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VaricellaPhase 3NCT03114943

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

A Phase 3 study testing NBP608 and Varivax in people with Varicella, run by SK Bioscience Co., Ltd. at 1 site in Philippines.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 12 months to 12 yearsHealthy volunteers can take part
Conditions the study is for
Varicella
What is being tested?
NBP608 and Varivax
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
516 participants
Where
1 sitePhilippines
Study dates
14 Jul 2016to 28 Jun 2017
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 months to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Philippines1 site

  • De La Salle Health Sciences Institute

    Dasmariñas, Cavite, 4114

Other trials in Philippines

About this study

Official 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

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.

Read the detailed description

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)

Conditions
Varicella
Being tested
NBP608, Varivax
Keywords
prevention of varicella, Varicella-zoster vaccine
Medical subject headings
Chickenpox

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NBP608Biological

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

  • VarivaxBiological

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

Study groups in NCT03114943
Study groupRoleWhat they receive
NBP608ExperimentalSingle dose 0.5mL of NBP608 by subcutaneous injection into the outer aspect of the upper arm or the anterolateral thigh
Receives: Biological: NBP608
VarivaxActive comparatorSingle dose 0.5mL of Varivax by subcutaneous injection into the outer aspect of the upper arm or the anterolateral thigh
Receives: Biological: Varivax

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 6 weeks after IP(Investigational Product) vaccination

Secondary outcomes (3)

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

    Measured: 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)

    Measured: 6 weeks after IP(Investigational Product) vaccination

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

    *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

    Measured: 6 weeks after IP(Investigational Product) vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2017
  2. Study start14 Jul 2016
  3. Primary completion28 Jun 2017
  4. Study completion28 Jun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
516 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03114943
Sponsor's protocol ID
NBP608_VZ_III_2015
Status last verified
Apr 2017
First submitted
11 Apr 2017
Last updated
8 May 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NBP608 and Varivax in people with Varicella, run by SK Bioscience Co., Ltd. at 1 site in Philippines.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

seroconversion rate by FAMA (Fluorescent Antibody to Membrane Antigen) assay (time frame: 6 weeks after IP(Investigational Product) vaccination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03114943.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2019.

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