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

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ClinicalTrials.gov Identifier: NCT01477671
Recruitment Status : Completed
First Posted : November 22, 2011
Last Update Posted : January 11, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

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.

Condition or disease
Dengue Dengue Fever Dengue Hemorrhagic Fever

Study Type : Observational
Actual Enrollment : 667 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Prospective Dengue Seroprevalence Study in 5 to 10 Year-old Children in India
Study Start Date : September 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dengue
U.S. FDA Resources

Group/Cohort
Study Group
Participants aged between 5 and 10 year-old on day of inclusion.



Primary Outcome Measures :
  1. Prevalence of positive samples with dengue specific serotype DENV 1, 2,3 and/or 4 [ Time Frame: Baseline ]

Secondary Outcome Measures :
  1. Prevalence of positive serum samples with JEV specific IgG antibodies [ Time Frame: Baseline ]


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT01477671     History of Changes
Other Study ID Numbers: DNG10
U1111-1124-7423 ( Other Identifier: WHO )
First Posted: November 22, 2011    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Dengue
Dengue Fever
Dengue Hemorrhagic Fever

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