NCT03114943

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

A Multi-national, Multi-center, Randomized, Double Blinded, Parallel-group Study to Assess the Immunogenicity and Safety of NBP608 Compared to Varivax in Healthy Children 12 Months to 12 Years of Age

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 516 (actual)
• Sponsor: SK Bioscience Co., Ltd. · Industry
• Sex: All
• Age: 12 Months – 12 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a multi-national, multi-center, randomized, double blinded, parallel-group study to assess the Immunogenicity and safety of NBP608 compared to varivax which are indicated for active immunization for the prevention of varicella. Total of 488 subjects of 12 months to 12 years of age are enrolled, and each subject is administered with single dose of vaccine which is randomly assigned in 1:1 ratio. Stratified randomization for age group is used to achieve the balance of treatment assignment within age strata. Total of four visits are scheduled including two visits via telephone contact. Blood sampling is conducted for immunogenicity assessment before and 6 weeks after vaccination at Visit 1 and Visit 3 respectively. Safety is monitored 1 week, 6 weeks and 26 weeks after vaccination through Visit 2\*, Visit 3 and Visit 4\* (\* telephone contact)

Conditions

• Varicella

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-07-14
• Primary completion: 2017-06-28
• Completion: 2017-06-28
• First posted: 2017-04-14
• Last updated: 2019-05-08

Locations

1 site across 1 country: Philippines