Status:

UNKNOWN

An Extended Follow up of a RTS,S/AS01E Malaria Vaccine Trial

Lead Sponsor:

KEMRI-Wellcome Trust Collaborative Research Program

Collaborating Sponsors:

GlaxoSmithKline

Conditions:

Malaria

Eligibility:

All Genders

19-35 years

Brief Summary

Malaria is one of the leading causes of deaths in children below five years old. Despite antimalarial drugs and insecticide treated bed nets, the established means of treatment and protection, malaria...

Detailed Description

The RTS,S/AS01E candidate malaria vaccine is being developed for the routine immunization of infants and children living in malaria-endemic areas as part of the Expanded Program of Immunization (EPI)....

Eligibility Criteria

Inclusion

  • Enrollment and vaccination in the RTS,S/AS01E clinical trial (NCT00380393)
  • Written or oral, signed or thumb-printed and witnessed informed consent obtained from the parent(s)/guardian(s) of the child.

Exclusion

  • Moving out of the study area, so that follow up is impractical.

Key Trial Info

Start Date :

February 1 2009

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

August 1 2016

Estimated Enrollment :

450 Patients enrolled

Trial Details

Trial ID

NCT00872963

Start Date

February 1 2009

End Date

August 1 2016

Last Update

December 7 2015

Active Locations (1)

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1

Kemri Wellcome Trust Research Programme

Kilifi, Coast Province, Kenya, 80108