The Evaluation of Immunogenicity and Safety of NBP608 in Healthy Children 12 Months to 12 Years of Age

Varicella Clinical Trial

Official title:

Randomized, Double-blinded, Parallel-group, Exploratory Study to Assess The Immunogenicity and Safety of NBP608 and Varivax in Healthy Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03114982
• Other study ID #: NBP608_VZ_II_2015
• 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
• 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

Related Conditions & MeSH terms

• Chickenpox
• Herpes Zoster
• Varicella

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