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A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Immunogenicity of the Respiratory Syncytial Virus IN006 Bivalent mRNA Vaccine (IN006) in Healthy Participants Aged 60 Years and Older
The study will evaluate the safety, tolerability, and immunogenicity of 2 dose levels of IN006 in healthy participants who aged at 60 years or older; of a revaccination of IN006 given 12 months or 24 months after the initial vaccination.
Details
| Lead sponsor | Shenzhen Shenxin Biotechnology Co., Ltd |
|---|---|
| Phase | Phase 2 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 500 |
| Start date | 2025-08-13 |
| Completion | 2029-10 |
Conditions
- Respiratory Syncytial Virus (RSV) Infection
Interventions
- Respiratory Syncytial Virus IN006 Bivalent mRNA 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 Unsolicited 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 3 years at most
- Percentage of Abnormal Results of Hematology On Day 3 After Initial Vaccination Compared with Baseline — From initial vaccination up to 3 days post initial vaccination
- Percentage of Abnormal Results of Clinical Chemistry On Day 3 After Initial Vaccination Compared with Baseline — From initial vaccination up to 3 days post initial vaccination
Countries
China