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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05639894 | Study of a Respiratory Syncytial Virus Candidate Encapsulated in a Lipid Nanoparticle Based Formulation in Adults Aged 18 to 50 Years and 60 Years and Older | PHASE1 | COMPLETED | 865 | — | — | Nov 17, 2022 | May 2, 2025 | May 31, 2025 | 33 | United States, Australia +1 |
Number of participants experienciing unsolicited systemic adverse events
Number of participants reporting: * injection site reactions: pain, erythema and swelling * systemic reactions: fever, headache, malaise, myalgia, arthralgia and chills
Number of participants experiencing unsolicited AEs
Number of participants experiencing MAAEs
Number of participants experiencing SAEs
Number of participants experiencing AESIs
Number of participants with biological safety assessment values out of normal range (as per the laboratory performing the test)
Nab titers pre-vaccination
Nab titers post-vaccination
| Arm | Type | Description |
|---|---|---|
| Group 1: Sentinel and Main Cohorts (Stage 1) | EXPERIMENTAL | 1 injection of RSV vaccine candidate (Dose A) via intramuscular injection |
| Group 2: Sentinel and Main Cohorts (Stage 1) | EXPERIMENTAL | 1 injection of RSV vaccine candidate (Dose A) via intramuscular injection |
| Group 3: Sentinel and Main Cohorts (Stage 1) | EXPERIMENTAL | 1 injection of RSV vaccine candidate (Dose B) via intramuscular injection |
| Group 4: Sentinel and Main Cohorts (Stage 1) | EXPERIMENTAL | 1 injection of RSV vaccine candidate (Dose B) via intramuscular injection |
| Group 5: Sentinel and Main Cohorts (Stage 1) | EXPERIMENTAL | 1 injection of RSV vaccine candidate (Dose C) via intramuscular injection |
| Group 6: Sentinel and Main Cohorts (Stage 1) | EXPERIMENTAL | 1 injection of RSV vaccine candidate (Dose C) via intramuscular injection |
| Group 7: Main, Sentinel and Booster Cohorts (Stage 1) | PLACEBO_COMPARATOR | 1 injection of placebo via intramuscular injection |
| Group 0: Phase IIa/Dose-ranging (Stage 2) | EXPERIMENTAL | 1 injection of RSV vaccine candidate (Dose A) via intramuscular injection |
| Group 1: Phase IIa/Dose-ranging (Stage 2) | EXPERIMENTAL | 1 injection of RSV vaccine candidate (Dose B) via intramuscular injection |
| Group 2: Phase 11a/Dose-ranging (Stage 2) | PLACEBO_COMPARATOR | 1 injection of placebo via intramuscular injection |
| Name | Type | Description |
|---|---|---|
| RSV vaccine candiate formulation 1 | BIOLOGICAL | Pharmaceutical Form: Liquid frozen solution in a vial Route of Administration: Intramuscular injection |
| RSV vaccine candidate formulation 2 | BIOLOGICAL | Pharmaceutical Form: Liquid frozen solution in a vial Route of Administration: Intramuscular injection |
| Placebo | OTHER | Pharmaceutical Form: Liquid Route of Administration: Intramuscular injection |
Inclusion Criteria: * Sentinel Cohort Stage 1: Aged 18 to 50 years on the day of inclusion * Main Cohort Stage 1 and Stage 2: Aged 60 years or older on the day of inclusion Stage 1 and Stage 2: * Sentinel Cohort: A female participant is eligible to participate if she is not pregnant or breastfeed...