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

NCT04091880 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1134

Last updated 2022-10-12

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Zhejiang Provincial Center for Disease Control and Prevention

    collaborator OTHER_GOV

  • Henan Center for Disease Control and Prevention

    collaborator OTHER_GOV

  • Guizhou Center for Disease Control and Prevention

    collaborator OTHER

  • Wuhan Institute of Biological Products Co., Ltd

    collaborator INDUSTRY

  • Changchun Institute of Biological Products Co., Ltd.

    collaborator INDUSTRY

  • Peking University

    collaborator OTHER

  • National Institutes for Food and Drug Control, China

    collaborator OTHER

  • China National Biotec Group Company Limited

    lead INDUSTRY

Principal Investigators

  • Hanqing He · Zhejiang Provincial Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-09-26
Primary Completion
2020-01-06
Completion
2021-08-10

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

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 NCT04091880 on ClinicalTrials.gov