Study characteristics | Industry HPV vaccine studies | Non-industry funded HPV vaccine studies | P valuek | ||||||
---|---|---|---|---|---|---|---|---|---|
Total: N = 145 | GSK (Cervarix): N = 69 | Merck (Gardasil and Gardasil 9): N = 66 | Otherj: N = 10 | Total: N = 61 | Cervarix: N = 6 | Gardasil and Gardasil 9: N = 48 | Other: N = 7 | ||
Type of study | |||||||||
Randomized clinical trial | 96 (67%) | 43 (62%) | 45 (68%) | 8 (80%) | 40 (65%) | 4 (67%) | 33 (69%) | 3 (43%) | 1.00 |
- “Placebo”a comparison | 5 of 96 (5%) | 0 of 43 (0%) | 3 of 45 (7%) | 2 of 8 (25%) | 12 of 40 (30%) | 0 of 4 (0%) | 11 of 33 (33%) | 1 of 3 (33%) | 0.0002 |
- Adjuvantb comparison | 36 of 96 (39%) | 15 of 43 (35%) | 19 of 45 (42%) | 2 of 8 (25%) | 0 of 40 (0%) | 0 of 4 (0%) | 0 of 33 (0%) | 0 of 3 (0%) | <0.0001 |
- Vaccinec comparison | 51 of 96 (51%) | 28 of 43 (65%) | 19 of 45 (42%) | 4 of 8 (50%) | 24 of 40 (60%) | 3 of 4 (75%) | 19 of 33 (58%) | 2 of 3 (67%) | 0.57 |
- No intervention in control arm | 0 of 96 (0%) | 0 of 43 (0%) | 0 of 45 (0%) | 0 of 8 (0%) | 3 of 40 (8%) | 1 of 4 (25%) | 2 of 33 (6%) | 0 of 3 (0%) | 0.027 |
- Unclear | 4 of 96 (5%) | 0 of 43 (0%) | 4 of 45 (9%) | 0 of 8 (0%) | 1 of 40 (2%) | 0 of 4 (0%) | 1 of 33 (3%) | 0 of 3 (0%) | 1.00 |
Follow-up to randomized clinical trial | 23 (16%) | 18 (26%) | 5 (8%) | 0 (0%) | 3 (5%) | 0 (0%) | 0 (0%) | 3 (43%) | 0.037 |
Non-randomized | 24 (16%) | 8 (12%) | 14 (21%) | 2 (20%) | 18 (30%) | 2 (33%) | 15 (31%) | 1 (14%) | 0.039 |
Unclear | 2 (1%) | 0 (0%) | 2 (3%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 1.00 |
Phase of studyd | |||||||||
I | 8 (5%) | 2 (3%) | 4 (6%) | 2 (20%) | 6 (10%) | 0 (0%) | 2 (4%) | 4 (57%) | 0.36 |
II | 32 (22%) | 14 (20%) | 14 (21%) | 4 (40%) | 7 (11%) | 0 (0%) | 6 (13%) | 1 (14%) | 0.081 |
III | 79 (55%) | 44 (64%) | 31 (47%) | 4 (40%) | 10 (16%) | 1 (17%) | 9 (19%) | 0 (0%) | <0.0001 |
IV | 9 (6%) | 4 (6%) | 5 (8%) | 0 (0%) | 22 (37%) | 5 (83%) | 17 (35%) | 0 (0%) | <0.0001 |
Unclear | 17 (12%) | 5 (7%) | 12 (18%) | 0 (0%) | 16 (26%) | 0 (0%) | 14 (29%) | 2 (29%) | 0.013 |
Type of HPV vaccine used | |||||||||
Monovalent | 5 (3%) | 0 (0%) | 5 (8%) | 0 (0%) | 4 (7%) | 0 (0%) | 0 (0%) | 4 (57%) | 0.45 |
Bivalent (e.g., Cervarix) | 76 (52%) | 65 (94%) | 2 (3%) | 9 (90%) | 7 (11%) | 6 (100%) | 0 (0%) | 1 (14%) | <0.0001 |
Quadrivalent (e.g., Gardasil) | 43 (30%) | 4 (6%) | 38 (57%) | 1 (10%) | 44 (72%) | 0 (0%) | 44 (92%) | 0 (0%) | <0.0001 |
Octavalent | 3 (2%) | 0 (0%) | 3 (5%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0.56 |
Ninevalent (e.g., Gardasil 9) | 17 (12%) | 0 (0%) | 17 (25%) | 0 (0%) | 4 (7%) | 0 (0%) | 4 (8%) | 0 (0%) | 0.45 |
Unclear | 1 (1%) | 0 (0%) | 1 (2%) | 0 (0%) | 2 (3%) | 0 (0%) | 0 (0%) | 2 (29%) | 0.21 |
Funding | |||||||||
Industry funded study | 128 (88%) | 69 (100%) | 49 (75%) | 10 (100%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | <0.0001 |
Industry co-funded study | 17 (12%) | 0 (0%) | 17 (25%)i | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0.004 |
Non-industry funded study | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 61 (100%) | 6 (100%) | 48 (100%) | 7 (100%) | <0.0001 |
Study completion status | |||||||||
Completed | 110 (76%) | 57 (83%) | 49 (75%) | 4 (40%) | 39 (64%) | 3 (50%) | 29 (60%) | 7 (100%) | 0.090 |
- Mean study time in monthse | 36.9 [2; 140] | 34.2 [2; 97] | 42.1 [8; 140] | 15.8 [8; 30] | 42.2 [5; 143] | 45 [12; 81] | 32.6 [6; 66] | 56 [5; 143] | NAl |
On going | 27 (19%) | 7 (10%) | 14 (20%) | 6 (60%) | 19 (31%) | 2 (33%) | 17 (36%) | 0 (0%) | 0.066 |
Terminated prematurely | 5 (3%) | 4 (6%) | 1 (2%) | 0 (0%) | 2 (3%) | 1 (17%) | 1 (2%) | 0 (0%) | 1.00 |
Unclear | 3 (2%) | 1 (1%) | 2 (3%) | 0 (0%) | 1 (2%) | 0 (0%) | 1 (2%) | 0 (0%) | 1.00 |
Study centre statusf | |||||||||
Single centre | 27 of 106 (25%) | 9 of 60 (15%) | 11 of 37 (30%) | 7 of 9 (78%) | 40 of 53 (75%) | 6 of 6 (100%) | 28 of 41 (68%) | 6 of 6 (100%) | <0.0001 |
Multicentre | 79 of 106 (75%) | 51 of 60 (85%) | 26 of 37 (70%) | 2 of 9 (22%) | 13 of 53 (25%) | 0 of 6 (0%) | 13 of 41 (32%) | 0 of 6 (0%) | <0.0001 |
- Mean centres per multicentre study | 36.5 [2; 105] | 35.3 [2; 135] | 39.9 [2; 105] | 6.0 [2; 10] | 21.5 [2; 134] | NA | 21.5 [2; 134] | NA | NA |
Unclear | 39 (27%) | 9 (13%) | 29 (44%) | 1 (10%) | 8 (13%) | 0 (0%) | 7 (15%) | 1 (14%) | 0.044 |
Participants | |||||||||
Both females and males | 22 (16%) | 4 (5%) | 16 (24%) | 2 (20%) | 19 (31%) | 0 (0%) | 14 (29%) | 5 (71%) | 0.013 |
Only females | 113 (78%) | 64 (93%) | 41 (62%) | 8 (80%) | 38 (62%) | 6 (100%) | 30 (63%) | 2 (29%) | 0.025 |
Only males | 5 (3%) | 1 (2%) | 4 (6%) | 0 (0%) | 4 (7%) | 0 (0%) | 4 (8%) | 0 (0%) | 0.45 |
Unclear | 5 (3%) | 0 (0%) | 5 (8%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0.32 |
Total number of enrolled participantsg | 522,298 | 122,323 | 376,643 | 23,332 | 100,707 | 42,801 | 47,452 | 10,454 | <0.0001 |
- Mean participants per studyg | 3602 [2; 189,629] | 1773 [2; 34,206] | 6726 [24; 189,629] | 2592 [90; 12,000] | 1767 [12; 24,000] | 8560 [200; 24,000] | 1054 [12; 20,000] | 1493 [45; 10,000] | NA |
- Mean participants per multicentre studyf,g | 2388 [20; 34,206] | 2073 [20; 34,206] | 2692 [67; 14,840] | 6450 [900; 12,000] | 2745 [75; 20,000] | NA | 2745 [75; 20,000] | NA | NA |
- Mean participants per centre in multicentre studiesf,g | 66 [2; 1513] | 59 [2; 1513] | 67 [10; 240] | 1075 [450; 1200] | 128 [5; 2222] | NA | 128 [5; 2222] | NA | NA |
Studies with > 1000 participantsg | 51 (35%) | 22 (32%) | 26 (39%) | 3 (30%) | 10 (16%) | 2 (33%) | 7 (15%) | 1 (14%) | 0.007 |
Studies with participants under age 18h | 77 (53%) | 23 (33%) | 49 (75%) | 5 (50%) | 28 (46%) | 4 (67%) | 23 (48%) | 1 (14%) | 0.36 |