Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RSV F vaccine · 2 trials · 1 indication
Percentages of infants with medically-significant RSV LRTI from delivery through 90, 120,150, and 180 days of life, as defined by: * The presence of RSV infection confirmed by detection of RSV genome by RT-PCR on respiratory secretions (obtained within the continuous illness episode which fulfills the other criteria listed below); AND * At least one manifestation of lower respiratory tract infection (LRTI) from among the following: cough, nasal flaring, lower chest wall indrawing, subcostal retractions, stridor, rales, rhonchi, wheezing, crackles/crepitations, or observed apnea; AND * Evidence of medical significance as defined by the presence of: * EITHER hypoxemia (peripheral oxygen saturation \[SpO2\] \< 95% at sea level or \< 92% at altitudes \> 1800 meters) OR * Tachypnea (≥ 70 breaths per minute \[bpm\] in infants 0 to 59 days of age and ≥ 60 bpm in infants ≥ 60 days of age).
In Maternal Subjects
In Maternal Subjects
In Maternal Subjects
In Maternal Subjects
In Infant subjects
In Infant Subjects
In Infant Subjects
In Infant Subjects
In Infant Subjects
| Arm | Type | Description |
|---|---|---|
| Treatment Group A | PLACEBO_COMPARATOR | Formulation buffer (0.5mL injection) |
| Treatment Group | ACTIVE_COMPARATOR | RSV F vaccine with adjuvant (0.5mL injection) |
| Treatment Group B | EXPERIMENTAL | RSV F vaccine with adjuvant (0.5mL injection) |
| Name | Type | Description |
|---|---|---|
| RSV F vaccine with adjuvant | BIOLOGICAL | - |
| Formulation buffer | BIOLOGICAL | - |
| Saline Placebo (0.5mL injection) | DRUG | - |
| RSV F vaccine (0.5mL injection) | DRUG | - |
Inclusion Criteria: 1. ≥18 and ≤40 years-of-age 2. Singleton pregnancy of 28 to 36 0/7 weeks gestation on the day of planned vaccination * Documentation of gestational age will be based on one of the following composite criteria. (Note: The Investigator was to use the earliest ultrasound data a...
RSV F Vaccine with Aluminum Adjuvant is an investigational vaccine being studied for the prevention of Respiratory Syncytial Virus (RSV) infections. It is being evaluated in clinical trials for use in pregnant women to protect infants via maternal immunization, as well as in older adults and young children.
RSV F Vaccine with Aluminum Adjuvant is being developed by Novavax, Inc., a biotechnology company traded on the NASDAQ under the ticker symbol NVAX. The vaccine is currently in clinical development and has not yet been approved by regulatory authorities.
RSV F Vaccine with Aluminum Adjuvant has completed clinical trials in Phase 1, Phase 2, and Phase 3. The most advanced completed study was a Phase 3 trial evaluating maternal immunization to protect infants from RSV. The vaccine remains investigational and is not yet approved.
RSV F Vaccine with Aluminum Adjuvant has been studied in four completed clinical trials. These include NCT02247726, a Phase 2 maternal immunization study in pregnant women; NCT02296463, a Phase 1 dose-ranging study in toddlers; NCT02624947, a Phase 3 maternal immunization efficacy trial; and NCT03026348, a Phase 2 study in older adults.
RSV F Vaccine with Aluminum Adjuvant is a specific vaccine formulation developed by Novavax that includes the RSV F protein combined with an aluminum adjuvant. It is distinct from other RSV vaccine candidates that may use different antigens or adjuvant systems, such as Matrix-M1.