A Surveillance Study of Diseases Specified as Adverse Events of Special Interest, of Other Advers… (NCT02374450) | Clinical Trial Compass
CompletedNot Applicable
A Surveillance Study of Diseases Specified as Adverse Events of Special Interest, of Other Adverse Events Leading to Hospitalisation or Death, and of Meningitis in Children in Africa Prior to Implementation of the RTS,S/AS01E Candidate Vaccine
The purpose of this pre-licensure cohort study was to estimate the incidence of adverse events of special interest (AESI), other adverse events (AE) leading to hospitalisation or death, meningitis and malaria in sub-Saharan African children under 5 years of age. The outcomes of this study provide the baseline data for the post-licensure EPI-MALARIA-003 (115056) study that evaluated the safety, effectiveness and impact of the RTS,S/AS01E vaccine.
An interim analysis was performed on a sub-group of study participants enrolled in active surveillance from sites where the vaccine was implemented, having 6 months of follow-up after the administration of dose 3 of DTP/HepB/Hib vaccine (6-12 weeks group), or 6 months after Visit 3 (mimicking the RTS,S/AS01E primary vaccination schedule) for the 5-17 months group; corresponding to Visit 5. The interim analysis concerned primary safety endpoints and the main secondary endpoints.
Who can participate
Age range
5 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
All subjects must satisfy ALL the following criteria at study entry:
* Subjects' parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
* Written informed consent provided from either the parent(s) or LAR of the subject.
* Subject living in the Health and Demographic Surveillance System (HDSS) area.
* For enrolment in active surveillance: children must be \<18 months of age. OR
* For enrolment in enhanced hospitalisation surveillance: children must be \<5 years of age and hospitalised at any time during the study.
Exclusion Criteria:
* Child in care.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With at Least One Adverse Events of Specific Interest (AESI) From Month 0 to Month 79
Timeframe: During the entire study period (From Month 0 up to Month 79)
2
Number of Participants With at Least One Adverse Event (AE) Leading to Hospitalization or Death From Month 0 to Month 79
Timeframe: During the entire study period (From Month 0 up to Month 79)
3
Number of Participants With at Least One Aetiology Confirmed Meningitis From Month 0 to Month 79
Timeframe: During the entire study period (From Month 0 up to Month 79)