A Study of Combined Immunization With Live Attenuated Varicella Vaccine and Inactivated Hepatitis A Vaccine
NCT ID: NCT05526820
Last Updated: 2022-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
450 participants
INTERVENTIONAL
2021-04-08
2022-02-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Months
15 Months
ALL
Yes
Sponsors
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Sinovac (Dalian) Vaccine Technology Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Dianmin Kang
Role: PRINCIPAL_INVESTIGATOR
Shandong Provincial Center for Disease Prevention and Control
Locations
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Feicheng Center for Disease Control and Prevention
Tai’an, Shandong, China
Countries
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References
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Sun D, Yu D, Du Z, Jia N, Liu X, Sun J, Xu Q, Sun Z, Luan C, Lv J, Xiong P, Zhang L, Sha X, Gao Y, Kang D. Immunogenicity and safety of a live attenuated varicella vaccine co-administered with inactive hepatitis A vaccine: A phase 4, single-center, randomized, controlled trial. Hum Vaccin Immunother. 2023 Dec 31;19(1):2161789. doi: 10.1080/21645515.2022.2161789. Epub 2023 Jan 2.
Other Identifiers
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PRO-VZV-4001
Identifier Type: -
Identifier Source: org_study_id
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