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

August 31, 2022 updated by: Sinovac (Dalian) Vaccine Technology Co., Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
450

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Seroconversion rates of the varicella antibody
Time Frame: 42 days after immunization of live attenuated varicella vaccine
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
Time Frame: 30 days after full immunization with hepatitis A vaccine
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Seropositive rates of varicella antibody
Time Frame: 42 days after immunization of live attenuated varicella vaccine
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
Time Frame: 42 days after immunization of live attenuated varicella vaccine
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
Time Frame: 42 days after immunization of live attenuated varicella vaccine
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
Time Frame: 30 days after full immunization with hepatitis A vaccine
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
Time Frame: 30 days after full immunization with hepatitis A vaccine
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
Time Frame: 30 days after full immunization with hepatitis A vaccine
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
Time Frame: 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.
within 0-42 days (or 0-30 days) after each dose of vaccine
The incidence of local and systemic solicitation adverse reactions
Time Frame: 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.
Within 0-14 days (or 0-7 days) after each dose of vaccine
The incidence of serious adverse events (SAE)
Time Frame: 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.
Within 42 days (or 30 days) after administration of each dose of vaccine

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sinovac (Dalian) Vaccine Technology Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dianmin Kang, Shandong Provincial Center for Disease Prevention and Control

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 8, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 8, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 27, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 31, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 2, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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