Varicella vaccine with lower potencies in healthy children aged 12 months to 12 years

Is this trial a fit for you?

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

What this trial studies

This is a Phase 3, randomized, double-blind, active-controlled, multinational study evaluating a two-dose regimen of NBP608 in children 12 months to 12 years old. Participants are randomly assigned to receive either NBP608 at two potencies or a licensed varicella vaccine (Varivax or SKYVaricella) or placebo, with seven in-clinic visits over about 15 months and follow-up calls after each vaccination. Immunogenicity is assessed via blood samples at predefined time points, while safety is monitored for adverse events, serious adverse events, and adverse events of special interest. The study aims to characterize safety and immune response to the two-dose regimen across a pediatric population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Participant must be ≥12 months to ≤12 years of age, at the time of informed consent.
2. Participant is healthy or medically stable, as determined by the investigator through medical history, physical examination, and overall clinical assessment.
3. Participant's parents/LARs are able and willing to comply with all study procedures and attend all scheduled visits.
4. Female participants of childbearing potential must agree to comply with applicable contraceptive requirements as defined in the protocol.
5. Female participants of a childbearing potential must have a negative urine pregnancy test at screening; pregnancy testing is not required for those not of childbearing potential.
6. Participant's parents/LARs are capable of providing signed informed consent, including agreement to comply with the requirements and restrictions specified in this protocol and in the informed consent form (ICF), before initiation of any study-specific procedures. Where applicable, the participant must also be able to provide written assent in accordance with local regulations and IRB/IEC requirements.

Exclusion Criteria:

1\. Participants with any acute illness, including fever or clinically significant symptoms, at the time of study vaccination. 2. History of varicella-zoster virus (VZV) infection or recent exposure to VZV.

3\. Presence of household contacts at high risk for severe VZV infection 4. History of immunodeficiency, autoimmune disease, or other conditions affecting the immune system.

5\. History of bleeding disorders contraindicating vaccination. 6. History of severe allergic reactions to vaccines or vaccine components. 7. History of Guillain-Barré syndrome associated with prior vaccination. 8. Active untreated tuberculosis infection. 9. Any significant medical condition that, in the investigator's judgment, may interfere with study participation or interpretation of results.

10\. Prior receipt of any varicella-containing vaccine. 11. Receipt or planned use of vaccines, medications, immunoglobulins, blood products, or immunosuppressive therapies that may interfere with study evaluation, as defined in the protocol.

12\. Participation in another clinical study involving an investigational intervention within a protocol-defined timeframe.

13\. Study staff, investigators, and their immediate family members.

Where it's running

• Tegucigalpa, site 102
  Tegucigalpa, Francisco Morazán Department, Honduras Recruiting
• Manila, site 301
  Manila, National Capital Region, Philippines Recruiting
• Quezon City, site 302
  Quezon City, National Capital Region, Philippines Recruiting
• Quezon City, site 303
  Quezon City, National Capital Region, Philippines Recruiting
• Daegu, site 404
  Daegu, Daegu, South Korea Recruiting
• Ansan, site 401
  Ansan, Gyeonggi-do, South Korea Recruiting

Study contacts

• Study coordinator: Bora Kim
• Email: bora.kim@sk.com
• Phone: 82-2-2008-2200

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Second dose of chickenpox (varicella) vaccine for healthy children

  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.

  Recruiting at 2 sites Phase 3 Sinovac (Dalian) Vaccine Technology Co., Ltd. · Akdeniz and 4 other locations · NCT07475000

• MG1111 (BARYCELA) versus VARIVAX for preventing chickenpox in children 1 to 12 years

  This will test whether the MG1111 (BARYCELA) vaccine is safe and produces an immune response comparable to VARIVAX in healthy children aged 12 months to 12 years.

  Recruiting Phase 3 GC Biopharma Corp · Khon Kaen, Changwat Khon Kaen · NCT07054099

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.