Varicella
Conditions
Keywords
prevention of varicella, Varicella-zoster vaccine
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)
Interventions
Sponsors
SK Bioscience Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Months to 12 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| seroconversion rate by FAMA (Fluorescent Antibody to Membrane Antigen) assay | 6 weeks after IP(Investigational Product) vaccination | \*FAMA(Fluorescent Antibody to Membrane Antigen) Seroconversion Rate: the rate of subjects who are converted from seronegative with FAMA(Fluorescent Antibody to Membrane Antigen) VZV(Varicella Zoster Virus) antibody titer \< 1:4 before IP(Investigational Product) vaccination to seropositive with FAMA(Fluorescent Antibody to Membrane Antigen) VZV(Varicella Zoster Virus) antibody titer ≥ 1:4 at 6 weeks post-vaccination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VZV (Varicella Zoster Virus) antibody GMT(Geometric Mean Titer) measured by FAMA (Fluorescent Antibody to Membrane Antigen) assay | 6 weeks after IP(Investigational Product) vaccination | — |
| VZV (Varicella Zoster Virus) antibody GMT(Geometric Mean Titer) measured by gpELISA (Glycoprotein Enzyme Linked Immunosorbent Assay) | 6 weeks after IP(Investigational Product) vaccination | — |
| seroconversion rate by gpELISA (Glycoprotein Enzyme Linked Immunosorbent Assay) | 6 weeks after IP(Investigational Product) vaccination | \*gpELISA(Glycoprotein Enzyme Linked Immunosorbent Assay) Seroconversion Rate : the rate of subjects who are converted from seronegative with \< 50mIU/mL before IP(Investigational Product) vaccination to seropositive with ≥ 50mIU/mL at 6 weeks post-vaccination |
Other
| Measure | Time frame | Description |
|---|---|---|
| Consistency Assessment between Countries | 6 weeks after IP(Investigational Product) vaccination | Comparison of seroconversion rate of NBP608 and Comparator in each country by FAMA(Fluorescent Antibody to Membrane Antigen) assay |
Countries
Philippines
Outcome results
None listed