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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01477671
First received: November 18, 2011
Last updated: April 25, 2014
Last verified: April 2014
  Purpose

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.

Condition
Dengue
Dengue Fever
Dengue Hemorrhagic Fever

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Prospective Dengue Seroprevalence Study in 5 to 10 Year-old Children in India

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Prevalence of positive samples with dengue specific serotype DENV 1, 2,3 and/or 4 [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prevalence of positive serum samples with JEV specific IgG antibodies [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Enrollment: 667
Study Start Date: September 2011
Study Completion Date: December 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Study Group
Participants aged between 5 and 10 year-old on day of inclusion.

  Eligibility

Ages Eligible for Study:   5 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

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:

  • N/A
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01477671

Locations
India
Kalyani, West Bengali, India, 741235
Bangalore, India, 560070
Hyderabad, India, 500063
New Delhi, India, 110002
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur SA
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01477671     History of Changes
Other Study ID Numbers: DNG10, U1111-1124-7423
Study First Received: November 18, 2011
Last Updated: April 25, 2014
Health Authority: India: Central Drugs Standard Control Organization

Keywords provided by Sanofi:
Dengue
Dengue Fever
Dengue Hemorrhagic Fever

Additional relevant MeSH terms:
Dengue
Fever
Severe Dengue
Hemorrhagic Fevers, Viral
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on August 19, 2014