Trial · NCT03143218
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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. | Passive surveillance to detect episode of fever (temperature \> 37.5 C), or a history of fever within the past 48 hours, that is severe enough to require treatment at a health centre and which is accompanied by a positive blood film with a parasite density of 5,000 per µl or more |
| 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. | Passive and active surveillance to detect cases with temperature \> 37.5o C), or a history of fever within the past 48 hours, with a positive blood film (any level of asexual parasitaemia) or a positive rapid diagnostic test (RDT) for malaria |
| 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. | Hospital admissions with malaria, including cases of severe malaria which meet WHO criteria for a diagnosis of severe malaria. |
| 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. | Active surveillance of malaria at household level to assess the prevalence of malaria infection not severe enough to warrant a clinic visit detected in a subset of randomly selected children. |
| 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. | The prevalence of malaria parasitaemia, including gametocytaemia, moderate and severe anaemia and malnutrition at the end of the 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. | Serious adverse events (SAEs), including any deaths, occurring at any time during the study with special reference to any cases of meningitis and cerebral malaria (WHO case definition) |
| 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. | After priming and after each booster dose, determined in a sub-sample of children |
| 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. | The presence of molecular markers of resistance to SP and AQ in parasite positive samples |
| 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). | The prevalence of malaria parasitaemia at the end of the malaria transmission season in school-age children resident in the study areas, to determine overall malaria transmission |
| 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. | The 28-day treatment outcome in children with asymptomatic malaria parasitaemia treated with SP+AQ. |
| Other | Acceptability of RTS,S and SMC | Data collection in Year 3 | The acceptability of the two interventions (separately and combined) to the health care deliverers and to the study communities (standardized questionnaires) |
| Other | Feasibility of Introducing Two Malaria Control Strategies Simultaneously | Data collection in Year 3 | The feasibility of introducing two malaria control strategies simultaneously from the health system perspective (structured observations and interviews with health system officials) |
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.
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