EncephalitisPhase 3NCT02367664
A Clinical Trial for Inactivated Japanese Encephalitis Vaccine in Healthy Chinese Infants
A Phase 3 study testing 0.5ml experimental vaccine on day 0,7 Vero cell-derived inactivated Japanese Encephalitis vaccine, 0.5ml experimental vaccine on day 0,28 Vero cell-derived inactivated Japanese Encephalitis vaccine and 0.5ml active comparator vaccine on day 0,7 inactivated freeze-dried Japanese Encephalitis vaccine(Vero cell) in people with Encephalitis, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.
Trial summary
Japanese encephalitis (JE) is an acute viral zoonotic disease. Neurologic manifestations of the disease range from subtle changes in behavior to serious problems, including blindness, ataxia, weakness, and movement disorders. The Japanese encephalitis virus (JEV) occurs primarily in Southeast Asian. Read more about this study
- Who is it for?
- Ages 6 to 11 monthsHealthy volunteers can take part
- Conditions the study is for
- Encephalitis
- What is being tested?
- 0.5ml experimental vaccine on day 0,7 Vero cell-derived inactivated Japanese Encephalitis vaccine, 0.5ml experimental vaccine on day 0,28 Vero cell-derived inactivated Japanese Encephalitis vaccine and 0.5ml active comparator vaccine on day 0,7 inactivated freeze-dried Japanese Encephalitis vaccine(Vero cell)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteChina
- Study dates
- Oct 2014to Jun 2016
- 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 6 to 11 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged from 6 to 11 months old on the day of inclusion
- Had never received any Japanese Encephalitis vaccine
- Subjects' legal guardians are able to understand and sign the informed consent
- In good general health judged from medical history and clinical examination at the time of inclusion
- Subjects and legal guardians can and will comply with the requirements of the protocol
- Subjects with temperature <=37.0°C on axillary setting
Who cannot join
- Subject who has a medical or family history of any of the following: allergic history, seizure, epilepsy, brain or mental disease
- Subject who is allergic to any ingredient of the vaccine
- Family history of congenital or hereditary immunodeficiency
- Subject with damaged or low immune function which has already been known
- Subject who had a Japanese Encephalitis medical history
- Subject with acute febrile illness or infectious disease
Show all 18Show fewer
- Major congenital defects or serious chronic illness, including perinatal brain damage
- Thrombocytopenia, blood coagulation disorder or bleeding difficulties with intramuscular injection
- Subject who has serious allergic history
- Subject with other medical history not suitable for vaccination such as fainting during injection or acupuncture treatment
- Any prior administration of immunodepressant or corticosteroids in last 6 months
- Any prior administration of blood products in last 3 months
- Any prior administration of other research medicine/vaccine in last 30 days
- Any prior administration of any attenuated live vaccine in last 30 days
- Any prior administration of subunit or inactivated vaccines in last 14 days, such as pneumococcal vaccine
- Any acute infection or serious infection needing systemic antibiotics or antiviral treatment in last 7 days
- Any fever with temperature >=38.0°C on axillary setting in last 3 days
- Any medical, psychological, social or other condition judged by investigator, that may interfere subject's compliance with the protocol or signature on informed consent
Trial locations and contacts
1 site in 1 country.
China1 site
Pizhou Center for Disease Control and Prevention
Xuzhou, Jiangsu, 221300
About this study
Official title: A Single-centre Phase III Clinical Trial for Vero Cell-derived Inactivated Japanese Encephalitis Vaccine Produced by Shandong Hengye Biotech Co., Ltd. in Healthy Chinese Infants Aged 6-11 Months, Aimed to Evaluate Immunogenicity and Safety
Japanese encephalitis (JE) is an acute viral zoonotic disease. Neurologic manifestations of the disease range from subtle changes in behavior to serious problems, including blindness, ataxia, weakness, and movement disorders. The Japanese encephalitis virus (JEV) occurs primarily in Southeast Asian. It is spread by culicine mosquitoes, most often Culex tritaeniorhynchus. Its incubation period is 5 to 15 days.In China, JE epidemic peak season is from June to August and it mainly occurred in children. JE has ranked in top ten infectious diseases according to either incidence or mortality. JE vaccines are used to protect the population especially young children and infants from encephalitis diseases. Live attenuated JE vaccines are now widely used. They are directly produced from attenuated virus which may increase the possibility of virulence reversion. Many developed countries are using purified model inactivated JE vaccine. Therefore, it is an inevitable trend in China to develop a new generation of safer and more effective inactivated vaccine to prevent and control epidemic encephalitis.
Read the detailed description
Japanese encephalitis (JE) is an acute viral zoonotic disease. Neurologic manifestations of the disease range from subtle changes in behavior to serious problems, including blindness, ataxia, weakness, and movement disorders. The Japanese encephalitis virus (JEV) occurs primarily in Southeast Asian. It is spread by culicine mosquitoes, most often Culex tritaeniorhynchus. Its incubation period is 5 to 15 days. In China, JE epidemic peak season is from June to August and it mainly occurred in children. JE has ranked in top ten infectious diseases according to either incidence or mortality. JE vaccines are used to protect the population especially young children and infants from encephalitis diseases. Live attenuated JE vaccines are now widely used. They are directly produced from attenuated virus which may increase the possibility of virulence reversion. Many developed countries are using purified model inactivated JE vaccine. Therefore, it is an inevitable trend in China to develop a new generation of safer and more effective inactivated vaccine to prevent and control epidemic encephalitis.
In order to evaluate immunogenicity and safety of Vero cell-derived inactivated Japanese Encephalitis vaccine produced by Shandong Hengye Biotech Co., Ltd. a single-centre phase III clinical trial is planned to conduct in healthy infants aged 6-11 months in China.
There will be two immunization programs. 600 healthy infants aged 6-11 months will be randomly assigned (1:1) to receive an experimental vaccine or a positive control vaccine at day 0,7. Another 300 healthy infants aged 6-11 months will be recruited to receive an experimental vaccine at day 0,28. All of them will be received a third dose as booster vaccination 12 months later.
- Conditions
- Encephalitis
- Being tested
- 0.5ml experimental vaccine on day 0,7 Vero cell-derived inactivated Japanese Encephalitis vaccine, 0.5ml experimental vaccine on day 0,28 Vero cell-derived inactivated Japanese Encephalitis vaccine, 0.5ml active comparator vaccine on day 0,7 inactivated freeze-dried Japanese Encephalitis vaccine(Vero cell)
- Keywords
- Japanese encephalitis, immunogenicity, safety, vaccine
- Medical subject headings
- Encephalitis, Encephalitis, Japanese
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5ml experimental vaccine on day 0,7 Vero cell-derived inactivated Japanese Encephalitis vaccineBiological
Vero cell-derived inactivated Japanese Encephalitis vaccine produced by Shandong Hengye Biotech Co., Ltd./0.5ml, two doses with 7 days interval, a booster dose 12 months after the first dose
0.5ml experimental vaccine on day 0,28 Vero cell-derived inactivated Japanese Encephalitis vaccineBiological
Vero cell-derived inactivated Japanese Encephalitis vaccine produced by Shandong Hengye Biotech Co., Ltd./0.5ml, two doses with 28 days interval, a booster dose 12 months after the first dose
0.5ml active comparator vaccine on day 0,7 inactivated freeze-dried Japanese Encephalitis vaccine(Vero cell)Biological
inactivated freeze-dried Japanese Encephalitis vaccine(Vero cell) produced by Beijing Tiantan Biological Products Co., Ltd. /0.5ml, two doses with 7 days interval, a booster dose 12 months after the first dose
| Study group | Role | What they receive |
|---|---|---|
| 0.5ml experimental vaccine on day 0,7 | Experimental | 0.5ml experimental vaccine on day 0,7 and a booster dose 12 months later Receives: Biological: 0.5ml experimental vaccine on day 0,7 Vero cell-derived inactivated Japanese Encephalitis vaccine |
| 0.5ml experimental vaccine on day 0,28 | Experimental | 0.5ml experimental vaccine on day 0,28 and a booster dose 12 months later Receives: Biological: 0.5ml experimental vaccine on day 0,28 Vero cell-derived inactivated Japanese Encephalitis vaccine |
| 0.5ml active comparator vaccine on day 0,7 | Active comparator | 0.5ml active comparator vaccine on day 0,7 and a booster dose 12 months later Receives: Biological: 0.5ml active comparator vaccine on day 0,7 inactivated freeze-dried Japanese Encephalitis vaccine(Vero cell) |
What is being measured
The primary outcome is the main question the study is designed to answer.
positive seroconversion rate of JE neutralizing antibody following primary vaccination
to evaluate the positive seroconversion rate of JE neutralizing antibody 28 days after primary vaccination
Measured: 28 days after primary vaccination
incidence of solicited adverse reactions (including systemic and local adverse reactions) following primary vaccination
to evaluate incidence of solicited adverse reactions (including systemic and local adverse reactions) within 0-7 days after primary vaccination
Measured: 0-7 days after primary vaccination
Secondary outcomes (8)
GMT of JE neutralizing antibody following primary vaccination
to evaluate the GMT of JE neutralizing antibody 28 days after primary vaccination
Measured: 28 days after primary vaccination
positive seroconversion rate of JE neutralizing antibody following booster vaccination
to evaluate the positive seroconversion rate of JE neutralizing antibody 28 days after booster vaccination
Measured: 28 days after booster vaccination
positive seroconversion rate of JE neutralizing antibody following primary vaccination
to evaluate the positive seroconversion rate of JE neutralizing antibody 12 months after primary vaccination
Measured: 12 months after primary vaccination
incidence of unsolicited adverse reactions (including systemic and local adverse reactions) following primary vaccination
to evaluate incidence of unsolicited adverse reactions (including systemic and local adverse reactions) within 0-28 days after primary vaccination
Measured: 0-28 days after primary vaccination
incidence of adverse event (AE) following booster vaccination
to evaluate incidence of adverse event (AE) within 0-28 days after booster vaccination
Measured: 0-28 days after booster vaccination
incidence of serious adverse event (SAE) during the whole study period
to evaluate incidence of serious adverse event (SAE) during the whole study period
Measured: Day 0 of the first dose up to Day 28 of the third dose
GMT of JE neutralizing antibody following booster vaccination
to evaluate the GMT and GMI of JE neutralizing antibody 28 days after booster vaccination
Measured: 28 days after booster vaccination
GMT of JE neutralizing antibody following primary vaccination
to evaluate the GMT of JE neutralizing antibody 12 months after primary vaccination
Measured: 12 months after primary vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2015 (estimated)
- Study startOct 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EncephalitisStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province Centers for Disease Control and Prevention
- Sponsor type
- Research network
- Collaborators
- Shandong Hengye Biotech Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02367664
- Sponsor's protocol ID
- JSVCT015
- Status last verified
- Aug 2015
- First submitted
- 2 Feb 2015
- Last updated
- 1 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centre Phase III Clinical Trial for Vero Cell-derived Inactivated Japanese Encephalitis Vaccine Produced by Shandong Hengye Biotech Co., Ltd. in Healthy Chinese Infants Aged 6-11 Months, Aimed to Evaluate Immunogenicity and Safety
- ClinicalTrials.gov ID
- NCT02367664
- Acronym / sponsor ID
- JSVCT015
- Conditions
- Encephalitis
- Keywords
- Japanese encephalitis, immunogenicity, safety, vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- Jiangsu Province Centers for Disease Control and PreventionResearch network
- Collaborators
- Shandong Hengye Biotech Co., Ltd.
- Study start
- Oct 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 20 Feb 2015 (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.
Japanese encephalitis (JE) is an acute viral zoonotic disease. Neurologic manifestations of the disease range from subtle changes in behavior to serious problems, including blindness, ataxia, weakness, and movement disorders. The Japanese encephalitis virus (JEV) occurs primarily in Southeast Asian. It is spread by culicine mosquitoes, most often Culex tritaeniorhynchus. Its incubation period is 5 to 15 days.In China, JE epidemic peak season is from June to August and it mainly occurred in children. JE has ranked in top ten infectious diseases according to either incidence or mortality. JE vaccines are used to protect the population especially young children and infants from encephalitis diseases. Live attenuated JE vaccines are now widely used. They are directly produced from attenuated virus which may increase the possibility of virulence reversion. Many developed countries are using purified model inactivated JE vaccine. Therefore, it is an inevitable trend in China to develop a new generation of safer and more effective inactivated vaccine to prevent and control epidemic encephalitis.
Detailed description
Japanese encephalitis (JE) is an acute viral zoonotic disease. Neurologic manifestations of the disease range from subtle changes in behavior to serious problems, including blindness, ataxia, weakness, and movement disorders. The Japanese encephalitis virus (JEV) occurs primarily in Southeast Asian. It is spread by culicine mosquitoes, most often Culex tritaeniorhynchus. Its incubation period is 5 to 15 days. In China, JE epidemic peak season is from June to August and it mainly occurred in children. JE has ranked in top ten infectious diseases according to either incidence or mortality. JE vaccines are used to protect the population especially young children and infants from encephalitis diseases. Live attenuated JE vaccines are now widely used. They are directly produced from attenuated virus which may increase the possibility of virulence reversion. Many developed countries are using purified model inactivated JE vaccine. Therefore, it is an inevitable trend in China to develop a new generation of safer and more effective inactivated vaccine to prevent and control epidemic encephalitis.
In order to evaluate immunogenicity and safety of Vero cell-derived inactivated Japanese Encephalitis vaccine produced by Shandong Hengye Biotech Co., Ltd. a single-centre phase III clinical trial is planned to conduct in healthy infants aged 6-11 months in China.
There will be two immunization programs. 600 healthy infants aged 6-11 months will be randomly assigned (1:1) to receive an experimental vaccine or a positive control vaccine at day 0,7. Another 300 healthy infants aged 6-11 months will be recruited to receive an experimental vaccine at day 0,28. All of them will be received a third dose as booster vaccination 12 months later.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0.5ml experimental vaccine on day 0,7 | Experimental | Biological: 0.5ml experimental vaccine on day 0,7 Vero cell-derived inactivated Japanese Encephalitis vaccine0.5ml experimental vaccine on day 0,7 and a booster dose 12 months later |
| 0.5ml experimental vaccine on day 0,28 | Experimental | Biological: 0.5ml experimental vaccine on day 0,28 Vero cell-derived inactivated Japanese Encephalitis vaccine0.5ml experimental vaccine on day 0,28 and a booster dose 12 months later |
| 0.5ml active comparator vaccine on day 0,7 | Active comparator | Biological: 0.5ml active comparator vaccine on day 0,7 inactivated freeze-dried Japanese Encephalitis vaccine(Vero cell)0.5ml active comparator vaccine on day 0,7 and a booster dose 12 months later |
Who may qualify
- Ages
- 6 to 11 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Aged from 6 to 11 months old on the day of inclusion
- Had never received any Japanese Encephalitis vaccine
- Subjects' legal guardians are able to understand and sign the informed consent
- In good general health judged from medical history and clinical examination at the time of inclusion
- Subjects and legal guardians can and will comply with the requirements of the protocol
Key exclusion criteria (18 listed)
- Subject who has a medical or family history of any of the following: allergic history, seizure, epilepsy, brain or mental disease
- Subject who is allergic to any ingredient of the vaccine
- Family history of congenital or hereditary immunodeficiency
- Subject with damaged or low immune function which has already been known
- Subject who had a Japanese Encephalitis medical history
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 |
|---|---|---|
| 0.5ml experimental vaccine on day 0,7 Vero cell-derived inactivated Japanese Encephalitis vaccineVero cell-derived inactivated Japanese Encephalitis vaccine produced by Shandong Hengye Biotech Co., Ltd./0.5ml, two doses with 7 days interval, a booster dose 12 months after the first dose | Biological | 0.5ml experimental vaccine on day 0,7 |
| 0.5ml experimental vaccine on day 0,28 Vero cell-derived inactivated Japanese Encephalitis vaccineVero cell-derived inactivated Japanese Encephalitis vaccine produced by Shandong Hengye Biotech Co., Ltd./0.5ml, two doses with 28 days interval, a booster dose 12 months after the first dose | Biological | 0.5ml experimental vaccine on day 0,28 |
| 0.5ml active comparator vaccine on day 0,7 inactivated freeze-dried Japanese Encephalitis vaccine(Vero cell)inactivated freeze-dried Japanese Encephalitis vaccine(Vero cell) produced by Beijing Tiantan Biological Products Co., Ltd. /0.5ml, two doses with 7 days interval, a booster dose 12 months after the first dose | Biological | 0.5ml active comparator vaccine on day 0,7 |
Primary outcome
positive seroconversion rate of JE neutralizing antibody following primary vaccination
Time frame: 28 days after primary vaccination
to evaluate the positive seroconversion rate of JE neutralizing antibody 28 days after primary vaccination
incidence of solicited adverse reactions (including systemic and local adverse reactions) following primary vaccination
Time frame: 0-7 days after primary vaccination
to evaluate incidence of solicited adverse reactions (including systemic and local adverse reactions) within 0-7 days after primary vaccination
8 secondary outcomes
GMT of JE neutralizing antibody following primary vaccination
Time frame: 28 days after primary vaccination
positive seroconversion rate of JE neutralizing antibody following booster vaccination
Time frame: 28 days after booster vaccination
positive seroconversion rate of JE neutralizing antibody following primary vaccination
Time frame: 12 months after primary vaccination
incidence of unsolicited adverse reactions (including systemic and local adverse reactions) following primary vaccination
Time frame: 0-28 days after primary vaccination
incidence of adverse event (AE) following booster vaccination
Time frame: 0-28 days after booster vaccination
incidence of serious adverse event (SAE) during the whole study period
Time frame: Day 0 of the first dose up to Day 28 of the third dose
GMT of JE neutralizing antibody following booster vaccination
Time frame: 28 days after booster vaccination
GMT of JE neutralizing antibody following primary vaccination
Time frame: 12 months after primary 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 1 Sep 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 0.5ml experimental vaccine on day 0,7 Vero cell-derived inactivated Japanese Encephalitis vaccine, 0.5ml experimental vaccine on day 0,28 Vero cell-derived inactivated Japanese Encephalitis vaccine and 0.5ml active comparator vaccine on day 0,7 inactivated freeze-dried Japanese Encephalitis vaccine(Vero cell) in people with Encephalitis, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.
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 6 inclusion and 18 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 1 Sep 2016. 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 China. 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?
positive seroconversion rate of JE neutralizing antibody following primary vaccination (time frame: 28 days after primary vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2016.