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

NCT06891872 | Not Yet Recruiting Phase 4

• 1 other identifier: PRO-VZV-4008
• Study Type: interventional
• Target: 720
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Varicella (chickenpox); MMR Vaccine; DTaP Vaccine

Keywords

Co-administered; VZV

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Seropositive rate of VZV antibody

  Day 30 after the administration of varicella vaccine

• Geometric mean titer (GMT) of VZV antibody

  Day 30 after the administration of varicella vaccine

• Geometric mean fold increase (GMI) of VZV antibody

  Day 30 after the administration of varicella vaccine

• Seroconversion rate of measles antibody, mumps antibody and rubella antibody

  Day 30 after the administration of MMR

• Seropositive rate of measles antibody, mumps antibody and rubella antibody

  Day 30 after the administration of MMR

Study Arms (3)

Group A (Varicella vaccine and DTaP co-administration group )

EXPERIMENTAL

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

Group B (Varicella vaccine and MMR co-administration group )

EXPERIMENTAL

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

Group C (Varicella vaccine group )

ACTIVE COMPARATOR

Participants will receive a single dose of varicella vaccine on Day 0.

Biological: Varicella Vaccine

Interventions

Vaicella Vaccine+DTaP on Day 0, MMR on Day 30 BIOLOGICAL

Varicella vaccine: lyophilized powder, subcutaneous injection DTaP: intramuscular injection MMR: lyophilized powder, subcutaneous injection

Group A (Varicella vaccine and DTaP co-administration group )

Varicella vaccine+MMR on Day 0，DTaP on Day 30 BIOLOGICAL

Varicella vaccine: lyophilized powder, subcutaneous injection MMR: lyophilized powder, subcutaneous injection DTaP: intramuscular injection

Group B (Varicella vaccine and MMR co-administration group )

Varicella Vaccine BIOLOGICAL

lyophilized powder, subcutaneous injection

Group C (Varicella vaccine group )

Eligibility Criteria

• Age: 18 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Chongqing Center for Disease Control and Prevention

Chongqing, 400042, China

Location

MeSH Terms

Conditions

Chickenpox

Interventions

Chickenpox Vaccine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Herpesvirus Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Central Study Contacts

XU Jiawei

CONTACT

023-68813088; 452712782@qq.com

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: March 2, 2025
• First Posted: March 24, 2025
• Study Start: May 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)