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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06442241 | A Safety and Immunogenicity Trial of a Respiratory Syncytial Virus Vaccine, LYB005 in Healthy Adults | PHASE1 | ACTIVE NOT_RECRUITING | 84 | — | — | Jul 31, 2024 | Dec 30, 2025 | Mar 13, 2025 | 1 | Australia |
The incidence and severity of any adverse events (AEs) within 30 minutes after the vaccination
The incidence and severity of any solicited local and systemic AEs and unsolicited AEs within 7 days after the vaccination
The incidence and severity of any unsolicited AEs within 28 days after the vaccination
The occurrence of clinically significant laboratory abnormalities 3 days, 7 days, 28 days and 90 days after vaccination
The incidence of any serious adverse events (SAEs) and adverse events of special interest (AESIs) within 6 months after the vaccination
| Arm | Type | Description |
|---|---|---|
| Group 1 (LYB005 low dose without adjuvant; young adults) | EXPERIMENTAL | Young adults (18-59 years old) will receive a single injection of low dose LYB005 (30μg) without adjuvant on Day 1. |
| Group 2 (LYB005 middle dose without adjuvant; young adults) | EXPERIMENTAL | Young adults (18-59 years old) will receive a single injection of middle dose LYB005 (60μg) without adjuvant on Day 1. |
| Group 3 (LYB005 high dose without adjuvant; young adults) | EXPERIMENTAL | Young adults (18-59 years old) will receive a single injection of high dose LYB005 (120μg) without adjuvant on Day 1. |
| Group 4 (LYB005 low dose with adjuvant; young adults) | EXPERIMENTAL | Young adults (18-59 years old) will receive a single injection of low dose LYB005 (30μg) with adjuvant on Day 1. |
| Group 5 (LYB005 middle dose with adjuvant; young adults) | EXPERIMENTAL | Young adults (18-59 years old) will receive a single injection of middle dose LYB005 (60μg) with adjuvant on Day 1. |
| Group 6 (LYB005 high dose with adjuvant; young adults) | EXPERIMENTAL | Young adults (18-59 years old) will receive a single injection of high dose LYB005 (120μg) with adjuvant on Day 1. |
| Group 7 (placebo; young adults) | PLACEBO_COMPARATOR | Young adults (18-59 years old) will receive a single injection of placebo on Day 1. |
| Group 8 (LYB005 low dose without adjuvant; older adults) | EXPERIMENTAL | Older adults (≥60 years old) will receive a single injection of low dose LYB005 (30μg) without adjuvant on Day 1. |
| Group 9 (LYB005 middle dose without adjuvant; older adults) | EXPERIMENTAL | Older adults (≥60 years old) will receive a single injection of middle dose LYB005 (60μg) without adjuvant on Day 1. |
| Group 10 (LYB005 high dose without adjuvant; older adults) | EXPERIMENTAL | Older adults (≥60 years old) will receive a single injection of high dose LYB005 (120μg) without adjuvant on Day 1. |
| Group 11 (LYB005 low dose with adjuvant; older adults) | EXPERIMENTAL | Older adults (≥60 years old) will receive a single injection of low dose LYB005 (30μg) with adjuvant on Day 1. |
| Group 12 (LYB005 middle dose with adjuvant; older adults) | EXPERIMENTAL | Older adults (≥60 years old) will receive a single injection of middle dose LYB005 (60μg) with adjuvant on Day 1. |
| Group 13 (LYB005 high dose with adjuvant; older adults) | EXPERIMENTAL | Older adults (≥60 years old) will receive a single injection of high dose LYB005 (120μg) with adjuvant on Day 1. |
| Group 14 (AREXVY; older adults) | ACTIVE_COMPARATOR | Older adults (≥60 years old) will receive a single injection of positive control AREXVY on Day 1. |
| Name | Type | Description |
|---|---|---|
| LYB005 low dose without adjuvant | BIOLOGICAL | Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection. |
| LYB005 middle dose without adjuvant | BIOLOGICAL | Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection. |
| LYB005 high dose without adjuvant | BIOLOGICAL | Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection. |
| LYB005 low dose with adjuvant | BIOLOGICAL | Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection. |
| LYB005 middle dose with adjuvant | BIOLOGICAL | Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection. |
| LYB005 high dose with adjuvant | BIOLOGICAL | Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection. |
| Placebo | BIOLOGICAL | 0.9% sodium chloride injection. Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection. |
| Positive control | BIOLOGICAL | AREXVY. Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection. |
Inclusion Criteria: 1. Part 1-A male or female aged 18-59 years at screening; Part 2-A male or female aged 60 years and older at screening. 2. Written informed consent obtained from the subject before any assessment is performed. 3. Subjects who the investigator believes that they can and will comp...