Phase 1CompletedAge-related condition
The Safety and Immunogenicity Study of the Recombinant Zoster Vaccine (CHO Cell)
A Randomized, Observer-Blinded, Active-Controlled, Phase I Study to Evaluate the Safety and Immunogenicity of the Recombinant Zoster Vaccine (CHO Cell) in Healthy Adults Aged 40 Years and Older
- Sponsor
- Jiangsu Rec-Biotechnology Co., Ltd. (Industry)
- Enrolment
- 48 enrolled
- Conditions
- Herpes Zoster
- Interventions
- REC610; Shingrix
- Ages
- adults, older adults
- Registry
- NCT05769049
Full record on ClinicalTrials.gov
From the registry
This is a randomized, observer-blinded, active-controlled Phase I study to evaluate the safety, reactogenicity, and immunogenicity of REC610, when administered as 2 intramuscular (IM) injections in healthy adults aged 40 years and older, who do not have known HZ and history of varicella or HZ vaccination. The recombinant HZ vaccine, Shingrix® (GlaxoSmithKline), will be used as the active control.
Primary outcomes
- Incidence of related AE
- Incidence of solicited AE
- Incidence of unsolicited AEs
- Incidence of clinically significant abnormalities in clinical laboratory tests
History
Last registry update
Primary completion
Registered
Started