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Recruiting Phase 1 NCT06645665

A Study to Describe the Safety and Immunogenicity of a Respiratory Syncytial Virus Vaccine IN006 in Healthy Adult Aged 18 Years and Above

Trial Parameters

Condition Respiratory Syncytial Virus Infections
Sponsor Shenzhen Shenxin Biotechnology Co., Ltd
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 240
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-11-11
Completion 2027-04
Interventions
Bivalent RSV Vaccine (IN006)Placebo

Brief Summary

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).

Eligibility Criteria

Key Inclusion Criteria: 1. Healthy people aged 18-59 (Part 1) or ≥60 (Part 2), male or female. 2. Body mass index (BMI) in the range of 18 to 29 kg/m\^2. 3. Laboratory tests, 12-lead electrocardiogram, chest radiograph, vital signs and physical examination results are normal during the screening period, or abnormal results assessed by the investigator had no clinical significance; Subjects ≥60 years old with stable medical conditions, whose risk was considered controllable by the investigator, could also be enrolled. 4. Women of childbearing age took effective contraception within 2 weeks before joining the study, and the pregnancy test results before vaccination are negative. All male and female subjects of reproductive age voluntarily agree to use effective contraception from the signing of informed consent until 6 months after vaccination. Key Exclusion Criteria: 1. The results of vital signs show: for subjects with no history of hypertension or hypotension, systolic blood pressure

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