@article{fdi:010064145,
  title = {{D}esign of a {P}hase {III} cluster randomized trial to assess the efficacy and safety of a malaria transmission blocking vaccine},
  author = {{D}elrieu, {I}. and {L}eboulleux, {D}. and {I}vinson, {K}. and {G}essner, {B}. {D}. and {C}handramohan, {D}. and {C}hurcher, {T}. and {D}rakeley, {C}. and {H}alloran, {E}. and {K}illeen, {G}. and {K}leinschmidt, {I}. and {M}illigan, {P}. and {R}obert, {V}incent and {R}ogier, {C}. and {S}aul, {A}. and {S}inden, {R}. and {S}mith, {T}.},
  editor = {},
  language = {{ENG}},
  abstract = {{V}accines interrupting {P}lasmodium falciparum malaria transmission targeting sexual, sporogonic, or mosquito-stage antigens ({SSM}-{VIMT}) are currently under development to reduce malaria transmission. {A}n international group of malaria experts was established to evaluate the feasibility and optimal design of a {P}hase {III} cluster randomized trial ({CRT}) that could support regulatory review and approval of an {SSM}-{VIMT}. {T}he consensus design is a {CRT} with a sentinel population randomly selected from defined inner and buffer zones in each cluster, a cluster size sufficient to assess true vaccine efficacy in the inner zone, and inclusion of ongoing assessment of vaccine impact stratified by distance of residence from the cluster edge. {T}rials should be conducted first in areas of moderate transmission, where {SSM}-{VIMT} impact should be greatest. {S}ample size estimates suggest that such a trial is feasible, and within the range of previously supported trials of malaria interventions, although substantial issues to implementation exist.},
  keywords = {{T}ransmission blocking vaccine ; {M}alaria ; {T}rial design ; {C}luster randomized trial ; {AFRIQUE} {SUBSAHARIENNE} ; {ZONE} {TROPICALE}},
  booktitle = {},
  journal = {{V}accine},
  volume = {33},
  numero = {13},
  pages = {1518--1526},
  ISSN = {0264-410{X}},
  year = {2015},
  DOI = {10.1016/j.vaccine.2015.01.050},
  URL = {https://www.documentation.ird.fr/hor/fdi:010064145},
}