SkyVaricella® (NBP608) Vaccine With Lower Potencies in Healthy Children Aged 12 Months to 12 Years (NCT07415252) | Clinical Trial Compass
Not Yet RecruitingPhase 3
SkyVaricella® (NBP608) Vaccine With Lower Potencies in Healthy Children Aged 12 Months to 12 Years
Honduras, Philippines, South Korea780 participantsStarted 2026-06-05
Plain-language summary
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.
Approximately 780 participants will take part in this study. Participants will be randomly assigned to receive either the investigational vaccine (NBP608) or licensed varicella vaccines. Some participants will receive two doses, while others will receive one dose, according to the assigned study group.
Participants will:
Receive two subcutaneous injections of a study vaccine, administered approximately three months apart (if applicable).
Visit the study clinic seven times over approximately 15 months. Receive follow-up phone calls 7 days after each vaccination to monitor for safety.
Who can participate
Age range
12 Months – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participant must be ≥12 months to ≤12 years of age, at the time of informed consent.
. Participant is healthy or medically stable, as determined by the investigator through medical history, physical examination, and overall clinical assessment.
. Participant's parents/LARs are able and willing to comply with all study procedures and attend all scheduled visits.
. Female participants of childbearing potential (i.e., post-menarcheal females) must agree to maintain complete sexual abstinence from heterosexual intercourse, from at least 4 weeks prior to the first study vaccination and through 12 weeks following the second study vaccination (Visit 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference in FAMA Assay-Measured Varicella-Zoster Virus (VZV) Seroconversion Rate 6 Weeks After the First Dose
Timeframe: 6 weeks after the first dose.
2
Difference in FAMA Assay-Measured Varicella-Zoster Virus (VZV) Seroconversion Rate 6 Weeks After the Second Dose
Timeframe: 6 weeks after the second dose.
3
Ratio of gpELISA Geometric Mean Titers 6 Weeks After the Second Dose
. 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
. Any clinically significant respiratory symptoms (e.g., cough, sore throat), febrile illness (tympanic temperature \>38°C), or acute illness within 24 hours prior to any study vaccination (Participant may be enrolled 24 hours after resolution of these symptoms).
. History of suspected or laboratory-confirmed VZV infection
. Close contact or household exposure to an individual with suspected or laboratory-confirmed VZV infection within 4 weeks prior to the first study vaccination.
. Household member(s) considered at high risk of severe VZV infection, including:
. History of congenital, hereditary, acquired immunodeficiency, or autoimmune disease.
. History of bleeding disorder or thrombocytopenia contraindicating subcutaneous vaccination, based on the investigator's judgment.
. History of hypersensitivity and severe allergic reaction (e.g., anaphylaxis) to any vaccines or to any components of the study intervention, including gelatin or neomycin.
. History of Guillain-Barre syndrome following receipt of any prior vaccines.