Japanese EncephalitisPhase 4NCT01815073
Immunogenicity and Safety of Live Attenuated Varicella Vaccine Combined With Live Attenuated JE Vaccine
A Phase 4 study testing Live Attenuated Varicella Vaccine + Live Attenuated JE Vaccine, Live Attenuated Varicella Vaccine and live attenuated JE vaccine in people with Japanese Encephalitis and Chickenpox, run by Changchun Keygen Biological Products Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to observe the occurrence of adverse events and seroconversion rate, geometric mean titres (GMTs) of live attenuated varicella vaccine，live attenuated JE vaccine and live attenuated varicella vaccine combined with live attenuated JE vaccine, respectively. Read more about this study
- Who is it for?
- Ages 1 year to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Japanese Encephalitis, Chickenpox
- What is being tested?
- Live Attenuated Varicella Vaccine + Live Attenuated JE Vaccine, Live Attenuated Varicella Vaccine and live attenuated JE vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 497 participants
- Where
- 1 siteChina
- Study dates
- Mar 2013to Jul 2013
- Phase
- Phase 4
- 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 1 year to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent
- Participant is aged ≥ 1 year to ≤ 3 years
- Participant without previous history of chickenpox, zoster and epidemic encephalitis B
- Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures
- Body temperature ≤ 37.5℃
Who cannot join
- Known allergy to any constituent of the vaccine
- Known acute illness, severe chronic disease, acute exacerbation of chronic disease and fever
- Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth
- Reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction
- Failed to the Expanded Programme on Immunization(EPI)
- Receipt of any vaccine in the 4 weeks preceding the trial vaccination
Show all 13Show fewer
- Plan to receive any vaccine in the 4 weeks following the trial vaccination
- Known bleeding disorder
- Receipt of whole blood, blood plasma or immunoglobulin in the 5 months preceding the trial vaccination
- Reported the history of acute illness had need systemic antibiotics or anti-viral treatment of infections in the 7 days preceding the trial vaccination
- An acute illness with or without fever (temperature ≥ 38.0℃) in the 3 days preceding enrollment in the trial
- Participation in any other interventional clinical trial
- Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine
Trial locations and contacts
1 site in 1 country.
China1 site
Guangzhou Haizhu District Center for Disease Control and Prevention
Guangzhou, Guangdong
About this study
Official title: A Study to Evaluate the Immunogenicity and Safety of Live Attenuated Varicella Vaccine Combined With Live Attenuated JE Vaccine
The purpose of this study is to observe the occurrence of adverse events and seroconversion rate, geometric mean titres (GMTs) of live attenuated varicella vaccine，live attenuated JE vaccine and live attenuated varicella vaccine combined with live attenuated JE vaccine, respectively.
- Conditions
- Japanese Encephalitis, Chickenpox
- Being tested
- Live Attenuated Varicella Vaccine + Live Attenuated JE Vaccine, Live Attenuated Varicella Vaccine, live attenuated JE vaccine
- Medical subject headings
- Encephalitis, Japanese, Chickenpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live Attenuated Varicella Vaccine + Live Attenuated JE VaccineBiological
Live Attenuated Varicella VaccineBiological
live attenuated JE vaccineBiological
| Study group | Role | What they receive |
|---|---|---|
| Live Attenuated Varicella Vaccine + Live Attenuated JE Vaccine | Experimental | use the left arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection Receives: Biological: Live Attenuated Varicella Vaccine + Live Attenuated JE Vaccine |
| Live Attenuated Varicella Vaccine | Experimental | use the right arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection Receives: Biological: Live Attenuated Varicella Vaccine |
| Live Attenuated JE Vaccine | Experimental | use the right arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection Receives: Biological: live attenuated JE vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion rate and GMTs for live attenuated varicella vaccine, live attenuated JE vaccine and live attenuated varicella vaccine combined with live attenuated JE vaccine, respectively.
Measured: 35-42 days after vaccination
Secondary outcomes (1)
Occurrence of adverse events.
Measured: within 30 days after each vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Japanese 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 497 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changchun Keygen Biological Products Co., Ltd.
- Sponsor type
- University, hospital or other
- Collaborators
- Guangdong Provincial Institute of Biological Products And Materia Medica
- Responsible party
- Sponsor
- Investigators
- Zheng Huizhen, Master, Principal investigator, Guangdong Center for Disease Prevention and Control
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01815073
- Sponsor's protocol ID
- NCT02049715
- Status last verified
- Feb 2014
- First submitted
- 18 Mar 2013
- Last updated
- 24 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Immunogenicity and Safety of Live Attenuated Varicella Vaccine Combined With Live Attenuated JE Vaccine
- ClinicalTrials.gov ID
- NCT01815073
- Acronym / sponsor ID
- NCT02049715
- Conditions
- Japanese Encephalitis, Chickenpox
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 497 participants (actual)
- Lead sponsor
- Changchun Keygen Biological Products Co., Ltd.University, hospital or other
- Collaborators
- Guangdong Provincial Institute of Biological Products And Materia Medica
- Study start
- Mar 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 20 Mar 2013 (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.
The purpose of this study is to observe the occurrence of adverse events and seroconversion rate, geometric mean titres (GMTs) of live attenuated varicella vaccine，live attenuated JE vaccine and live attenuated varicella vaccine combined with live attenuated JE vaccine, respectively.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Live Attenuated Varicella Vaccine + Live Attenuated JE Vaccine | Experimental | Biological: Live Attenuated Varicella Vaccine + Live Attenuated JE Vaccineuse the left arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection |
| Live Attenuated Varicella Vaccine | Experimental | Biological: Live Attenuated Varicella Vaccineuse the right arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection |
| Live Attenuated JE Vaccine | Experimental | Biological: live attenuated JE vaccineuse the right arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection |
Who may qualify
- Ages
- 1 year to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent
- Participant is aged ≥ 1 year to ≤ 3 years
- Participant without previous history of chickenpox, zoster and epidemic encephalitis B
- Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures
- Body temperature ≤ 37.5℃
Key exclusion criteria (13 listed)
- Known allergy to any constituent of the vaccine
- Known acute illness, severe chronic disease, acute exacerbation of chronic disease and fever
- Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth
- Reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction
- Failed to the Expanded Programme on Immunization(EPI)
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 |
|---|---|---|
| Live Attenuated Varicella Vaccine + Live Attenuated JE Vaccine | Biological | Live Attenuated Varicella Vaccine + Live Attenuated JE Vaccine |
| Live Attenuated Varicella Vaccine | Biological | Live Attenuated Varicella Vaccine |
| live attenuated JE vaccine | Biological | Live Attenuated JE Vaccine |
Primary outcome
Seroconversion rate and GMTs for live attenuated varicella vaccine, live attenuated JE vaccine and live attenuated varicella vaccine combined with live attenuated JE vaccine, respectively.
Time frame: 35-42 days after vaccination
1 secondary outcome
Occurrence of adverse events.
Time frame: within 30 days after each 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 24 Feb 2014.
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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.
Zheng Huizhen, Master principal investigator
Guangdong Center for Disease Prevention and Control
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Live Attenuated Varicella Vaccine + Live Attenuated JE Vaccine, Live Attenuated Varicella Vaccine and live attenuated JE vaccine in people with Japanese Encephalitis and Chickenpox, run by Changchun Keygen Biological Products Co., Ltd. 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 13 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 24 Feb 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 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 and GMTs for live attenuated varicella vaccine, live attenuated JE vaccine and live attenuated varicella vaccine combined with live attenuated JE vaccine, respectively. (time frame: 35-42 days after vaccination). 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 24 Feb 2014.