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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03143218 |
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Date of registration:
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22/03/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Seasonal Malaria Vaccination (RTS,S/AS01) and Seasonal Malaria Chemoprevention (SP/AQ)
RTSS-SMC |
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Scientific title:
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A Phase IIIB Comparative Trial of Seasonal Vaccination With the Malaria Vaccine RTS,S/AS01, Seasonal Malaria Chemoprevention and of the Two Interventions Combined |
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Date of first enrolment:
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April 17, 2017 |
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Target sample size:
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5920 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03143218 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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Phase 3
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Countries of recruitment
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Burkina Faso
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Mali
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Contacts
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Name:
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Ogobara Doumbo, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Malaria Research & Training Center, Bamako |
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Name:
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Alassane Dicko, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Malaria Research & Training Center, Bamako |
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Name:
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Jean Bosco Ouedraogo, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institut de Recherche en Sciences de la Santé, Direction Régionale de l'Ouest (IRSS-DRO) |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- The child is a permanent resident of the study area and likely to remain a resident
for the duration of the trial
- The child is 5 - 17 months of age at the time of first vaccination
- A parent or legally recognised guardian provides informed consent for the child to
join the trial
Exclusion Criteria:
- The child is a transient resident in the study area
- The child is in care
- The age of the child is outside the stipulated range
- The child has a history of an adverse reaction to SP or AQ
- The child has a serious underlying illness, including known HIV infection, unless this
is well controlled by treatment, or severe malnutrition (weight for age or mid arm
circumference Z scores < 3 SD)
- The child is known to have an immune deficiency disease or is receiving an
immunosuppressive drug
- The child has previously received a malaria vaccine.
- The child is enrolled in another malaria intervention trial
- The parents or guardians do not provide informed consent
Age minimum:
5 Months
Age maximum:
17 Months
Gender:
All
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Health Condition(s) or Problem(s) studied
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Children, Only
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Malaria,Falciparum
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Intervention(s)
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Biological: RABIPUR®
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Biological: RTS,S/AS01
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Drug: SMC placebo
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Drug: SMC with SP+AQ
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Primary Outcome(s)
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Incidence of clinical episodes of malaria
[Time Frame: 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.]
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Secondary Outcome(s)
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Prevalence of malaria parasitaemia in school aged children
[Time Frame: 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).]
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Hospital admissions with malaria, including severe malaria
[Time Frame: 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.]
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Prevalence of malaria parasitaemia, including gametocytaemia and the prevalence of moderate and severe anemia and malnutrition
[Time Frame: Blood sample collection during 2-week cross sectional survey at the end of each malaria transmission season.]
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Serious adverse events (SAEs)
[Time Frame: Through study completion (for 30 months), each SAE will be treated and documented according to ICH-GCP.]
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Immune response to the vaccine (anti-CSP antibody concentrations)
[Time Frame: 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.]
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SP+AQ drug sensitivity
[Time Frame: 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.]
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Drug resistance to SP and AQ
[Time Frame: Blood sample collection during the 2-week cross sectional survey conducted at the end of malaria transmission season in 2019.]
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Prevalence of malaria infection not severe enough to warrant a clinic visit
[Time Frame: Weekly home visits through study completion from July 2017 - April 2020 to screen study children for malaria.]
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Clinical episodes of uncomplicated febrile illness
[Time Frame: 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.]
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Secondary ID(s)
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ITDCZJ29 - Greenwood
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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