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Safety monitoring of mpox vaccines using cohort event monitoring: a WHO protocol / World Health Organization

Tác giả : World Health Organization

Nhà xuất bản : World Health Organization

Năm xuất bản : 2024

ISBN : 9789240104068 (electronic version); 9789240104075 (print version)

Chủ đề : 1. Advisory Committees. 2. Breast Feeding. 3. Cohort Effect. 4. Data Management. 5. Disease Outbreaks. 6. Ethical Review. 7. Form. 8. Immunization. 9. Incidence. 10. Infant, Newborn. 11. Monitoring, Immunologic. 12. Monkeypox -- prevention and control. 13. Monkeypox virus -- epidemiology. 14. Pregnancy. 15. Safety Management. 16. Vaccination. 17. World Health Organization. 18. Publications.

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xi, 49 p.On the front page also: "Protocol identifying number: ERC.0004184. Use of this protocol: As a master protocol to be approved by WHO Ethical Review Committee (ERC), study sites will submit this protocol to national ERCs with amendments including the names of the national principal investigators (PIs) and research teams and study sites. Only changes that would be made on a country-specific basis would be those to facilitate translation into the local language, address the specific concerns of local ERCs, and adding local study facility sites and study teams. Amended site-specific protocols developed for implementation in countries under this WHO master protocol will be submitted for review and approval to the WHO ERC prior to implementation."
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https://iris.who.int/handle/10665/379659