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A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Respiratory Syncytial Virus IN006 Bivalent mRNA Vaccine (IN006) in Healthy Adult Participants
The study will evaluate the safety, tolerability, and immunogenicity of a single injection of up to 4 dose levels of IN006 in younger adults and 3 dose levels of IN006 in older adults; of a revaccination of IN006 given approximately 12 months after the initial vaccination in older adults.
Details
| Lead sponsor | Shenzhen Shenxin Biotechnology Co., Ltd |
|---|---|
| Phase | Phase 1 |
| Status | NOT_YET_RECRUITING |
| Enrolment | 200 |
| Start date | 2026-12 |
| Completion | 2028-04 |
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 Any Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and AEs Leading to Study Discontinuation Through 12 Months After Initial Vaccination — From initial vaccination up to 12 months post initial vaccination
- Percentage of Participants With Any Medically Attended AEs (MAAEs) Through 6 Months After Initial Vaccination — From initial vaccination up to 6 months post initial vaccination