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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 375 (actual)
• Sponsor: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 6 Weeks – 49 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

This is a Phase I, single center, randomized, double-blind, placebo-controlled, dose escalation clinical trial conducted in Hebei Province, China. The purpose of this study is to evaluate the safety and tolerability of the inactivated rotavirus vaccine and explore its preliminary immunogenicity.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	Inactivated rotavirus vaccine (low dose)	The protein content of each dose is 2.5 μg. The antigen content shall not be less than 2000U, and each person shall receive one dose of 0.5ml.
BIOLOGICAL	Inactivated rotavirus vaccine (high dose)	The protein content of each dose is 5 μg. The antigen content shall not be less than 4000U, and each person shall receive one dose of 0.5ml.
BIOLOGICAL	Placebo	Aluminum hydroxide adjuvant.

Timeline

• Start date: 2021-08-03
• Primary completion: 2023-11-30
• Completion: 2024-10-31
• First posted: 2024-04-05
• Last updated: 2024-04-05

Locations

1 site across 1 country: China