Table 1. Included studies.
Study name | V501–007 | V501–013 | V501–015 | V501–019 | HPV–008 | HPV–009 | HPV–015 | HPV–039 | HPV–032/063 | |
---|---|---|---|---|---|---|---|---|---|---|
Trial number | NCT00365716 | NCT00092521 | NCT00092534 | NCT00090220 | NCT00122681 | NCT00128661 | NCT00294047 | NCT00779766 | NCT00316693 | |
Year | 2000–2004 | 2001–2007 | 2002–2007 | 2004–2009 | 2005–2010 | 2005–2012 | 2006–2012 | 2008–2014 | 2009–2013 | |
Phase | III | III | III | III | III | III | III | II/III | II | |
Intervention | Gardasil | Gardasil | Gardasil | Gardasil | Cervarix | Cervarix | Cervarix | Cervarix | Cervarix | |
Comparator | Placebo | Placebo | Placebo | Placebo | Hep A vaccine | Hep A vaccine | Placebo | Placebo | Hep A vaccine | |
Country | International | International | International | International | International | Costa Rica | International | China | Japan | |
Key inclusion criteria | ||||||||||
Age | 16–23 | 16–23 | 15–26 | 24–45 | 15–25 | 18–25 | ≥26 | 18–25 | 20–25 | |
Lifetime partners | 0–4 | 0–4 | 0–4 | Any | 0–6 | Any | Any | NR | NR | |
Endpoints | ||||||||||
Point prevalence at 4 years | x | |||||||||
6-mo persistent infection | x | x | x | x | ||||||
12-mo persistent infection | x | x | x | x | ||||||
CIN1+ | x | x | x | x | x | x | x | |||
CIN2+ | x | x | x | x | x | x | ||||
Participants | ||||||||||
Total vaccine | 9,087 | 2,723 | 6,087 | 1,910 | 9,319 | 3,727 | 2,877 | 3,026 | 375 | |
Total control | 9,087 | 2,732 | 6,080 | 1,907 | 9,325 | 3,729 | 2,870 | 3,025 | 377 | |
SPDN vaccine | 1,298 | 377 | 498 | 496 | 1,710 | 986 | 2,870 | 286 | 117 | |
SPDN control | 1,319 | 379 | 524 | 505 | 1,777 | 980 | 2,908 | 270 | 90 |
CIN, cervical intraepithelial neoplasia; HPV, human papillomavirus; NR, not reported; SPDN, seropositive, DNA negative.