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Study Population: Participants of the previous PRIMVAC vaccine trial and women aged 18 to 35 years
Sample Size: 90
Study duration: 21 months
Subject duration: 12 months if pregnancy doesn't occurred. In case of pregnancy, the participant will be followed up until the delivery.
Study Design: Long term observational study comparing the immunology trend of 3 groups of i) women who received the PRIMVAC Vaccine or Placebo during the phase 1b trial in Burkina Faso; ii) women of the same age and nulligravid who did not participate in the phase 1b trial iii) women of the same age and primigravid who did not participate in the phase 1b trial
Co Primary objectives
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Full description
It is a long-term observational study comparing the immunology trend of 3 groups of women:
The proposed cohort study will build on the previous phase 1b study which was conducted within the health district of Saponé (ClinicalTrials.gov Identifier: NCT02658253). The enrolment and follow up of the subjects will last 12 months. Pregnancy which occurred during the follow up period will monitored until the delivery. An additional six months is necessary for sample analysis in the laboratory, the data analysis and the preparation of reports and publications.
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Exclusion criteria
90 participants in 3 patient groups
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Central trial contact
Maurice S Ouattara, MD, MSc; Alphonse Ouedraogo, MD, PhD
Data sourced from clinicaltrials.gov
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