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<p>The RTS,S/AS01 malaria vaccine implementation programme evaluated safety signals from the phase 3 trial using sentinel hospital and community-based mortality surveillance. Strengthened pharmacovigilance was used to identify rare, unanticipated signals related to vaccination. Cohort event monitoring was designed to identify rare conditions of special interest. We summarise the strengths and weaknesses of these complementary approaches to safety monitoring.</p>

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Assessing safety in the RTS,S/AS01 malaria vaccine implementation programme: an overview and comparison of methods

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年4月25日

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  • David Schellenberg,
  • Mary Hamel,
  • Patricia Njuguna,
  • Eliane Furrer,
  • Nicolas Praet,
  • Madhava Ram Balakrishnan,
  • Sujeet Jain,
  • Diadié Maiga,
  • Lode Schuerman,
  • Cynthia G. Whitney

摘要

The RTS,S/AS01 malaria vaccine implementation programme evaluated safety signals from the phase 3 trial using sentinel hospital and community-based mortality surveillance. Strengthened pharmacovigilance was used to identify rare, unanticipated signals related to vaccination. Cohort event monitoring was designed to identify rare conditions of special interest. We summarise the strengths and weaknesses of these complementary approaches to safety monitoring.