ClinicalTrials.gg
RecruitingNCT07475000Updated Mar 16, 2026

Second Dose of Varicella Vaccine in Healthy Children

A Phase 3 interventional study of PROVARIX in Varicella (Chickenpox) and Varicella Immunisation, sponsored by Sinovac (Dalian) Vaccine Technology Co., Ltd.. Recruiting at 5 sites in Turkey (Türkiye). Open to participants aged 15 Months to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-16.

Sponsored by Sinovac (Dalian) Vaccine Technology Co., Ltd. (part of Sinovac Biotech Co., Ltd) · Phase 3, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Jul 2026, 3 months ago, but the record still lists the study as recruiting.
  • Started Jan 2026; still recruiting 9 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
300
Allocation
Non-randomized
Ages
15 Months to 12 Years
Sex
All
01

Study summary

This study aim to assess the immunogenicity and safety of interchangeable administration of the second dose of varicella vaccine. A total of 300 healthy participants aged 15 months - 12 years will be enrolled. Written informed consent form will be obtained from participants' parents or legally acceptable representatives (and assents will be obtained from participants aged above 9 years old and written consent forms will be prepared and consent will be obtained in writing if possible from the participants aged 3-8 years old.) before enrollment. Participants will be assigned to 5 groups according to the brand of first dose varicella vaccine they received at the age of 12 months. All participants will receive the second dose of varicella vaccine manufactured by Sinovac.

The duration of individual participation from enrollment to the last onsite visit will be a maximum of 42 days. The end of study is considered the completion of the last visit for the last participant in this study.

Blood samples (2.5 - 3.0ml per time) for immunogenicity assessment will be collected. The blood samples will be collected before vaccination and 42 days after vaccination.

02

Conditions studied

  • Varicella (Chickenpox)
  • Varicella Immunisation

Browse trials for

03

In context

Chickenpox

180 studies on the registry are indexed under Chickenpox; 28 are open to participants now.

This study's planned enrollment of 300 is below the median of 475 across 149 interventional studies indexed under Chickenpox.

Browse Chickenpox studies →

Lead sponsor

Sinovac (Dalian) Vaccine Technology Co., Ltd. is the lead sponsor of 20 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Months to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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 disease (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid disease, asplenia, functional asplenia, or 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 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 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 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.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    Group 1

    The first dose administered was VARIVAX(varicella vaccine manufactured by Merck)

    Biological: PROVARIX

  • Experimental
    Group 2

    The first dose administered was VARILRIX(varicella vaccine manufactured by GSK)

    Biological: PROVARIX

  • Experimental
    Group 3

    The first dose administered was SUDUVAX(varicella vaccine manufactured by GC Biopharma)

    Biological: PROVARIX

  • Experimental
    Group 4

    The first dose administered was SKYVaricella(varicella vaccine manufactured by SK bioscience)

    Biological: PROVARIX

  • Experimental
    Group 5

    The first dose administered was PROVARIX(varicella vaccine manufactured by Sinovac)

    Biological: PROVARIX

Interventions

  • BiologicalPROVARIX

    Participants will receive one dose (0.5 mL) of PROVARIX (VarV), a live attenuated varicella vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd., administered as the second dose of varicella vaccination.

06

What researchers measure

Primary outcomes

  1. Geometric Mean Concentration (GMC) of Varicella-Zoster Virus (VZV) Antibodies

    Time frame: 42 days after vaccination (Day 42)

  2. Geometric Mean Fold Rise (GMFR) of Varicella-Zoster Virus (VZV) Antibodies

    Time frame: 42 days after vaccination (Day 42)

Secondary outcomes

  1. Seropositive Rate of Varicella-Zoster Virus (VZV) Antibodies

    Time frame: 42 days after vaccination (Day 42)

  2. Seroresponse Rate of Varicella-Zoster Virus (VZV) Antibodies

    Time frame: 42 days after vaccination (Day 42)

  3. Incidence of Adverse Reactions Within 42 Days After Vaccination

    Time frame: Day 0 to Day 42 after vaccination

  4. Incidence of Serious Adverse Events (SAEs)

    Time frame: Day 0 to Day 180 after vaccination

07

Study locations

2 of 5 sites recruiting
  • Akdeniz University Health, Research and Application Center (Hospital), Department of Child Health and Diseases, Department of Social Pediatrics
    Akdeniz, Turkey (Türkiye)
    Recruiting
  • Ankara Bilkent City Hospital, Pediatrics and Pediatric Infectious Diseases Clinic
    Ankara, Turkey (Türkiye)
    Not yet recruiting
  • Hacettepe University Hospitals, Department of Pediatrics, Department of Social Pediatrics
    Ankara, Turkey (Türkiye)
    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
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07475000
Responsible party
Sponsor
First posted
Mar 16, 2026
Start date
Jan 28, 2026
Primary completion
Jul 15, 2026 (estimated)
Completion
Nov 15, 2026 (estimated)
Last update
Mar 16, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion