VaricellaPhase 4NCT01830283
The Safety, Immunogenicity and Immune Effect Research of the Varicella Vaccine After the 2nd Dose Vaccination
A Phase 4 study testing varicella vaccine in people with Varicella, run by Beijing Center for Disease Control and Prevention at 1 site in China.
Trial summary
To investigate the safety, immunogenicity and immune effect of the Varicella vaccine after the 2nd dose vaccination in Chao yang district, Bei jing, since the 2nd varicella vaccination was promoted by Beijing Center for Disease Control and Prevention in November, 2012. Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Varicella
- What is being tested?
- varicella vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50,000 participants
- Where
- 1 siteChina
- Study dates
- Apr 2013to Apr 2018
- 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 4 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participants were between 4-12 years old
- Participants were in good healthy determined through medical history, physical examination, clinical judgment of the investor
Who cannot join
- Having a fever (axillary temperature >37.0℃) before enrollment;
- Having a disease history of seizures, brain and mental disease and the vaccination history of allergies and convulsions;
- Antibiotics allergy;
- Having a problem of intramuscular injection because thrombocytopenia or other blood coagulation disorder;
- Having immunodeficiency or under immunosuppression therapy, radiation therapy;
- Having respiratory diseases, acute infection, chronic disease and HIV infection;
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- Having systemic skin rash, skin tinea, herpes;
- Chronic liver and kidney disease;
- Heart disease, and severe hypertension;
- Have received whole blood, plasma or immunoglobulin therapy 3 months before enrollment;
- Have not received other vaccination in 7 days before enrollment
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Chaoyang District Centers for Disease Control and Prevention
Beijing
About this study
Official title: Phase 4 Study of the Varicella Vaccine After the 2nd Dose Vaccination
To investigate the safety, immunogenicity and immune effect of the Varicella vaccine after the 2nd dose vaccination in Chao yang district, Bei jing, since the 2nd varicella vaccination was promoted by Beijing Center for Disease Control and Prevention in November, 2012.
Read the detailed description
"Breakthrough" varicella cases and varicella cases were monitored to evaluate the protective effective in a large population.
Make the basic evaluation of safety for the two dose of varicella vaccination
Monitoring the Varicella virus origin and virus types from illness cases in Chao yang district
Make the evaluation of healthy costs reduce for the varicella emergency vaccination after large number of varicella cases occurred.
- Conditions
- Varicella
- Being tested
- varicella vaccine
- Medical subject headings
- Chickenpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
varicella vaccineBiological
The providers would get varicella vaccine
| Study group | Role | What they receive |
|---|---|---|
| 1 dose varicella vaccine | Active comparator | The providers would get the 2nd dose since they had one dose varicella vaccine Receives: Biological: varicella vaccine |
| 2 dose varicella vaccine | Experimental | The provider never get the varicella vaccine Receives: Biological: varicella vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of varicella after 2 dose vaccination
Detection the Varicella virus origin and virus types from illness cases in Chao yang district
Measured: 5 years
Secondary outcomes (1)
Adverse event rate of varicella vaccine after 2 dose injection
Adverse event rate of varicella vaccine after 2 dose injection
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionJun 2013 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaricellaStudies 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
- 50,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Center for Disease Control and Prevention
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Nianmin Shi, Principal investigator, Beijing Chaoyang District Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01830283
- Sponsor's protocol ID
- BJCDPC-8
- Status last verified
- Apr 2013
- First submitted
- 3 Apr 2013
- Last updated
- 29 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of the Varicella Vaccine After the 2nd Dose Vaccination
- ClinicalTrials.gov ID
- NCT01830283
- Acronym / sponsor ID
- BJCDPC-8
- Conditions
- Varicella
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- Beijing Center for Disease Control and PreventionOther government
- Study start
- Apr 2013
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 12 Apr 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.
To investigate the safety, immunogenicity and immune effect of the Varicella vaccine after the 2nd dose vaccination in Chao yang district, Bei jing, since the 2nd varicella vaccination was promoted by Beijing Center for Disease Control and Prevention in November, 2012.
Detailed description
"Breakthrough" varicella cases and varicella cases were monitored to evaluate the protective effective in a large population.
Make the basic evaluation of safety for the two dose of varicella vaccination
Monitoring the Varicella virus origin and virus types from illness cases in Chao yang district
Make the evaluation of healthy costs reduce for the varicella emergency vaccination after large number of varicella cases occurred.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 dose varicella vaccine | Active comparator | Biological: varicella vaccineThe providers would get the 2nd dose since they had one dose varicella vaccine |
| 2 dose varicella vaccine | Experimental | Biological: varicella vaccineThe provider never get the varicella vaccine |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Participants were between 4-12 years old
- Participants were in good healthy determined through medical history, physical examination, clinical judgment of the investor
Key exclusion criteria (11 listed)
- Having a fever (axillary temperature >37.0℃) before enrollment;
- Having a disease history of seizures, brain and mental disease and the vaccination history of allergies and convulsions;
- Antibiotics allergy;
- Having a problem of intramuscular injection because thrombocytopenia or other blood coagulation disorder;
- Having immunodeficiency or under immunosuppression therapy, radiation therapy;
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 |
|---|---|---|
| varicella vaccineThe providers would get varicella vaccine | Biological | 1 dose varicella vaccine, 2 dose varicella vaccine |
Primary outcome
Incidence of varicella after 2 dose vaccination
Time frame: 5 years
Detection the Varicella virus origin and virus types from illness cases in Chao yang district
1 secondary outcome
Adverse event rate of varicella vaccine after 2 dose injection
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2013.
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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.
Nianmin Shi principal investigator
Beijing Chaoyang District Centers for Disease Control and Prevention
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 varicella vaccine in people with Varicella, run by Beijing Center 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 2 inclusion and 11 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 29 May 2013. 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?
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?
Incidence of varicella after 2 dose vaccination (time frame: 5 years). 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 29 May 2013.