MeaslesEWMMNCT02219061
Early Waning of Maternal Measles and Meningitis C Antibodies
An observational study of Measles, run by Guangzhou Center for Disease Control and Prevention at 1 site in China.
Trial summary
Maternal antibodies (measles and meningitis C) may wane in the first six months after birth. Geometric mean titers(GMTs) of measles and meningitis C. Follow-up on 0 month, 3rd month,5th month and 7th month after birth. Read more about this study
- Who is it for?
- Ages Up to 7 monthsHealthy volunteers can take part
- Conditions the study is for
- Measles
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- May 2014to Dec 2014
- Phase
- Observational
- 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 Up to 7 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants.
Who may be able to join
- Healthy infants.
Who cannot join
- Infants with poor score.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangzhou Center for Disease Control and Prevention
Guangzhou, Guangdong, 510440
Chuanxi, +86 20 36055887
Ming, 48280698@qq.com
About this study
Official title: Observation Study on Early Waning of Maternal Measles and Meningitis C Antibodies
Maternal antibodies (measles and meningitis C) may wane in the first six months after birth.
- Geometric mean titers(GMTs) of measles and meningitis C.
- Follow-up on 0 month, 3rd month,5th month and 7th month after birth.
Read the detailed description
Measles and meningitis C are hot topics in China in recent years. Although China had set the goal of measles elimination, many measles cases were found to be those aged < 8 months and meningitis C is becoming public health issue since meningitis group A has been controlled at a very low level and little is known on C group. So the investigators designed the observation study on the two antibodies.
Maternal antibodies are supposed to wane after birth. Serums of the placenta(0 month), children of 3 months, 5 months and 7 months old will be collected and the geometric mean titers (GMTs) of measles and meningitis C will be confirmed by using the ELISA test.
- Conditions
- Measles
- Keywords
- Measles, Meningitis C, waning, Geometric Mean Titer, China
- Medical subject headings
- Measles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| GMT | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Titer
Measured: Up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2014 (estimated)
- Study startMay 2014
- Primary completionOct 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 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Center for Disease Control and Prevention
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ming Wang, Principal investigator, Guangzhou CDC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02219061
- Sponsor's protocol ID
- GZCDC001
- Acronym
- EWMM
- Status last verified
- Aug 2014
- First submitted
- 13 Aug 2014
- Last updated
- 18 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation Study on Early Waning of Maternal Measles and Meningitis C Antibodies
- ClinicalTrials.gov ID
- NCT02219061
- Acronym / sponsor ID
- EWMM / GZCDC001
- Conditions
- Measles
- Keywords
- Measles, Meningitis C, waning, Geometric Mean Titer, China
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Guangzhou Center for Disease Control and PreventionOther government
- Study start
- May 2014
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 18 Aug 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.
Maternal antibodies (measles and meningitis C) may wane in the first six months after birth.
- Geometric mean titers(GMTs) of measles and meningitis C.
- Follow-up on 0 month, 3rd month,5th month and 7th month after birth.
Detailed description
Measles and meningitis C are hot topics in China in recent years. Although China had set the goal of measles elimination, many measles cases were found to be those aged < 8 months and meningitis C is becoming public health issue since meningitis group A has been controlled at a very low level and little is known on C group. So the investigators designed the observation study on the two antibodies.
Maternal antibodies are supposed to wane after birth. Serums of the placenta(0 month), children of 3 months, 5 months and 7 months old will be collected and the geometric mean titers (GMTs) of measles and meningitis C will be confirmed by using the ELISA test.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GMT | – | – |
Who may qualify
- Ages
- Up to 7 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants.
Key inclusion criteria (1 listed)
- Healthy infants.
Key exclusion criteria (1 listed)
- Infants with poor score.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Geometric Mean Titer
Time frame: Up to six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 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.
Ming Wang principal investigator
Guangzhou CDC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Measles, run by Guangzhou 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 1 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 18 Sep 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.
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 Chuanxi Fu, PhD (+86 20 36055887, fuchuanxi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geometric Mean Titer (time frame: Up to six 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 18 Sep 2014.