Japanese EncephalitisPhase 3NCT01150942
Clinical Trial to Assess the Immunogenicity and Safety of the Vero Cell-derived JE Vaccine in Korea
A Phase 3 study testing JE vaccine in people with Japanese Encephalitis, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
Trial summary
To assess the immunogenicity and safety of the vero cell-derived inactivated JE vaccine in Korean healthy children aged 12~23 months Read more about this study
- Who is it for?
- Ages 12 to 23 monthsHealthy volunteers can take part
- Conditions the study is for
- Japanese Encephalitis
- What is being tested?
- JE vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2010to Feb 2013
- 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 to 23 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children aged 12-23 months
- Written informed consent
Who cannot join
- History of documented HIV
- Known or suspected impairment of immunologic function
- History of serious chronic disease
- Received any JE vaccine prior to enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Active-control, Randomized, Double-blind Phase 3 Clinical Trial to Assess the Immunogenicity and Safety of the Vero Cell-derived Inactivated Japanese Encephalitis Vaccine 'KD-287(JEIMMUGEN INJ.) in Korean Healthy Children Aged 12~23 Months
To assess the immunogenicity and safety of the vero cell-derived inactivated JE vaccine in Korean healthy children aged 12~23 months
Read the detailed description
To compare the Vero cell-derived inactivated Japanese encephalitis(JE) vaccine 'KD-287(JEIMMUGEN INJ.)' with the mouse brain-derived inactivated JE vaccine in terms of the immunogenicity and safety, in Korean healthy children aged 12~23 months
- Conditions
- Japanese Encephalitis
- Being tested
- JE vaccine
- Keywords
- JEV, vero cell
- Medical subject headings
- Encephalitis, Japanese
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JE vaccineBiological
3 times, IM
| Study group | Role | What they receive |
|---|---|---|
| vero cell-derived JE vaccine | Experimental | vero cell-derived vaccine group Receives: Biological: JE vaccine |
| Mouse brain-derived JE vaccine | Active comparator | Mouse brain-derived JE vaccine group Receives: Biological: JE vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
immunogenicity
the seroconversion rates for JE antibodies 4 weeks after 3rd vaccination
Measured: pre-dose, after 3rd vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2010 (estimated)
- Study startAug 2010
- Primary completionSep 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Japanese EncephalitisStudies of the same condition, open and under way.
- More trials run by Boryung Pharmaceutical Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Seoul National University Hospital, Gachon University Gil Medical Center, Inha University Hospital, Inje University, Korea Cancer Center Hospital, Samsung Medical Center, The Catholic University of Korea, Ewha Womans University, Wonju Severance Christian Hospital, Kyunghee University Medical Center
- Responsible party
- Sponsor
- Investigators
- Hoan Jong Lee, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01150942
- Sponsor's protocol ID
- KD287-BR-CT-301
- Status last verified
- Feb 2011
- First submitted
- 24 Jun 2010
- Last updated
- 30 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yun KW, Lee HJ, Kang JH, Eun BW, Kim YJ, Kim KH, Kim NH, Hong YJ, Kim DH, Kim HM, Cha SH. Safety and immunogenicity of a freeze-dried, Vero cell culture-derived, inactivated Japanese encephalitis vaccine (KD-287, ENCEVAC(R)) versus a mouse brain-derived inactivated Japanese encephalitis vaccine in children: a phase III, multicenter, double-blinded, randomized trial. BMC Infect Dis. 2015 Jan 8;15:7. doi: 10.1186/s12879-014-0744-4.
PubMed 25567119
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Active-control, Randomized, Double-blind Phase 3 Clinical Trial to Assess the Immunogenicity and Safety of the Vero Cell-derived Inactivated Japanese Encephalitis Vaccine 'KD-287(JEIMMUGEN INJ.) in Korean Healthy Children Aged 12~23 Months
- ClinicalTrials.gov ID
- NCT01150942
- Acronym / sponsor ID
- KD287-BR-CT-301
- Conditions
- Japanese Encephalitis
- Keywords
- JEV, vero cell
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Seoul National University Hospital, Gachon University Gil Medical Center, Inha University Hospital, Inje University, Korea Cancer Center Hospital, Samsung Medical Center, The Catholic University of Korea, Ewha Womans University, Wonju Severance Christian Hospital, Kyunghee University Medical Center
- Study start
- Aug 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 25 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the immunogenicity and safety of the vero cell-derived inactivated JE vaccine in Korean healthy children aged 12~23 months
Detailed description
To compare the Vero cell-derived inactivated Japanese encephalitis(JE) vaccine 'KD-287(JEIMMUGEN INJ.)' with the mouse brain-derived inactivated JE vaccine in terms of the immunogenicity and safety, in Korean healthy children aged 12~23 months
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vero cell-derived JE vaccine | Experimental | Biological: JE vaccinevero cell-derived vaccine group |
| Mouse brain-derived JE vaccine | Active comparator | Biological: JE vaccineMouse brain-derived JE vaccine group |
Who may qualify
- Ages
- 12 to 23 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Healthy children aged 12-23 months
- Written informed consent
Key exclusion criteria (4 listed)
- History of documented HIV
- Known or suspected impairment of immunologic function
- History of serious chronic disease
- Received any JE vaccine prior to enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JE vaccine3 times, IM | Biological | Mouse brain-derived JE vaccine, vero cell-derived JE vaccine |
Primary outcome
immunogenicity
Time frame: pre-dose, after 3rd vaccination
the seroconversion rates for JE antibodies 4 weeks after 3rd vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2014.
- Derived from this study: PubMed 25567119Yun KW, Lee HJ, Kang JH, Eun BW, Kim YJ, Kim KH, Kim NH, Hong YJ, Kim DH, Kim HM, Cha SH. Safety and immunogenicity of a freeze-dried, Vero cell culture-derived, inactivated Japanese encephalitis vaccine (KD-287, ENCEVAC(R)) versus a mouse brain-derived inactivated Japanese encephalitis vaccine in children: a phase III, multicenter, double-blinded, randomized trial. BMC Infect Dis. 2015 Jan 8;15:7. doi: 10.1186/s12879-014-0744-4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hoan Jong Lee, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing JE vaccine in people with Japanese Encephalitis, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
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 4 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 30 Jan 2014. 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 South Korea. 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?
immunogenicity (time frame: pre-dose, after 3rd 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 NCT01150942, which also lists 1 linked publication.
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 30 Jan 2014.