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A Study of Combined Immunization With Live Attenuated Varicella Vaccine and Inactivated Hepatitis A Vaccine

NCT05526820 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2022-09-02

No results posted yet for this study

Summary

This study is a randomized and controlled Phase IV clinical trial.The purpose of this study is to evaluate the immunogenicity and safety of combined immunization with live attenuated varicella vaccine and inactivated hepatitis A vaccine in children aged 12-15 months.

Conditions

  • Varicella

Interventions

BIOLOGICAL

The live attenuated varicella vaccine and the inactivated hepatitis A vaccine

The live attenuated varicella vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd,the inactivated hepatitis A vaccine was manufactured by Sinovac Biotech Co., Ltd. The live attenuated varicella vaccine:live varicella-zoster virus in 0.5 mL of sucrose, sodium glutamate,sodium chloride,potassium chloride,sodium dihydrogen phosphate, potassium dihydrogen phosphate and injection water per injection. The inactivated hepatitis A vaccine:250 U inactivated virus in 0.5mL of aluminium hydroxide solution per injection. All subjects received hepatitis A vaccine in the upper left arm and varicella vaccine in the upper right arm.

Sponsors & Collaborators

  • Sinovac (Dalian) Vaccine Technology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Dianmin Kang · Shandong Provincial Center for Disease Prevention and Control

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-04-08
Primary Completion
2021-04-08
Completion
2022-02-27

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 NCT05526820 on ClinicalTrials.gov