Study of Live Attenuated Varicella Vaccine Co-administered with MMR Vaccine or DTaP Vaccine

March 17, 2025 updated by: Sinovac (Dalian) Vaccine Technology Co., Ltd.

Immunogenicity and Safety of Live Attenuated Varicella Vaccine Co-administered with MMR Vaccine or DTaP Vaccine in Healthy Children Aged 18~24 Months: an Open-label, Randomized, Phase Ⅳ Study Clinical Trial

This is a phase Ⅳ clinical trial of live attenuated varicella vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.The primary objective of this study is to evaluate the immunogenicity of live attenuated varicella vaccine co-administered with MMR vaccine or DTaP vaccine. The secondary objective is to evaluate the safety of the vaccines when administered simultaneously.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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

A total of 720 children aged 18~24 months who have not received varicella vaccine, the second dose of MMR and the fourth dose of DTaP (or vaccines containing related ingredients) will be recruited and randomly assigned to one of three study groups (1:1:1 ratio): Group A, Group B and Group C. Participants in Group A will receive varicella vaccine and DTaP simultaneously on Day 0 and receive MMR on Day 30. Participants in Group B will varicella vaccine and MMR simultaneously on Day 0 and receive DTaP on Day 30. Participants in Group C will receive varicella vaccine only.

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 (Estimated)

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.
720

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Chongqing, China, 400042
        • Chongqing Center for Disease Control and Prevention
        • Contact:

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

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Infants aged 18-24 months;
  • have completed 3 doses of DTaP for primary immunization in their first year of life without the fourth dose of Dtap-containing vaccine;
  • have completed the first dose of MMR in their first year of life without a second dose of MMR;
  • Guardians of participants who are able to understand and voluntarily sign informed consent;
  • Provision of legal proof of identity.

Exclusion Criteria:

  • Having a history of previous varicella vaccination;
  • Having a history of chickenpox, pertussis, diphtheria, tetanus, measles, mumps, and rubella;
  • Having a history of uncontrolled chronic or serious diseases, including but not limited to cardiovascular diseases, hematological diseases, liver and kidney diseases, digestive diseases, respiratory diseases, malignant tumors, major functional organ transplantation, etc.;
  • Presence of autoimmune diseases, immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid disease, asplenia, functional asplenia, HIV infection);
  • Presence of abnormal coagulation function (e.g. coagulation factor deficiency, platelet abnormality);
  • Having/Previous having a severe neurological disorder (epilepsy, seizures, or convulsions) or psychosis, or have a family history of psychosis;
  • Acute onset of various acute or chronic illnesses within the last 7 days, or known or suspected active infection;
  • Receipt of > 14 days of immunosuppressive or other immunomodulatory therapy (prednisone ≥2 mg/kg/ day or its equivalent, except topical or inhaled corticosteroids), cytotoxic therapy within the past 6 months, or planned to receive such therapy during the trial;
  • Having received immune globulin or other blood products within the past 3 months or plan to receive such treatment during the trial;
  • Receipt of another study drug or vaccine within the past 30 days or plans to receive such drug or vaccine during the trial;
  • Administration of live attenuated vaccine within the past 28 days or subunit, inactivated, or other process vaccine within the past 7 days;
  • Known allergies to the vaccine or vaccine components, such as urticaria after vaccination, dyspnea, angioedema;
  • Having fever on the day of scheduled vaccination (axillary temperature > 37.0 ° C);
  • Failure of medical examination on the planned vaccination day;
  • Participants have any other factors that, in the judgment of the investigator, make them ineligible to participate in a 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: Group A (Varicella vaccine and DTaP co-administration group )
Participants will receive a single dose of varicella vaccine and DTaP vaccine on Day 0 and a single dose of MMR on Day 30.
Biological: Vaicella Vaccine+DTaP on Day 0, MMR on Day 30

Varicella vaccine: lyophilized powder, subcutaneous injection

DTaP: intramuscular injection

MMR: lyophilized powder, subcutaneous injection
Experimental: Group B (Varicella vaccine and MMR co-administration group )
Participants will receive a single dose of varicella vaccine and MMR on Day 0 and DTaP vaccine on Day 30.
Biological: Varicella vaccine+MMR on Day 0，DTaP on Day 30

Varicella vaccine: lyophilized powder, subcutaneous injection

MMR: lyophilized powder, subcutaneous injection

DTaP: intramuscular injection
Active Comparator: Group C (Varicella vaccine group )
Participants will receive a single dose of varicella vaccine on Day 0.
Biological: Varicella Vaccine
lyophilized powder, subcutaneous injection

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
Varicella zoster virus (VZV) antibody seroconversion rate
Time Frame: Day 30 after the administration of varicella vaccine
Seroconversion rate of VZV antibody on Day 30 after the administration of varicella vaccine.
Day 30 after the administration of varicella 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 rate of VZV antibody
Time Frame: Day 30 after the administration of varicella vaccine
Seropositive rate of VZV antibody on Day 30 after the administration of varicella vaccine.
Day 30 after the administration of varicella vaccine
Geometric mean titer (GMT) of VZV antibody
Time Frame: Day 30 after the administration of varicella vaccine
GMT of VZV antibody on Day 30 after the administration of varicella vaccine.
Day 30 after the administration of varicella vaccine
Geometric mean fold increase (GMI) of VZV antibody
Time Frame: Day 30 after the administration of varicella vaccine
GMI of VZV antibody on Day 30 after the administration of varicella vaccine.
Day 30 after the administration of varicella vaccine
Seroconversion rate of measles antibody, mumps antibody and rubella antibody
Time Frame: Day 30 after the administration of MMR
Seroconversion rate of measles antibody, mumps antibody and rubella antibody on Day 30 after the administration of MMR
Day 30 after the administration of MMR
Seropositive rate of measles antibody, mumps antibody and rubella antibody
Time Frame: Day 30 after the administration of MMR
Seropositive rate of measles antibody, mumps antibody and rubella antibody on Day 30 after the administration of MMR
Day 30 after the administration of MMR
Geometric mean concentration (GMC) of measles antibody, mumps antibody and rubella antibody
Time Frame: Day 30 after the administration of MMR
GMC of measles antibody, mumps antibody and rubella antibody on Day 30 after the administration of MMR
Day 30 after the administration of MMR
GMI of measles antibody, mumps antibody and rubella antibody
Time Frame: Day 30 after the administration of MMR
GMI of measles antibody, mumps antibody and rubella antibody on Day 30 after the administration of MMR
Day 30 after the administration of MMR
Seroconversion rate of pertussis antibody, diphtheria antibody and tetanus antibody
Time Frame: Day 30 after the administration of DTaP
Seroconversion rate of pertussis antibody, diphtheria antibody and tetanus antibody on Day 30 after the administration of DTaP
Day 30 after the administration of DTaP
Seropositive rate of pertussis antibody, diphtheria antibody and tetanus antibody
Time Frame: Day 30 after the administration of DTaP
Seropositive rate of pertussis antibody, diphtheria antibody and tetanus antibody on Day 30 after the administration of DTaP
Day 30 after the administration of DTaP
GMC of pertussis antibody, diphtheria antibody and tetanus antibody
Time Frame: Day 30 after the administration of DTaP
GMC of pertussis antibody, diphtheria antibody and tetanus antibody on Day 30 after the administration of DTaP
Day 30 after the administration of DTaP
GMI of pertussis antibody, diphtheria antibody and tetanus antibody
Time Frame: Day 30 after the administration of DTaP
GMI of pertussis antibody, diphtheria antibody and tetanus antibody on Day 30 after the administration of DTaP
Day 30 after the administration of DTaP
The incidence of adverse reactions within 0~14 days
Time Frame: 0~14 days after each dose vaccination
The incidence of adverse reactions within 0~14 days after each dose vaccination.
0~14 days after each dose vaccination
The incidence of adverse reactions within 0~30 days
Time Frame: 0~30 days after each dose vaccination
The incidence of adverse reactions within 0~30 days after each dose vaccination.
0~30 days after each dose vaccination
The incidence of serious adverse events (SAEs) within 0~30 days
Time Frame: 0~30 days after each dose vaccination
The incidence of SAEs within 0~30 days after each dose vaccination.
0~30 days after each dose vaccination

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.

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 (Estimated)

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.
May 1, 2025

Primary Completion (Estimated)

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.
December 1, 2025

Study Completion (Estimated)

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.
December 1, 2025

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).
March 2, 2025

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.
March 17, 2025

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.
March 25, 2025

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.
March 25, 2025

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.
March 17, 2025

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.
March 1, 2025

More Information

Terms related to this study

Keywords

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-4008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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