NCT04133584

The Immunogenicity and Safety of the Vaccination of Inactivated Enterovirus 71 Vaccine and Seasonal Influenza Vaccine

Multiple Centers, Randomized, and Control Trail on the Immunogenicity and Safety of the Simultaneously Vaccination of Inactivated Enterovirus 71 Vaccine (EV71) and Seasonal Influenza Vaccine(SIV)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,134 (actual)
• Sponsor: Zhejiang Provincial Center for Disease Control and Prevention · Other Government
• Sex: All
• Age: 6 Months – 11 Months
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the Immunogenicity and safety of the simultaneously vaccination of Inactivated Enterovirus 71 Vaccine (EV71) and seasonal influenza vaccine(SIV)

Detailed description

Main subjects: The seroconversion rate for each antigen when EV71 is administrated with SIV Secondary subjects: The positive rate of antibody for each antigen when EV71 is administrated with SIV The safety for each antigen when EV71 is administrated with SIV

Conditions

• Seasonal Influenza
• Hand, Foot and Mouth Disease

Interventions

Type	Name	Description
BIOLOGICAL	EV71 +SIV	Give 2 doses of EV71 +SIV, get 2 blood samples before the first dose and 28-43 days after the last dose.
BIOLOGICAL	EV71	Give 2 doses of EV71 , get 2 blood samples before the first dose and 28-43 days after the last
BIOLOGICAL	SIV	Give 2 doses of SIV , get 2 blood samples before the first dose and 28-43 days after the last

Timeline

• Start date: 2019-09-16
• Primary completion: 2021-06-30
• Completion: 2021-11-30
• First posted: 2019-10-21
• Last updated: 2022-07-13

Locations

1 site across 1 country: China