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Clinical Study on Combined Immune Effect of EV71 Inactivated Vaccine

NCT03519568 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1944

Last updated 2018-05-09

No results posted yet for this study

Summary

Background: To prevent and control the epidemic of HFMD and related diseases caused by EV71 infection, the development of EV71 vaccine has been developed in many countries or regions. According to the requirements of drug registration approval, we need to evaluate immunogenicity and safety effect on combined immune effect of EV71 inactivated vaccine and other vaccines (HepB、MPSV-A、MR、JE-L).

Method: Four experimental groups (HepB:3+EV71, MPSV-A:1+EV71, MR+EV71, JE-L+EV71) were included in this clinical trail. In addition to the meningococcal vaccine research group, the other three groups were followed up for the 4 times. The initial blood samples were collected, and the first dose vaccine was inoculated at the same time. EV71 second doses of vaccine were inoculated at 30 day, the blood was collected after 30 days of immunization with second doses. 6 months of safety follow-up was carried out in the whole clinical trial after vaccination. The meningococcal vaccine research group increased 1 follow-up after the second dose of MPSV-A vaccine. The index of immunogenicity and safety effect in four experimental groups need to be evaluated.

Conditions

  • Enterovirus 71 Inactivated Vaccine
  • HFMD

Interventions

BIOLOGICAL

EV71 (inoculation vaccine)

EV71 vaccine 0.5ml per dose, Wuhan Biological Products Co., Ltd., Wuhan, Hubei Province, China 10μg HepB 0.5ml per dose, Wuhan Biological Products Co., Ltd., Wuhan, Hubei Province, China 30ug MPSV-A 0.5ml per dose, Wuhan Biological Products Co., Ltd., Wuhan, Hubei Province, China MR 0.5ml per dose, Beijiing Biological Products Co., Ltd., Beijing, China JE-L 0.5ml per dose, Chengdu Biological Products Co., Ltd., Chengdu,Sichuan Province, China

Sponsors & Collaborators

  • Hunan Provincial Center for Disease Control and Prevention

    collaborator OTHER

  • Shaanxi Provincial Center for Disease Control and Prevention

    collaborator OTHER

  • Shandong Province Centers for Disease Control and Prevention

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
12 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2018-12-31
Completion
2019-04-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03519568 on ClinicalTrials.gov