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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01477671
First Posted: November 22, 2011
Last Update Posted: April 28, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
  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 ( Sanofi Pasteur, a Sanofi Company ):

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

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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:

  Contacts and Locations
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
  More Information

Additional Information:
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 Submitted: November 18, 2011
First Posted: November 22, 2011
Last Update Posted: April 28, 2014
Last Verified: April 2014

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