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. 2020 Sep 23;17(3):880–896. doi: 10.1080/21645515.2020.1801071

Table 2.

Selected efficacy clinical trials* of four WHO prequalified live oral RV vaccines

Vaccines Study Time/Reporting Time Countries or Regions Enrollments Observation Duration (Year) Doses Efficacy on Conditions Efficacy, %(95%CI) Reference
Rotarix™ 2001–2003 Singapore 2464 1 2 RVGE 82.0% (N/A) 231
  2003–2004 Latin American, Finland 63,225 1 2 severe RVGE 84.7% (71.7%-92.4%) 110
  2004–2005 Europe countries 3994 1 2 RVGE 78.9% (72.7%-83.8%) 106
severe RVGE 90.4% (85.1%-94.1%)
  2003–2008 Hong Kong, Singapore, Taiwan 10,708 2 2 severe RVGE 96.1% (85.1%-99.5%) 113
3 2 severe RVGE 96.9% (88.3%-99.6%) 114
  2003–2005 Singapore 6542 3 2 severe RVGE 95.2% (70.5%-99.9%) 232
  2003–2005 Hong Kong 3025 3 2 severe RVGE 96.1% (76.5%-99.9%) 233
  2005 South Africa, Malawi 4939 1 2/3 severe RVGE 61.2% (44.0%-73.2%) 25
  2006–2007 Malawi 1773 3 2/3 severe RVGE 38.1% (9.8%-57.3%) 118
RotaTeq™ 2001–2004 Belgium, Costa Rica, Finland, Germany, Guatemala, Italy, Jamaica,
Mexico, Puerto Rico, Sweden, Taiwan,
United States
70,301 First RV season 3 RVGE 74% (66.8%-79.9%) 84
severe RVGE 98% (88.3%-100%)
second RV season RVGE 62.6% (44.3%-75.4%)
severe RVGE 88% (49.4%-98.7%)
  2001–2004 Finland 23,422 3.1 3 RVGE hospitalizations and ED visits 93.8% (90.8%-95.9%) 88
  2007–2009 Ghana, Kenya,
Mali
5560 2 3 severe RVGE 39.3% (19.1%-54.7%) 24
  2007–2009 Bangladesh, Vietnam 2119 2 3 severe RVGE 48.3% (22.3%-66.1%) 27
  2014–2015 China 4173 At least 14 d after the third dose 3 RVGE 69.3% (54.5%-79.7%) 95
severe RVGE 78.9% (59.1%-90.1%)
Rotavac™ 2011–2013 India 6799 1 3 severe RVGE 53.6% (35.0%-66.9%) 133
2 3 severe RVGE 55.1% (39.9%-66.4%) 132
RotaSiil™ 2014–2015 Niger 4137 28 d after the third dose 3 severe RVGE 66.7% (49.9%-77.9%) 144

Abbreviations: RV, rotavirus; RVGE, RV gastroenteritis; CI, confidence interval; ED, emergency department; N/A, not applicable.

*These selected clinical trials were chosen in terms of the representative researches and the number of participants more than 1500.