ChickenpoxPhase 4NCT01982409
Immune Persistence After Inoculated With One-dose Freeze-Dried Live Attenuated Varicella Vaccine in Children Vaccine in Children
A Phase 4 study testing Live Attenuated Varicella Vaccine in people with Chickenpox, run by Changchun Changsheng Life Science and Technology Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to observe the persistence of protection, duration of protection, safety and breakthrough infection rates afforded by live attenuated varicella vaccine in children over a 5-year period. Read more about this study
- Who is it for?
- Ages 1 year to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Chickenpox
- What is being tested?
- Live Attenuated Varicella Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteChina
- Study dates
- Jun 2013to Dec 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 1 year to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participant are healthy children aged 1-6 years, who has inquired for medical history and physical examination, and met the requirement of the vaccine trial
- Parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent
- Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures
- Body temperature ≤37℃
Who cannot join
- Participant with previous history of chickenpox or zoster
- Receipt of varicella vaccine
- Reported the family history of allergies, convulsions, epilepsy and mental illness
- Known allergy to any constituent of the vaccine
- Known serve illness, in a fever, acute infection and chronic disease activity
- Receipt of steroid
Show all 14Show fewer
- Reported the history of thrombocytopenia or other coagulation disorders, which may cause
- Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth
- Known congenital malformation, developmental disorders and severe chronic disease (e.g. Down's syndrome, diabetes, sickle cell anemia and neurologic disorders)
- Known dermatopathy with allergy, herpes, fester, and fungal infection
- Receipt of whole blood, blood plasma or immunoglobulin in the 3 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
- Participant with fever(temperature≥ 38℃) in the days
- Any condition, which, in the opinion of the investigator, would pose a health risk to the subject
Trial locations and contacts
1 site in 1 country.
China1 site
Maoming Center for Disease Control and Prevention
Maoming, Guangdong
About this study
Official title: A Study of Immune Persistence After Inoculated With One-dose Freeze-dried Live Attenuated Varicella Vaccine in Children Aged 1-6 Years
The purpose of this study is to observe the persistence of protection, duration of protection, safety and breakthrough infection rates afforded by live attenuated varicella vaccine in children over a 5-year period.
- Conditions
- Chickenpox
- Being tested
- Live Attenuated 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.
Live Attenuated Varicella VaccineBiological
| Study group | Role | What they receive |
|---|---|---|
| Live Attenuated Varicella Vaccine | Experimental | use the 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune protective effect and persistence after inoculated with live attenuated varicella vaccine
Clinical subjects are drawn 3ml's vein blood，respectively before vaccination, six weeks and every year in 5 years study period after inoculation of the live varicella vaccine. FAMA methods are used to test antibody rate of pox virus.
Measured: Before vaccination, six weeks and every year in 5 years study period after inoculation of the live varicella vaccine
Secondary outcomes (2)
Breakthrough rate, duration and severity of varicella in vaccinated children
Measured: 5 years period
Occurrence of adverse events
Measured: Up to 4 weeks after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study startJun 2013
- Primary completionJan 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChickenpoxStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changchun Changsheng Life Science and Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Guangdong Provincial Institute of Biological Products And Materia Medica
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01982409
- Sponsor's protocol ID
- NCT02038508
- Status last verified
- Mar 2014
- First submitted
- 24 Oct 2013
- Last updated
- 27 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Immune Persistence After Inoculated With One-dose Freeze-dried Live Attenuated Varicella Vaccine in Children Aged 1-6 Years
- ClinicalTrials.gov ID
- NCT01982409
- Acronym / sponsor ID
- NCT02038508
- Conditions
- Chickenpox
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Changchun Changsheng Life Science and Technology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Guangdong Provincial Institute of Biological Products And Materia Medica
- Study start
- Jun 2013
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 13 Nov 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 persistence of protection, duration of protection, safety and breakthrough infection rates afforded by live attenuated varicella vaccine in children over a 5-year period.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Live Attenuated Varicella Vaccine | Experimental | Biological: Live Attenuated Varicella Vaccineuse the 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 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Participant are healthy children aged 1-6 years, who has inquired for medical history and physical examination, and met the requirement of the vaccine trial
- Parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent
- Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures
- Body temperature ≤37℃
Key exclusion criteria (14 listed)
- Participant with previous history of chickenpox or zoster
- Receipt of varicella vaccine
- Reported the family history of allergies, convulsions, epilepsy and mental illness
- Known allergy to any constituent of the vaccine
- Known serve illness, in a fever, acute infection and chronic disease activity
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 | Live Attenuated Varicella Vaccine |
Primary outcome
Immune protective effect and persistence after inoculated with live attenuated varicella vaccine
Time frame: Before vaccination, six weeks and every year in 5 years study period after inoculation of the live varicella vaccine
Clinical subjects are drawn 3ml's vein blood，respectively before vaccination, six weeks and every year in 5 years study period after inoculation of the live varicella vaccine. FAMA methods are used to test antibody rate of pox virus.
2 secondary outcomes
Breakthrough rate, duration and severity of varicella in vaccinated children
Time frame: 5 years period
Occurrence of adverse events
Time frame: Up to 4 weeks after vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Chickenpox, run by Changchun Changsheng Life Science and Technology 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 4 inclusion and 14 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 27 Mar 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?
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?
Immune protective effect and persistence after inoculated with live attenuated varicella vaccine (time frame: Before vaccination, six weeks and every year in 5 years study period after inoculation of the live varicella vaccine). 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 27 Mar 2014.