ChickenpoxPhase 4NCT01684072
Safety and Immunogenicity Study of Live Attenuated Vaccine Against Varicella Without Gelatin
A Phase 4 study testing vaccine without gelatin and vaccine with gelatin in people with Chickenpox and Zoster, run by Beijing Center for Disease Control and Prevention at 3 sites in China.
Trial summary
The purpose of this study is to observe the occurrence of adverse reaction and antibody positive rate, the elevated level of antibody，Geometric mean titer (GMT) between groups of live attenuated varicella vaccine without gelatin. Read more about this study
- Who is it for?
- Ages 1 year to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Chickenpox, Zoster
- What is being tested?
- vaccine without gelatin and vaccine with gelatin
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 3 sitesChina
- Study dates
- Jan 2011to Jan 2012
- 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
- Parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent
- Participant is considered to be in good health including the body and mental status on the basis of reported medical history and limited physical examination and live in local ≥ 12 months
- Participant is aged ≥ 1 year to ≤ 12 years
- Body temperature ≤ 37.0℃
- Participant without preventive inoculation of varicella vaccine and previous history of chickenpox and zoster
Who cannot join
- Known allergy to any constituent of the vaccine
- Reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction
- Known bleeding disorder
- Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth
- Participation in any other interventional clinical trial
- An acute illness with or without fever (temperature > 37.0℃) in the latest week preceding enrollment in the trial
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- Inoculated other vaccines, immunoglobulin or investigational drugs within 4 weeks prior to participation in the study
- Reported clearly the infection of the upper respiratory tract with 6 months
- Clinical Manifestation of Metabolic, blood system, lungs, heart, the gastrointestinal tract, nervous system, kidneys, urinary system, endocrine, liver disease or malignant tumor
- Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine
Trial locations and contacts
3 sites in 1 country.
China3 sites
Jiuyuan Center for Disease Control and Prevention
Baotou, Inner Mongolia
Chaoyang District Center for Disease Control and Prevention
Beijing, Beijing Municipality
Sanhe Center for Disease Control and Prevention
Langfang, Hebei
About this study
Official title: Evaluation of Safety and Immunogenicity Receiving Live Attenuated Vaccine Against Varicella Without Gelatin
The purpose of this study is to observe the occurrence of adverse reaction and antibody positive rate, the elevated level of antibody，Geometric mean titer (GMT) between groups of live attenuated varicella vaccine without gelatin.
Read the detailed description
Observational Objectives:
To describe the safety of evaluated vaccine, in children aged ≥ 1th birthday and ≤ 12th birthday.
To describe the immunogenicity of evaluated vaccine, in children aged ≥ 1th birthday and ≤ 12th birthday.
- Conditions
- Chickenpox, Zoster
- Being tested
- vaccine without gelatin, vaccine with gelatin
- Keywords
- varicella vaccine, gelatin
- Medical subject headings
- Chickenpox, Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaccine without gelatinBiological
use the upper arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection
vaccine with gelatinBiological
use the upper arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection
| Study group | Role | What they receive |
|---|---|---|
| vaccine without gelatin | Experimental | use the upper arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection Receives: Biological: vaccine without gelatin; Biological: vaccine with gelatin |
| vaccine with gelatin | Active comparator | use the upper arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection Receives: Biological: vaccine without gelatin; Biological: vaccine with gelatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the immunogenicity of evaluated vaccine
The immunologic equivalence of 4weeks after vaccination of influenza virus vaccine was measured in terms of the level of antibody.
Measured: 8 months
Secondary outcomes (1)
To evaluate the safety of live attenuated varicella vaccine
The incidence of adverse events was analyzed statistically.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2012 (estimated)
- Study startJan 2011
- Primary completionSep 2011
- Study completionJan 2012
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,200 participants (actual)
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 Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01684072
- Sponsor's protocol ID
- BJCDPC-2
- Status last verified
- Sep 2012
- First submitted
- 9 Sep 2012
- Last updated
- 12 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Immunogenicity Receiving Live Attenuated Vaccine Against Varicella Without Gelatin
- ClinicalTrials.gov ID
- NCT01684072
- Acronym / sponsor ID
- BJCDPC-2
- Conditions
- Chickenpox, Zoster
- Keywords
- varicella vaccine, gelatin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Beijing Center for Disease Control and PreventionOther government
- Study start
- Jan 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 12 Sep 2012 (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 reaction and antibody positive rate, the elevated level of antibody，Geometric mean titer (GMT) between groups of live attenuated varicella vaccine without gelatin.
Detailed description
Observational Objectives:
To describe the safety of evaluated vaccine, in children aged ≥ 1th birthday and ≤ 12th birthday.
To describe the immunogenicity of evaluated vaccine, in children aged ≥ 1th birthday and ≤ 12th birthday.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vaccine without gelatin | Experimental | Biological: vaccine without gelatin, Biological: vaccine with gelatinuse the upper arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection |
| vaccine with gelatin | Active comparator | Biological: vaccine without gelatin, Biological: vaccine with gelatinuse the upper 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 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent
- Participant is considered to be in good health including the body and mental status on the basis of reported medical history and limited physical examination and live in local ≥ 12 months
- Participant is aged ≥ 1 year to ≤ 12 years
- Body temperature ≤ 37.0℃
- Participant without preventive inoculation of varicella vaccine and previous history of chickenpox and zoster
Key exclusion criteria (10 listed)
- Known allergy to any constituent of the vaccine
- Reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction
- Known bleeding disorder
- Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth
- Participation in any other interventional clinical trial
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 |
|---|---|---|
| vaccine without gelatinuse the upper arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection | Biological | vaccine with gelatin, vaccine without gelatin |
| vaccine with gelatinuse the upper arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection | Biological | vaccine with gelatin, vaccine without gelatin |
Primary outcome
To evaluate the immunogenicity of evaluated vaccine
Time frame: 8 months
The immunologic equivalence of 4weeks after vaccination of influenza virus vaccine was measured in terms of the level of antibody.
1 secondary outcome
To evaluate the safety of live attenuated varicella vaccine
Time frame: 4 months
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 12 Sep 2012.
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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 study chair
Beijing Chaoyang District Center for Disease Control and Prevention
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing vaccine without gelatin and vaccine with gelatin in people with Chickenpox and Zoster, run by Beijing Center for Disease Control and Prevention at 3 sites 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 10 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 12 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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?
To evaluate the immunogenicity of evaluated vaccine (time frame: 8 months). 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 12 Sep 2012.