NCT01477671

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
667

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2011

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 22, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 11, 2018

Status Verified

January 1, 2018

Enrollment Period

1 year

First QC Date

November 18, 2011

Last Update Submit

January 9, 2018

Conditions

Keywords

DengueDengue FeverDengue Hemorrhagic Fever

Outcome Measures

Primary Outcomes (1)

  • Prevalence of positive samples with dengue specific serotype DENV 1, 2,3 and/or 4

    Baseline

Secondary Outcomes (1)

  • Prevalence of positive serum samples with JEV specific IgG antibodies

    Baseline

Study Arms (1)

Study Group

Participants aged between 5 and 10 year-old on day of inclusion.

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Kalyani, West Bengali, 741235, India

Location

Unknown Facility

Bangalore, 560070, India

Location

Unknown Facility

Hyderabad, 500063, India

Location

Unknown Facility

New Delhi, 110002, India

Location

Related Publications (2)

  • 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.

  • Bhavsar A, Tam CC, Garg S, Jammy GR, Taurel AF, Chong SN, Nealon J. Estimated dengue force of infection and burden of primary infections among Indian children. BMC Public Health. 2019 Aug 14;19(1):1116. doi: 10.1186/s12889-019-7432-7.

MeSH Terms

Conditions

DengueSevere Dengue

Condition Hierarchy (Ancestors)

Mosquito-Borne DiseasesVector Borne DiseasesInfectionsArbovirus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, Viral

Study Officials

  • Medical Director

    Sanofi Pasteur SA

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2011

First Posted

November 22, 2011

Study Start

September 1, 2011

Primary Completion

September 1, 2012

Study Completion

December 1, 2013

Last Updated

January 11, 2018

Record last verified: 2018-01

Locations