A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z | AA | AB | AC | AD | |
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1 | Nos | Cochrane Review - characteristics of included studies tables | numbers in characteristics table | number in table in text of review | Study location | HPV analysis response | enrollment on trials.gov | Numbers in Jorgensen table | Location | Trial.gov | ||||||||||||||||||||
2 | 1 | Phase2 trial (ph2,1v) | 2392 | 2392 | USA | |||||||||||||||||||||||||
3 | 2 | Japanese trial (ph2,2v) | 1040 | 1040 | Japan | HPV-063-NCT00929526 | 752 | 752 | HPV-063 was a follow-up study to HPV-032. SAE data not included in the Cochrane HPV review meta-analysis | |||||||||||||||||||||
4 | 3 | Phase2 trial (ph2,2v) | 1113 | 1113 | Brazil | HPV-023 -NCT00518336 | 433 | 433 | 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 | 4 | African_2 country trial (ph3,2v) | 676 | 676 | Senegal or Tanzania | |||||||||||||||||||||||||
6 | 5 | Chinese trial (ph3,2v)_young | 3819 | 6051 | Jiangsu Province | |||||||||||||||||||||||||
7 | 6 | Chinese trial (ph3,2v)_ adolescent | 750 | 750 | Jiangsu Province | |||||||||||||||||||||||||
8 | 7 | Chinese trial (ph3,2v)_mid‐adult | 1212 | 1212 | Jiangsu Province | |||||||||||||||||||||||||
9 | 8 | Co‐vaccination_dTpa_IPV trial (ph3,2v) | 751 | 494 | Fr, Ger, Spain | |||||||||||||||||||||||||
10 | 9 | Co‐vaccination_HepB trial (ph3, 2v) | 741 | 541 | Neth, Sweden | HPV-030 -NCT00652938 | 744 | 493 | SAE data not included in the Cochrane HPV review meta-analysis | 744 participants reported enrolled in trials.gov | ||||||||||||||||||||
11 | 10 | Co‐vaccination_HAB trial (Ph3, 2v) | 813 | 494 | Can, Den, Hungary and Sweden | HPV-029 -NCT00578227 | 814 | 541 | SAE data not included in the Cochrane HPV review meta-analysis | 814 participants reported enrolled in trials.gov | ||||||||||||||||||||
12 | 11 | CVT (ph3,2v) | 7466 | 7466 | Costa Rica | |||||||||||||||||||||||||
13 | 12 | Hong Kong trial (ph3,2v) | 294 | 294 | Hong Kong | |||||||||||||||||||||||||
14 | 13 | Immunobridging(ph3,2v) | 2067 | 2067 | Aus, Colombia, Ch Republic, Fr | |||||||||||||||||||||||||
15 | 14 | Indian trial (ph3,2v) | 354 | 354 | Hong Kong | |||||||||||||||||||||||||
16 | 15 | Korean trial (ph3,2v) | 321 | 321 | Korea | |||||||||||||||||||||||||
17 | 16 | Korean trial (ph3b,2v) | 208 | 208 | Korea | |||||||||||||||||||||||||
18 | 17 | Malaysian trial (ph3,2v) | 271 | 271 | Malaysia | |||||||||||||||||||||||||
19 | 18 | PATRICIA trial (ph3,2v) | 18644 | 18644 | 14 countries | |||||||||||||||||||||||||
20 | 19 | PATRICIA & CVT (ph3,2v) | 26130 | Patricia and costa rica trial | ||||||||||||||||||||||||||
21 | 20 | VIVIANE trial (ph3,2v) | 5752 | 5752 | 12 countries | |||||||||||||||||||||||||
22 | 21 | Japanese trial (ph2,4v) | 1021 | 1021 | Japan | |||||||||||||||||||||||||
23 | 22 | Korean trial (ph2,4v) | 176 | 176 | Korea | |||||||||||||||||||||||||
24 | 23 | Phase2 trial (ph2,4v) | 1158 | 552 | ||||||||||||||||||||||||||
25 | 24 | African_3 country trial (ph3,4v) | 250 | 98 | Ghana, Kenya and Senegal | |||||||||||||||||||||||||
26 | 25 | FUTURE I trial (ph3,4v) | 5455 | 5455 | 16 countries | |||||||||||||||||||||||||
27 | 26 | FUTURE II trial (ph3,4v) | 12167 | 12167 | 13 countries | |||||||||||||||||||||||||
28 | 27 | FUT I/II trials (ph3,4v) | 17622 | |||||||||||||||||||||||||||
29 | 28 | FUTURE III trial (ph3,4v) | 3819 | 3819 | 7 countries | |||||||||||||||||||||||||
30 | 116482 | 73428 | ||||||||||||||||||||||||||||
31 | Cochrane Editors response Appendix B | |||||||||||||||||||||||||||||
32 | 29 | NCT01627561 | 148 | Colombia, Mexico, Panama | HPV-073 - NCT01627561 | 148 | Likely include | HPV-073 was identified and added to the Cochrane review in the Cochrane editors’ reassessment (1). | ||||||||||||||||||||||
33 | 30 | NCT00834106 | 3006 | China | not in list of 20 trials | Likely include | ||||||||||||||||||||||||
34 | 31 | NCT00411749 | 107 | Japan | V501-028- NCT00411749 | 107 | Likely include | V501-028 was identified and added to the Cochrane review in the Cochrane editors’ reassessment (1) | ||||||||||||||||||||||
35 | 32 | NCT01489527 | 406 | South Africa | NCT01489527 | 406 | Likely include | identified as eligible but not included in the Cochrane HPV review. | ||||||||||||||||||||||
36 | 33 | NCT01047345 | 924 | 8 countries | V503-006 - NCT01047345 R | 924 | Likely include | V503-006 was identified and added to the Cochrane review in the Cochrane editors’ reassessment (1 | ||||||||||||||||||||||
37 | HPV-003- | 61 | Likely 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- NCT00534638 | 20515 | Likely 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 -NCT00092547 | 939 | Likely include | gender-specific data are available and can be obtained from EMA. | ||||||||||||||||||||||||||
40 | V501-030 - NCT00496626 | 400 | Likely 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 - NCT01245764 | 250 | Likely include | V501-046 was identified and added to the Cochrane review in the Cochrane editors’ reassessment (1). | ||||||||||||||||||||||||||
42 | HPV-PRO-002 -NCT01356823 | 1600 | Likely include | HPV-PRO-002 was identified and added to the Cochrane review in the Cochrane editors’ reassessment (1) | ||||||||||||||||||||||||||
43 | 2010- 1090/GaReCo - NCT20101090 | 200 | Likely 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 include | MENACWY-TT054-NCT01755689 | 1300 | unlikely | 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 include | V501-002 | unclear | Numbers unsure - write to manufacturer | ||||||||||||||||||||||||||
46 | Jorgensen et all possibly include | V501-004 | unclear | Numbers unsure - write to manufacturer | ||||||||||||||||||||||||||
47 | Jorgensen et all possibly include | V503-018 | 615 | unclear | 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 include | V503-019 | unclear | Numbers unsure - write to manufacturer | ||||||||||||||||||||||||||
49 | Jorgensen et all possibly include | V505-001 -NCT00520598 | 511 | unclear | V505-001 appears to have six arms where one arm receives “placebo.” | |||||||||||||||||||||||||
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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. | |||||||||||||||||||||||||||||
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