SaniVac Trial - Sanitation and Oral Rotavirus Vaccine Performance

• Register: ClinicalTrials.gov
• Last refreshed on: 10 April 2023
• Main ID: NCT03313128
• Date of registration: 06/10/2017
• Prospective Registration: No
• Primary sponsor: London School of Hygiene and Tropical Medicine
• Public title: SaniVac Trial - Sanitation and Oral Rotavirus Vaccine Performance
• Scientific title: SaniVac Trial: An Assessment of Oral Rotavirus Vaccine Performance Among Infants Enrolled in a Controlled Before-after Study in Low-income Neighbourhoods of Maputo, Mozambique
• Date of first enrolment: October 1, 2017
• Target sample size: 200
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03313128
• Study type: Observational

Countries of recruitment

Mozambique

Contacts

• Name: Edna Viegas, MD

• Name: Edna Viegas, MD
• Affiliation: Centro de Investigação em Saúde da Polana Caniço (CISPOC)

• Name: Oliver D Cumming, MSc

• Name: Oliver D Cumming, MSc
• Affiliation: London School of Hygiene and Tropical Medicine

Key inclusion & exclusion criteria

Inclusion Criteria:

1. 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

2. Mother being pregnant and having gestational age between 3 and 9 months or being
puerperal (up to 40 days postpartum)

3. Mother planning to use the prenatal care, delivery and vaccination services provided
by the Ministry of Health of Mozambique

4. Mother able to understand and complete the informed consent process and allow your
newborn to participate in the study

5. Mother at least 16 years of age

6. Infant eligible to receive rotavirus vaccination

Exclusion criteria:

1. Infant whose medical team considers that they cannot be part of the study

2. Infant with complications associated with gestation, childbirth or postpartum,
including congenital malformations

3. 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

4. Infant who has already received the rotavirus vaccine



Age minimum: 16 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Environmental Enteric Dysfunction

Rotavirus Infections

Enteric Infections

Intervention(s)

Other: Sanitation

Primary Outcome(s)

Oral rotavirus vaccine seroconversion [Time Frame: Approx. 16 weeks age of infant (4 weeks after second dose of oral rotavirus vaccine)]

Secondary Outcome(s)

Environmental Enteric Dysfunction [Time Frame: Approx. 8 weeks age of infant (date of first dose of oral rotavirus vaccine)]

Enteric infection [Time Frame: Approx. 8 weeks age of infant (date of first dose of oral rotavirus vaccine)]

Secondary ID(s)

QA919

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Georgia Institute of Technology

Centers for Disease Control and Prevention

Instituto Nacional de Saúde, Mozambique