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NOT YET RECRUITING
NCT07611513
PHASE3

Protective Efficacy , Immunogenicity and Safety of the Tetravalent Inactivated Enterovirus Vaccine (Vero Cell).

Sponsor: Sinovac Biotech Co., Ltd

View on ClinicalTrials.gov

Summary

This multicenter, randomized, double-blind, placebo-controlled phase IIIa clinical trial aims to evaluate the protective efficacy , immunogenicity and safety of the Tetravalent Inactivated Enterovirus Vaccine (Vero Cell) in Children aged 6 to 71 months. Participants will be randomly assigned in a 1:1 ratio to the trial group and the placebo group, receiving two doses of experimental vaccine or placebo , with a one-month interval between the two doses.

Official title: Multicenter, Randomized, Double-blind, Placebo-Controlled Phase IIIa Clinical Trial on the Protective Efficacy , Immunogenicity and Safety of the Tetravalent Inactivated Enterovirus Vaccine (Vero Cell) in Children Aged 6 to 71 Months.

Key Details

Gender

All

Age Range

6 Months - 71 Months

Study Type

INTERVENTIONAL

Enrollment

6000

Start Date

2026-05

Completion Date

2028-09

Last Updated

2026-05-28

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

Tetravalent Inactivated Enterovirus Vaccine (Vero Cell)

Two doses are administered with a one-month interval between each dose.

BIOLOGICAL

Placebo

Two doses are administered with a one-month interval between each dose.

Locations (5)

Anhui Provincial Center for Disease Control and Prevention

Hefei, Anhui, China

Fujian Provincial Center for Disease Control and Prevention

Fujian, China

Henan Provincial Center for Disease Control and Prevention

Henan, China

Hubei Provincial Center for Disease Control and Prevention

Hubei, China

Sichuan Provincial Center for Disease Control and Prevention

Sichuan, China