Health TrialsbyHealthPanel

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

ConditionVaricella (Chickenpox)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12-12
SponsorSK Bioscience Co., Ltd.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • NBP608 (Mid Potency)

    Biological/Vaccine

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

  • NBP608 (Low Potency)

    Biological/Vaccine

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

  • Varivax®

    Biological/Vaccine

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

  • SKYVaricella®

    Biological/Vaccine

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

  • Normal Saline (Placebo)

    Other intervention

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

Treatment groups

780 Participants
are divided into 4 treatment groups
Group A: Test group 1: NBP608 (Mid Potency)Experimental treatment 2 interventions
Group B: Test group 2: NBP608 (Low Potency)Experimental treatment 2 interventions
Group C: Active control group 1: Varivax®Experimental treatment 2 interventions
Group D: Active control group 2: SKYVaricella®Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Seroconversion rate of varicella-zoster virus(VZV)

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

Time frame
6 weeks after each dose.
2

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

Time frame
6 weeks after the second dose.

Secondary outcomes

1

Seroconversion Rates

Proportion of participants who are seronegative prior to vaccination at each specified assessment time point.

Time frame
Time Frame: 6 weeks after each vaccination, 6 months after the second vaccination
2

Geometric Mean Titers (GMTs)

VZV IgG antibodies at each specified time point.

Time frame
6 weeks after each vaccination, 6 months after the second vaccination
3

Geometric Mean Fold Rise (GMFR)

Fold increases in VZV IgG antibody titers

Time frame
from baseline to each post-vaccination timepoint
4

Geometric Mean Fold Reduction (GMFRd)

Fold reductions in VZV IgG antibody titers

Time frame
from baseline to each post-vaccination timepoint

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

SK Bioscience Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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