Clinical trial NCT05526820: A Study of Combined Immunization With Live Attenuated Varicella Vaccine and Inactivated Hepatitis A Vaccine
Official title: A Randomized, Controlled Clinical Trial to Evaluate the Immunogenicity and Safety of Live Attenuated Varicella Vaccine Combined With Inactivated Hepatitis A Vaccine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Varicella
Lead sponsor: Sinovac (Dalian) Vaccine Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-09-02
Enrollment: 450
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Seroconversion rates of the varicella antibody
timeFrame: 42 days after immunization of live attenuated varicella vaccine
measure: Seroconversion rates of anti-HAV antibody
timeFrame: 30 days after full immunization with hepatitis A vaccine
Secondary outcomes:
measure: Seropositive rates of varicella antibody
timeFrame: 42 days after immunization of live attenuated varicella vaccine
measure: GMT of varicella antibody
timeFrame: 42 days after immunization of live attenuated varicella vaccine
measure: GMI of varicella antibody
timeFrame: 42 days after immunization of live attenuated varicella vaccine
measure: Seropositive rates of anti-HAV antibody
timeFrame: 30 days after full immunization with hepatitis A vaccine
measure: GMC of anti-HAV antibody
timeFrame: 30 days after full immunization with hepatitis A vaccine
measure: GMI of anti-HAV antibody
timeFrame: 30 days after full immunization with hepatitis A vaccine
measure: The incidence of adverse events
timeFrame: within 0-42 days (or 0-30 days) after each dose of vaccine
measure: The incidence of local and systemic solicitation adverse reactions
timeFrame: Within 0-14 days (or 0-7 days) after each dose of vaccine
measure: The incidence of serious adverse events (SAE)
timeFrame: Within 42 days (or 30 days) after administration of each dose of vaccine
Other outcomes:
Locations:
city: Tai'an
country: China
facility: Feicheng Center for Disease Control and Prevention
state: Shandong
Study officials:
affiliation: Shandong Provincial Center for Disease Prevention and Control
name: Dianmin Kang
role: PRINCIPAL_INVESTIGATOR
References: