MeaslesPhase 4NCT03160820
Study on Immunization Schedule of Beijing Tiantan Biological's Measles-mumps-rubella(MMR) Vaccine
A Phase 4 study testing Measles, mumps and rubella Combined Vaccine, Live in people with Measles and Mumps, run by Centers for Disease Control and Prevention, China at 4 sites in China.
Trial summary
This study will evaluate the immunogenicity and safety of Beijing Tiantan's MMR vaccine in subjects 18 months of age and older. The MMR vaccine may be administered as a second dose to 4-6 year-old persons with one dose immunization with MMR vaccine or as a first dose to 18 month-old subjects with one dose immunization… Read more about this study
- Who is it for?
- Ages 18 months to 6 yearsHealthy volunteers can take part
- What is being tested?
- Measles, mumps and rubella Combined Vaccine, Live
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 873 participants
- Where
- 4 sitesChina
- Study dates
- Mar 2016to Feb 2017
- 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 18 months to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- healthy children; 150 subjects 18 months old; 150 subjects 4 years old;300 subjects 5 years old; 150 subjects 6 years old; their guardians signed informed consent;
- undiagnosed as measles, mumps and rubella;
- in good health as determined by the outcome of medical history, physical examination and clinical judgment; suitable to MMR immunization;
- guardians would comply with the requirements of the protocol;
- immunized with MR or measles vaccine(MV) at 8 months old;immunized with MMR at 18 months old(not applicable to subjects 18 months old); unvaccinated by biological products within one month;
- Axillary temperature ≤37℃;
- the local household population or permanent population;
Who cannot join
- history of allergic disease or reactions likely to be exacerbated by any component of the vaccine(any previous vaccination history of allergies and egg allergy history);
- Current confirmed as acute disease, severe chronic diseases or acute development of chronic diseases;
- Participating in another clinical trial at the same time;
Trial locations and contacts
4 sites in 1 country.
China4 sites
Inner Mongolia Center for Disease Control and Prevention
Hohhot, Inner Mongolia, 010031
Hebei Provincial Center for Disease Control and Prevention
Shijiazhuang, Hebei, 050021
Shanxi Provincial Center for Disease Control and Prevention
Taiyuan, Shanxi, 030012
Tianjin Center for Disease Control and Prevention
Tianjin, Tianjin Municipality, 300011
About this study
Official title: Comparison of Immunization Schedules of Beijing Tiantan Biological's MMR Vaccine in 18-72 Month-Old Children
This study will evaluate the immunogenicity and safety of Beijing Tiantan's MMR vaccine in subjects 18 months of age and older. The MMR vaccine may be administered as a second dose to 4-6 year-old persons with one dose immunization with MMR vaccine or as a first dose to 18 month-old subjects with one dose immunization with measles-rubella(MR).
Read the detailed description
This study will evaluate the immunogenicity and safety of Beijing Tiantan's MMR vaccine in subjects 18 months of age and older.
The MMR vaccine may be administered as a second dose to 4-6 year-old persons with one dose immunization with MMR vaccine or as a first dose to 18 month-old subjects with one dose immunization with MR.
Immune efficacy and safety will be compared among different immunization schedules,including inoculation doses,enhanced immunity age,vaccination interval time.
Antibody persistence of 1 dose of MMR vaccine will be evaluated in this study.
- Conditions
- Measles, Mumps, Rubella, Adverse Event Following Immunisation
- Being tested
- Measles, mumps and rubella Combined Vaccine, Live
- Medical subject headings
- Measles, Mumps, Rubella
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measles, mumps and rubella Combined Vaccine, LiveBiological
Also called Beijing Tiantan Biological Products Co., Ltd
Subjects will be inoculated one dose of MMR vaccine and collected blood samples before and after vaccination.
| Study group | Role | What they receive |
|---|---|---|
| one dose of MMR | Other | Subjects are vaccinated with MMR(Measles, mumps and rubella Combined Vaccine, Live) on 18 months old. Receives: Biological: Measles, mumps and rubella Combined Vaccine, Live |
| 30 months after two doses of MMR | Other | Subjects are vaccinated two doses of MMR(Measles, mumps and rubella Combined Vaccine, Live) on 18 month and 4 years old, sequentially. Receives: Biological: Measles, mumps and rubella Combined Vaccine, Live |
| 42 months after two doses of MMR | Other | Subjects are vaccinated two doses of MMR(Measles, mumps and rubella Combined Vaccine, Live) on 18 month and 5 years old, sequentially. Receives: Biological: Measles, mumps and rubella Combined Vaccine, Live |
| 54 months after two doses of MMR | Other | Subjects are vaccinated two doses of MMR(Measles, mumps and rubella Combined Vaccine, Live) on 18 month and 6 years old, sequentially. Receives: Biological: Measles, mumps and rubella Combined Vaccine, Live |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity of the MMR vaccines in terms of antibody concentration
For measles virus, seroresponse is defined as post-vaccination anti-measles virus antibody concentration (Ab conc) >200 mIU/mL.
For mumps virus, seroresponse is defined as post-vaccination anti-mumps virus Ab conc >100 IU/mL.
For rubella virus, seroresponse is defined as post-vaccination anti-rubella virus Ab conc >20 IU/mL.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study startMar 2016
- Primary completionDec 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeaslesStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 873 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention, China
- Sponsor type
- Other government
- Collaborators
- Beijing Tiantan Biological Products Co., Ltd.
- Responsible party
- Principal investigator, Wu Jiang, Centers for Disease Control and Prevention, China
- Investigators
- Jiang Wu, Principal investigator, Beijing Center for Diseases Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03160820
- Sponsor's protocol ID
- BJCDCWJ201601
- Status last verified
- May 2017
- First submitted
- 10 May 2017
- Last updated
- 19 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Immunization Schedules of Beijing Tiantan Biological's MMR Vaccine in 18-72 Month-Old Children
- ClinicalTrials.gov ID
- NCT03160820
- Acronym / sponsor ID
- BJCDCWJ201601
- Conditions
- Measles, Mumps, Rubella, Adverse Event Following Immunisation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 873 participants (actual)
- Lead sponsor
- Centers for Disease Control and Prevention, ChinaOther government
- Collaborators
- Beijing Tiantan Biological Products Co., Ltd.
- Study start
- Mar 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 19 May 2017 (actual)
- 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.
This study will evaluate the immunogenicity and safety of Beijing Tiantan's MMR vaccine in subjects 18 months of age and older. The MMR vaccine may be administered as a second dose to 4-6 year-old persons with one dose immunization with MMR vaccine or as a first dose to 18 month-old subjects with one dose immunization with measles-rubella(MR).
Detailed description
This study will evaluate the immunogenicity and safety of Beijing Tiantan's MMR vaccine in subjects 18 months of age and older.
The MMR vaccine may be administered as a second dose to 4-6 year-old persons with one dose immunization with MMR vaccine or as a first dose to 18 month-old subjects with one dose immunization with MR.
Immune efficacy and safety will be compared among different immunization schedules,including inoculation doses,enhanced immunity age,vaccination interval time.
Antibody persistence of 1 dose of MMR vaccine will be evaluated in this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| one dose of MMR | Other | Biological: Measles, mumps and rubella Combined Vaccine, LiveSubjects are vaccinated with MMR(Measles, mumps and rubella Combined Vaccine, Live) on 18 months old. |
| 30 months after two doses of MMR | Other | Biological: Measles, mumps and rubella Combined Vaccine, LiveSubjects are vaccinated two doses of MMR(Measles, mumps and rubella Combined Vaccine, Live) on 18 month and 4 years old, sequentially. |
| 42 months after two doses of MMR | Other | Biological: Measles, mumps and rubella Combined Vaccine, LiveSubjects are vaccinated two doses of MMR(Measles, mumps and rubella Combined Vaccine, Live) on 18 month and 5 years old, sequentially. |
| 54 months after two doses of MMR | Other | Biological: Measles, mumps and rubella Combined Vaccine, LiveSubjects are vaccinated two doses of MMR(Measles, mumps and rubella Combined Vaccine, Live) on 18 month and 6 years old, sequentially. |
Who may qualify
- Ages
- 18 months to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- healthy children; 150 subjects 18 months old; 150 subjects 4 years old;300 subjects 5 years old; 150 subjects 6 years old; their guardians signed informed consent;
- undiagnosed as measles, mumps and rubella;
- in good health as determined by the outcome of medical history, physical examination and clinical judgment; suitable to MMR immunization;
- guardians would comply with the requirements of the protocol;
- immunized with MR or measles vaccine(MV) at 8 months old;immunized with MMR at 18 months old(not applicable to subjects 18 months old); unvaccinated by biological products within one month;
Key exclusion criteria (3 listed)
- history of allergic disease or reactions likely to be exacerbated by any component of the vaccine(any previous vaccination history of allergies and egg allergy history);
- Current confirmed as acute disease, severe chronic diseases or acute development of chronic diseases;
- Participating in another clinical trial at the same time;
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 |
|---|---|---|
| Measles, mumps and rubella Combined Vaccine, LiveAlso: Beijing Tiantan Biological Products Co., LtdSubjects will be inoculated one dose of MMR vaccine and collected blood samples before and after vaccination. | Biological | 30 months after two doses of MMR, 42 months after two doses of MMR, 54 months after two doses of MMR, one dose of MMR |
Primary outcome
Immunogenicity of the MMR vaccines in terms of antibody concentration
Time frame: through study completion, an average of 1 year
For measles virus, seroresponse is defined as post-vaccination anti-measles virus antibody concentration (Ab conc) >200 mIU/mL. For mumps virus, seroresponse is defined as post-vaccination anti-mumps virus Ab conc >100 IU/mL. For rubella virus, seroresponse is defined as post-vaccination anti-rubella virus Ab conc >20 IU/mL.
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 19 May 2017.
- Individual participant dataSharing planned: No
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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.
Jiang Wu principal investigator
Beijing Center for Diseases Control and Prevention
4 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 Measles, mumps and rubella Combined Vaccine, Live in people with Measles and Mumps, run by Centers for Disease Control and Prevention, China at 4 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 7 inclusion and 3 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 19 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Immunogenicity of the MMR vaccines in terms of antibody concentration (time frame: through study completion, an average of 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 19 May 2017.