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NCT02499172 · ClinicalTrials.gov registry record · NA
Follow-up of Pregnant Women After a Mass Vaccination of Oral Cholera Vaccine (ShancholTM) in Nsanje Malawi
A NA study, sponsored by Johns Hopkins Bloomberg School of Public Health.
- Terminated
- Registry status
- NA
- Development phase
- 2,758
- Enrollment target
NCT02499172 is a NA study that was terminated before completion, run by Johns Hopkins Bloomberg School of Public Health. The registered enrollment target is 2,758 participants.
The verdict
NCT02499172, a NA study, was terminated before completion, sponsored by Johns Hopkins Bloomberg School of Public Health.
- TERMINATED
- Registry status
- NA
- Development phase
- 2,758 participants
- Enrollment target
Study Summary
This study, to be carried out immediately following an emergency, reactive cholera vaccination campaign in Nsanje District, Malawi, will be a cohort study to estimate the safety of killed oral cholera vaccine (OCV), in pregnant women as measured by ShancholTM, on pregnancy outcomes and birth defects. While limited evidence which suggests that the vaccine is safe in pregnant women, this setting will allow investigators to answer this question in a community where more than 100,000 people will receive vaccine with no restrictions on pregnancy status. In past cholera vaccine campaigns including clinical trials, pregnant women were excluded due to lack of safety data. However, in this campaign, the decision by the Ministry of Health is that the benefits of offering vaccine to all individuals regardless of pregnancy status far outweigh any theoretical risk. Here the investigators specifically propose to: Specific Objective 1: To conduct surveillance of pregnant women to detect adverse pregnancy outcomes within communities in Nsanje District, Malawi that received oral cholera vaccine in a reactive vaccination campaign that started on 30 March 2015. Through household surveying and enrollment of pregnant women with monthly follow-up visits, the investigators will determine the cumulative incidence of adverse pregnancy outcomes among vaccinated and unvaccinated women in Nsanje and Chikwawa Districts, Malawi. Specific Objective 2: To compare the cumulative incidence of pregnancy loss (miscarriage and stillbirth) of women who received oral cholera vaccine while they were pregnant to women who were vaccinated and became pregnant after the end of the final round of vaccination in Nsanje and Chikwawa Districts, Malawi. Specific Objective 3: To compare the incidence of newborn malformations in a cohort of infants that had fetal exposure to oral cholera vaccine compared to those without such exposure in Nsanje and Chikwawa Districts, Malawi.
Interventions
- BIOLOGICAL Shanchol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,758 participants |
| Start Date | 2015-06 |
| Est. Completion | 2016-10-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02499172
The ClinicalTrials.gov registry entry for NCT02499172 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 2,758 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins Bloomberg School of Public Health, which has 187 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Shanchol is the first listed.
NCT02499172 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02499172 about?
NCT02499172 is a clinical study titled "Follow-up of Pregnant Women After a Mass Vaccination of Oral Cholera Vaccine (ShancholTM) in Nsanje Malawi". This study, to be carried out immediately following an emergency, reactive cholera vaccination campaign in Nsanje District, Malawi, will be a cohort study to estimate the safety of killed oral cholera vaccine (OCV), in pregnant women as measured by ShancholTM, on pregnancy outcomes and birth defects...
What is the current status of trial NCT02499172?
This trial is currently terminated. It is a NA study. The enrollment target is 2,758 participants. The study started on 2015-06. Estimated completion is 2016-10-30.
What interventions are being tested in trial NCT02499172?
The interventions under investigation include: Shanchol (BIOLOGICAL).
Who is sponsoring clinical trial NCT02499172?
This trial is sponsored by Johns Hopkins Bloomberg School of Public Health, which has 187 total clinical trials registered on ClinicalTrials.gov.
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