No. | ID Internal |
ID NCT |
ID Cochrane |
Publications | Phase | Countries/ continents | Age | Number |
Reason exclusion |
Safety | Efficacy |
1. Bivalent vaccine | |||||||||||
1.1. Published reports included in the Cochrane review | |||||||||||
1 | HPV‐001 | NCT00689741 | Phase 2 trial (v2) |
Harper 2004 Harper 2006 De Carvalho 2010 |
IIb | Brazil, Canada, USA | 16‐25y | 1113 | ‐ | + | + |
2 | HPV‐008 | NCT00122681 | PATRICIA |
Paavonen 2007 Paavonen 2009 Wacholder 2010 Szarewski 2011 Wheeler 2011 Lehtinen 2012 |
III | America, Asia, Europe, Oceania | 15‐25y | 18,644 | ‐ | + | + |
3 | HPV‐009 | NCT00128661 | CVT | Herrero 2011 | III | Costa Rica | 18‐25y | 7466 | ‐ | + | + |
4 | HPV‐013 | NCT00196924 NCT00316706 | immuno‐bridging (ph3,2v) |
Medina 2010 Schwarz 2012 |
III | America, Asia, Europe, Oceania | 10‐14y | 2067 | ‐ | + | _ |
5 | HPV‐015 | NCT00294047 | VIVIANE | Skinner 2014 | III | Europe | ≥26y | 5752 | ‐ | + | + |
6 | HPV‐021 | NCT00481767 | African_2 country trial (ph3,2v) | Sow 2013 | III | Africa | 10‐25y | 676 | ‐ | + | ‐ |
7 | HPV‐031 | NCT00344032 | India trial (ph3,2v) | Bhatla 2010 | III | India | 18‐35y | 354 | ‐ | + | ‐ |
8 | HPV‐032 | NCT00316693 | Japanese trial(ph2, 2v) |
Konno 2010 Konno 2010a Konno 2014 |
II | Japan | 20‐25y | 1046 | ‐ | + | ‐ |
9 | HPV‐033 | NCT00290277 | Korean trial (ph3b,2v) | Kim 2010 | III | Korea | 10‐14y | 321 | ‐ | + | ‐ |
10 | HPV‐035 | NCT00306241 NCT00811798 | Hong Kong trial (ph3,2v) | Ngan 2010 | III | Hong Kong | 18‐35y | 300 | ‐ | + | ‐ |
11 | HPV‐036 | NCT00345878 | Malaysian trial (ph3,2v) | Lim 2014 | III | Malaysia | 18‐35y | 271 | ‐ | + | ‐ |
12 | HPV‐038 | NCT00485732 | Korean trial (ph3,2v) | Kim 2011 | III | S‐Korea | 15‐25y | 225 | ‐ | + | ‐ |
13 | HPV‐058 | NCT00996125 | Chinese trial (ph3,2v)_adolescent | Zhu 2014a | III | China | 9‐17y | 750 | ‐ | + | ‐ |
14 | HPV‐039 | NCT00779766 | Chinese trial (ph3,2v)_young | Zhu 2014 | III | China | 18‐25y | 6051 | ‐ | + | + |
15 | HPV‐069 | NCT01277042 | Chinese trial (ph3,2v)_mid‐adult | Zhu 2014a | III | China | 26‐45y | 1212 | ‐ | + | ‐ |
1.2. Excluded studies | |||||||||||
16 | HPV‐020 | NCT00586339 | ‐ | Denny 2013 | II | S‐Africa | 18‐25y | 150 | HIV sero+ women: randomised to vaccine or placebo. Small group HIV sero‐ women: all received vaccine. | + | ‐ |
1.3. Non published studies* | |||||||||||
17 | HPV‐003 | NCT00263744 | ‐ | ‐ | I/II | USA | 18‐30y | 60 | Trial evaluating safety and immunogenicity in HPV16/18 DNA positive women. No data published | + | ‐ |
18 | HPV‐004 | NCT00693615 | ‐ | ‐ | II | USA | 18‐30y | 60 | All randomised women received the HPV vaccine with ASO4 adjuvants, aluminium adjuvants or no adjuvants. There was no placebo control group who did not receive the bivalent vaccine. | + | ‐ |
19 | HPV‐005 | NCT00693966 | ‐ | ‐ | II | USA | 18‐30y | 210 | Dose escalating trial without placebo group. There was no placebo control group who did not receive the bivalent vaccine. | + | ‐ |
20 | HPV‐012 | NCT00169494 | ‐ | ‐ | III | Europe | 10‐25y | 770 | Trial evaluating lot‐to‐lot consistency and consistency with new manufacturing process.There was no placebo control group who did not receive the bivalent vaccine. | + | ‐ |
+ | ‐ | ||||||||||
Total 1.1.‐1.3. | 47,498 | ||||||||||
In Cochrane review (1.1) | 46,248 | 97.4% | |||||||||
Not included in Cochrane review (1.2 + 1.3) | 1,250 | 2.6% | |||||||||
1.4. Sub‐studies already included | |||||||||||
21 | HPV‐007 (HPV‐001 FU‐extension) | NCT00120848 | Phase 2 trial (v2) | Romanowski 2009 | IIb | Brazil, Canada, USA | 15‐25y | 776 | ‐ | + | + |
22 | ‐ | NCT00456807 | ‐ | ‐ | III | Netherlands | ≥26y | 100 | Sub‐study of HPV‐015 investigating additional immunogenicity parameters in an included study. | + | ‐ |
2.Quadrivalent vaccine | |||||||||||
2.1. Published reports included in the Cochrane review | |||||||||||
23 | V501‐005 | NCT00365378 | Phase2 trial (1v) |
Koutsky 2002 Mao 2006 Rowhani‐Rahbar 2009 |
II | USA | 16‐23y | 2392 | ‐ | + | + |
24 | V501‐007 | NCT00365716 | Phase 2 trial (4v) |
Villa 2005 Villa 2006 Villa 2006a |
II | America, Europe | 16‐23y | 1158 | ‐ | + | + |
25 | V501‐013 | NCT00092521 | Future I trial | Garland 2007 | III | Asia‐Pacific, America, Europe | 16‐24y | 5455 | ‐ | + | + |
26 | V501‐015 | NCT00092534 | FUTURE II trial | FUTURE‐II 2007 | III | America, Asia, Europe | 15‐26y | 12,167 | ‐ | + | + |
27 | V501‐019 | NCT00090220 | FUTURE III trial |
Munoz 2009 Castellsagué 2011 |
III | America, Asia, Europe | 24‐45y | 3819 | ‐ | + | + |
28 | V501‐023 | NCT00157950 | Korean trial (ph2,4v) | Kang 2008 | III | Korea | 9‐15y 16‐23y | 176 | ‐ | + | ‐ |
29 | V501‐027 | NCT00378560 | Japanese trial (ph2,4v) | Yoshikawa 2013 | II | Japan | 18‐26y | 1021 | ‐ | + | + |
30 | V501‐046 | NCT01245764 | African_3 country trial (ph3, 4v) | Mugo 2015 | III | Ghana, Kenya, Senegal | Females 9‐26y | 250 | ‐ | + | ‐ |
2.2. Excluded studies | |||||||||||
31 | V501‐018 | NCT00092547 | ‐ | Reisinger 2007 | III | America, Europe Asia | Girls 9‐15y | 939 | Study included also male participants. Data could not be separated by gender. | + | ‐ |
32 | V501‐030 | NCT00496626 | ‐ | Li 2012 | III | China | Females 9‐45y | 400 | Study included also male participants. Data could not be separated by gender. Request for data for female participants only was not answered | + | ‐ |
2.3. Non published reports | |||||||||||
Total 2.1.‐2.3. | 27,777 | ||||||||||
Included in Cochrane review (2.1) | 26,438 | 95.2% | |||||||||
Not included in Cochrane review (2.2 + 2.3) | 1339 | 4.8% | |||||||||
4. Sub‐studies already included | |||||||||||
33 | V501‐011 | NCT00517309 | FUTURE I trial sub | Wheeler 2008 | III | Asia‐Pacific, America, Europe | 16‐23 yrs | 1877 | ‐ | + | + |
34 | V501‐012 | NCT00092482 | FUTURE I sub | Garland 2007a | III | Asia‐Pacific, America, Europe | 16‐23 yrs | 3882 | ‐ | + | + |