Early Waning of Maternal Measles and Meningitis C Antibodies | NCT02219061

Studies
Early Waning of Maternal Measles and Meningitis C Antibodies

NCT02219061

Sponsor

Guangzhou Center for Disease Control and Prevention

Status

Unknown status

Last Update Posted

Sep 18, 2014Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Measles

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014

Primary Completion Date

Oct 2014Estimated

Completion Date

Dec 2014Estimated

First Submitted Date

Aug 13, 2014

First Submission Date that Met QC Criteria

Aug 14, 2014

First Posted Date

Aug 18, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 16, 2014

Last Update Posted Date

Sep 18, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Label	Type	Description	Intervention Names
GMT

Measure	Description	Time Frame
Geometric Mean Titer		Up to six months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy infants.

Exclusion Criteria:

Infants with poor score.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

7 Months

Standard Ages

Child

Study Population

Infants.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chuanxi Fu, PhD	Contact	+86 20 36055887		fuchuanxi@gmail.com

Overall Officials

Name	Affiliation	Role
Ming Wang	Guangzhou CDC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Guangzhou Center for Disease Control and Prevention	Recruiting	Guangzhou	Guangdong	510440	China

Condition Browse Module

MeSH Terms

ID	Term
D008457	Measles

Ancestor Terms

ID	Term
D018185	Morbillivirus Infections
D018184	Paramyxoviridae Infections
D018701	Mononegavirales Infections
D012327	RNA Virus Infections

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