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Safety and Immunogenicity of Concomitant Administration of EV71 Vaccine With EPI Vaccines

NCT03274102 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 780

Last updated 2021-07-29

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and immunogenicity of concomitant administration of EV71 vaccine with recombinant hepatitis B vaccine/Group A meningococcal polysaccharide vaccine.

Conditions

  • Hand, Foot and Mouth Disease

Interventions

BIOLOGICAL

Concomitant administration of EV71 vaccine with EPI vaccines

1. The investigated EV17 vaccine was manufactured by Sinovac Biotech Co., Ltd.； the recombinant hepatitis B vaccine was manufactured by Shenzhen Kangtai Biological Products Co., Ltd; the Group A meningococcal polysaccharide vaccine was manufactured by Wuhan Institute of Biological Products Co., Ltd. 2. The primary vaccination schedule of hepatitis B vaccine includes 3 doses with a schedule of 0,1,6 month, and subjects only receive 3rd vaccination in this study; the primary vaccination schedule of Group A meningococcal polysaccharide vaccine includes 2 doses with 3 months interval between doses, and subjects only receive 1st vaccination in this study

BIOLOGICAL

Single injection of EPI vaccine

1. The recombinant hepatitis B vaccine was manufactured by Shenzhen Kangtai Biological Products Co., Ltd; the Group A meningococcal polysaccharide vaccine was manufactured by Wuhan Institute of Biological Products Co., Ltd. 2. The primary vaccination schedule of hepatitis B vaccine includes 3 doses with a schedule of 0,1,6 month, and subjects only receive 3rd vaccination in this study; the primary vaccination schedule of Group A meningococcal polysaccharide vaccine includes 2 doses with 3 months interval between doses, and subjects only receive 1st vaccination in this study

BIOLOGICAL

EV71 Vaccine only

The investigated EV17 vaccine was manufactured by Sinovac Biotech Co., Ltd.

Sponsors & Collaborators

  • Guangdong Center for Disease Prevention and Control

    collaborator OTHER_GOV

  • Sinovac Biotech Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Huizhen Zheng · Guangdong Center for Disease Prevention and Control

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-04-22
Primary Completion
2017-11-01
Completion
2017-11-01

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 NCT03274102 on ClinicalTrials.gov