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A Surveillance Study of Diseases Specified as Adverse Events of Special Interest, of Other Adverse Events Leading to Hospitalisation or Death, and of Meningitis in Children in Africa Prior to Implementation of the RTS,S/AS01E Candidate Vaccine

NCT02374450 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 36366

Last updated 2024-09-19

Study results available
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Summary

The purpose of this pre-licensure cohort study was to estimate the incidence of adverse events of special interest (AESI), other adverse events (AE) leading to hospitalisation or death, meningitis and malaria in sub-Saharan African children under 5 years of age. The outcomes of this study provide the baseline data for the post-licensure EPI-MALARIA-003 (115056) study that evaluated the safety, effectiveness and impact of the RTS,S/AS01E vaccine.

An interim analysis was performed on a sub-group of study participants enrolled in active surveillance from sites where the vaccine was implemented, having 6 months of follow-up after the administration of dose 3 of DTP/HepB/Hib vaccine (6-12 weeks group), or 6 months after Visit 3 (mimicking the RTS,S/AS01E primary vaccination schedule) for the 5-17 months group; corresponding to Visit 5. The interim analysis concerned primary safety endpoints and the main secondary endpoints.

Conditions

Interventions

PROCEDURE

Blood collection

For all hospitalised children suspected of having an AESI or meningitis, a sample of 5 ml of whole blood was collected and the serum was stored.

Sponsors & Collaborators

  • PATH

    collaborator OTHER

  • Agence de Médecine Préventive, France

    collaborator OTHER

  • Réseau en Afrique Francophone pour la Télémédecine,

    collaborator OTHER

  • Iqvia Pty Ltd

    collaborator INDUSTRY

  • Parexel

    collaborator INDUSTRY

  • Clinical Laboratory Services

    collaborator OTHER

  • GlaxoSmithKline

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Eligibility

Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-05
Primary Completion
2022-08-02
Completion
2022-08-02

Countries

  • Burkina Faso
  • Ghana
  • Kenya

Study Locations

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Entities

Diseases
Companies

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 NCT02374450 on ClinicalTrials.gov