ABCDEFGHIJKLMNOPQRSTUVWXYZAAABACAD
1
Nos Cochrane Review - characteristics of included studies tablesnumbers in characteristics tablenumber in table in text of reviewStudy locationHPV analysis responseenrollment on trials.govNumbers in Jorgensen tableLocationTrial.gov
2
1Phase2 trial (ph2,1v)23922392USA
3
2Japanese trial (ph2,2v)10401040JapanHPV-063-NCT00929526752752
HPV-063 was a follow-up study to HPV-032. SAE data not included in the Cochrane HPV review meta-analysis
4
3Phase2 trial (ph2,2v)11131113BrazilHPV-023 -NCT00518336 433433
HPV-023 was a follow-up study to HPV-001 SAE data not included in the Cochrane HPV review meta-analysis
Follow-up Study to Evaluate the Long-term Efficacy of a HPV Vaccine (580299) in Healthy Young Adult Women in Brazil
5
4African_2 country trial (ph3,2v)676676Senegal or Tanzania
6
5Chinese trial (ph3,2v)_young38196051Jiangsu Province
7
6Chinese trial (ph3,2v)_ adolescent750750Jiangsu Province
8
7Chinese trial (ph3,2v)_mid‐adult12121212Jiangsu Province
9
8Co‐vaccination_dTpa_IPV trial (ph3,2v)751494Fr, Ger, Spain
10
9Co‐vaccination_HepB trial (ph3, 2v)741541Neth, SwedenHPV-030 -NCT00652938 744493
SAE data not included in the Cochrane HPV review meta-analysis
744 participants reported enrolled in trials.gov
11
10Co‐vaccination_HAB trial (Ph3, 2v)813494Can, Den, Hungary and SwedenHPV-029 -NCT00578227 814541
SAE data not included in the Cochrane HPV review meta-analysis
814 participants reported enrolled in trials.gov
12
11CVT (ph3,2v)74667466Costa Rica
13
12Hong Kong trial (ph3,2v)294294Hong Kong
14
13Immunobridging(ph3,2v)20672067Aus, Colombia, Ch Republic, Fr
15
14Indian trial (ph3,2v)354354Hong Kong
16
15Korean trial (ph3,2v)321321Korea
17
16Korean trial (ph3b,2v)208208Korea
18
17Malaysian trial (ph3,2v)271271Malaysia
19
18PATRICIA trial (ph3,2v)186441864414 countries
20
19PATRICIA & CVT (ph3,2v)26130Patricia and costa rica trial
21
20VIVIANE trial (ph3,2v)5752575212 countries
22
21Japanese trial (ph2,4v)10211021Japan
23
22Korean trial (ph2,4v)176176Korea
24
23Phase2 trial (ph2,4v)1158552
25
24African_3 country trial (ph3,4v)25098Ghana, Kenya and Senegal
26
25FUTURE I trial (ph3,4v)5455545516 countries
27
26FUTURE II trial (ph3,4v)121671216713 countries
28
27FUT I/II trials (ph3,4v)17622
29
28FUTURE III trial (ph3,4v)381938197 countries
30
11648273428
31
Cochrane Editors response Appendix B
32
29NCT01627561148Colombia, Mexico, PanamaHPV-073 - NCT01627561148Likely include
HPV-073 was identified and added to the Cochrane review in the Cochrane editors’ reassessment (1).
33
30NCT008341063006Chinanot in list of 20 trialsLikely include
34
31NCT00411749107JapanV501-028- NCT00411749107Likely include
V501-028 was identified and added to the Cochrane review in the Cochrane editors’ reassessment (1)
35
32NCT01489527406South AfricaNCT01489527 406Likely include
identified as eligible but not included in the Cochrane HPV review.
36
33NCT010473459248 countries V503-006 - NCT01047345 R924Likely include
V503-006 was identified and added to the Cochrane review in the Cochrane editors’ reassessment (1
37
HPV-003- 61Likely include
Listed in the Cochrane review as "not published"; however, HPV-003's clinical study report can be downloaded from GSK trial register. The Cochrane review include data from GSK trial register,
38
HPV-040- NCT0053463820515Likely include
HPV-040 was excluded from the Cochrane review, as it was considered a “phase IV” study (Cochrane review only included phase II and III studies). We included HPV-040 in our list, as a “phase III/IV” study in the freely available CSR from GSKs trial register. HPV-040 includes the bulk of the additional eligible participants: 32,176 of which 20,515 were females.
39
V501-018 -NCT00092547939Likely include
gender-specific data are available and can be obtained from EMA.
40
V501-030 - NCT00496626400Likely include
V501-030 had been excluded from the Cochrane review, as gender-specific data could not be obtained. However, the gender-specific data are available and can be obtained from EMA.
41
V501-046 - NCT01245764250Likely include
V501-046 was identified and added to the Cochrane review in the Cochrane editors’ reassessment (1).
42
HPV-PRO-002 -NCT01356823 1600Likely include
HPV-PRO-002 was identified and added to the Cochrane review in the Cochrane editors’ reassessment (1)
43
2010- 1090/GaReCo - NCT20101090200Likely include
2010-1090/GaReCo is not included in Cochrane review, but data for safety outcomes are eligible for
inclusion: http://apps.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2012-004007-13-DE
44
Jorgensen et all possibly includeMENACWY-TT054-NCT017556891300unlikely
MENACWY-TT-054 is a five-arm trial in which,
during a one-month window, exposure to Cervarix was directly compared to another vaccine (Nimenrix), but
at study completion all arms may have received Cervarix.
45
Jorgensen et all possibly includeV501-002 unclear
Numbers unsure - write to manufacturer
46
Jorgensen et all possibly includeV501-004unclear
Numbers unsure - write to manufacturer
47
Jorgensen et all possibly includeV503-018615unclear
may be a study that compares females with males that all were vaccinated with Gardasil.
Therefore, V503-018 is “possibly eligible.”
48
Jorgensen et all possibly includeV503-019 unclear
Numbers unsure - write to manufacturer
49
Jorgensen et all possibly includeV505-001 -NCT00520598511unclear
V505-001 appears to have six arms where
one arm receives “placebo.”
50
51
52
Of 21 studies ideintified (twenty by Jorgensen et al, one by the Cochrane editors () in the list 17 are likely to be included (5 of these idenitifed by the Cochrane Editors), for 5 it is unclear, Four studies in the Jorgensen et al table are inluded in the Cochrane HPV review but available serious adverse event data from the ideintified long term follow up studies has not been used. One study (MENACWY-TT054-NCT01755689) is unlikely to be included but this requires checking. Therefore data from twenty trials will potentially be eligible for inlcusion in the Cochrane HPV review.
53
54
55
56
57
58
59
60
61
62
63
64
65
66
67
68
69
70
71
72
73
74
75
76
77
78
79
80
81
82
83
84
85
86
87
88
89
90
91
92
93
94
95
96
97
98
99
100