---|---|
| Stage 1, Arm 1 | EXPERIMENTAL | Participants will receive a single IM (Intramuscular) injection on day 1 and day 22 of the H5 Flu vaccines according to their randomization schedule. |
| Stage 1, Arm 2 | EXPERIMENTAL | Participants will receive a single IM (Intramuscular) injection on day 1 and day 22 of the H5 Flu vaccines according to their randomization schedule. |
| Stage 1, Arm 3 | EXPERIMENTAL | Participants will receive a single IM (Intramuscular) injection on day 1 and day 22 of the H5 Flu vaccines according to their randomization schedule. |
| Stage 1, Arm 4 | EXPERIMENTAL | Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule. |
| Stage 1, Arm 5 | EXPERIMENTAL | Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule. |
| Stage 1, Arm 6 | EXPERIMENTAL | Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule. |
| Stage 2, Arm 1 | EXPERIMENTAL | Participants will receive a single IM (Intramuscular) injection on day 1 and day 22 of the H5 Flu vaccines according to their randomization schedule. |
| Stage 2, Arm 2 | EXPERIMENTAL | Participants will receive a single IM (Intramuscular) injection on day 1 and day 22 of the H5 Flu vaccines according to their randomization schedule. |
| Stage 2, Arm 3 | EXPERIMENTAL | Participants will receive a single IM (Intramuscular) injection on day 1 and day 22 of the H5 Flu vaccines according to their randomization schedule. |
| Stage 2, Arm 4 | EXPERIMENTAL | Participants will receive a single IM (Intramuscular) injection on day 1 and day 22 of the H5 Flu vaccines according to their randomization schedule. |
| Stage 2, Arm 5 | EXPERIMENTAL | Participants will receive a single IM (Intramuscular) injection on day 1 and day 22 of the H5 Flu vaccines according to their randomization schedule. |
| Stage 2, Arm 6 | EXPERIMENTAL | Participants will receive a single IM (Intramuscular) injection on day 1 and day 22 of the H5 Flu vaccines according to their randomization schedule. |
| Name | Type | Description |
|---|---|---|
| H5 Flu Investigational Medical Product (IMP) 1 | BIOLOGICAL | Suspension for injection. Route of administration: Intramuscular (IM) injection |
| H5 Flu IMP 2 | BIOLOGICAL | Suspension for injection. Route of administration: Intramuscular (IM) injection |
| H5 Flu IMP 3 | BIOLOGICAL | Suspension for injection. Route of administration: Intramuscular (IM) injection |
| RSV IMP 4 | BIOLOGICAL | Suspension for injection. Route of administration: Intramuscular (IM) injection |
| RSV IMP 5 | BIOLOGICAL | Suspension for injection. Route of administration: Intramuscular (IM) injection |
| RSV IMP 6 | BIOLOGICAL | Suspension for injection. Route of administration: Intramuscular (IM) injection |
| H5 Flu IMP 7 | BIOLOGICAL | Suspension for injection. Route of administration: Intramuscular (IM) injection |
| H5 Flu IMP 8 | BIOLOGICAL | Suspension for injection. Route of administration: Intramuscular (IM) injection |
| H5 Flu IMP 9 | BIOLOGICAL | Suspension for injection. Route of administration: Intramuscular (IM) injection |
| H5 Flu IMP 10 | BIOLOGICAL | Suspension for injection. Route of administration: Intramuscular (IM) injection |
| H5 Flu IMP 11 | BIOLOGICAL | Suspension for injection. Route of administration: Intramuscular (IM) injection |
| H5 Flu IMP 12 | BIOLOGICAL | Suspension for injection. Route of administration: Intramuscular (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 of the following conditions applies: * Is of NCBP (Non-Child-Bearing Potential). To be considered of NCBP, a female must be post-menopausal...
H5 Flu Investigational Medical Product 1 is a monoclonal antibody being developed for Respiratory Syncytial Virus (RSV). It is currently in Phase 1 clinical development and is being studied in healthy volunteers aged 18 to 49 years.
H5 Flu Investigational Medical Product 1 is a monoclonal antibody, but its specific molecular target has not been disclosed. It is being investigated for its potential role in preventing or treating Respiratory Syncytial Virus (RSV) infection.
H5 Flu Investigational Medical Product 1 is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker symbol SNY.
H5 Flu Investigational Medical Product 1 is in Phase 1 clinical development. It is an investigational product and has not been approved by regulatory authorities. The ongoing trial is recruiting participants.
H5 Flu Investigational Medical Product 1 is being studied in a Phase 1 trial with the identifier NCT07516418. This randomized, double-blind, controlled study is evaluating different formulations of vaccines encoding the RSV monovalent antigen or the Flu H5 antigen in 570 participants aged 18 to 49 years in Australia.
Yes, H5 Flu Investigational Medical Product 1 is also known as H5 Flu Investigational Medical Product (IMP) 1. Both names refer to the same investigational monoclonal antibody being developed by Sanofi.