Herpes Zoster Clinical Trial
Official title:
A Randomized, Observer-Blind, Phase 2 Study To Assess the Safety and Immunogenicity of CRV-101 Vaccine Head-To-Head With SHINGRIX® for the Prevention of Herpes Zoster in Adults Aged 50 Years and Older
The purpose of this study is to assess the safety and immunogenicity of CRV-101, an investigational vaccine compared to Shingrix for the prevention of herpes zoster in adults aged 50 years and older
In the first part of the trial, participants will be randomized 1:1:1 to CRV-101 Vaccine high antigen dose, CRV-101 Vaccine low antigen dose, or Shingrix. In the second part of the trial, participants will be randomized 5:1 to receive CRV-101 high adjuvant dose, middle adjuvant dose, or low adjuvant dose versus Shingrix. Both study vaccines, CRV-101 Vaccine and Shingrix, will be administered by intramuscular injection on Month 0 and Month 2. Safety, reactogenicity, and immunogenicity analysis will be performed overall and by age group. Participants will be followed for safety, immunogenicity, and herpes zoster cases, from Day 0 to the main study end (Month 14), and through the long-term follow up (LTFU) extension period up to 6 years. ;
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