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Template protocol for clinical trials investigating vaccines—Focus on safety elements

Jan Bonhoeffer, Egeruan B. Imoukhuede, Grace M. Aldrovandi, Novilia Sjafri Bachtiar, Eng-Soon Chan, Soju Chang, Robert T. Chen, Rohini Fernandopulle, Karen L. Goldenthal, James D. Heffelfinger,

Vaccine · 2013 · 23 citations · 19 references

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References

19

Anaphylaxis: Case definition and guidelines for data collection, analysis, and presentation of immunization safety data

J. Rüggeberg, Michael Gold, José-María Bayas et al. · Vaccine · 2007 · 386 citations

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Encephalitis, myelitis, and acute disseminated encephalomyelitis (ADEM): Case definitions and guidelines for collection, analysis, and presentation of immunization safety data

James J. Sejvar, Katrin Kohl, Roman Bilynsky et al. · Vaccine · 2007 · 192 citations

, , +14

Aseptic meningitis: Case definition and guidelines for collection, analysis and presentation of immunization safety data

Terhi Tapiainen, Rebecca Prevots, Héctor S. Izurieta et al. · Vaccine · 2007 · 113 citations

, , +14

A local reaction at or near injection site: Case definition and guidelines for collection, analysis, and presentation of immunization safety data

Jane Gidudu, Katrin Kohl, Scott A. Halperin et al. · Vaccine · 2008 · 95 citations

, , +16

Immunological Outcomes of New Tuberculosis Vaccine Trials: WHO Panel Recommendations

Willem A. Hanekom, Hazel M. Dockrell, Tom H. M. Ottenhoff et al. · PLoS Medicine · 2008 · 88 citations · Full text

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