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

NCT05526820 | Completed Phase 4

• 1 other identifier: PRO-VZV-4001
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

Varicella

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Seropositive rates 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

• GMI 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

• GMC of anti-HAV antibody

  30 days after full immunization with hepatitis A vaccine

Study Arms (2)

The combined immunization group

EXPERIMENTAL

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 Non-combined immunization group

ACTIVE COMPARATOR

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

Interventions

The live attenuated varicella vaccine and the inactivated hepatitis A vaccine BIOLOGICAL

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; The combined immunization group

Eligibility Criteria

• Age: 12 Months - 15 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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 ℃;

Sponsors & Collaborators

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

Study Sites (1)

Feicheng Center for Disease Control and Prevention

Tai’an, Shandong, China

Location

Related Publications (1)

• 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.

  PMID: 36593652 DERIVED

MeSH Terms

Conditions

Chickenpox

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Dianmin Kang

  Shandong Provincial Center for Disease Prevention and Control

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2022
• First Posted: September 2, 2022
• Study Start: April 8, 2021
• Primary Completion: April 8, 2021
• Study Completion: February 27, 2022
• Last Updated: September 2, 2022

Record last verified: 2022-08

Locations

CN (1)