Malaria,FalciparumMVPENCT03806465
Malaria Vaccine Pilot Evaluation
An observational study of Malaria,Falciparum and Feasibility, run by Rafiq OKINE at 3 sites in 3 countries.
Trial summary
The RTS,S/AS01 malaria vaccine is being introduced sub-nationally in phased pilot introductions through the EPI programmes in Malawi Ghana and Kenya. Vaccine introduction is by the respective MoH in selected areas randomly assigned to receive the vaccine at the beginning of the pilots. Read more about this study
- Who is it for?
- Ages 1 month to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Malaria,Falciparum, Feasibility, Safety
- What is being tested?
- Feasibility survey, Sentinel hospital surveillance and Community mortality surveillance
- Type of treatment
- Vaccines
- How many people
- 30,124 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 25 Feb 2019to 31 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study population will comprise children aged 1-59 months living in the areas geographically-defined for this evaluation of the RTS,S/AS01 Malaria Vaccine Implementation in three countries (Ghana, Kenya and Malawi) in sub-Saharan Africa.
Who may be able to join
- Children aged 1-59 months
Who cannot join
- Children aged less than 1 month or greater than 59 months
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: An Evaluation of the Pilot Implementation of RTS,S/AS01 Through Routine Health Systems in Moderate to High Malaria Transmission Settings in Africa
The RTS,S/AS01 malaria vaccine is being introduced sub-nationally in phased pilot introductions through the EPI programmes in Malawi Ghana and Kenya. Vaccine introduction is by the respective MoH in selected areas randomly assigned to receive the vaccine at the beginning of the pilots. In the context of this programmatic activity, the Malaria Vaccine Pilot Evaluation (MVPE) registered here as observational evaluations during early vaccine introduction, include a series of 3 household surveys, and sentinel hospital and community mortality surveillance, building on routine systems.
These observational evaluations will measure:
- The programmatic feasibility of delivering a 4 dose schedule;
- Safety in routine use, with focus on cerebral malaria and meningitis;
- The impact of the malaria vaccine in routine use on severe malaria and all-cause mortality
Read the detailed description
An evaluation of the pilot implementation of RTS,S/AS01 through routine health systems in moderate to high malaria transmission settings in Ghana, Kenya and Malawi. In the context of the new vaccine introduction, the Ministries of Health in the three countries will introduce the malaria vaccine (RTS,S/AS01) in a phased fashion (with some areas introducing the malaria vaccine first and the latter half, after the evaluation period) building on the national immunization programmes which routinely deliver vaccines and expanding the schedule of their routine EPI contacts.
The evaluation of the pilot implementation will run for a total of about 46 months in each country. This will focus on the three main primary objectives of feasibility, safety and impact. The pilot implementation assumes that a total of 46-60 clusters will be identified per country, evenly split between implementation and comparison areas, with each cluster contributing approximately 4,000 children per year to the evaluation of RTS,S/AS01. Hence a total of approximately 120,000 children will receive the RTS,S vaccine in each country in each year. Evaluation data will be collected in the following ways.
COMMUNITY BASED MORTALITY SURVEILLANCE
Community based mortality surveillance will be established across the pilot evaluation areas to enable the evaluation of the impact of the malaria vaccine on all-cause mortality. This will use a network of Village Reporters (VR) to document all deaths among children aged up to 48 months in the implementation and comparison areas. Once the death is notified, a standardized, WHO-approved Verbal Autopsy (VA) will be performed, according to WHO guidelines and locally acceptable practices. The VA will focus is on confirming death, age and vaccination status. The total number of clusters per country is expected to range from 46-60. Assuming 4,000 children born per cluster per year, 30 months of vaccination and a total follow-up of 44 months, each cluster will contribute 23,134 person years at risk (pyar), allowing for 1% mortality in the first month of life, and 0.08% mortality for every month after the first month. This equates to a mortality risk of 22.2 per 1000 for children aged 5 to 36 months. A mortality risk of 21 per 1,000 equates to a rate, over 2.5 years, of 8.489455 per 1,000 pyar. Based on a minimum mortality rate of 8.5 per 1000 pyar, 23 clusters in each arm, each with an annual birth cohort of approximately 4,000 subjects, would have 80% power to detect, at the 5% significance level, a decrease of at least 10% in overall mortality in each country.
With this mortality risk, the pilot evaluation it is estimated to have approximately 80% power to detect an interaction between gender and treatment of 1.15 (i.e an increased risk of mortality in girls of 1.035), compared with the 1.9-fold increase in risk among girls receiving RTS,S/AS01 in the RTS,S Phase 3 trial.
FEASIBILITY (CROSS SECTIONAL HOUSEHOLD) SURVEYS)
Three household surveys will be conducted to evaluate the programmatic feasibility to deliver a 4 dose schedule at baseline (before vaccination starts), 18 months and 30 months after start of vaccination.
A sample size of 100 houses per cluster will estimate the cluster-specific coverage of RTS,S/AS01 to within 10% (ie 95% CI from 40 to 60%) using a conservative estimate of 50% coverage and a high response rate above 95% in each cluster. Assuming a design effect of 1.5 between clusters, the overall precision in RTS,S/AS01 and coverage estimates of other vaccines over the pilot programme's implementation and comparison areas will be 2% (ie 95%CI 48% to 52%) in each country. This will result in 15,800 (6,600 in Ghana, 4,600 each in Kenya and Malawi) households included in the surveys. The second household survey may be powered to generate coverage estimates in each arm, rather than in each cluster, to within ±2% of the true value.
SENTINEL HOSPITAL SURVEILLANCE
Four to eight sentinel hospitals will be identified in each country to collect information on a larger scale on the safety of the malaria vaccine in children aged less than 5 years admitted with a focus on cases of cerebral malaria and meningitis. The catchment area of each hospital (approximately a cluster) is expected to have an annual birth cohort of, and provide services for, approximately 4,000 children in the MVPE. Hence a total catchment area of 48,000 children in implementation areas and another 48,000 children in comparison areas will contribute to the hospital-based evaluation of safety across the programme (three countries, Ghana, Kenya and Malawi). This is expected to provide 80% power to detect a 1.7-fold increase in risk of cerebral malaria and 2.6-fold increase in risk of meningitis. Children admitted to the sentinel hospitals in this age group will be assessed for severe malaria and meningitis using a standardised surveillance approach.
- Conditions
- Malaria,Falciparum, Feasibility, Safety, Mortality
- Being tested
- Feasibility survey, Sentinel hospital surveillance, Community mortality surveillance
- Keywords
- Vaccine, Malaria, Africa, Child
- Medical subject headings
- Malaria, Falciparum, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feasibility surveyOther
A survey questionnaire will be administered at each household. At the baseline household survey, each child aged less than 5 years will be tested for malaria using a rapid malaria test.
Sentinel hospital surveillanceOther
Cerebrospinal samples will be collected from all children hospitalised and suspected of having meningitis.
Community mortality surveillanceOther
A verbal autopsy will be performed
| Study group | Role | What they receive |
|---|---|---|
| Feasibility survey | These will be children living in the vaccinating and in non-vaccinating areas aged less than 5 years of age. For the midline household survey, this would be restricted to children aged 12-23 months of age. Receives: Other: Feasibility survey | |
| Sentinel hospital surveillance | These will be children living in the vaccinating and in non-vaccinating areas aged less than 5 years of age who are hospitalized in the 18 sentinel hospitals. Receives: Other: Sentinel hospital surveillance | |
| Community mortality surveillance | These will be children whose deaths are reported in the vaccinating and in non-vaccinating areas aged less than 5 years of age . Receives: Other: Community mortality surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of deaths of any cause
Number of deaths of any cause in children aged 1-59 months.
Measured: From 0 to 46 months after vaccination starts
Number of children admitted with a diagnosis of probable and confirmed meningitis cases
Number of children with probable and confirmed meningitis A probable case if in a suspected case, the macroscopic aspect of the CSF is turbid, cloudy or purulent; or the CSF leukocyte count is >10 cells/mm3. A confirmed case is if a suspected or probable case is laboratory confirmed by culturing or identifying (i.e. by polymerase chain reaction, immunochromatographic dipstick or latex agglutination) bacterial, viral or other aetiology in the CSF.
Measured: From 0 to 30 months after vaccination starts
Number of children admitted with a diagnosis of cerebral malaria
Cerebral malaria is defined as Severe P. falciparum malaria with coma (Glasgow coma score < 11 in children two years of age or older [≥ 2 years] or Blantyre coma score < 3 in children less than two years of age [(< 2 years]); and If malaria with seizure: coma persisting for > 30 min after the seizure. Other treatable causes of coma should be excluded before diagnosing cerebral malaria (e.g. hypoglycaemia, bacterial meningitis)
Measured: From 0 to 30 months after vaccination starts
Number of children aged 12-23 months who have completed the primary series (the 3 dose regime) of the malaria vaccine
Prevalence of children aged 12-23 months who had completed three doses of RTS,S/AS01 at the second household survey
Measured: At 18 months after vaccination starts
Number of children aged 27-38 months who have completed the 4th dose of the malaria vaccine
Prevalence of children aged 27-38 months who had completed four doses of RTS,S/AS01 at the third household survey
Measured: At 30 months after vaccination starts
Secondary outcomes (14)
Number of deaths in children by gender
Number of deaths in children stratified by gender in children aged 1-59 months
Measured: From 0 to 46 months after vaccination starts
Number of deaths in hospitalised children by gender
Number of deaths in hospitalized children stratified by gender in children aged 1-59 months.
Measured: From 0 to 46 months after vaccination starts
Number of malaria associated deaths in hospitalised children by gender
Number of malaria specific deaths stratified by gender in hospitalized children aged 1-59 months.
Measured: From 0 to 46 months after vaccination starts
Number of children with a diagnosis of severe malaria
Hospital admissions with malaria which meet WHO criteria for a diagnosis of severe malaria.
Measured: From 0 to 30 months after vaccination starts
Number of deaths excluding those attributed to trauma, poisoning and drowning
Number of non traumatic deaths in children aged 1-59 months.
Measured: From 0 to 46 months after vaccination starts
Number of children with a diagnosis of aetiology confirmed meningitis
Number of hospital admissions which meet WHO criteria for a diagnosis of aetiologically confirmed meningitis admitted to sentinel hospitals
Measured: 30 months after vaccination starts
Number of children with a diagnosis of suspected meningitis
Number of hospital admissions which meet WHO criteria for a diagnosis of suspected meningitis admitted to sentinel hospitals
Measured: From 0 to 30 months after vaccination starts
Number of children with a diagnosis of probable meningitis
Number of hospital admissions which meet WHO criteria for a diagnosis of probable meningitis admitted to sentinel hospitals
Measured: From 0 to 30 months after vaccination starts
Number of children with a diagnosis of malaria
Number of hospital admissions which meet WHO criteria for a diagnosis of malaria admitted to sentinel hospitals
Measured: From 0 to 30 months after vaccination starts
Number of children with a non-malaria diagnosis
Number of hospital admissions which do not meet WHO criteria for a diagnosis of malaria admitted to sentinel hospitals
Measured: From 0 to 30 months after vaccination starts
Number of children with a diagnosis of anaemia
Number of hospital admissions which meet WHO criteria for a diagnosis of anaemia admitted to sentinel hospitals . Anaemia is haemoglobin less than 11g/dL.
Measured: From 0 to 30 months after vaccination starts
Number of children who have received all their routine EPI vaccines as recommended by their national immunization schedule
Routine EPI vaccines include all doses of OPV, pentavalent, rotavirus, pneumococcal and measles vaccines
Measured: At 18 and 30 months after vaccination starts
Number of children who have received all the recommended malaria prevention and control measures
Recommended malaria prevention and control measures include insecticide treated bed nets, IPTi and indoor residual spraying.
Measured: At 18 and 30 months after vaccination starts
Number of children who have received all of the other key childhood interventions
Other key childhood interventions include anti-helminth administration (deworming) and Vitamin A supplementation
Measured: At 18 and 30 months after vaccination starts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start25 Feb 2019
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Malaria,FalciparumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30,124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rafiq OKINE
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rafiq OKINE, World Health Organization
- Investigators
- Don Mathanga, PhD, Principal investigator, College of Medicine, MalawiKwaku Poku Asante, PhD, Principal investigator, Kintampo Health Research Centre, GhanaAaron Samuels, MD, Principal investigator, CDC-Kenya Malaria Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03806465
- Sponsor's protocol ID
- RTSS MVPE
- Acronym
- MVPE
- Status last verified
- Dec 2024
- First submitted
- 14 Dec 2018
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Malaria vaccine: WHO position paper-January 2016. Wkly Epidemiol Rec. 2016 Jan 4;91(4):33-51. No abstract available. English, French.
PubMed 26829826RTS,S Clinical Trials Partnership. Efficacy and safety of RTS,S/AS01 malaria vaccine with or without a booster dose in infants and children in Africa: final results of a phase 3, individually randomised, controlled trial. Lancet. 2015 Jul 4;386(9988):31-45. doi: 10.1016/S0140-6736(15)60721-8. Epub 2015 Apr 23.
PubMed 25913272Mwapasa V, Asante KP, Milligan P, Akech S, Oduro A, Mathanga DP, Fogelson A, Kwambai TK, Hamel MJ, Kapito-Tembo A, Gyan T, Westercamp N, Okine RNA, Moore KA, Pellaux-Furrer E, Stanley CC, Ansong D, Kariuki S, Njuguna P, Mvalo T, Welaga P, Otieno L, Snell P, Schellenberg D, Chimala A, Afari EA, Bejon P, Maleta K, Agbenyega T, Snow RW, Zulu M, Odei-Lartey E, Chinkhumba J, Samuels AM; Malaria Vaccine Programme Evaluation partners. Impact of introducing RTS,S/AS01E malaria vaccine on mortality in young children in Ghana, Kenya, and Malawi: an observational evaluation of a cluster-randomised implementation programme. Lancet. 2026 May 9;407(10541):1796-1808. doi: 10.1016/S0140-6736(26)00248-5.
PubMed 42107373Westercamp N, Nyangau I, Kwambai TK, Seda B, Akach D, Okanda I, Marube E, Siambe P, Radiro E, Wafula F, Ondiegi B, Shah MP, Seffren V, Moore KA, Fogelson A, Milligan P, Kariuki S, Samuels AM. The Malaria Vaccine Programme Evaluation in Kenya: results of a baseline household survey prior to the introduction of the RTS,S/AS01 vaccine. Malar J. 2026 Apr 21;25(1):198. doi: 10.1186/s12936-026-05911-2.
PubMed 42015261Hoyt J, Okello G, Bange T, Kariuki S, Jalloh MF, Webster J, Hill J. RTS,S/AS01 malaria vaccine pilot implementation in western Kenya: a qualitative longitudinal study to understand immunisation barriers and optimise uptake. BMC Public Health. 2023 Nov 18;23(1):2283. doi: 10.1186/s12889-023-17194-2.
PubMed 37980467
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Pilot Implementation of RTS,S/AS01 Through Routine Health Systems in Moderate to High Malaria Transmission Settings in Africa
- ClinicalTrials.gov ID
- NCT03806465
- Acronym / sponsor ID
- MVPE / RTSS MVPE
- Conditions
- Malaria,Falciparum, Feasibility, Safety, Mortality
- Keywords
- Vaccine, Malaria, Africa, Child
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30,124 participants (actual)
- Lead sponsor
- Rafiq OKINEUniversity, hospital or other
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 16 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The RTS,S/AS01 malaria vaccine is being introduced sub-nationally in phased pilot introductions through the EPI programmes in Malawi Ghana and Kenya. Vaccine introduction is by the respective MoH in selected areas randomly assigned to receive the vaccine at the beginning of the pilots. In the context of this programmatic activity, the Malaria Vaccine Pilot Evaluation (MVPE) registered here as observational evaluations during early vaccine introduction, include a series of 3 household surveys, and sentinel hospital and community mortality surveillance, building on routine systems.
These observational evaluations will measure:
- The programmatic feasibility of delivering a 4 dose schedule;
- Safety in routine use, with focus on cerebral malaria and meningitis;
- The impact of the malaria vaccine in routine use on severe malaria and all-cause mortality
Detailed description
An evaluation of the pilot implementation of RTS,S/AS01 through routine health systems in moderate to high malaria transmission settings in Ghana, Kenya and Malawi. In the context of the new vaccine introduction, the Ministries of Health in the three countries will introduce the malaria vaccine (RTS,S/AS01) in a phased fashion (with some areas introducing the malaria vaccine first and the latter half, after the evaluation period) building on the national immunization programmes which routinely deliver vaccines and expanding the schedule of their routine EPI contacts.
The evaluation of the pilot implementation will run for a total of about 46 months in each country. This will focus on the three main primary objectives of feasibility, safety and impact. The pilot implementation assumes that a total of 46-60 clusters will be identified per country, evenly split between implementation and comparison areas, with each cluster contributing approximately 4,000 children per year to the evaluation of RTS,S/AS01. Hence a total of approximately 120,000 children will receive the RTS,S vaccine in each country in each year. Evaluation data will be collected in the following ways.
COMMUNITY BASED MORTALITY SURVEILLANCE
Community based mortality surveillance will be established across the pilot evaluation areas to enable the evaluation of the impact of the malaria vaccine on all-cause mortality. This will use a network of Village Reporters (VR) to document all deaths among children aged up to 48 months in the implementation and comparison areas. Once the death is notified, a standardized, WHO-approved Verbal Autopsy (VA) will be performed, according to WHO guidelines and locally acceptable practices. The VA will focus is on confirming death, age and vaccination status. The total number of clusters per country is expected to range from 46-60. Assuming 4,000 children born per cluster per year, 30 months of vaccination and a total follow-up of 44 months, each cluster will contribute 23,134 person years at risk (pyar), allowing for 1% mortality in the first month of life, and 0.08% mortality for every month after the first month. This equates to a mortality risk of 22.2 per 1000 for children aged 5 to 36 months. A mortality risk of 21 per 1,000 equates to a rate, over 2.5 years, of 8.489455 per 1,000 pyar. Based on a minimum mortality rate of 8.5 per 1000 pyar, 23 clusters in each arm, each with an annual birth cohort of approximately 4,000 subjects, would have 80% power to detect, at the 5% significance level, a decrease of at least 10% in overall mortality in each country.
With this mortality risk, the pilot evaluation it is estimated to have approximately 80% power to detect an interaction between gender and treatment of 1.15 (i.e an increased risk of mortality in girls of 1.035), compared with the 1.9-fold increase in risk among girls receiving RTS,S/AS01 in the RTS,S Phase 3 trial.
FEASIBILITY (CROSS SECTIONAL HOUSEHOLD) SURVEYS)
Three household surveys will be conducted to evaluate the programmatic feasibility to deliver a 4 dose schedule at baseline (before vaccination starts), 18 months and 30 months after start of vaccination.
A sample size of 100 houses per cluster will estimate the cluster-specific coverage of RTS,S/AS01 to within 10% (ie 95% CI from 40 to 60%) using a conservative estimate of 50% coverage and a high response rate above 95% in each cluster. Assuming a design effect of 1.5 between clusters, the overall precision in RTS,S/AS01 and coverage estimates of other vaccines over the pilot programme's implementation and comparison areas will be 2% (ie 95%CI 48% to 52%) in each country. This will result in 15,800 (6,600 in Ghana, 4,600 each in Kenya and Malawi) households included in the surveys. The second household survey may be powered to generate coverage estimates in each arm, rather than in each cluster, to within ±2% of the true value.
SENTINEL HOSPITAL SURVEILLANCE
Four to eight sentinel hospitals will be identified in each country to collect information on a larger scale on the safety of the malaria vaccine in children aged less than 5 years admitted with a focus on cases of cerebral malaria and meningitis. The catchment area of each hospital (approximately a cluster) is expected to have an annual birth cohort of, and provide services for, approximately 4,000 children in the MVPE. Hence a total catchment area of 48,000 children in implementation areas and another 48,000 children in comparison areas will contribute to the hospital-based evaluation of safety across the programme (three countries, Ghana, Kenya and Malawi). This is expected to provide 80% power to detect a 1.7-fold increase in risk of cerebral malaria and 2.6-fold increase in risk of meningitis. Children admitted to the sentinel hospitals in this age group will be assessed for severe malaria and meningitis using a standardised surveillance approach.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Feasibility survey | – | Other: Feasibility surveyThese will be children living in the vaccinating and in non-vaccinating areas aged less than 5 years of age. For the midline household survey, this would be restricted to children aged 12-23 months of age. |
| Sentinel hospital surveillance | – | Other: Sentinel hospital surveillanceThese will be children living in the vaccinating and in non-vaccinating areas aged less than 5 years of age who are hospitalized in the 18 sentinel hospitals. |
| Community mortality surveillance | – | Other: Community mortality surveillanceThese will be children whose deaths are reported in the vaccinating and in non-vaccinating areas aged less than 5 years of age . |
Who may qualify
- Ages
- 1 month to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study population will comprise children aged 1-59 months living in the areas geographically-defined for this evaluation of the RTS,S/AS01 Malaria Vaccine Implementation in three countries (Ghana, Kenya and Malawi) in sub-Saharan Africa.
Key inclusion criteria (1 listed)
- Children aged 1-59 months
Key exclusion criteria (1 listed)
- Children aged less than 1 month or greater than 59 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Feasibility surveyA survey questionnaire will be administered at each household. At the baseline household survey, each child aged less than 5 years will be tested for malaria using a rapid malaria test. | Other | Feasibility survey |
| Sentinel hospital surveillanceCerebrospinal samples will be collected from all children hospitalised and suspected of having meningitis. | Other | Sentinel hospital surveillance |
| Community mortality surveillanceA verbal autopsy will be performed | Other | Community mortality surveillance |
Primary outcome
The number of deaths of any cause
Time frame: From 0 to 46 months after vaccination starts
Number of deaths of any cause in children aged 1-59 months.
Number of children admitted with a diagnosis of probable and confirmed meningitis cases
Time frame: From 0 to 30 months after vaccination starts
Number of children with probable and confirmed meningitis A probable case if in a suspected case, the macroscopic aspect of the CSF is turbid, cloudy or purulent; or the CSF leukocyte count is >10 cells/mm3. A confirmed case is if a suspected or probable case is laboratory confirmed by culturing or identifying (i.e. by polymerase chain reaction, immunochromatographic dipstick or latex agglutination) bacterial, viral or other aetiology in the CSF.
Number of children admitted with a diagnosis of cerebral malaria
Time frame: From 0 to 30 months after vaccination starts
Cerebral malaria is defined as Severe P. falciparum malaria with coma (Glasgow coma score < 11 in children two years of age or older [≥ 2 years] or Blantyre coma score < 3 in children less than two years of age [(< 2 years]); and If malaria with seizure: coma persisting for > 30 min after the seizure. Other treatable causes of coma should be excluded before diagnosing cerebral malaria (e.g. hypoglycaemia, bacterial meningitis)
Number of children aged 12-23 months who have completed the primary series (the 3 dose regime) of the malaria vaccine
Time frame: At 18 months after vaccination starts
Prevalence of children aged 12-23 months who had completed three doses of RTS,S/AS01 at the second household survey
Number of children aged 27-38 months who have completed the 4th dose of the malaria vaccine
Time frame: At 30 months after vaccination starts
Prevalence of children aged 27-38 months who had completed four doses of RTS,S/AS01 at the third household survey
14 secondary outcomes
Number of deaths in children by gender
Time frame: From 0 to 46 months after vaccination starts
Number of deaths in hospitalised children by gender
Time frame: From 0 to 46 months after vaccination starts
Number of malaria associated deaths in hospitalised children by gender
Time frame: From 0 to 46 months after vaccination starts
Number of children with a diagnosis of severe malaria
Time frame: From 0 to 30 months after vaccination starts
Number of deaths excluding those attributed to trauma, poisoning and drowning
Time frame: From 0 to 46 months after vaccination starts
Number of children with a diagnosis of aetiology confirmed meningitis
Time frame: 30 months after vaccination starts
Number of children with a diagnosis of suspected meningitis
Time frame: From 0 to 30 months after vaccination starts
Number of children with a diagnosis of probable meningitis
Time frame: From 0 to 30 months after vaccination starts
Number of children with a diagnosis of malaria
Time frame: From 0 to 30 months after vaccination starts
Number of children with a non-malaria diagnosis
Time frame: From 0 to 30 months after vaccination starts
Number of children with a diagnosis of anaemia
Time frame: From 0 to 30 months after vaccination starts
Number of children who have received all their routine EPI vaccines as recommended by their national immunization schedule
Time frame: At 18 and 30 months after vaccination starts
Number of children who have received all the recommended malaria prevention and control measures
Time frame: At 18 and 30 months after vaccination starts
Number of children who have received all of the other key childhood interventions
Time frame: At 18 and 30 months after vaccination starts
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Background: PubMed 26829826Malaria vaccine: WHO position paper-January 2016. Wkly Epidemiol Rec. 2016 Jan 4;91(4):33-51. No abstract available. English, French.
- Background: PubMed 25913272RTS,S Clinical Trials Partnership. Efficacy and safety of RTS,S/AS01 malaria vaccine with or without a booster dose in infants and children in Africa: final results of a phase 3, individually randomised, controlled trial. Lancet. 2015 Jul 4;386(9988):31-45. doi: 10.1016/S0140-6736(15)60721-8. Epub 2015 Apr 23.
- Derived from this study: PubMed 42107373Mwapasa V, Asante KP, Milligan P, Akech S, Oduro A, Mathanga DP, Fogelson A, Kwambai TK, Hamel MJ, Kapito-Tembo A, Gyan T, Westercamp N, Okine RNA, Moore KA, Pellaux-Furrer E, Stanley CC, Ansong D, Kariuki S, Njuguna P, Mvalo T, Welaga P, Otieno L, Snell P, Schellenberg D, Chimala A, Afari EA, Bejon P, Maleta K, Agbenyega T, Snow RW, Zulu M, Odei-Lartey E, Chinkhumba J, Samuels AM; Malaria Vaccine Programme Evaluation partners. Impact of introducing RTS,S/AS01E malaria vaccine on mortality in young children in Ghana, Kenya, and Malawi: an observational evaluation of a cluster-randomised implementation programme. Lancet. 2026 May 9;407(10541):1796-1808. doi: 10.1016/S0140-6736(26)00248-5.
- Derived from this study: PubMed 42015261Westercamp N, Nyangau I, Kwambai TK, Seda B, Akach D, Okanda I, Marube E, Siambe P, Radiro E, Wafula F, Ondiegi B, Shah MP, Seffren V, Moore KA, Fogelson A, Milligan P, Kariuki S, Samuels AM. The Malaria Vaccine Programme Evaluation in Kenya: results of a baseline household survey prior to the introduction of the RTS,S/AS01 vaccine. Malar J. 2026 Apr 21;25(1):198. doi: 10.1186/s12936-026-05911-2.
- Derived from this study: PubMed 37980467Hoyt J, Okello G, Bange T, Kariuki S, Jalloh MF, Webster J, Hill J. RTS,S/AS01 malaria vaccine pilot implementation in western Kenya: a qualitative longitudinal study to understand immunisation barriers and optimise uptake. BMC Public Health. 2023 Nov 18;23(1):2283. doi: 10.1186/s12889-023-17194-2.
- Key milestones in the development of the Malaria Vaccine Implementation Programme (MVIP): from pilot recommendation to vaccine introductionLink provided by the sponsor.
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Malaria,Falciparum
Active, not recruitingPhase 1
A Study to Assess the Experimental Malaria Vaccines R78C and RH5.1 Combined With R21/Matrix-M (a "Multi-stage" Malaria Vaccine)
Malaria,Falciparum
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Don Mathanga, PhD principal investigator
College of Medicine, Malawi
Kwaku Poku Asante, PhD principal investigator
Kintampo Health Research Centre, Ghana
Aaron Samuels, MD principal investigator
CDC-Kenya Malaria Program
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria,Falciparum and Feasibility, run by Rafiq OKINE at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Ghana, Kenya, Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of deaths of any cause (time frame: From 0 to 46 months after vaccination starts). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03806465, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.