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

A Randomized, Controlled Clinical Trial to Evaluate the Immunogenicity and Safety of Live Attenuated Varicella Vaccine Combined With Inactivated Hepatitis A Vaccine

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.

Study Overview

• Status: Completed
• Conditions: Varicella
• Intervention / Treatment: Biological: The live attenuated varicella vaccine and the inactivated hepatitis A vaccine

Detailed Description

This study is a randomized and controlled phase IV clinical trial in children aged 1 year old (12-15 months).The purpose of this study is to evaluate the immunogenicity and safety of live attenuated varicella vaccine co-administration with 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.A total of 450 subjects aged 1 year old (12-15 months) were be enrolled.Subjects were be randomly divided into 2 groups in a ratio of 1:1.Subjects in the combined immunization group received one dose of live attenuated varicella vaccine and the first dose inactivated hepatitis A vaccine on day 0 and the second dose of inactivated hepatitis A vaccine on day 180.Subjects in the Non-combined immunization group received one dose of live attenuated varicella vaccine on day 0,the first dose of inactivated hepatitis A vaccine on day 42 and the second dose of inactivated hepatitis A vaccine on day 222.

• Study Type: Interventional
• Enrollment (Actual): 450
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shandong
    • Tai'an, Shandong, China
      • Feicheng Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy child aged 1 year old (12-15 months old);
• Proven legal identity;
• The subjects'guardians should be capable of understanding the informed consent form, and such form should be signed prior to enrolment.

Exclusion Criteria:

• History of vaccination of varicella vaccine or hepatitis A vaccine.
• Previous history of varicella infection or hepatitis A infection;
• History of asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, and angioedema;
• Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc;
• Thyroid disease or history of thyroidectomy, asplenia,functional asplenia,asplenia or splenectomy resulting from any condition;
• Suffering from serious chronic diseases, serious cardiovascular diseases, liver and kidney diseases, malignant tumors, etc;
• Family history of psychosis,severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
• Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;
• Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids(excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) within 6 months before enrollment;
• Receipt of blood products within the past 3 months;
• Receipt of other investigational vaccines or drugs within 28 days prior to receiving the investigational vaccine;
• Receipt of attenuated live vaccines in the past 28 days;
• Receipt of inactivated or subunit vaccines in the past 7 days;
• Onset of various acute or chronic diseases within 7 days prior to the study;
• Armpit temperature in subjects with fever prior to vaccination with the investigational vaccine. 37.4 ℃;
• According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The combined immunization group; 225 participants received one dose of live attenuated varicella vaccine and the first dose inactivated hepatitis A vaccine on day 0 and the second dose of inactivated hepatitis A vaccine on day 180.	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.
Active Comparator: The Non-combined immunization group; 225 participants received one dose of live attenuated varicella vaccine on day 0,the first dose of inactivated hepatitis A vaccine on day 42 and the second dose of inactivated hepatitis A vaccine on day 222.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seroconversion rates of the varicella antibody	Seroconversion rate of varicella antibody 42 days after immunization of live attenuated varicella vaccine.	42 days after immunization of live attenuated varicella vaccine
Seroconversion rates of anti-HAV antibody	Seroconversion rate of anti-HAV antibody 30 days after full immunization with hepatitis A vaccine.	30 days after full immunization with hepatitis A vaccine

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seropositive rates of varicella antibody	Seropositive rates of varicella antibody 42 days after immunization of live attenuated varicella vaccine.	42 days after immunization of live attenuated varicella vaccine
GMT of varicella antibody	GMT of varicella antibody 42 days after immunization of live attenuated varicella vaccine.	42 days after immunization of live attenuated varicella vaccine
GMI of varicella antibody	GMI of varicella antibody 42 days after immunization of live attenuated varicella vaccine.	42 days after immunization of live attenuated varicella vaccine
Seropositive rates of anti-HAV antibody	Seropositive rates of anti-HAV antibody 30 days after full immunization with hepatitis A vaccine.	30 days after full immunization with hepatitis A vaccine
GMC of anti-HAV antibody	GMC of anti-HAV antibody 30 days after full immunization with hepatitis A vaccine.	30 days after full immunization with hepatitis A vaccine
GMI of anti-HAV antibody	GMI of anti-HAV antibody 30 days after full immunization with hepatitis A vaccine.	30 days after full immunization with hepatitis A vaccine
The incidence of adverse events	Incidence of adverse events within 0-42 days (or 0-30 days) after each dose of vaccine.	within 0-42 days (or 0-30 days) after each dose of vaccine
The incidence of local and systemic solicitation adverse reactions	The incidence of local and systemic solicitation adverse reactions within 0-14 days (or 0-7 days) after each dose of vaccine.	Within 0-14 days (or 0-7 days) after each dose of vaccine
The incidence of serious adverse events (SAE)	The incidence of serious adverse events (SAE) within 42 days (or 30 days) after administration of each dose of vaccine.	Within 42 days (or 30 days) after administration of each dose of vaccine

Collaborators and Investigators

• Sponsor: Sinovac (Dalian) Vaccine Technology Co., Ltd.
• Investigators: Principal Investigator: Dianmin Kang, Shandong Provincial Center for Disease Prevention and Control

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2021
• Primary Completion (Actual): April 8, 2021
• Study Completion (Actual): February 27, 2022

Study Registration Dates

• First Submitted: August 31, 2022
• First Submitted That Met QC Criteria: August 31, 2022
• First Posted (Actual): September 2, 2022

Study Record Updates

• Last Update Posted (Actual): September 2, 2022
• Last Update Submitted That Met QC Criteria: August 31, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Liver Diseases; Hepatitis, Viral, Human; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Herpesviridae Infections; Varicella Zoster Virus Infection; Hepatitis; Hepatitis A; Herpes Zoster; Chickenpox; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: PRO-VZV-4001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No