Immunogenicity and Safety of Varicella Vaccine, Live in Healthy Vietnamese Children

NCT07473427 | Not Yet Recruiting Phase 3

• 1 other identifier: PRO-VZV-4009
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single armed, Phase 3 study to assess the immunogenicity and safety of the varicella vaccine manufactured by Sinovac. A total of 300 healthy participants aged 1-12 years will be enrolled. All participants will receive a single dose of varicella vaccine manufactured by Sinovac.

Conditions

Varicella (Chickenpox); Varicella Immunisation

Outcome Measures

Primary Outcomes (1)

• The seroresponse rate of varicella-zoster virus (VZV) antibodies among susceptible population without varicella immunization history

  42 days after vaccination

Secondary Outcomes (7)

• The Geometric Mean Concentration(GMC) of VZV antibodies among susceptible population without varicella immunization history

  42 days after vaccination

• The Geometric Mean Concentration(GMC) of VZV antibodies in total population

  42 days after vaccination

• The seropositive rate of VZV antibodies in total population

  42 days after vaccination

• The geometric mean fold rise (GMFR) of VZV antibodies in total population

  42 days after vaccination

• The geometric mean fold rise (GMFR) of VZV antibodies among population with varicella immunization history

  42 days after vaccination

Study Arms (2)

No vaccination history group

EXPERIMENTAL

Participants aged 1-12 years with no vaccination history of varicella-containing vaccine

Biological: Varicella Vaccine

Vaccination history group

EXPERIMENTAL

Participants aged 2-12 years have received 1 dose of varicella vaccine

Biological: Varicella Vaccine

Interventions

Varicella Vaccine BIOLOGICAL

Varicella vaccine manufactured by Sinovac

No vaccination history group; Vaccination history group

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy children aged 1-12 years;
• Vaccination history:
• Participants aged 1 year old: no vaccination history with any varicella containing vaccine;
• Participants aged 2\~12 years old: no vaccination history with any varicella containing vaccine, or have received 1 dose of varicella vaccine at least 3 months before enrollment;
• Participants and/or their legal guardians are able to understand and sign the informed consent/assent voluntarily;
• Participants are able to comply with the study procedures based on the assessment of the investigator;
• Participants should provide verifiable identification, to be contacted, and to contact the investigator during the study period.

You may not qualify if:

• Prior history of VZV infection;
• Have been exposed to VZV at home, day care, school, etc. within 4 weeks before enrollment;
• Known allergy to vaccines or vaccine ingredients, or serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneurotic edema;
• Autoimmune diseases, immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid diseases, asplenia, functional asplenia, and HIV infection);
• Coagulation disorders (e.g. factor deficiency, platelet disorders), or history of bleeding, hematoma, or bruising following intramuscular injections or venipuncture;
• Poorly controlled chronic illnesses or history of severe diseases that, including but not limited to cardiovascular diseases, hematological disorders, liver and kidney diseases, digestive system disorders, respiratory diseases, malignancies, and a history of major organ transplantation;
• Any confirmed or suspected syphilis, hepatitis B or hepatitis C infection;
• Current or history of severe neurological diseases (epilepsy, convulsions or seizures \[excluding history of febrile seizures\]) or psychiatric disorders, or presence of a family history of psychiatric disorders;
• Receipt of ≥14 days of immunosuppressive or other immunomodulatory therapy (prednisone ≥20mg/day, or prednisone ≥2mg/kg/day, or its equivalent), cytotoxic therapy within 180 days prior to screening, or plans for such treatment during the trial;
• Receipt of blood products or immunoglobulins within 180 days prior to screening, or plans to receive these treatments in the trial;
• Receipt of other investigational drugs/vaccines within 30 days prior to screening, or plans to receive such drugs or vaccines during the study period;
• Receipt of attenuated live vaccines or nucleic acid vaccines within 28 days prior to screening, or subunit or inactivated vaccines within 7 days prior to screening;
• Fever on vaccination day, with axillary temperature \>37.2°C pre-vaccination, or vital signs outside normal range, or failure to pass physical examination;
• Presence of skin injuries, inflammation, ulcers, rashes, scars, or other conditions at the intended injection site that may interfere with drug administration or observation of local reactions;
• Acute onset of various acute diseases or chronic diseases within the past 7 days, or known or suspected active infections;

Sponsors & Collaborators

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

Study Sites (1)

Hanoi Medical University

Hanoi, 100000, Vietnam

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

Pham Thi Van Anh

CONTACT

+84- 915 595 690; phamthivananh.hmu@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 16, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)