Table 1.
Study | Subjects, n | Age, yr | HPV vaccine (Type of HPV) | Control | Country/Region | Follow-up, months | Reporting of adverse events | Outcome | |||
---|---|---|---|---|---|---|---|---|---|---|---|
2vHPV | 4vHPV | 9vHPV | Primary | Secondary | |||||||
027 Study [26] | 841 | 22.8 ± 2.1 | ✓ | placebo | Japan | 30 | Self-reported | ✓ | |||
028 Study [26] | 107 | 12.7 ± 2.4 | ✓ | placebo | Japan | 30 | Self-reported | ✓ | |||
Bhatla 2010 [27] | 354 | 28.4 ± 4.91 | ✓ | placebo | India | 7 | Self-reported | ✓ | ✓ | ||
Draper 2013 [28] | 198 | 12 (median) | ✓ | 4vHPV | United Kingdom | Not mention (at least 7 days) |
Self-reported | ✓ | |||
Einstein 2009 [29] | 1106 | 30.5 | ✓ | 4vHPV | United States | 7 | Self-reported | ✓ | |||
FUTURE II 2007 [30] | 12,167 | 20.0 ± 2.2 (HPV) 19.9 ± 2.1 (Control) |
✓ | placebo | Multinational | 36 | Self-reported | ✓ | ✓ | ||
Harper 2004 [31] | 1113 | 20 ± 3 | ✓ | placebo | Multinational | 27 | Self-reported | ✓ | ✓ | ||
Kang 2008 [32] | 176 | 16.6 | ✓ | placebo | Korea | 7 | Self-reported | ✓ | ✓ | ||
Kim 2011 [33] | 225 | 22 ± 2.37 | ✓ | placebo | Korea | Not mention (at least 30 days) | Self-reported | ✓ | ✓ | ||
Kim 2010 [34] | 321 | 11.9 ± 1.41 | ✓ | hepatitis A vaccine | Korea | 7 | Self-reported | ✓ | ✓ | ||
Konno 2009 [35] | 1022 | 22.5 ± 1.7 | ✓ | hepatitis A vaccinea | Japan | 7 | Self-reported | ✓ | |||
Lim 2014 [36] | 271 | 24.9 ± 4.02 | ✓ | placebo | Malesia | Not mention (at least 30 days) | Self-reported | ✓ | |||
Medina 2010 [37] | 2067 | 12.1 ± 1.4 | ✓ | hepatitis A vaccine | Multinational | 12 | Self-reported | ✓ | ✓ | ||
Mugo 2015 [38] | 250 | - | ✓ | placebo | Africa | 7 | Self-reported | ✓ | ✓ | ||
Munoz 2009 [39] | 3819 | 34.3 ± 6.3 | ✓ | placebo | Multinational | Not mention (at least 15 days) | Self-reported | ✓ | |||
Ngan 2010 [40] | 300 | 26 ± 4 | ✓ | placebo | Hong-Kong | 7 | Self-reported | ✓ | |||
Paavonen 2007 [41] | 18,644 | 20.0 ± 3.1 | ✓ | hepatitis A vaccine | Multinational | 12 | Self-reported | ✓ | ✓ | ||
Perez 2008 [42] | 6004 | 19.8 ± 3.0 (HPV) 20.3 ± 2.2 (Control) |
✓ | placebo | Multinational | 7 | Self-reported | ✓ | |||
Skinner 2014 [43] | 5752 | 37.0 ± 7.2 (HPV) 37.0 ± 7.3 (Control) |
✓ | placebo | Multinational | 48 | Self-reported | ✓ | |||
Sow 2013 [44] | 676 | 16.9 ± 4.29 | ✓ | placebo | Africa | 12 | Reported by trained field worker | ✓ | |||
Vesikari 2015 [45] | 600 | 12.6 ± 1.9 | ✓ | 4vHPV | Europe | 7 | Self-reported | ✓ | ✓ | ||
Villa 2006 [46] | 1106 | 20.0 ± 1.7 | ✓ | placebo | Multinational | 7 | Self-reported | ✓ | ✓ | ||
Zhu-1 2014 [47] | 750 | 13.1 ± 2.43 | ✓ | placebo | China | 12 | Self-reported | ✓ | ✓ | ||
Zhu-2 2014 [47] | 1212 | 35.7 ± 4.99 | ✓ | hepatitis B vaccine | China | 12 | Self-reported | ✓ | ✓ |
Primary outcome in our study was the overall incident of solicited local and systemic symptoms, and that of unsolicited symptoms after HPV vaccination. Secondary outcomes was were all the components of the primary outcome as well as cumulative incidence of grade 3 solicited local symptoms, solicited systemic symptoms, and unsolicited symptoms
Abbreviations: HPV human papillomavirus, 2vHPV bivalent human papillomavirus, 4vHPV quadrivalent human papillomavirus, 9vHPV 9-valent human papillomavirus
aContained no aluminum as adjuvant