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

NCT07415252 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 780

Last updated 2026-06-15

No results posted yet for this study

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.

Conditions

  • Varicella (Chickenpox)

Interventions

BIOLOGICAL

NBP608 (Mid Potency)

NBP608 (mid potency) is a live attenuated varicella virus vaccine (Oka/SK strain). It is supplied as a lyophilized single-dose vial with a separate diluent and administered as a 0.5 mL subcutaneous injection. Each dose contains ≥2,400 PFU after reconstitution.

BIOLOGICAL

NBP608 (Low Potency)

NBP608 (low potency) is a live attenuated varicella virus vaccine (Oka/SK strain). It is supplied as a lyophilized single-dose vial with a separate diluent and administered as a 0.5 mL subcutaneous injection. Each dose contains ≥2,400 PFU after reconstitution.

BIOLOGICAL

Varivax®

Varivax® is a licensed live attenuated varicella virus vaccine (Oka/Merck strain). It is supplied as a lyophilized single-dose vial with a separate diluent and administered as a 0.5 mL subcutaneous injection. Each dose contains ≥1,350 PFU after reconstitution.

BIOLOGICAL

SKYVaricella®

SKYVaricella® is a licensed live attenuated varicella virus vaccine (Oka/SK strain). It is supplied as a lyophilized single-dose vial with a separate diluent and administered as a 0.5 mL subcutaneous injection. Each dose contains ≥2,400 PFU after reconstitution.

OTHER

Normal Saline (Placebo)

Placebo consisting of normal saline (0.9% sodium chloride solution), administered as a 0.5 mL subcutaneous injection.

Sponsors & Collaborators

  • SK Bioscience Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-05
Primary Completion
2027-02-13
Completion
2028-01-02

Countries

  • Honduras
  • Philippines
  • South Korea
  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07415252 on ClinicalTrials.gov