Japanese Encephalitis Virus DiseasePhase 3NCT04223037
Purified Inactivated Japanese Encephalitis Vaccine
A Phase 3 study testing Japanese Encephalitis Vaccine produced by IMBCAMS and Japanese Encephalitis Vaccine produced by Liaoning Chenda in people with Japanese Encephalitis Virus Disease, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This study evaluates the immunogenicity and safety of a purified inactivated JE vaccine compared to a commercialized JE vaccine. In this phase III, randomized, blind trial, infants at 6-23 months of age were randomly assigned to three groups to receive experimental vaccine or control vaccine with two different… Read more about this study
- Who is it for?
- Ages 6 to 23 monthsHealthy volunteers can take part
- Conditions the study is for
- Japanese Encephalitis Virus Disease
- What is being tested?
- Japanese Encephalitis Vaccine produced by IMBCAMS and Japanese Encephalitis Vaccine produced by Liaoning Chenda
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,050 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2015to 31 Dec 2022
- 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 23 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 6-23 months old infants, no vaccination history of JE vaccine, no vaccination contraindication.
- informed consent of guardian / lawful written guardian, and signed informed consent;
- the guardian and family can comply with the requirements of the clinical trial scheme.
- there was no immunization history of immunoglobulins within three months, and there was no history of live vaccination within 14 days.
- the axillary temperature ≤ 37℃.
Who cannot join
- Allergy to any ingredient in the vaccine (any previous history of vaccine allergy); There are allergic, convulsive, epileptic, encephalopathy and psychiatric symptoms or signs.
- People with known or suspected (or high-risk) impairment or abnormality of immune function, such as those receiving immunosuppressive or immunopotentiator therapy, receiving blood products or plasma extracts within three months, or having an immunodeficiency virus infection or related disease in the mother or child.
- A history of thrombocytopenia or other coagulation disorders clearly diagnosed by the medical department, or a history of hemorrhagic constitution or prolonged bleeding time;
- Infected patients with known or suspected to have respiratory diseases, acute infections or active chronic diseases and are receiving antibiotic or antiviral treatment;
- In the past 3 days, fever (axillary body temperature≥38℃), oral or steroid hormones were given.
- Infectious or allergic skin diseases.
- Participating in another clinical researcher; or any situation that the researcher considers likely to affect the evaluation of the trial
Trial locations and contacts
1 site in 1 country.
China1 site
Disease prevention and control center of Inner Mongolia autonomous region
Hohhot, Inner Mongolia, 010031
About this study
Official title: Phase III Clinical Trial of Purified Inactivated Japanese Encephalitis Vaccine
This study evaluates the immunogenicity and safety of a purified inactivated JE vaccine compared to a commercialized JE vaccine. In this phase III, randomized, blind trial, infants at 6-23 months of age were randomly assigned to three groups to receive experimental vaccine or control vaccine with two different vaccination schedule respectively.
Read the detailed description
The clinical study used randomized, blind method, commercialize inactivated Japanese encephalitis vaccine as control. In Infants at 6-23 months of age were injected with experimental vaccine with 0,7 days and 0,28 days vaccination schedule to evaluate immunogenicity and safety of the experimental vaccine and the effectiveness of different vaccination schedule. Participates were assigned to three groups (350 per group): group 1 with experimental vaccine using 0,7 days vaccination schedule; group 2 with control vaccine using 0, 7 days vaccination schedule; group 3 with experimental vaccine using 0, 28 vaccination schedule.
Blood samples were collected before immunization and 30 days after immunization, and the neutralization antibody of Japanese encephalitis was detected by plaque reduction neutralization test. Medical observation was conducted 30 minutes after each injection. Body temperature of participates was continuously measured for 7 days, and any adverse events were observed and recorded from the first dose to 30 days after the whole vaccination. Serious adverse events were collected within 6 months after the first dose.
- Conditions
- Japanese Encephalitis Virus Disease
- Being tested
- Japanese Encephalitis Vaccine produced by IMBCAMS, Japanese Encephalitis Vaccine produced by Liaoning Chenda
- Keywords
- Japanese Encephalitis Vaccine, Phase III Clinical Trial
- Medical subject headings
- Encephalitis, Japanese
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Japanese Encephalitis Vaccine produced by IMBCAMSBiological
Dosage form: 0.5mL/vial
Japanese Encephalitis Vaccine produced by Liaoning ChendaBiological
Dosage form: 0.5mL/vial
| Study group | Role | What they receive |
|---|---|---|
| Day 0，7 immunization shedule | Active comparator | Japanese Encephalitis Vaccine produced by Institute of Medical Biology, Chinese Academy of Medical Sciences (IMBCAMS) and Japanese Encephalitis Vaccine produced by Liaoning Chenda CO.,LTD Dosage form: 0.5mL/vial Two Dose injection with 7 days interval Receives: Biological: Japanese Encephalitis Vaccine produced by IMBCAMS; Biological: Japanese Encephalitis Vaccine produced by Liaoning Chenda |
| Day 0，28 immunization shedule | Experimental | Japanese Encephalitis Vaccine produced by IMBCAMS Dosage form: 0.5mL/vial Two Dose injection with 28 days interval Receives: Biological: Japanese Encephalitis Vaccine produced by IMBCAMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local and systemic adverse reactions
The main endpoint of safety observation was 30 days after 2 doses vaccination. If serious adverse reactions related to vaccines occur during the observation period, or the adverse reactions of grade 3 and above reached 10%, or three symptoms similar to grade 3 and above occur within 24 hours, the trial should be suspended and vaccine-related adverse reactions occurred. The death of the subjects will be terminated at any time. Follow up and collection of serious adverse events within 6 months after first dose immunization via close monitoring or diary card.
Measured: Within 6 months after immunization
Immunogenecity detected by plaque reduction neutralization test
Blood samples were collected from all subjects before and 30 days after the whole course of immunization, and neutralizing antibody was detected by plaque reduction neutralization test.
Measured: 1 month after immunization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start1 Sep 2015
- Primary completion7 Mar 2018
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Japanese Encephalitis Virus DiseaseStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,050 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mingbo Sun, Chinese Academy of Medical Sciences
- Investigators
- Shaohong Yan, Principal investigator, Disease prevention and control center of Inner Mongolia autonomous region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04223037
- Sponsor's protocol ID
- 074201504
- Status last verified
- Mar 2022
- First submitted
- 6 Jan 2020
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Clinical Trial of Purified Inactivated Japanese Encephalitis Vaccine
- ClinicalTrials.gov ID
- NCT04223037
- Acronym / sponsor ID
- 074201504
- Conditions
- Japanese Encephalitis Virus Disease
- Keywords
- Japanese Encephalitis Vaccine, Phase III Clinical Trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,050 participants (actual)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 7 Mar 2018 (actual)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 10 Jan 2020 (actual)
- 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.
This study evaluates the immunogenicity and safety of a purified inactivated JE vaccine compared to a commercialized JE vaccine. In this phase III, randomized, blind trial, infants at 6-23 months of age were randomly assigned to three groups to receive experimental vaccine or control vaccine with two different vaccination schedule respectively.
Detailed description
The clinical study used randomized, blind method, commercialize inactivated Japanese encephalitis vaccine as control. In Infants at 6-23 months of age were injected with experimental vaccine with 0,7 days and 0,28 days vaccination schedule to evaluate immunogenicity and safety of the experimental vaccine and the effectiveness of different vaccination schedule. Participates were assigned to three groups (350 per group): group 1 with experimental vaccine using 0,7 days vaccination schedule; group 2 with control vaccine using 0, 7 days vaccination schedule; group 3 with experimental vaccine using 0, 28 vaccination schedule.
Blood samples were collected before immunization and 30 days after immunization, and the neutralization antibody of Japanese encephalitis was detected by plaque reduction neutralization test. Medical observation was conducted 30 minutes after each injection. Body temperature of participates was continuously measured for 7 days, and any adverse events were observed and recorded from the first dose to 30 days after the whole vaccination. Serious adverse events were collected within 6 months after the first dose.
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 |
|---|---|---|
| Day 0，7 immunization shedule | Active comparator | Biological: Japanese Encephalitis Vaccine produced by IMBCAMS, Biological: Japanese Encephalitis Vaccine produced by Liaoning ChendaJapanese Encephalitis Vaccine produced by Institute of Medical Biology, Chinese Academy of Medical Sciences (IMBCAMS) and Japanese Encephalitis Vaccine produced by Liaoning Chenda CO.,LTD Dosage form: 0.5mL/vial Two Dose injection with 7 days interval |
| Day 0，28 immunization shedule | Experimental | Biological: Japanese Encephalitis Vaccine produced by IMBCAMSJapanese Encephalitis Vaccine produced by IMBCAMS Dosage form: 0.5mL/vial Two Dose injection with 28 days interval |
Who may qualify
- Ages
- 6 to 23 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 6-23 months old infants, no vaccination history of JE vaccine, no vaccination contraindication.
- informed consent of guardian / lawful written guardian, and signed informed consent;
- the guardian and family can comply with the requirements of the clinical trial scheme.
- there was no immunization history of immunoglobulins within three months, and there was no history of live vaccination within 14 days.
- the axillary temperature ≤ 37℃.
Key exclusion criteria (7 listed)
- Allergy to any ingredient in the vaccine (any previous history of vaccine allergy); There are allergic, convulsive, epileptic, encephalopathy and psychiatric symptoms or signs.
- People with known or suspected (or high-risk) impairment or abnormality of immune function, such as those receiving immunosuppressive or immunopotentiator therapy, receiving blood products or plasma extracts within three months, or having an immunodeficiency virus infection or related disease in the mother or child.
- A history of thrombocytopenia or other coagulation disorders clearly diagnosed by the medical department, or a history of hemorrhagic constitution or prolonged bleeding time;
- Infected patients with known or suspected to have respiratory diseases, acute infections or active chronic diseases and are receiving antibiotic or antiviral treatment;
- In the past 3 days, fever (axillary body temperature≥38℃), oral or steroid hormones were given.
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 |
|---|---|---|
| Japanese Encephalitis Vaccine produced by IMBCAMSDosage form: 0.5mL/vial | Biological | Day 0，28 immunization shedule, Day 0，7 immunization shedule |
| Japanese Encephalitis Vaccine produced by Liaoning ChendaDosage form: 0.5mL/vial | Biological | Day 0，7 immunization shedule |
Primary outcome
Local and systemic adverse reactions
Time frame: Within 6 months after immunization
The main endpoint of safety observation was 30 days after 2 doses vaccination. If serious adverse reactions related to vaccines occur during the observation period, or the adverse reactions of grade 3 and above reached 10%, or three symptoms similar to grade 3 and above occur within 24 hours, the trial should be suspended and vaccine-related adverse reactions occurred. The death of the subjects will be terminated at any time. Follow up and collection of serious adverse events within 6 months after first dose immunization via close monitoring or diary card.
Immunogenecity detected by plaque reduction neutralization test
Time frame: 1 month after immunization
Blood samples were collected from all subjects before and 30 days after the whole course of immunization, and neutralizing antibody was detected by plaque reduction neutralization test.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
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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.
Shaohong Yan principal investigator
Disease prevention and control center of Inner Mongolia autonomous region
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 Japanese Encephalitis Vaccine produced by IMBCAMS and Japanese Encephalitis Vaccine produced by Liaoning Chenda in people with Japanese Encephalitis Virus Disease, run by Chinese Academy of Medical Sciences 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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 9 Mar 2022. 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?
Results are not available in the source record.
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?
Local and systemic adverse reactions (time frame: Within 6 months after immunization). 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 9 Mar 2022.