Prospective Study of Infant Dengue
A Prospective Study of Dengue Virus Infections During Infancy to Define Correlates of Protective Immunity
1 other identifier
observational
20,000
1 country
1
Brief Summary
Dengue is a common disease and a major health concern in the Philippines. Dengue is caused by a virus transmitted from the bite of an infected mosquito. The purpose of this study is to understand why some infants remain well or have a mild illness, and why other infants become very sick from this virus. Studies have shown that the mother's immune response to dengue can play a role in the infant's immune response and affect whether or not the infant becomes sick. This study will enroll up to 10,000 healthy infants 6-14 weeks old and their mothers in San Pablo City. At the first study visit, information about the mother and birth will be collected and blood samples will be taken from the mother and infant. The infant will have blood drawn at all 3 study visits. The infants will be followed until the age of 16 months. The information obtained from this study may help in the development and future testing of a safe and effective dengue vaccine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2006
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 14, 2006
CompletedFirst Posted
Study publicly available on registry
September 18, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedAugust 27, 2010
October 1, 2007
September 14, 2006
August 26, 2010
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- Infants born to mother residing in San Pablo Health District
- Planned residence in San Pablo Health District for at least 1 year
- Age 6-14 weeks\*
- Informed consent
- General good health \* Except on study initiation, when over the first 5 months of Year 1 (est. Feb-June 2006), infants between the ages of 6-24 weeks will be allowed to enter the study.
You may not qualify if:
- Infant born with congenital medical disorder
- Mother known to be HIV seropositive
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Research Institute for Tropical Medicine
City of Muntinlupa, 1781, Philippines
Related Publications (1)
Libraty DH, Acosta LP, Tallo V, Segubre-Mercado E, Bautista A, Potts JA, Jarman RG, Yoon IK, Gibbons RV, Brion JD, Capeding RZ. A prospective nested case-control study of Dengue in infants: rethinking and refining the antibody-dependent enhancement dengue hemorrhagic fever model. PLoS Med. 2009 Oct;6(10):e1000171. doi: 10.1371/journal.pmed.1000171. Epub 2009 Oct 27.
PMID: 19859541DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
Study Record Dates
First Submitted
September 14, 2006
First Posted
September 18, 2006
Study Start
September 1, 2006
Study Completion
September 1, 2010
Last Updated
August 27, 2010
Record last verified: 2007-10