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NCT Number: NCT03114943

Immunogenicity and Safety of NBP608 Compared to Varivax in Healthy Children 12 Months to 12 Years of Age

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.

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Key information

Conditions

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

Age range

12 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

De La Salle Health Sciences Institute

Dasmariñas, Cavite, 4114, Philippines

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NBP608

Biological

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

Varivax

Biological

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

Primary outcomes

  1. seroconversion rate by FAMA (Fluorescent Antibody to Membrane Antigen) assay

    Time frame: 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 outcomes

  1. VZV (Varicella Zoster Virus) antibody GMT(Geometric Mean Titer) measured by FAMA (Fluorescent Antibody to Membrane Antigen) assay

    Time frame: 6 weeks after IP(Investigational Product) vaccination

  2. VZV (Varicella Zoster Virus) antibody GMT(Geometric Mean Titer) measured by gpELISA (Glycoprotein Enzyme Linked Immunosorbent Assay)

    Time frame: 6 weeks after IP(Investigational Product) vaccination

  3. seroconversion rate by gpELISA (Glycoprotein Enzyme Linked Immunosorbent Assay)

    Time frame: 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 outcomes

  1. Consistency Assessment between Countries

    Time frame: 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

Sponsors and collaborators

Lead sponsor

SK Bioscience Co., Ltd.

Industry

Registry information

Official study title

A Multi-national, Multi-center, Randomized, Double Blinded, Parallel-group Study to Assess the Immunogenicity and Safety of NBP608 Compared to Varivax in Healthy Children 12 Months to 12 Years of Age

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 14, 2017
Registry last updated
May 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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