NCT07415252

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
780

participants targeted

Target at P75+ for phase_3

Timeline
15mo left

Started Jul 2026

Geographic Reach
4 countries

14 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress17%
Jul 2026Jan 2028

First Submitted

Initial submission to the registry

January 27, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

July 4, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2027

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2028

Last Updated

September 15, 2026

Status Verified

September 1, 2026

Enrollment Period

7 months

First QC Date

January 27, 2026

Last Update Submit

September 11, 2026

Conditions

Varicella (Chickenpox)

Keywords

SKYVaricellaNBP608Varicella vaccineChickenpox vaccinePediatric vaccination

Outcome Measures

Primary Outcomes (2)

  • Seroconversion rate of varicella-zoster virus(VZV)

    Seroconversion rate of varicella-zoster virus(VZV) IgG antibodies at 6 weeks after each vaccination

    6 weeks after each dose.

  • Geometric mean antibody titer (GMT) of varicella-zoster virus(VZV) IgG antibodies

    Geometric mean antibody titer (GMT) of varicella-zoster virus(VZV) IgG antibodies at 6 weeks after the second vaccination

    6 weeks after the second dose.

Secondary Outcomes (9)

  • Seroconversion Rates

    Time Frame: 6 weeks after each vaccination, 6 months after the second vaccination

  • Geometric Mean Titers (GMTs)

    6 weeks after each vaccination, 6 months after the second vaccination

  • Geometric Mean Fold Rise (GMFR)

    from baseline to each post-vaccination timepoint

  • Geometric Mean Fold Reduction (GMFRd)

    from baseline to each post-vaccination timepoint

  • Immediate reactions

    Within 30 minutes

  • +4 more secondary outcomes

Study Arms (4)

Test group 1: NBP608 (Mid Potency)

EXPERIMENTAL

Participants receive either a one-dose regimen or a two-dose regimen consisting of two subcutaneous injections administered.

Biological: NBP608 (Mid Potency)Other: Normal Saline (Placebo)

Test group 2: NBP608 (Low Potency)

EXPERIMENTAL

Participants receive either a one-dose regimen or a two-dose regimen consisting of two subcutaneous injections administered.

Biological: NBP608 (Low Potency)Other: Normal Saline (Placebo)

Active control group 1: Varivax®

EXPERIMENTAL

Participants receive either a one-dose regimen or a two-dose regimen consisting of two subcutaneous injections administered.

Biological: Varivax®Other: Normal Saline (Placebo)

Active control group 2: SKYVaricella®

EXPERIMENTAL

Participants receive either a one-dose regimen or a two-dose regimen consisting of two subcutaneous injections administered.

Biological: SKYVaricella®Other: Normal Saline (Placebo)

Interventions

NBP608 (Mid Potency)BIOLOGICAL

NBP608 (mid potency) is a live attenuated varicella virus vaccine (Oka/SK strain).

Test group 1: NBP608 (Mid Potency)
NBP608 (Low Potency)BIOLOGICAL

NBP608 (low potency) is a live attenuated varicella virus vaccine (Oka/SK strain).

Test group 2: NBP608 (Low Potency)
Varivax®BIOLOGICAL

Varivax® is a licensed live attenuated varicella virus vaccine (Oka/Merck strain).

Active control group 1: Varivax®
SKYVaricella®BIOLOGICAL

SKYVaricella® is a licensed live attenuated varicella virus vaccine (Oka/SK strain).

Active control group 2: SKYVaricella®
Normal Saline (Placebo)OTHER

Placebo consisting of normal saline (0.9% sodium chloride solution).

Active control group 1: Varivax®Active control group 2: SKYVaricella®Test group 1: NBP608 (Mid Potency)Test group 2: NBP608 (Low Potency)

Eligibility Criteria

Age12 Months - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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 must agree to comply with applicable contraceptive requirements as defined in the protocol.
  • 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.
  • 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.

You may not qualify if:

  • \. 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.
  • \. Presence of household contacts at high risk for severe VZV infection 4. History of immunodeficiency, autoimmune disease, or other conditions affecting the immune system.
  • \. 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.
  • \. 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.
  • \. Participation in another clinical study involving an investigational intervention within a protocol-defined timeframe.
  • \. Study staff, investigators, and their immediate family members.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

San Pedro Sula, site 101

San Pedro Sula, Cortés Department, 21104, Honduras

NOT YET RECRUITING

Tegucigalpa, site 102

Tegucigalpa, Francisco Morazán Department, 11101, Honduras

RECRUITING

Manila, site 301

Manila, National Capital Region, 1000, Philippines

RECRUITING

Quezon City, site 302

Quezon City, National Capital Region, 1113, Philippines

RECRUITING

Quezon City, site 303

Quezon City, National Capital Region, 1118, Philippines

RECRUITING

Daegu, site 404

Daegu, Daegu, 42601, South Korea

RECRUITING

Ansan, site 401

Ansan, Gyeonggi-do, 15355, South Korea

RECRUITING

Hwaseong-si, site 406

Hwaseong-si, Gyeonggi-do, 18450, South Korea

NOT YET RECRUITING

Seongnam-sit, site 405

Seongnam-si, Gyeonggi-do, 13620, South Korea

NOT YET RECRUITING

Incheon, site 403

Incheon, Incheon, 21431, South Korea

RECRUITING

Seoul, site 402

Seoul, Seoul, 02841, South Korea

RECRUITING

Seoul, site 408

Seoul, Seoul, 07985, South Korea

NOT YET RECRUITING

Seoul, site 407

Seoul, Seoul, 08308, South Korea

NOT YET RECRUITING

Khon Kaen City, site 201

Khon Kaen, Changwat Khon Kaen, 40002, Thailand

NOT YET RECRUITING

MeSH Terms

Conditions

Chickenpox

Interventions

Chickenpox VaccineSaline Solution

Condition Hierarchy (Ancestors)

Varicella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

Herpesvirus VaccinesViral VaccinesVaccinesBiological ProductsComplex MixturesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Central Study Contacts

Bora Kim

CONTACT

82-2-2008-2200bora.kim@sk.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2026

First Posted

February 17, 2026

Study Start

July 4, 2026

Primary Completion (Estimated)

February 13, 2027

Study Completion (Estimated)

January 2, 2028

Last Updated

September 15, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

PH(3)TH(1)HO(2)KR(8)