Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02624947 | A Study to Determine the Safety and Efficacy of the RSV F Vaccine to Protect Infants Via Maternal Immunization | PHASE3 | COMPLETED | 4,636 | — | — | Dec 1, 2015 | Jul 12, 2019 | May 6, 2025 | 88 | United States, Argentina +9 |
| NCT02247726 | RSV F Vaccine Maternal Immunization Study in Healthy Third-trimester Pregnant Women. | PHASE2 | COMPLETED | 50 | — | — | Sep 1, 2014 | Jul 1, 2016 | May 27, 2022 | 7 | United States |
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...