NCT04091880

Evaluation of the Safety and Immunogenicity of Simultaneously Administration of EV71 Vaccine and Influenza Vaccine

A Randomized, Controlled, Multicenter Phase 4 Clinic Trial to Evaluate the Safety and Immunogenicity of Simultaneously Administration of EV71 Vaccine and Influenza Vaccine (Split Virion),Inactivated

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,134 (actual)
• Sponsor: China National Biotec Group Company Limited · Industry
• Sex: All
• Age: 6 Months – 11 Months
• Healthy volunteers: Accepted

Summary

Subjects will be recruited and divided into 3 groups: 1. Experimental Group (378 subjects): combined immunization of EV71 vaccine and influenza vaccine; 2. Control Group A (378 subjects): EV71 vaccine only; 3. Control Group B (378 subjects): influenza vaccine only; All blood samples will be collected before and one month after vaccinatioin. The immunogenicity and safety of both experimental and control groups will be compared and the data be analyzed.

Detailed description

To further evaluate the feasibility of simultaneously administration of EV71 vaccine and flu vaccine, we design this clinical trial to test its immunogenicity and safety. 1134 subjects aged from 6 to 11 months old are divided into one experimental group and two control groups (control group A and B). 378 subjects from the experimental group will be simultaneously administrated with one dose of EV71 vaccine (0.5 ml) and one dose of influenza vaccine (0.25 ml). One month later, they are going to receive a second dose of EV71 vaccine and influenza vaccine, simultaneously. Blood samples are collected before the first vaccination, and one month following the second vaccination. 378 subjects from the control group A will be only administrated with two doses of EV71 vaccine (0.5 ml) (1 month apart). Blood samples are collected before the first vaccination, and one month following the second vaccination. 378 subjects from the control group B will be only administrated with two doses of influenza vaccine (0.25 ml) (1 month apart). Blood samples are collected before the first vaccination, and one month following the second vaccination. To evaluate the immunogenicity, we will detect and compare the neutralization antibody levels, the seroprotection rates, and antibody geometric mean concentrations. The safety of all groups will be monitored as well.

Conditions

• Enterovirus Infections
• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	EV71 vaccine and influenza vaccine	simultaneously administrated with EV71 vaccine and influenza vaccine
BIOLOGICAL	EV71 vaccine	administrated with EV71 vaccine only
BIOLOGICAL	influenza vaccine	administrated with influenza vaccine only

Timeline

• Start date: 2019-09-26
• Primary completion: 2020-01-06
• Completion: 2021-08-10
• First posted: 2019-09-17
• Last updated: 2022-10-12

Locations

1 site across 1 country: China