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.
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).
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.
Immunocompromised individuals