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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03114982
Other study ID # NBP608_VZ_II_2015
Secondary ID
Status Completed
Phase Phase 2
First received April 11, 2017
Last updated April 11, 2017
Start date May 2016
Est. completion date November 2016

Study information

Verified date April 2017
Source SK Chemicals Co.,Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study evaluates the immunogenicity and safety of three different potencies of NBP608 and Varivax which are indicated for active immunization for the prevention of varicella. Total of 152 subjects (38 subjects per each 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.


Description:

This is a multi-center, randomized, double blinded, active controlled, parallel-group study to evaluate the immunogenicity and safety of three different potencies of NBP608(low, middle, high potency) and Varivax which are indicated for active immunization for the prevention of varicella. Total of 152 subjects (38 subjects per each 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 in 1:1:1:1 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)


Recruitment information / eligibility

Status Completed
Enrollment 152
Est. completion date November 2016
Est. primary completion date July 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Months to 12 Years
Eligibility 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) 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
NBP608
Preparation of the Oka/SK strain of live, attenuated varicella virus
Varivax
Preparation of the Oka/Merck strain of live, attenuated varicella virus

Locations

Country Name City State
Philippines Research Insitute for Torpical Medicine Muntinlupa City Metro Manila

Sponsors (1)

Lead Sponsor Collaborator
SK Chemicals Co.,Ltd.

Country where clinical trial is conducted

Philippines, 

Outcome

Type Measure Description Time frame Safety issue
Primary Seroconversion rate measured by FAMA(Fluorescent Antibody to Membrane Antigen) assay *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 6 weeks after IP(Investigational Product) vaccination
Secondary 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
Secondary VZV (Varicella Zoster Virus) antibody GMT (Geometric Mean Titer) measured by gpELISA (Glycoprotein Enzyme Linked Immunosorbent Assay) 6 weeks after IP(Investigational Product) vaccination
Secondary Seroconversion rate measured by gpELISA (Glycoprotein Enzyme Linked Immunosorbent Assay) *gpELISA Seroconversion Rate : the rate of subjects who are converted from seronegative with < 50mIU/mL before IP vaccination to seropositive with = 50mIU/mL at 6 weeks post-vaccination 6 weeks after IP(Investigational Product) vaccination
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