VaricellaPhase 4NCT02146469
Study on Effectiveness of 2-dose Live Attenuated Varicella Vaccine
A Phase 4 study testing 2 doses with an 3 months interval, A second dose with an 1 year interval and A second dose with an 3 year interval in people with Varicella, run by Shanghai Municipal Center for Disease Control and Prevention at 1 site in China.
Trial summary
The objective of the study is as follows: 1. To know the antibody level during different interval after received 1 dose varicella vaccine. 2. To know safety and effectiveness of received 2 doses varicella vaccine with different interval. 3. Read more about this study
- Who is it for?
- Ages 1 year to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Varicella
- What is being tested?
- 2 doses with an 3 months interval, A second dose with an 1 year interval and A second dose with an 3 year interval
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- Dec 2012to Dec 2014
- 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 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged 1 to 7
- Without a previous history of varicella
- With an axillary temperature ≤37.5℃ at the time of vaccination
- Appropriate varicella vaccination history
- With guardian signing the informed consent and available for clinical observation
Who cannot join
- Hypersensitive to any active substance of the vaccine including excipients and antibiotics
- With acute illness, severe or acute attack of chronic illness or fever
- With immunodeficiency or weakened immune system or being treated with immunosuppressant drugs
- Suffering a brain disease, uncontrolled epilepsy or progressive nerve system disease
- With a family or personal history of seizure, chronic illness, epilepsy or allergy
- With unknown immunization history or unable to follow the immunization schedule of EPI
Show all 13Show fewer
- Received any vaccine within 4 weeks or willing to receive any vaccine in 1 month
- With hemorrhagic tendency or prolonged period of bleeding
- Received whole blood, plasma or immunoglobulin within 5 months
- Received systemic antibiotics or antiviral treatment for acute illness within 7 days
- With an axillary temperature ≥38℃ within 3 days
- Participating in another clinical trial
- Any situation that might influence the consequence of the clinical trial
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai municipal center for disease control and prevention
Shanghai, Shanghai Municipality, 021
About this study
The objective of the study is as follows:
- To know the antibody level during different interval after received 1 dose varicella vaccine.
- To know safety and effectiveness of received 2 doses varicella vaccine with different interval.
- To know safety and effectiveness of received varicella vaccine and MMR at the same time.
To achieve that, this study selects children with specific varicella vaccine history, gives 1 or 2 doses varicella vaccine, collects blood specimens and makes a follow-up visit after vaccination.
All blood specimens will be tested by a third-party detection institution.
- Conditions
- Varicella
- Being tested
- 2 doses with an 3 months interval, A second dose with an 1 year interval, A second dose with an 3 year interval, A second dose with an 5 year interval, 1 dose Varicella vaccine and 1 dose MMR given at the same time
- Keywords
- varicella vaccination
- Medical subject headings
- Chickenpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 doses with an 3 months intervalBiological
varicella vaccination
A second dose with an 1 year intervalBiological
varicella vaccine
A second dose with an 3 year intervalBiological
varicella vaccine
A second dose with an 5 year intervalBiological
varicella vaccine
1 dose Varicella vaccine and 1 dose MMR given at the same timeBiological
varicella vaccine and MMR
1 dose MMRBiological
MMR
| Study group | Role | What they receive |
|---|---|---|
| None varicella vaccine history | Experimental | 2 doses with an 3 months interval Receives: Biological: 2 doses with an 3 months interval |
| 1 year after first dose | Experimental | A second dose with an 1 year interval Receives: Biological: A second dose with an 1 year interval |
| 3 years after first dose | Experimental | A second dose with an 3 year interval Receives: Biological: A second dose with an 3 year interval |
| 5 years after first dose | Experimental | A second dose with an 5 year interval Receives: Biological: A second dose with an 5 year interval |
| Testing group for conbined immunization | Experimental | 1 dose Varicella vaccine and 1 dose MMR given at the same time Receives: Biological: 1 dose Varicella vaccine and 1 dose MMR given at the same time |
| Control group for conbined immunization | Placebo comparator | 1 dose MMR Receives: Biological: 1 dose MMR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion rate and GMCs after varicella vaccination
Measured: 35-42 days after each dose vaccination
Secondary outcomes (1)
The incidence of Adverse Events Following Immunization
Measured: 30 days after each dose vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2014 (estimated)
- Study startDec 2012
- Primary completionJun 2014 (estimated)
- Study completionDec 2014 (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
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Municipal Center for Disease Control and Prevention
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Institute Of Biological Products
- Responsible party
- Sponsor
- Investigators
- Xiaodong Sun, Study director, Shanghai Municipal Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02146469
- Sponsor's protocol ID
- SH2012VAR
- Status last verified
- May 2014
- First submitted
- 21 May 2014
- Last updated
- 23 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Effectiveness of 2-dose Live Attenuated Varicella Vaccine
- ClinicalTrials.gov ID
- NCT02146469
- Acronym / sponsor ID
- SH2012VAR
- Conditions
- Varicella
- Keywords
- varicella vaccination
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Shanghai Municipal Center for Disease Control and PreventionUniversity, hospital or other
- Collaborators
- Shanghai Institute Of Biological Products
- Study start
- Dec 2012
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 23 May 2014 (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 objective of the study is as follows:
- To know the antibody level during different interval after received 1 dose varicella vaccine.
- To know safety and effectiveness of received 2 doses varicella vaccine with different interval.
- To know safety and effectiveness of received varicella vaccine and MMR at the same time.
To achieve that, this study selects children with specific varicella vaccine history, gives 1 or 2 doses varicella vaccine, collects blood specimens and makes a follow-up visit after vaccination.
All blood specimens will be tested by a third-party detection institution.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| None varicella vaccine history | Experimental | Biological: 2 doses with an 3 months interval2 doses with an 3 months interval |
| 1 year after first dose | Experimental | Biological: A second dose with an 1 year intervalA second dose with an 1 year interval |
| 3 years after first dose | Experimental | Biological: A second dose with an 3 year intervalA second dose with an 3 year interval |
| 5 years after first dose | Experimental | Biological: A second dose with an 5 year intervalA second dose with an 5 year interval |
| Testing group for conbined immunization | Experimental | Biological: 1 dose Varicella vaccine and 1 dose MMR given at the same time1 dose Varicella vaccine and 1 dose MMR given at the same time |
| Control group for conbined immunization | Placebo comparator | Biological: 1 dose MMR1 dose MMR |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Aged 1 to 7
- Without a previous history of varicella
- With an axillary temperature ≤37.5℃ at the time of vaccination
- Appropriate varicella vaccination history
- With guardian signing the informed consent and available for clinical observation
Key exclusion criteria (13 listed)
- Hypersensitive to any active substance of the vaccine including excipients and antibiotics
- With acute illness, severe or acute attack of chronic illness or fever
- With immunodeficiency or weakened immune system or being treated with immunosuppressant drugs
- Suffering a brain disease, uncontrolled epilepsy or progressive nerve system disease
- With a family or personal history of seizure, chronic illness, epilepsy or allergy
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 |
|---|---|---|
| 2 doses with an 3 months intervalvaricella vaccination | Biological | None varicella vaccine history |
| A second dose with an 1 year intervalvaricella vaccine | Biological | 1 year after first dose |
| A second dose with an 3 year intervalvaricella vaccine | Biological | 3 years after first dose |
| A second dose with an 5 year intervalvaricella vaccine | Biological | 5 years after first dose |
| 1 dose Varicella vaccine and 1 dose MMR given at the same timevaricella vaccine and MMR | Biological | Testing group for conbined immunization |
| 1 dose MMRMMR | Biological | Control group for conbined immunization |
Primary outcome
Seroconversion rate and GMCs after varicella vaccination
Time frame: 35-42 days after each dose vaccination
1 secondary outcome
The incidence of Adverse Events Following Immunization
Time frame: 30 days after each dose vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 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.
Xiaodong Sun study director
Shanghai Municipal Center 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 2 doses with an 3 months interval, A second dose with an 1 year interval and A second dose with an 3 year interval in people with Varicella, run by Shanghai Municipal 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 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: status not confirmed, as of the sponsor's last update on 23 May 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. 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?
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 GMCs after varicella vaccination (time frame: 35-42 days after each dose 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 23 May 2014.