NCT06080906View on ClinicalTrials.gov

Phase II Clinical Trial of the Inactivated Rotavirus Vaccine

PHASE2RecruitingINTERVENTIONAL
Enrollment

600

Participants

Timeline

Start Date

October 20, 2023

Primary Completion Date

February 17, 2025

Study Completion Date

June 17, 2025

Conditions
Rotavirus InfectionsDiarrhea
Interventions
BIOLOGICAL

IRV on a 0- and 28-day schedule

Inactivated Rotavirus vaccine (Vero Cells) of 320EU/0.5ml on Day 0, 28

BIOLOGICAL

IRV on a 0-, 28- and 56-day schedule

Inactivated Rotavirus vaccine (Vero cell) of 320EU/0.5ml on Day 0, 28, 56

BIOLOGICAL

Placebo on Day 0, 28

Two doses of placebo at the vaccination schedule of Day 0, 28

BIOLOGICAL

Placebo on Day 0, 28, 56

Three doses of placebo at the vaccination schedule of Day 0, 28, 56

Trial Locations (1)

Unknown

RECRUITING

Tongxu Center for Disease Prevention and Control, Kaifeng

All Listed Sponsors
collaborator

Henan Center for Disease Control and Prevention

OTHER_GOV

lead

Institute of Medical Biology, Chinese Academy of Medical Sciences

OTHER