Clinical trial NCT03114943: Immunogenicity and Safety of NBP608 Compared to Varivax in Healthy Children 12 Months to 12 Years of Age
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Varicella
Keywords: prevention of varicella
Varicella-zoster vaccine
Lead sponsor: SK Chemicals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-04-14
Enrollment: 516
Sex: ALL
Minimum age (years): 12
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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)

Eligibility criteria: 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

Primary outcomes:
measure: seroconversion rate by FAMA (Fluorescent Antibody to Membrane Antigen) assay
timeFrame: 6 weeks after IP(Investigational Product) vaccination
Secondary outcomes:
measure: VZV (Varicella Zoster Virus) antibody GMT(Geometric Mean Titer) measured by FAMA (Fluorescent Antibody to Membrane Antigen) assay
timeFrame: 6 weeks after IP(Investigational Product) vaccination
measure: VZV (Varicella Zoster Virus) antibody GMT(Geometric Mean Titer) measured by gpELISA (Glycoprotein Enzyme Linked Immunosorbent Assay)
timeFrame: 6 weeks after IP(Investigational Product) vaccination
measure: seroconversion rate by gpELISA (Glycoprotein Enzyme Linked Immunosorbent Assay)
timeFrame: 6 weeks after IP(Investigational Product) vaccination
Other outcomes:
measure: Consistency Assessment between Countries
timeFrame: 6 weeks after IP(Investigational Product) vaccination
Locations:
city: Dasmariñas
country: Philippines
facility: De La Salle Health Sciences Institute
state: Cavite
Study officials:
affiliation: De La Salle Health Sciences Institute
name: DELIA C. YU, Dr
role: PRINCIPAL_INVESTIGATOR
References: