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SkyVaricella® (NBP608) Vaccine With Lower Potencies in Healthy Children Aged 12 Months to 12 Years

RecruitingPhase 3Ages 12 Months - 12 YearsAllSK Bioscience Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

The goal of this study is to evaluate the safety and immunogenicity of an investigational varicella vaccine in children. Researchers will compare the investigational vaccine, NBP608, with licensed varicella vaccines. The study includes children aged 12 months to 12 years. Participants will be randomly assigned to receive either the investigational vaccine (NBP608) or licensed varicella vaccines. Participants will: Receive two subcutaneous injections of a study vaccine administered. Visit the study clinic seven times over approximately 15 months. Receive follow-up phone calls 7 days after each vaccination to monitor for safety.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • NBP608 (Mid Potency)
  • NBP608 (Low Potency)
  • Varivax®
  • SKYVaricella®
  • Normal Saline (Placebo)
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Where

14 sites
San Pedro Sula, site 101
San Pedro Sula, Honduras
Tegucigalpa, site 102
Tegucigalpa, Honduras
Manila, site 301
Manila, Philippines
Quezon City, site 302
Quezon City, Philippines
Quezon City, site 303
Quezon City, Philippines
Daegu, site 404
Daegu, South Korea
Ansan, site 401
Ansan, South Korea
Hwaseong-si, site 406
Hwaseong-si, South Korea

…and 6 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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