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Immunogenicity and Safety of NBP608 Compared to Varivax in Healthy Children 12 Months to 12 Years of Age

NCT03114943 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 516

Last updated 2019-05-08

No results posted yet for this study

Summary

This study assesses non-inferiority by comparing seroconversion rate of NBP608 to Varivax which are indicated for active immunization for prevention of varicella. Total of 488 subjects (244 subjects per treatment arm) of 12 months to 12 years of age are enrolled, and each subject is administered with single dose of vaccine which is randomly assigned.

Conditions

  • Varicella

Interventions

BIOLOGICAL

NBP608

Preparation of the Oka/SK strain of live, attenuated varicella virus

BIOLOGICAL

Varivax

Preparation of the Oka/Merck strain of live, attenuated varicella virus

Sponsors & Collaborators

  • SK Bioscience Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • DELIA C. YU, Dr · De La Salle Health Sciences Institute

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
2016-07-14
Primary Completion
2017-06-28
Completion
2017-06-28

Countries

  • Philippines

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 NCT03114943 on ClinicalTrials.gov