Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RSV vaccine formulation 1 · 1 trial · 1 indication
An AE is any untoward medical occurrence in a participant or in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. An unsolicited AE is an observed AE that does not fulfill the conditions pre-listed in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. Systemic AEs are all AEs that were not injection or administration site reactions. Immediate events are recorded to capture medically relevant unsolicited systemic AEs (including those related to the product administered) that occur within the first 30 minutes after vaccination.
All noxious and unintended responses to a medicinal product related to any dose are considered adverse reactions (AR). A solicited reaction is an "expected" AR (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB. An administration site reaction is an AR at and around the administration site. Systemic ARs are all ARs that are not injection or administration site reactions.
An AE is any untoward medical occurrence in a participant or in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. An unsolicited AE is an observed AE that does not fulfill the conditions pre-listed in the CRB in terms of diagnosis and/or onset window post-vaccination.
An AESI is one of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate.
An MAAE is a new onset or a worsening of a condition that prompts the participant or participant's parent/guardian/legally authorized representative to seek unplanned medical advice at a physician's office or Emergency Department.
An SAE is any untoward medical occurrence that at any dose results in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect or is an important medical event.
RSV A neutralizing antibody measured by microneutralization. RSV-naïve participants are defined as undetectable serum anti-RSV A IgA antibodies.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 (RSV vaccine formulation 1) | EXPERIMENTAL | 1 administration of RSV vaccine formulation 1 on Day 0 |
| Cohort 1 (Placebo) | PLACEBO_COMPARATOR | 1 administration of placebo on Day 0 |
| Cohort 2 (RSV vaccine formulation 1) | EXPERIMENTAL | 2 administrations of RSV vaccine formulation 1 on Day 0 and Day 56 |
| Cohort 2 (Placebo) | PLACEBO_COMPARATOR | 2 administrations of placebo on Day 0 and Day 56 |
| Cohort 3 (RSV vaccine formulation 2) | EXPERIMENTAL | 1 administration of RSV vaccine formulation 2 on Day 0 |
| Cohort 3 (Placebo) | PLACEBO_COMPARATOR | 1 administration of placebo on Day 0 |
| Cohort 4 (RSV vaccine formulation 1) | EXPERIMENTAL | 2 administrations of RSV vaccine formulation 1 on Day 0 and Day 56 |
| Cohort 4 (RSV vaccine formulation 2) | EXPERIMENTAL | 2 administrations of RSV vaccine formulation 2 on Day 0 and Day 56 |
| Cohort 4 (Placebo) | PLACEBO_COMPARATOR | 2 administrations of placebo on Day 0 and Day 56 |
| Name | Type | Description |
|---|---|---|
| RSV vaccine formulation 1 | BIOLOGICAL | Pharmaceutical form: Suspension of virus Route of administration: Intranasal |
| RSV vaccine formulation 2 | BIOLOGICAL | Pharmaceutical form: Suspension of virus Route of administration: Intranasal |
| Placebo | BIOLOGICAL | Pharmaceutical form: Suspension Route of administration: Intranasal |
Inclusion Criteria: Inclusion criteria : * Aged 6 through 18 months at Day 0. * Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative (and by independent witness if required by local regulations). * Participant and parent / guardian / legally a...
RSV vaccine formulation 1 is a monoclonal antibody being developed for the prevention of Respiratory Syncytial Virus (RSV) infection. It is intended for use in infants and toddlers, as studied in a clinical trial enrolling children as young as 6 months old.
RSV vaccine formulation 1 is being developed by Sanofi, a biopharmaceutical company listed on the stock exchange under the ticker SNY. The company is conducting clinical research to evaluate this investigational monoclonal antibody for Respiratory Syncytial Virus infection.
RSV vaccine formulation 1 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied for safety and efficacy in clinical trials.
RSV vaccine formulation 1 has been studied in one completed Phase 1 clinical trial, identified as NCT04491877. This trial, titled 'Study of an Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers,' enrolled 259 participants in the United States, Chile, and Honduras.
RSV vaccine formulation 1 is a monoclonal antibody, which means it is designed to target and neutralize the Respiratory Syncytial Virus. By binding to the virus, it may help prevent infection or reduce the severity of the disease in infants and toddlers.
Despite its name, RSV vaccine formulation 1 is a monoclonal antibody, not a traditional vaccine. It is being studied for the prevention of Respiratory Syncytial Virus infection in infants and toddlers, and it is currently in Phase 1 clinical development.