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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03114943 |
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Date of registration:
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11/04/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Immunogenicity and Safety of NBP608 Compared to Varivax in Healthy Children 12 Months to 12 Years of Age
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Scientific title:
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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 |
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Date of first enrolment:
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July 14, 2016 |
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Target sample size:
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516 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03114943 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Philippines
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Contacts
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Name:
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DELIA C. YU, Dr |
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Address:
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Telephone:
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Email:
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Affiliation:
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De La Salle Health Sciences Institute |
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Key inclusion & exclusion criteria
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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
Age minimum:
12 Months
Age maximum:
12 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Varicella
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Intervention(s)
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Biological: Varivax
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Biological: NBP608
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Primary Outcome(s)
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seroconversion rate by FAMA (Fluorescent Antibody to Membrane Antigen) assay
[Time Frame: 6 weeks after IP(Investigational Product) vaccination]
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Secondary Outcome(s)
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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]
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seroconversion rate by gpELISA (Glycoprotein Enzyme Linked Immunosorbent Assay)
[Time Frame: 6 weeks after IP(Investigational Product) vaccination]
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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]
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Secondary ID(s)
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NBP608_VZ_III_2015
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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