NCT05041556 Strengthening the Evidence for Policy on the RTS,S/AS01 Malaria Vaccine
| NCT ID | NCT05041556 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kintampo Health Research Centre, Ghana |
| Condition | Malaria |
| Study Type | OBSERVATIONAL |
| Enrollment | 9,280 participants |
| Start Date | 2021-10-18 |
| Primary Completion | 2025-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 9,280 participants in total. It began in 2021-10-18 with a primary completion date of 2025-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The ongoing Malaria Vaccine Pilot Evaluation (MVPE) is being conducted in Ghana, Malawi and Kenya through community and sentinel hospital surveillance systems and a series of household surveys (to measure vaccine coverage). The Malaria Vaccine Pilot Evaluation-Case Control (MVPE-CC) registered here as observational study is embedded within MVPE comprising case-control studies of clinical and mortality outcomes. Each case will require four controls, and caregiver informed consent will be required prior to study activities. These observational case control studies will measure as complementary information to what is being collected through MVPE: 1. Safety among children who received the malaria vaccine, with focus on cerebral malaria, meningitis and severe malaria 2. The impact of the malaria vaccine on all-cause mortality for boys and girls, AND 3. Promote use of case-control approaches by Expanded Programmes on Immunization (EPI) and malaria control programmes.
Eligibility Criteria
Inclusion Criteria: * Willingness to participate in study evidenced by written informed consent provided by an adult caregiver * Resident in an RTS,S/AS01 implementation area within the catchment area of MVPE sentinel hospitals * Eligible, based on date of birth and age, to have received RTSS/AS01 * Meets the case or control definitions above. Exclusion Criteria: * Caregiver not willing to provide consent
Contact & Investigator
Kwaku Poku Asante, PhD
PRINCIPAL INVESTIGATOR
Kintampo Health Research Centre, Ghana
Frequently Asked Questions
Who can join the NCT05041556 clinical trial?
This trial is open to participants of all sexes, aged 6 Months or older, up to 59 Months, studying Malaria. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05041556 currently recruiting?
Yes, NCT05041556 is actively recruiting participants. Contact the research team at thomas.gyan@kintampo-hrc.org for enrollment information.
Where is the NCT05041556 trial being conducted?
This trial is being conducted at Kintampo, Ghana, Nairobi, Kenya, Nairobi, Kenya, Blantyre, Malawi.
Who is sponsoring the NCT05041556 clinical trial?
NCT05041556 is sponsored by Kintampo Health Research Centre, Ghana. The principal investigator is Kwaku Poku Asante, PhD at Kintampo Health Research Centre, Ghana. The trial plans to enroll 9,280 participants.