Study of Rubella Immunity. Response to Vaccination of Sub... | NCT02934295

Studies
Study of Rubella Immunity. Response to Vaccination of Subjects With Very Low, Equivocal or Undetectable Titers of Rubella Virus Antibodies

NCT02934295

Sponsor

Hopital Foch

Status

Completed

Last Update Posted

Feb 1, 2017Estimated

Enrollment

192Actual

Phase

Not Applicable

Conditions

Pregnancy

Interventions

Determination of Anti-Rubella Antibody, E1

Countries

France

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

ID	Type	Description	Link
2011-A01445-36	Other Identifier	ANSM

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2012

Primary Completion Date

May 2014Actual

Completion Date

Oct 2014Actual

First Submitted Date

Oct 13, 2016

First Submission Date that Met QC Criteria

Oct 13, 2016

First Posted Date

Oct 14, 2016Estimated

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

Jan 31, 2017

Last Update Posted Date

Feb 1, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

The aim of the research is to study humoral and cellular immunity in pregnant women for who the level of rubella virus antibodies is weakly positive, equivocal or negative with the usual laboratory technique.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

192Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pregnant women	Experimental		Biological: Determination of Anti-Rubella Antibody, E1

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Determination of Anti-Rubella Antibody, E1	Biological		Pregnant women

Measure	Description	Time Frame
Level of Anti-Rubella Antibody, E1		8 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women over 18
Rubella serology negative, ambiguous or weakly positive during a first prenatal consultation and for which the second determination of the immunity anti rubella is necessary after 18 weeks of pregnancy
Accepting the rubella vaccination after the childbirth;
Accepting a blood test, during a postnatal consultation, 6 in 8 weeks after vaccination, to verify their immunity towards the virus of the rubella.
Affiliated to a social security scheme
Having given a written consent

Exclusion Criteria:

Rubella contracted since the first serology realized during the first prenatal consultation
Autoimmune pathologies
Intolerance / allergy known about a previous vaccination whatever it is
Immunosuppression (HIV, transplants)
Injection of multivalent immunoglobulins (except anti-D)

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Olivier Picone	Hôpital Foch	Principal Investigator
Christelle VAULOUP-FELLOUS, MD	Hôpital Brousse	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Antoine-Béclère		Clamart		92140	France
Hôpital Foch

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C042762	methyl N-acetylsibirosaminide

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided