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2.6. Sample size

AO Alphonse Ouédraogo
EB Edith Christiane Bougouma
NP Nirianne Marie Q. Palacpac
SH Sophie Houard
IN Issa Nebie
JS Jean Sawadogo
GB Gloria D. Berges
IS Issiaka Soulama
AD Amidou Diarra
DH Denise Hien
AO Amidou Z. Ouedraogo
AK Amadou T. Konaté
SK Seni Kouanda
AM Akira Myoui
SE Sachiko Ezoe
KI Ken J. Ishii
TS Takanobu Sato
FD Flavia D’Alessio
OL Odile Leroy
AT Alfred B. Tiono
SC Simon Cousens
TH Toshihiro Horii
SS Sodiomon B. Sirima
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One hundred and thirty-five (135) healthy participants were planned for 3 cohorts of malaria-exposed African adults and children as described above. The sample size was calculated to address the primary objective (safety). In each cohort (assuming n = 29 evaluable participants in the BK-SE36/CpG arm), the probability of seeing at least one SAE was 95% if the underlying risk of an SAE was 10%. If the risk of an SAE was 5% then the probability of seeing at least one SAE was 77%. With 87 vaccinees the probability of detecting at least one SAE was >99% if the risk was 10%; 99% if the risk was 5% and 58% if the risk was 1%.

Copyright and License information:  ©2023 Ouédraogo, Bougouma, Palacpac, Houard, Nebie, Sawadogo, Berges, Soulama, Diarra, Hien, Ouedraogo, Konaté, Kouanda, Myoui, Ezoe, Ishii, Sato, D’Alessio, Leroy, Tiono, Cousens, Horii and Sirima
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