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A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of Respiratory Syncytial Virus IN006 Bivalent mRNA Vaccine (IN006) in Healthy Adult Aged 18 Years and Above
The study will evaluate the safety, tolerability, and immunogenicity of 3 dose levels of IN006 in healthy adults aged 18 Years and Above; of a revaccination of IN006 given approximately 12 months after the initial vaccination in older adults (aged ≥60 years).
Details
| Lead sponsor | Shenzhen Shenxin Biotechnology Co., Ltd |
|---|---|
| Phase | Phase 1 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 240 |
| Start date | 2024-11-11 |
| Completion | 2027-04 |
Conditions
- Respiratory Syncytial Virus Infections
Interventions
- Bivalent RSV Vaccine (IN006)
- Placebo
Primary outcomes
- Percentage of Participants With Solicited Local and Systemic Adverse Reactions Through 14 Days After Initial Vaccination — From initial vaccination up to14 days post initial vaccination
- Percentage of Participants With Unsolicited Adverse Events (AEs) Through 28 Days After Initial Vaccination — From initial vaccination up to 28 days post initial vaccination
- Percentage of Participants With AEs Through 30 Minutes After Initial Vaccination — From initial vaccination up to 30 minutes post initial vaccination
- Percentage of Participants With Any Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) During Study — Through study completion, about 2 years at most
- Percentage of Abnormal Results of Hematology On Day 3 After Initial Vaccination Compared with Baseline — From initial vaccination up to day 3 post initial vaccination
- Percentage of Abnormal Results of Clinical Chemistry On Day 3 After Initial Vaccination Compared with Baseline — From initial vaccination up to day 3 post initial vaccination
Countries
China