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

Phase 4

Completed

• Conditions: Varicella
• Interventions: Biological: The live attenuated varicella vaccine and the inactivated hepatitis A vaccine

• Registration Number: NCT05526820
• Lead Sponsor: Sinovac (Dalian) Vaccine Technology Co., Ltd.

Brief 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.

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 Timeline

• Study Start: 2021-04-08
• Primary Completion: 2021-04-08
• Study Completion: 2022-02-27
• Status Verified: 2022-08
• Study First Submitted: 2022-08-31
• Study First Submitted QC: 2022-08-31
• Last Update Submitted: 2022-08-31
• Study First Posted: 2022-09-02
• Last Update Posted: 2022-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The combined immunization group	The live attenuated varicella vaccine and the inactivated hepatitis A vaccine	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.
The Non-combined immunization group	The live attenuated varicella vaccine and the inactivated hepatitis A vaccine	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Feicheng Center for Disease Control and Prevention; 🇨🇳 Tai'an, Shandong, China