Trial · NCT04319380
Seasonal Malaria Vaccination (RTS,S/AS01) and Seasonal Malaria Chemoprevention (SP/AQ) Extension Study
NCT04319380, Phase 3, Completed, London School of Hygiene and Tropical Medicine; results first posted 2024-09-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Seasonal Malaria Vaccination (RTS,S/AS01) and Seasonal Malaria Chemoprevention (SP/AQ) Extension Study. Trials, record NCT04319380. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04319380
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Seasonal Malaria Vaccination (RTS,S/AS01) and Seasonal Malaria Chemoprevention (SP/AQ) Extension Study
- NCT number
- NCT04319380
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 5,098 participants, actual
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Conditions
- Malaria,Falciparum, Child, Only
- Interventions
- Tetanus/diphtheria toxoids, SMC with SP+AQ, RTS,S/AS01, SMC placebo
- First posted
- 2020-03-24
- Last updated
- 2024-09-20
- Results first posted
- 2024-09-20
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Clinical Episodes of Malaria | Passive surveillance of clinical episodes of malaria within the study area over 24 months (1 April 2020 until 31 March 2022). | 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 starting 1 April 2020 until 31 March 2022. | 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, each child admitted in a study hospital will be treated and monitored until complete cure or death (a period of 2 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 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 (November 2020/21).). | 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 2 years), 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 0-7 days before and one month after the booster doses (year 1 and 2). | Anti-CSP antibody concentrations obtained before and after each booster dose, determined in a sub-sample of children. |
| Secondary | Prevalence of Malaria Parasitaemia in School Aged Children | Blood sample collection during the 2-week cross sectional survey at the end of each malaria transmission season (November 2020/21). | The prevalence of malaria parasitaemia at the end of each malaria transmission season in school-age children resident in the study areas, to determine overall malaria transmission |
| Secondary | Polymorphisms in the P. Falciparum CSP | Blood sample collection from children with clinical episodes of malaria and in children with parasitaemia at the 2-week cross-sectional survey (November 2020/21)). | The prevalence of mutations in the Th2 or Th3 locus of the Plasmodium falciparum csp gene in isolates from children who have received RTS,S/AS01 that differ from those of the isolate used in the preparation of the vaccine |
| Secondary | Drug Resistance to SP and AQ | Blood sample collection during the final 2-week cross sectional survey conducted at the end of malaria transmission season (November 2021) | The presence of molecular markers of resistance to SP and AQ in parasite positive samples |
| Secondary | SP+AQ Drug Sensitivity | Children with asymptomatic malaria parasitaemia identified during the final cross-sectional survey (November 2021), 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. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 over 24 months (1 April 2020 until 31 March 2022). | Episodes per 1,000 child years at risk | NUMBER | |
| SECONDARY | Clinical Episodes of Uncomplicated Febrile Illness | Passive surveillance in all health centers within the study area starting 1 April 2020 until 31 March 2022. | |||
| SECONDARY | Hospital Admissions With Malaria, Including Severe Malaria | Through study completion, each child admitted in a study hospital will be treated and monitored until complete cure or death (a period of 2 years). Documentation of each hospital admission according to ICH-GCP | |||
| 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 (November 2020/21).). | |||
| SECONDARY | Serious Adverse Events (SAEs) | Through study completion (for 2 years), each SAE will be treated and documented according to ICH-GCP. | |||
| SECONDARY | Immune Response to the Vaccine (Anti-CSP Antibody Concentrations) | Blood sample collection 0-7 days before and one month after the booster doses (year 1 and 2). | |||
| SECONDARY | Prevalence of Malaria Parasitaemia in School Aged Children | Blood sample collection during the 2-week cross sectional survey at the end of each malaria transmission season (November 2020/21). | |||
| SECONDARY | Polymorphisms in the P. Falciparum CSP | Blood sample collection from children with clinical episodes of malaria and in children with parasitaemia at the 2-week cross-sectional survey (November 2020/21)). | |||
| SECONDARY | Drug Resistance to SP and AQ | Blood sample collection during the final 2-week cross sectional survey conducted at the end of malaria transmission season (November 2021) | |||
| SECONDARY | SP+AQ Drug Sensitivity | Children with asymptomatic malaria parasitaemia identified during the final cross-sectional survey (November 2021), treated with a full course of SP+AQ over 3 days and followed for 28 days. |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of Clinical Episodes of Malaria | SMC With SP+AQ | 338.1 | 95% Confidence Interval 315.4 to 362.2 | Episodes per 1,000 child years at risk | |
| Incidence of Clinical Episodes of Malaria | RTS,S/AS01 | 421.3 | 95% Confidence Interval 395.5 to 448.2 | Episodes per 1,000 child years at risk | |
| Incidence of Clinical Episodes of Malaria | RTS,S/AS01 Plus SMC With SP+AQ | 178.9 | 95% Confidence Interval 162.5 to 196.7 | Episodes per 1,000 child years at risk |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SMC With SP+AQ | 1,683 | |
| Overall Study | STARTED | RTS,S/AS01 | 1,705 | |
| Overall Study | STARTED | RTS,S/AS01 Plus SMC With SP+AQ | 1,710 | |
| Overall Study | COMPLETED | SMC With SP+AQ | 1,644 | |
| Overall Study | COMPLETED | RTS,S/AS01 | 1,650 | |
| Overall Study | COMPLETED | RTS,S/AS01 Plus SMC With SP+AQ | 1,661 | |
| Overall Study | NOT COMPLETED | SMC With SP+AQ | 39 | |
| Overall Study | NOT COMPLETED | RTS,S/AS01 | 55 | |
| Overall Study | NOT COMPLETED | RTS,S/AS01 Plus SMC With SP+AQ | 49 |
Source ClinicalTrials.gov
Adverse events3
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Hospitalisations (all causes) | General disorders | SMC With SP+AQ | 11 | 1,683 | |
| serious | Hospitalisations (all causes) | General disorders | RTS,S/AS01 | 16 | 1,705 | |
| serious | Hospitalisations (all causes) | General disorders | RTS,S/AS01 Plus SMC With SP+AQ | 16 | 1,710 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SMC With SP+AQ | 2 | 1,683 |
| Total, all-cause mortality | RTS,S/AS01 | 10 | 1,705 |
| Total, all-cause mortality | RTS,S/AS01 Plus SMC With SP+AQ | 4 | 1,710 |
| Total, other adverse events | SMC With SP+AQ | 0 | 0 |
| Total, other adverse events | RTS,S/AS01 | 0 | 0 |
| Total, other adverse events | RTS,S/AS01 Plus SMC With SP+AQ | 0 | 0 |
| Total, serious adverse events | SMC With SP+AQ | 11 | 1,683 |
| Total, serious adverse events | RTS,S/AS01 | 16 | 1,705 |
| Total, serious adverse events | RTS,S/AS01 Plus SMC With SP+AQ | 16 | 1,710 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04319380
GET https://conductscience.org/api/trials/v1/NCT04319380/registered