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NCT06350058

Phase I Clinical Trial of Inactivated Rotavirus Vaccine in a Population Aged 6 Weeks-49 Years Old

A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Dose Escalation Study to Evalution the Safety, Tolerability of Inactivated Rotavirus Vaccine in a Population Aged 6 Weeks-49 Years Old
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd·Phase 1·ClinicalTrials.gov·biologicalRecruitment Completed
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Healthy Volunteers
Drug/Device/Intervention
Inactivated rotavirus vaccine (low dose)
Study type
Interventional
Intervention type
biological
Sponsor & location
Primary sponsor
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Location
Shijiangzhuang, China
Timeline & enrollment
Phase
Phase 1
Start date
Aug 03, 2021
End date
Oct 31, 2024
Enrollment
375 participants
Primary outcome

Incidence rate of AE,Incidence rate of SAE

Summary

The research objective is to evaluate the safety and tolerability of the inactivated
 rotavirus vaccine and explore its preliminary immunogenicity.

ICD-10 classifications
Healthy person accompanying sick personRoutine general health check-up of armed forcesRoutine general health check-up of sports teamsRoutine general health check-up of inhabitants of institutions
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06350058
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06350058 through Pure Global AI's free database. This Phase 1 trial is sponsored by Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd and is currently Recruitment Completed. The study focuses on Healthy Volunteers. Target enrollment is 375 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.