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

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: Not yet recruiting
• Conditions: DTaP Vaccine; MMR Vaccine; Varicella (chickenpox)
• Intervention / Treatment: Biological: Vaicella Vaccine+DTaP on Day 0, MMR on Day 30; Biological: Varicella vaccine+MMR on Day 0，DTaP on Day 30; Biological: Varicella Vaccine

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: Interventional
• Enrollment (Estimated): 720
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: XU Jiawei; Phone Number: 023-68813088; Email: 452712782@qq.com

Study Locations

• China
  • Chongqing, China, 400042
    • Chongqing Center for Disease Control and Prevention
    • Contact: XU Jiawei; Phone Number: 023-68813088; Email: 452712782@qq.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Varicella zoster virus (VZV) antibody seroconversion rate	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

Outcome Measure	Measure Description	Time Frame
Seropositive rate of VZV antibody	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	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	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	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	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	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	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	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	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	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	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	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	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	The incidence of SAEs within 0~30 days after each dose vaccination.	0~30 days after each dose vaccination

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 2, 2025
• First Submitted That Met QC Criteria: March 17, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 17, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: VZV; Co-administered
• Additional Relevant MeSH Terms: Varicella Zoster Virus Infection; Infections; Virus Diseases; DNA Virus Infections; Herpesviridae Infections; Herpes Zoster; Chickenpox; Immunologic Factors; Physiological Effects of Drugs; Vaccines
• Other Study ID 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