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

NCT03114982 | Completed Phase 2 DMC

• 1 other identifier: NBP608_VZ_II_2015
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Varicella

Keywords

Prevention of varicella; Varicella-zoster vaccine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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 measured by gpELISA (Glycoprotein Enzyme Linked Immunosorbent Assay)

  6 weeks after IP(Investigational Product) vaccination

Study Arms (4)

Low potency of NBP608

EXPERIMENTAL

Single dose 0.5mL of low potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm or the anterolateral thigh

Biological: NBP608

Middle potency of NBP608

EXPERIMENTAL

Single dose 0.5mL of middle potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm or the anterolateral thigh

Biological: NBP608

High potency of NBP608

EXPERIMENTAL

Single dose 0.5mL of high potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm or the anterolateral thigh

Biological: NBP608

Varivax

ACTIVE COMPARATOR

Single dose 0.5mL of Varivax by subcutaneous injection into the outer aspect of the upper arm or the anterolateral thigh

Biological: Varivax

Interventions

NBP608 BIOLOGICAL

Preparation of the Oka/SK strain of live, attenuated varicella virus

High potency of NBP608; Low potency of NBP608; Middle potency of NBP608

Varivax BIOLOGICAL

Preparation of the Oka/Merck strain of live, attenuated varicella virus

Varivax

Eligibility Criteria

• Age: 12 Months - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SK Chemicals Co., Ltd.: lead

Study Sites (1)

Research Insitute for Torpical Medicine

Muntinlupa City, National Capital Region, 1781, Philippines

Location

MeSH Terms

Conditions

Chickenpox

Interventions

Chickenpox Vaccine

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Herpesvirus Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Maria Rosario Z. capeding, Dr

  Research Institute for Tropical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: April 14, 2017
• Study Start: May 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: November 1, 2016
• Last Updated: April 14, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

PH (1)