NCT03114943

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
516

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jul 2016

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 14, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 14, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2017

Completed
Last Updated

May 8, 2019

Status Verified

April 1, 2017

Enrollment Period

12 months

First QC Date

April 11, 2017

Last Update Submit

May 6, 2019

Conditions

Varicella

Keywords

prevention of varicellaVaricella-zoster vaccine

Outcome Measures

Primary Outcomes (1)

  • seroconversion rate 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 by gpELISA (Glycoprotein Enzyme Linked Immunosorbent Assay)

    6 weeks after IP(Investigational Product) vaccination

Other Outcomes (1)

  • Consistency Assessment between Countries

    6 weeks after IP(Investigational Product) vaccination

Study Arms (2)

NBP608

EXPERIMENTAL

Single dose 0.5mL 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

NBP608BIOLOGICAL

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

NBP608
VarivaxBIOLOGICAL

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

Varivax

Eligibility Criteria

Age12 Months - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (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) 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

De La Salle Health Sciences Institute

Dasmariñas, Cavite, 4114, Philippines

Location

MeSH Terms

Conditions

Chickenpox

Interventions

Chickenpox Vaccine

Condition Hierarchy (Ancestors)

Varicella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

Herpesvirus VaccinesViral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • DELIA C. YU, Dr

    De La Salle Health Sciences Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
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

July 14, 2016

Primary Completion

June 28, 2017

Study Completion

June 28, 2017

Last Updated

May 8, 2019

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

PH(1)