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

SK Bioscience

Status and phase

Completed

Phase 3

Conditions

Varicella

Treatments

Biological: Varivax

Biological: NBP608

Study type

Interventional

Funder types

Industry

Identifiers

NCT03114943

NBP608_VZ_III_2015

Details and patient eligibility

About

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.

Full 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)

Enrollment

516 patients

Sex

All

Ages

12 months to 12 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy children aged between 12 months and 12 years old who are available for the follow-up during the study period
After menarche females who are confirmed to be negative in a pregnancy test on the day of vaccination and agree to practice birth control for 3 months after the vaccination

Exclusion criteria

Those with hypersensitivity to any component of the IPs(Investigational Products), such as gelatin or neomycin
Those who have received a varicella vaccine previously
Those with a history of hypersensitivity to vaccination, such as Guillain-Barre syndrome
Those with congenital or acquired immunodeficiency
Those with active untreated tuberculosis
Those who have received or are expected to receive salicylates from 14 days prior to IP(Investigational Product) vaccination to Visit 3
Those who have received or are expected to receive other vaccines from 1 month prior to IP(Investigational Product) vaccination to Visit 3
Those who have received or are expected to receive other IPs(Investigational Products) in another clinical study from 1 month prior to IP(Investigational Product) vaccination to Visit 3