Clinical trial Recruiting at 2 sites Phase 3 Interventional Ages 15 Months to 12

Second dose of chickenpox (varicella) vaccine for healthy children

Official title: Immunogenicity and Safety of the Second Dose of Varicella Vaccine in Healthy Children: An Open-label Study

Run by Sinovac (Dalian) Vaccine Technology Co., Ltd. · NCT07475000 · Data updated 2026-11-12

This project will give a Sinovac second dose of the chickenpox vaccine to children aged 15 months–12 years who had a first dose at 12 months to see if switching brands is safe and produces good immune responses.

More Varicella (Chickenpox) trials

Quick facts

PhasePhase 3
Study typeInterventional
Ages15 Months to 12 Years
SexAll
Enrollment300 (estimated)
SponsorSinovac (Dalian) Vaccine Technology Co., Ltd.
Industry-sponsored
Drugs / interventionsprednisone
Locations5 sites (Akdeniz and 4 other locations)
StatusRecruiting
StartedJanuary 28, 2026
Main results expectedJuly 15, 2026
Study endsNovember 15, 2026
Registry record updatedMarch 16, 2026
Trial IDNCT07475000 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Healthy children aged 15 months to 12 years who received one varicella vaccine dose at 12 months in Turkey and whose parents or legal guardians can provide consent and attend study visits.

Probably not a fit

Children with prior reported chickenpox infection, recent exposure to varicella, those who have already received more than one varicella dose, or those with a known severe allergy to vaccine components are unlikely to benefit from this protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 trial will enroll about 300 healthy children in Turkey who received a first varicella dose at 12 months and assign them to five groups based on the brand of their initial vaccine. All participants will receive the second dose manufactured by Sinovac and will be followed for up to 42 days to record safety events and immune responses. Blood samples will be collected before and after vaccination to measure antibody responses and document immunogenicity. Written parental consent and age-appropriate assent will be obtained prior to enrollment.

Why it matters

Potential benefit: If successful, the results could support safely giving a Sinovac second dose after different first-dose brands, simplifying vaccination schedules and improving protection against chickenpox.

How similar studies have gone: Two-dose varicella schedules are known to produce stronger immunity than a single dose, but evidence specifically about switching brands for the second dose is more limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Healthy children aged 15 months to 12 years.
2. Have received one dose of varicella vaccine at 12 months of age in Turkey (verified by vaccination card or official electronic immunization record).
3. Written informed consent obtained from parent(s) or legally authorized representative(s); assent obtained from children as applicable according to local regulations.
4. Able to comply with study procedures, as assessed by the investigator.
5. Able to provide verifiable identification and be contacted for study follow-up during the study period.

Exclusion Criteria:

1. History of varicella-zoster virus (VZV) infection (based on parental report or medical record).
2. Known exposure to VZV within 4 weeks prior to screening.
3. Receipt of more than one dose of varicella vaccine.
4. Interval between first dose of varicella vaccine and enrollment less than 3 months.
5. Known allergy to any vaccine component or history of severe allergic reaction to any vaccine (e.g., urticaria, dyspnea, angioedema).
6. Known or suspected immunodeficiency or autoimmune disease (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid disease, asplenia, functional asplenia, or HIV infection).
7. Poorly controlled chronic disease or history of severe systemic disease.
8. Current or history of severe neurological disorders (e.g., epilepsy, convulsions or seizures excluding simple febrile seizures) or psychiatric disorders.
9. Receipt of ≥14 days of immunosuppressive or immunomodulatory therapy (e.g., prednisone ≥20 mg/day or ≥2 mg/kg/day or equivalent), or cytotoxic therapy within 180 days prior to screening, or planned use during the study period.
10. Receipt of blood products or immunoglobulins within 180 days prior to screening, or planned receipt during the study period.
11. Receipt of other investigational drugs or vaccines within 30 days prior to screening, or planned receipt during the study period.
12. Receipt of live attenuated or nucleic acid vaccines within 28 days prior to screening, or subunit or inactivated vaccines within 7 days prior to screening.
13. Fever (axillary temperature \>37.2°C), abnormal vital signs, or clinically significant abnormal findings on physical examination on the day of vaccination.
14. Skin conditions at the intended injection site (e.g., inflammation, ulceration, rash, scar, or other conditions that may interfere with administration or safety assessment).
15. Acute illness or exacerbation of chronic disease within 7 days prior to vaccination, or known or suspected active infection.
16. Any condition that, in the opinion of the investigator, would make the participant unsuitable for participation in the study.

Where it's running

  • Akdeniz University Health, Research and Application Center (Hospital), Department of Child Health and Diseases, Department of Social Pediatrics
    Akdeniz, Turkey (Türkiye)
    Recruiting
  • Hacettepe University Hospitals, Department of Pediatrics, Department of Social Pediatrics
    Ankara, Turkey (Türkiye)
    Recruiting
  • Ankara Bilkent City Hospital, Pediatrics and Pediatric Infectious Diseases Clinic
    Ankara, Turkey (Türkiye)
    Not yet recruiting
  • REPUBLIC of TURKEY MINISTRY of HEALTH ANKARA BILKENT CITY HOSPITAL
    Ankara, Turkey (Türkiye)
    Not yet recruiting
  • Ege University Hospital (Application and Research Center) Department of Child Health and Diseases
    Ege, Turkey (Türkiye)
    Not yet recruiting

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.