Varicella (Chickenpox)
Conditions
Keywords
SKYVaricella, NBP608, Varicella vaccine, Chickenpox vaccine, Pediatric vaccination
Brief 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. 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.
Detailed description
This is a Phase III, randomized, Double-blinded, Active-controlled, Multinational, Multicenter study designed to evaluate the safety and immunogenicity of a two-dose regimen of NBP608 in children aged 12 months to 12 years. Immunogenicity will be assessed using blood samples collected at predefined time points to evaluate immune responses to varicella. Safety will be evaluated throughout the study by monitoring adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) following vaccination. Each participant will take part in the study for approximately 15 months, including scheduled clinic visits and follow-up assessments.
Interventions
BIOLOGICALNBP608 (Mid Potency)
NBP608 (mid potency) is a live attenuated varicella virus vaccine (Oka/SK strain).
BIOLOGICALNBP608 (Low Potency)
NBP608 (low potency) is a live attenuated varicella virus vaccine (Oka/SK strain).
BIOLOGICALVarivax®
Varivax® is a licensed live attenuated varicella virus vaccine (Oka/Merck strain).
BIOLOGICALSKYVaricella®
SKYVaricella® is a licensed live attenuated varicella virus vaccine (Oka/SK strain).
OTHERNormal Saline (Placebo)
Placebo consisting of normal saline (0.9% sodium chloride solution).
Sponsors
SK Bioscience Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Months to 12 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seroconversion rate of varicella-zoster virus(VZV) | 6 weeks after each dose. | Seroconversion rate of varicella-zoster virus(VZV) IgG antibodies at 6 weeks after each vaccination |
| Geometric mean antibody titer (GMT) of varicella-zoster virus(VZV) IgG antibodies | 6 weeks after the second dose. | Geometric mean antibody titer (GMT) of varicella-zoster virus(VZV) IgG antibodies at 6 weeks after the second vaccination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Seroconversion Rates | Time Frame: 6 weeks after each vaccination, 6 months after the second vaccination | Proportion of participants who are seronegative prior to vaccination at each specified assessment time point. |
| Geometric Mean Titers (GMTs) | 6 weeks after each vaccination, 6 months after the second vaccination | VZV IgG antibodies at each specified time point. |
| Geometric Mean Fold Rise (GMFR) | from baseline to each post-vaccination timepoint | Fold increases in VZV IgG antibody titers |
| Geometric Mean Fold Reduction (GMFRd) | from baseline to each post-vaccination timepoint | Fold reductions in VZV IgG antibody titers |
| Immediate reactions | Within 30 minutes | Percentage of participants reporting any immediate reactions following each vaccination. |
| Solicited adverse events | Within 14 days | Percentage of participants reporting solicited adverse events following each vaccination. |
| Unsolicited adverse events | Within 42 days | Percentage of participants experiencing any unsolicited adverse events following each vaccination. |
| Serious adverse events, medically attended AEs, and AEs leading to withdrawal | during study period | Percentage of participants experiencing any serious adverse events, medically attended adverse events, or adverse events leading to withdrawal during the study period. |
| Adverse events of special interest | during the study period | Percentage of participants experiencing any adverse events of special interest during the study period. |
Countries
Honduras, Philippines, South Korea, Thailand
Contacts
CONTACTBora Kim
Outcome results
None listed