Table 1.
All Phase 2 and 3 trials by vaccine and control, sponsor, country, start and end dates, number and age of participants and length of follow-up.
| Vaccine and control | Trial name, NCT number (and sponsor) | Research papers | Phase | Country | Start date | End date | Number of participants | Age at enrolment | Average (mean) length of follow-up |
|---|---|---|---|---|---|---|---|---|---|
| Cervarix versus aluminium-hydroxide containing control | HPV-001/580299 NCT00689741 (GSK) | Harper et al.20 | 2 | USA (incl. Puerto Rico), Brazil, Canada | Jan-01 | Apr-03 | 1113 | 15–25 | Up to 27 months (average not given) |
| Cervarix versus placebo aluminium-hydroxide containing control | HPV-007; follow-on study from HPV-001 NCT00120848 (GSK) | Harper et al.,21 Romanowski et al.22 | 2 | USA, Brazil, Canada | Nov-03 | Aug-07 | 776 | 15–25 | 5.9 years from first vaccination |
| Cervarix versus aluminium-hydroxide containing control | HPV-023/109616; follow-on study from HPV-001 and HPV-007 NCT00518336 (GSK) | De Carvalho et al.,23 Roteli-Martins et al.,24 Naud et al.25 | 2 | Brazil | Nov-07 | Jul-08 | 437 | 15–25 | 8.9 years from first vaccination |
| Cervarix versus Hepatitis A vaccine | 104798 (Konno) NCT00316693 (GSK) | Konno et al.26,27 | 2 | Japan | Apr-06 | Feb-09 | 1040 | 20–25 | 24 month after first vaccination |
| Cervarix versus Hepatitis A vaccine | PATRICIA/HPV-008 NCT00122681 (GSK) | Paavonen et al.,28,29 Lehtinen et al.,30 Wheeler et al.,31 Palmroth et al.,32 Szarewski et al.,33 Apter et al.,34 Struyf et al.35 | 3 | USA, Australia, Belgium, Brazil, Canada, Finland, Germany, Italy, Mexico, Philippines, Spain, Taiwan, Thailand, UK | May-04 | Nov-09 | 18,644 | 15–25 | Mean 43.7 months (median 47.4) |
| Cervarix versus Hepatitis A vaccine | Costa Rica Vaccine Trial/CVT/ HPV-009 NCT00128661 (NCI & GSK) | Herrero et al.,36 Kreimer et al.,37 Rodriguez et al.,38 Hildesheim et al.,39,40 Beachler et al.41 | 3 | Costa Rica | Jun-04 (initiation into trial) | Dec-10 (final data collection for primary outcome) | 7465 | 18–25 | 53.8 months |
| Cervarix versus aluminium-hydroxide containing control | VIVIANE/HPV-015/104820 NCT00294047 (GSK) | Skinner et al.,42 Wheeler et al.43 | 3 | Australia, Canada, Mexico, Netherlands, Peru, Philippines, Portugal, Russia, Singapore, Thailand, UK, USA | Feb-06 | Jan-14 | 5747 | 26+ | 5.9 years TVC from first vaccination, 5.7 years in ATP-E group from third vaccination |
| Cervarix versus aluminium-hydroxide containing control | 107638/Zhu NCT00779766 (GSK) | Zhu et al.44,45 | 3 | China | Oct-08 | Oct-14 | 6051 | 18–25 | Mean 57 months TVC-E from first vaccination, 52 months ATP-E group from third vaccination |
| Gardasil versus aluminium hydroxyphosphate sulphate adjuvant containing control | V501-007 NCT00365716 (Merck) | Villa et al.46,47 | 2 | Brazil, Finland, Sweden, Norway, USA | May-00 | May-04 | 552 (initial study up to three years), 241 (extension study up to five years) | 16–23 | Initial study up to 36 months (average not given). Extension study up to five years (results given for 226 women who completed study to 60 months, average not given) |
| Gardasil versus aluminium hydroxyphosphate sulphate adjuvant containing control | FUTURE I/V501-013 NCT00092521 (Merck) | Garland et al.48 | 3 | Australia, Austria, Brazil, Canada, Colombia, Czech Republic, Germany, Hong Kong, Italy, Mexico, New Zealand, Russia, Thailand, UK, USA (incl. Puerto Rico) | Dec-01 | Jul-07 | 5455 | 16–24 | Average three years from first vaccination |
| Gardasil versus aluminium hydroxyphosphate sulphate adjuvant containing control | FUTURE II/ V501-015 NCT00092534 (Merck) | Future II Study Group49 | 3 | Brazil, Colombia, Denmark, Finland, Iceland, Mexico, Norway, Peru, Poland, Singapore, Sweden, UK, USA (incl. Puerto Rico) | Jun-02 | Jul-07 | 12,167 | 15–26 | Average three years from first vaccination |
| Gardasil versus aluminium hydroxyphosphate sulphate adjuvant containing control | FUTURE III/V501-019 NCT00090220 (Merck) | Munoz et al.50 Castellsague et al.51 | 3 | Colombia, France, Germany, Philippines, Thailand, USA, Spain | Jun-04 | May-09 | 3819 | 24–45 | Median 4 years (mean 3.8 years) |
| Gardasil versus aluminium hydroxyphosphate sulphate adjuvant containing control | V501-027 NCT00378560 (Merck) | Yoshikawa et al.52 | 2 | Japan | Jun-06 | Sep-09 | 1021 | 18–26 | 30 months (23 months after month 7) |
| Gardasil versus aluminium hydroxyphosphate sulphate adjuvant containing control | V501-041 NCT00834106 (Merck) | Wei et al.53 | 3 | China | Jan-09 | Sep-16 | 3006 | 20–45 | Mean 6.07 years after first vaccination |