VaricellaPhase 4NCT01866566
The Safety and Immunogenicity Research of Live Attenuated Varicella Vaccine After the 2 Doses Vaccination
A Phase 4 study testing HBV-3, HBV-6 and varicella-3 in people with Varicella, run by Beijing Center for Disease Control and Prevention at 1 site in China.
Trial summary
Through evaluating the immunogenicity and safety for Varicella vaccine two doses immune procedure we could supply scientific and practical evidence for this two doses immune procedure promotion and management. Read more about this study
- Who is it for?
- Ages 1 year to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Varicella
- What is being tested?
- HBV-3, HBV-6 and varicella-3
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,800 participants
- Where
- 1 siteChina
- Study dates
- Jun 2013to Jan 2016
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- -Participants from Shanxi province are between 1-12 years old are in good healthy determined through medical inquiry, 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 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 received other live attenuated vaccine vaccination in 30 days before enrollment;
- Had been infected with Varicella virus and displayed symptom;
- Have received one or two dose of Varicella vaccine before enrollment;
- Congenital malformations, growth disorders such as Down's syndrome, diabetes, sickle cell anemia and nervous disorders
- Guillain-barre syndrome
- Thyroid resection history or thyroid disease treatment in the past 12 months;
- Asthma
- Have participated in other clinical research;
- Have serious adverse reactions after vaccination, such as allergies, hives, breathing difficulties, angioneurotic edema.
Trial locations and contacts
1 site in 1 country.
Li Li contact
China1 site, 1 recruiting
- Recruiting
Shanxi Centers for Disease Control and Prevention
Yuncheng, Shanxi
Li
Guohua Li
About this study
Official title: Phase 4 Study of Live Attenuated Varicella Vaccine After the 2 Doses Vaccination
Through evaluating the immunogenicity and safety for Varicella vaccine two doses immune procedure we could supply scientific and practical evidence for this two doses immune procedure promotion and management.
Read the detailed description
Healthy participants aged 1 to 12 years old who had never received Varicella Vaccine are divided into three age groups, 1 to 3 years old group, 4 to 6 years old group and 7-12 years old group. In each age group, participants are randomly divided into experiment group and control groups.
- Conditions
- Varicella
- Being tested
- HBV-3, HBV-6, varicella-3, varicella-6
- Medical subject headings
- Chickenpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBV-3Biological
Give a single 0.5 mL HBV and get blood samples at 0,1.5,4.5 month
HBV-6Biological
Give a single 0.5 mL HBV and get blood samples at 0,1.5,7.5 month
varicella-3Biological
Give 2 doses varicella vaccine (a single 0.5 mL) and get blood samples at 0,1.5,4.5 month
varicella-6Biological
Give 2 doses varicella vaccine (a single 0.5 mL) and get blood samples at 0,1.5,7.5 month
| Study group | Role | What they receive |
|---|---|---|
| HBV-3 | Placebo comparator | one dose HBV Receives: Biological: HBV-3 |
| HBV-6 | Placebo comparator | one dose HBV Receives: Biological: HBV-6 |
| varicella-3 | Experimental | 2 doses varicella vaccine either BCHT or Kengen and 3 month of the interval time Receives: Biological: varicella-3 |
| varicella-6 | Experimental | 2 doses varicella vaccine either BCHT or Kengen and 6 month of the interval time Receives: Biological: varicella-6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody titer after 2 doses lived attenuated varicella vaccination
Serums are collected from all participants before and 42 days after the first vaccination, and also 42 days after the second vaccination. The antibody titer to Varicella was detected through FAMA test.
Measured: 1 year
Secondary outcomes (1)
Number of participants who have adverse reaction
The safety is evaluated by systemic and local reaction after each vaccination.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2013 (estimated)
- Study startJun 2013
- Primary completionJan 2014 (estimated)
- Study completionJan 2016 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Center for Disease Control and Prevention
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Nianmin Shi, Study chair, Beijing Chaoyang District Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01866566
- Sponsor's protocol ID
- BJCDPC-9
- Status last verified
- May 2013
- First submitted
- 28 May 2013
- Last updated
- 26 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Live Attenuated Varicella Vaccine After the 2 Doses Vaccination
- ClinicalTrials.gov ID
- NCT01866566
- Acronym / sponsor ID
- BJCDPC-9
- Conditions
- Varicella
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Beijing Center for Disease Control and PreventionOther government
- Study start
- Jun 2013
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 31 May 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.
Through evaluating the immunogenicity and safety for Varicella vaccine two doses immune procedure we could supply scientific and practical evidence for this two doses immune procedure promotion and management.
Detailed description
Healthy participants aged 1 to 12 years old who had never received Varicella Vaccine are divided into three age groups, 1 to 3 years old group, 4 to 6 years old group and 7-12 years old group. In each age group, participants are randomly divided into experiment group and control groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HBV-3 | Placebo comparator | Biological: HBV-3one dose HBV |
| HBV-6 | Placebo comparator | Biological: HBV-6one dose HBV |
| varicella-3 | Experimental | Biological: varicella-32 doses varicella vaccine either BCHT or Kengen and 3 month of the interval time |
| varicella-6 | Experimental | Biological: varicella-62 doses varicella vaccine either BCHT or Kengen and 6 month of the interval time |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- -Participants from Shanxi province are between 1-12 years old are in good healthy determined through medical inquiry, physical examination, clinical judgment of the investor.
Key exclusion criteria (19 listed)
- Having a fever (axillary temperature>37.0℃) before enrollment;
- Having a disease history of seizures, brain 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 |
|---|---|---|
| HBV-3Give a single 0.5 mL HBV and get blood samples at 0,1.5,4.5 month | Biological | HBV-3 |
| HBV-6Give a single 0.5 mL HBV and get blood samples at 0,1.5,7.5 month | Biological | HBV-6 |
| varicella-3Give 2 doses varicella vaccine (a single 0.5 mL) and get blood samples at 0,1.5,4.5 month | Biological | varicella-3 |
| varicella-6Give 2 doses varicella vaccine (a single 0.5 mL) and get blood samples at 0,1.5,7.5 month | Biological | varicella-6 |
Primary outcome
Antibody titer after 2 doses lived attenuated varicella vaccination
Time frame: 1 year
Serums are collected from all participants before and 42 days after the first vaccination, and also 42 days after the second vaccination. The antibody titer to Varicella was detected through FAMA test.
1 secondary outcome
Number of participants who have adverse reaction
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 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.
Li Li contact
Nianmin Shi study chair
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 HBV-3, HBV-6 and varicella-3 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 1 inclusion and 19 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 26 Jun 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. Some participants in this study may receive a placebo. 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?
Contact Nianmin Shi (86-010-67773550, cycdc2011@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibody titer after 2 doses lived attenuated varicella vaccination (time frame: 1 year). 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 26 Jun 2013.