Trial · NCT03143218
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of Clinical Episodes of Malaria | Passive surveillance of clinical episodes of malaria within the study area starting from the date of the first dose of study vaccines (April/May 2017) until 31st March 2020- a total of 36 months. | No. of events/1000 person years at risk | NUMBER | |
| SECONDARY | Clinical Episodes of Uncomplicated Febrile Illness | Passive surveillance in all health centers within the study area, active surveillance in a sub set of study children starting July 2017 till April 2020. | |||
| SECONDARY | Hospital Admissions With Malaria, Including Severe Malaria | Through study completion (30 months), each child admitted in a study hospital will be treated and monitored until complete cure or death (a period of 3 years). Documentation of each hospital admission according to ICH-GCP. | |||
| SECONDARY | Prevalence of Malaria Infection Not Severe Enough to Warrant a Clinic Visit | Weekly home visits through study completion from July 2017 - April 2020 to screen study children for malaria. | |||
| SECONDARY | Prevalence of Malaria Parasitaemia, Including Gametocytaemia and the Prevalence of Moderate and Severe Anemia and Malnutrition | Blood sample collection during 2-week cross sectional survey at the end of each malaria transmission season. | |||
| SECONDARY | Serious Adverse Events (SAEs) | Through study completion (for 30 months), each SAE will be treated and documented according to ICH-GCP. | |||
| SECONDARY | Immune Response to the Vaccine (Anti-CSP Antibody Concentrations) | Blood sample collection prior to 1st dose of vaccine and 1 month after 3rd dose of the primary series of vaccination. In years 2 and 3 blood will be collected before the booster dose and 1 month after administration of the 4th (and 5th) vaccine dose. | |||
| SECONDARY | Drug Resistance to SP and AQ | Blood sample collection during the 2-week cross sectional survey conducted at the end of malaria transmission season in 2019. | |||
| SECONDARY | Prevalence of Malaria Parasitaemia in School Aged Children | Blood sample collection during the 2-week cross sectional survey at the end of the malaria transmission season in Year 2 and 3 (November 2018/19). | |||
| SECONDARY | SP+AQ Drug Sensitivity | Children with asymptomatic malaria parasitaemia identified during the final cross-sectional survey (November 2019), treated with a full course of SP+AQ over 3 days and followed for 28 days. | |||
| OTHER_PRE_SPECIFIED | Acceptability of RTS,S and SMC | Data collection in Year 3 | |||
| OTHER_PRE_SPECIFIED | Feasibility of Introducing Two Malaria Control Strategies Simultaneously | Data collection in Year 3 |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT03143218/outcomes