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. Author manuscript; available in PMC: 2010 Jan 26.
Published in final edited form as: J Infect Dis. 2009 Aug 1;200(3):321–328. doi: 10.1086/603560

Table 1.

Summary of Study Populations and Severe Adverse Events (SAEs) Observed in H5N1 Clinical Trials

Type of vaccine Total study population
 SAEs
Children Adults Elderly
persons		 Total Observed number Upper bound for the
risk of SAE
Inactivated whole virion 12 3077 190 3279 0 1 of 1095
Inactivated split virion 370 9038 196 9604 0 1 of 3206
Inactivated subunit 0 5728 173 5901 0 1 of 1970
 Total 382 17,843 559 18,784 0 1 of 6270

NOTE. Data are based on information presented to the World Health Organization SAGE Group, April 2009 [25]. The upper bound for the risk of SAE is for type 1 error α = 5% (Appendix A).