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Clinical Trial Summary

This phase 1 study in Australia will evaluate the safety, reactogenicity and immunogenicity of the bivalent SCB-1019 vaccine candidate with or without aluminium hydroxide in young adults (18-59 years) and older adults (60-85 years).


Clinical Trial Description

The study design includes an age- and dose-escalation (low/high dose) in two adult age groups (young adults [18-59 years] and older adults [60-85 years]). Study will be conducted in two parts, part 1 will enrolled young adults and part 2 will enroll older adults. A sentinel dosing approach will be used for close monitoring of safety to minimize risk to participants. Detailed characterization of safety (including safety laboratory evaluation) and immune responses is planned. A placebo will be used as a control. The sample size for this study is not based on formal statistical hypothesis testing but is acceptable for safety and immunogenicity evaluation in a phase 1 study. The study will be overseen by a safety monitoring committee. ;


Study Design


Related Conditions & MeSH terms

  • Respiratory Syncytial Virus Infection
  • Respiratory Syncytial Virus Infections

NCT number NCT06194318
Study type Interventional
Source Clover Biopharmaceuticals AUS Pty Ltd
Contact xuesong pei, MD
Phone 18515445890
Email xuesong.pei@cloverbiopharma.com
Status Recruiting
Phase Phase 1
Start date December 13, 2023
Completion date May 2025

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