Actively Recruiting

Age: 6Months - 59Months
All Genders
NCT05041556

Strengthening the Evidence for Policy on the RTS,S/AS01 Malaria Vaccine

Led by Kintampo Health Research Centre, Ghana · Updated on 2025-02-28

9280

Participants Needed

4

Research Sites

184 weeks

Total Duration

On this page

Sponsors

K

Kintampo Health Research Centre, Ghana

Lead Sponsor

E

European Vaccine Initiative

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Strengthening the Evidence for Policy on the RTS,S/AS01 Malaria Vaccine

Who Can Participate

Age: 6Months - 59Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • Caregiver not willing to provide consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Kintampo Health Research Centre

Kintampo, Ghana

Actively Recruiting

2

African Research Collaboration for Health Limited

Nairobi, Kenya

Actively Recruiting

3

Kenya Medical Research Institute (KEMRI)

Nairobi, Kenya

Actively Recruiting

4

College of Medicine, University of Malawi

Blantyre, Malawi

Actively Recruiting

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Research Team

T

Thomas Gyan

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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