NCT06350058View on ClinicalTrials.gov

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

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

375

Participants

Timeline

Start Date

August 3, 2021

Primary Completion Date

November 30, 2023

Study Completion Date

October 31, 2024

Conditions
Healthy Volunteers
Interventions
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.

Trial Locations (1)

050021

Hebei Provincial Center for Disease Control and Prevention, Shijiangzhuang

All Listed Sponsors
lead

Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

INDUSTRY

NCT06350058 - Phase I Clinical Trial of Inactivated Rotavirus Vaccine in a Population Aged 6 Weeks-49 Years Old | Biotech Hunter | Biotech Hunter