Skip to main content
. 2018 May 9;2018(5):CD009069. doi: 10.1002/14651858.CD009069.pub3
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 + +