Evaluating the RTS,S malaria vaccine's safety and effectiveness

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study is part of the Malaria Vaccine Pilot Evaluation (MVPE) and aims to assess the safety and effectiveness of the RTS,S/AS01 malaria vaccine through case-control studies in Ghana, Malawi, and Kenya. It will involve recruiting children aged 6 to 59 months from sentinel hospitals and surrounding communities, where each case will be matched with four controls. The study will focus on measuring safety outcomes, including severe malaria and all-cause mortality, while also promoting the use of case-control methodologies in immunization programs.

Why it matters

Who can join: the full rules

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

Where it's running

• Kintampo Health Research Centre
  Kintampo, Ghana Recruiting
• African Research Collaboration for Health Limited
  Nairobi, Kenya Recruiting
• Kenya Medical Research Institute (KEMRI)
  Nairobi, Kenya Recruiting
• College of Medicine, University of Malawi
  Blantyre, Malawi Recruiting

Study contacts

• Principal investigator: Kwaku Poku Asante, PhD — Kintampo Health Research Centre, Ghana
• Study coordinator: Thomas Gyan
• Email: thomas.gyan@kintampo-hrc.org
• Phone: 0208398541

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.