Status:
COMPLETED
Age of Exposure and Immunity to Malaria in Infants
Lead Sponsor:
Hospital Clinic of Barcelona
Collaborating Sponsors:
European Commission
Conditions:
Malaria
Eligibility:
All Genders
Up to 1 years
Phase:
NA
Brief Summary
The overall objective is to evaluate the effect of exposure to Plasmodium (P.) falciparum erythrocytic stage antigens during different periods of infancy on the development of naturally acquired immun...
Eligibility Criteria
Inclusion
- Inclusion criteria for pregnant women:
- Healthy HIV-negative pregnant females less than 50 years of age who attend the voluntary counseling and testing (VCT) center at the Maragra or Manhiça antenatal clinic,
- Permanent residents of the Manhiça area and expecting to be living in the area with their infant for at least 2 years.
- Inclusion criteria for newborn infants:
- Healthy infants, weighing \>= 2 kg and having an alive mother.
Exclusion
- Exclusion criteria for pregnant women:
- Plan to leave the area in less than 2 years from the start of the study;
- Women not willing to get tested for HIV infection at the VCT center;
- Test positive for HIV;
- Not willing to provide informed consent;
- Cannot understand either Portuguese or Changana (consent forms are written in these languages).
- Exclusion criteria for newborn infants:
- Any obvious congenital malformation;
- Any signs of cerebral asphyxia;
- Any obvious neonatal infection;
- Same gender Twins;
- Low birth weight (\<2 kg).
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
349 Patients enrolled
Trial Details
Trial ID
NCT00231452
Start Date
September 1 2005
End Date
March 1 2009
Last Update
October 28 2011
Active Locations (1)
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1
Centro de Investigaçao em Saude da Manhiça
Manhiça, Maputo Province, Mozambique, 1929