Status:
COMPLETED
SaniVac Trial - Sanitation and Oral Rotavirus Vaccine Performance
Lead Sponsor:
London School of Hygiene and Tropical Medicine
Collaborating Sponsors:
Instituto Nacional de Saúde, Mozambique
Georgia Institute of Technology
Conditions:
Rotavirus Infections
Environmental Enteric Dysfunction
Eligibility:
FEMALE
16+ years
Brief Summary
This is a controlled cohort study to assess the effect of improved sanitation on oral rotavirus vaccine performance in low-income urban neighbourhoods of Maputo, Mozambique. The specific hypotheses ar...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Mother residing in an intervention or control compound of a previous sanitation trial (NCT02362932) for at least 6 months prior to recruitment and not intending to switch study compound over the next 9 months
- Mother being pregnant and having gestational age between 3 and 9 months or being puerperal (up to 40 days postpartum)
- Mother planning to use the prenatal care, delivery and vaccination services provided by the Ministry of Health of Mozambique
- Mother able to understand and complete the informed consent process and allow your newborn to participate in the study
- Mother at least 16 years of age
- Infant eligible to receive rotavirus vaccination
- Exclusion criteria:
- Infant whose medical team considers that they cannot be part of the study
- Infant with complications associated with gestation, childbirth or postpartum, including congenital malformations
- Infant with any medical, psychiatric or social condition, occupational reason, or other responsibility on the part of the pregnant woman, which, in the opinion of the investigator, is a contraindication to protocol compliance or impedes the participant's ability to give informed consent
- Infant who has already received the rotavirus vaccine
Exclusion
Key Trial Info
Start Date :
October 5 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 12 2024
Estimated Enrollment :
261 Patients enrolled
Trial Details
Trial ID
NCT03313128
Start Date
October 5 2017
End Date
December 12 2024
Last Update
December 26 2025
Active Locations (1)
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1
Centro de Investigação em Saúde da Polana Caniço (CISPOC)
Maputo, Mozambique, 264