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Malaria Vaccine Pilot Evaluation

NCT03806465 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30124

Last updated 2024-12-17

No results posted yet for this study

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. 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:

1. The programmatic feasibility of delivering a 4 dose schedule;
2. Safety in routine use, with focus on cerebral malaria and meningitis;
3. The impact of the malaria vaccine in routine use on severe malaria and all-cause mortality

Conditions

  • Malaria,Falciparum
  • Feasibility
  • Safety
  • Mortality

Interventions

OTHER

Feasibility survey

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.

OTHER

Sentinel hospital surveillance

Cerebrospinal samples will be collected from all children hospitalised and suspected of having meningitis.

OTHER

Community mortality surveillance

A verbal autopsy will be performed

Sponsors & Collaborators

  • Rafiq OKINE

    lead OTHER

Principal Investigators

  • Don Mathanga, PhD · College of Medicine, Malawi

  • Kwaku Poku Asante, PhD · Kintampo Health Research Centre, Ghana

  • Aaron Samuels, MD · CDC-Kenya Malaria Program

Eligibility

Min Age
1 Month
Max Age
59 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-25
Primary Completion
2023-07-31
Completion
2023-07-31

Countries

  • Ghana
  • Kenya
  • Malawi

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03806465 on ClinicalTrials.gov