Prospective Dengue Seroprevalence Study in 5 to 10 Year-o... | NCT01477671

Studies
Prospective Dengue Seroprevalence Study in 5 to 10 Year-old Children

NCT01477671

Sponsor

Sanofi Pasteur, a Sanofi Company

Status

Completed

Last Update Posted

Jan 11, 2018Actual

Enrollment

667Actual

Phase

Not provided

Conditions

Dengue
Dengue Fever
Dengue Hemorrhagic Fever

Interventions

Not provided

Countries

India

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
U1111-1124-7423	Other Identifier	WHO

Status Module

Record Verification Date

Jan 2018

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

Sep 2011

Primary Completion Date

Sep 2012Actual

Completion Date

Dec 2013Actual

First Submitted Date

Nov 18, 2011

First Submission Date that Met QC Criteria

Nov 18, 2011

First Posted Date

Nov 22, 2011Estimated

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 9, 2018

Last Update Posted Date

Jan 11, 2018Actual

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

This is a descriptive prospective community-based seroprevalence study.

Primary objective:

To determine the prevalence of specific antibodies (immunoglobulin G [IgG]) against dengue in healthy 5 to 10 year-old children in India.

Secondary objectives:

To determine the dengue virus serotype (DeNV-1,2,3 and /or 4) specific to the antibodies in positive (IgG) samples
To estimate the prevalence of specific antibodies (IgG) against Japanese encephalitis in healthy 5 to 10 year-old children in India.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

667Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study Group		Participants aged between 5 and 10 year-old on day of inclusion.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of positive samples with dengue specific serotype DENV 1, 2,3 and/or 4		Baseline

Secondary Outcomes

Measure	Description	Time Frame
Prevalence of positive serum samples with JEV specific IgG antibodies		Baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged between 5 and 10 year-old on the day of inclusion
Healthy child as reported by the parent or legally qualified guardian
Being registered in selected study site
Provision of the informed consent form signed by at least one parent or legally qualified guardian
For children between 8 and 10 years old, provision of the assent form signed.

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

10 Years

Standard Ages

Child

Study Population

Participants aged between 5 and 10 year-old that are registered in health centers in India.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Medical Director	Sanofi Pasteur SA	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Kalyani	West Bengali	741235	India

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27825949	Result	Garg S, Chakravarti A, Singh R, Masthi NR, Goyal RC, Jammy GR, Ganguly E, Sharma N, Singh MM, Ferreira G, Moureau A, Ojha S, Nealon J; DNG10 study group. Dengue serotype-specific seroprevalence among 5- to 10-year-old children in India: a community-based cross-sectional study. Int J Infect Dis. 2017 Jan;54:25-30. doi: 10.1016/j.ijid.2016.10.030. Epub 2016 Nov 4.
31412836

ID	Term
D003715	Dengue
D019595	Severe Dengue

ID	Term
D000096724	Mosquito-Borne Diseases
D000079426	Vector Borne Diseases
D007239	Infections
D001102	Arbovirus Infections