VaricoceleNCT02983656
Analysis on AEFI Surveillance Data for Live Attenuated Varicella Vaccine
An observational study of Varicocele, run by Zhejiang Provincial Center for Disease Control and Prevention.
Trial summary
The purpose of this study is to observe the occurrence of adverse events of live attenuated varicella vaccine. Read more about this study
- Who is it for?
- Ages 1 year to 15 years
- Conditions the study is for
- Varicocele
- What is being tested?
- live attenuated varicella vaccine
- Type of treatment
- Vaccines
- How many people
- 394 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to 31 Aug 2017
- Phase
- Observational
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Participant preventive inoculation of varicella vaccine in 2014-2015
Who may be able to join
- The registered permanent residence or resident place are local (reside more than 3 months);
- Participant preventive inoculation of varicella vaccine in 2014-2015;
- Adverse reactions occurred and should be reported in the AEFI monitoring system.
Who cannot join
- Subjects with a known allergy to any ingredient of the vaccine, and with any allergy history to any vaccine;
- Subjects with any acute diseases, severe chronic diseases, acute bout of chronic diseases, and catching cold and fever;
- Subjects with uncontrolled seizures and other progressive neurological diseases, with a history of Guillain-Barré syndrome.
About this study
The purpose of this study is to observe the occurrence of adverse events of live attenuated varicella vaccine.
- Conditions
- Varicocele
- Being tested
- live attenuated varicella vaccine
- Keywords
- Vaccine Safety
- Medical subject headings
- Varicocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
live attenuated varicella vaccineBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of adverse reactions
Measured: 1 year after the first and second doses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study startNov 2016
- Primary completion31 Aug 2017
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaricoceleStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 394 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Provincial Center for Disease Control and Prevention
- Sponsor type
- Other government
- Collaborators
- Changchun Keygen Biological Products Co., Ltd.
- Responsible party
- Principal investigator, Qian Li, Zhejiang Provincial Center for Disease Control and Prevention
- Investigators
- Qian Li, Bachelor, Principal investigator, Zhejiang Provincial Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02983656
- Sponsor's protocol ID
- ZJCDC20161121
- Status last verified
- Jan 2018
- First submitted
- 1 Dec 2016
- Last updated
- 11 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis on AEFI Surveillance Data for Live Attenuated Varicella Vaccine
- ClinicalTrials.gov ID
- NCT02983656
- Acronym / sponsor ID
- ZJCDC20161121
- Conditions
- Varicocele
- Keywords
- Vaccine Safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 394 participants (actual)
- Lead sponsor
- Zhejiang Provincial Center for Disease Control and PreventionOther government
- Collaborators
- Changchun Keygen Biological Products Co., Ltd.
- Study start
- Nov 2016
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 6 Dec 2016 (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 of live attenuated varicella vaccine.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Participant preventive inoculation of varicella vaccine in 2014-2015
Key inclusion criteria (3 listed)
- The registered permanent residence or resident place are local (reside more than 3 months);
- Participant preventive inoculation of varicella vaccine in 2014-2015;
- Adverse reactions occurred and should be reported in the AEFI monitoring system.
Key exclusion criteria (3 listed)
- Subjects with a known allergy to any ingredient of the vaccine, and with any allergy history to any vaccine;
- Subjects with any acute diseases, severe chronic diseases, acute bout of chronic diseases, and catching cold and fever;
- Subjects with uncontrolled seizures and other progressive neurological diseases, with a history of Guillain-Barré syndrome.
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 | Biological | – |
Primary outcome
incidence of adverse reactions
Time frame: 1 year after the first and second doses
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 11 Jan 2018.
- Individual participant dataSharing planned: No
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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.
Qian Li, Bachelor principal investigator
Zhejiang Provincial Center for Disease Control and Prevention
Questions about this trial
What is this clinical trial studying?
An observational study of Varicocele, run by Zhejiang Provincial Center for Disease Control and Prevention.
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 3 inclusion and 3 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 11 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
incidence of adverse reactions (time frame: 1 year after the first and second doses). 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 11 Jan 2018.