Table 2 |
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|
Baseline characteristics of participants in the intention-to-treat cohort of randomized controlled trials included in the review. |
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|
Characteristics, n (%) |
Koutsky & Mao et al. § |
Harper et al. |
Villa et al. |
FUTURE I |
FUTURE II |
PATRICIA |
Muñoz et al. |
|||||||
|
|
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|
Vaccine (n = 768) |
Control (n = 765) |
Vaccine (n = 560) |
Control (n = 553) |
Vaccine (n = 277) |
Control (n = 275) |
Vaccine (n = 2723) |
Control (n = 2732) |
Vaccine (n = 6087) |
Control (n = 6080) |
Vaccine (n = 9319) |
Control (n = 9325) |
Vaccine (n = 1911) |
Control (n = 1908) |
|
|
|
||||||||||||||
|
Age, mean (SD) |
20.0 (1.6) |
20.1 (1.6) |
20.4 (2.8) |
20.5 (2.7) |
20.2 (1.7) |
20.0 (1.7) |
20.2 (1.8) |
20.3 (1.8) |
20.0 (2.2) |
19.9 (2.1) |
20.0 (3.1) |
20 (3.1) |
34.3 (6.3) |
34.3 (6.3) |
|
HPV 16 Positivity |
||||||||||||||
|
DNA |
-- |
-- |
-- |
-- |
49 (17.7)† |
51(18.5)† |
238 (8.9) |
227 (8.4) |
543 (9.1) |
545 (9.1) |
516 (5.6) |
478 (5.2) |
-- |
-- |
|
Serology |
143 (12.0) |
166 (13.9) |
-- |
-- |
312 (11.5) |
319 (11.7) |
652 (10.7) |
688 (11.3) |
1544 (16.7) |
1552 (16.8) |
-- |
-- |
||
|
HPV 18 Positivity |
||||||||||||||
|
DNA |
-- |
-- |
-- |
-- |
17 (6.1)† |
21 (7.6)† |
86 (3.2) |
83 (3.1) |
230 (3.8) |
242 (4.0) |
215 (2.3) |
216 (2.3) |
-- |
-- |
|
Serology |
-- |
-- |
-- |
-- |
93 (3.4) |
90 (3.3) |
227 (3.7) |
236 (3.9) |
1076 (11.7) |
1070 (11.6) |
||||
|
Lifetime no. of sexual partners |
≤ 5 |
≤ 6 |
≤ 4 |
≤ 4 |
≤ 4 |
≤ 6 |
No restriction |
|||||||
|
None |
38 (5) |
34 (4) |
90 (16) |
85 (16) |
17 (6) |
16 (6) |
-- |
-- |
-- |
-- |
294 (3)†† |
292 (3)†† |
0 (0) |
2 (0.1) |
|
One |
218 (28) |
200 (26) |
197 (35) |
188 (35) |
80 (29) |
88 (32) |
-- |
-- |
-- |
-- |
5862 (63)†† |
5869 (63)†† |
719 (38) |
751 (39) |
|
Two/Two to five |
173 (23) |
173 (23) |
259 (46) |
242 (45) |
73 (26) |
75 (27) |
-- |
-- |
-- |
-- |
1114 (12)†† |
1161 (13)†† |
385 (20) |
362 (19) |
|
Three/Three or more |
138 (18) |
131 (17) |
-- |
-- |
67 (24) |
50 (18) |
-- |
-- |
-- |
-- |
636 (7)†† |
595 (6)†† |
229 (12) |
223 (12) |
|
Four/Four or more |
105 (14) |
144 (19) |
-- |
-- |
40 (14) |
46 (17) |
-- |
-- |
-- |
-- |
-- |
-- |
142 (7) |
130 (7) |
|
Five/Five or more |
96 (13) |
83 (11) |
14 (3) |
18 (3) |
-- |
-- |
-- |
-- |
-- |
-- |
433 (23) |
437 (23) |
||
|
Smoking status |
||||||||||||||
|
Never smoker |
-- |
-- |
102 (18) |
85 (16) |
-- |
-- |
-- |
-- |
-- |
-- |
6401 (69)* |
6388 (69)* |
923 (48) |
935 (49) |
|
Former smoker |
-- |
-- |
164 (30) |
138 (26) |
-- |
-- |
-- |
-- |
-- |
-- |
2706 (29)* |
2726 (29)* |
159 (8) |
148 (8) |
|
Current smoker |
183 (24) |
190 (25) |
294 (52) |
310 (58) |
-- |
-- |
696 (26) |
716 (26) |
-- |
-- |
-- |
-- |
339 (18) |
332 (17) |
|
Chlamydia trachomatis |
||||||||||||||
|
Negative |
-- |
-- |
-- |
-- |
-- |
-- |
2565 (94) |
2545 (93) |
5723 (94) |
5737 (94) |
8155 (88) |
8188 (88) |
-- |
-- |
|
Positive |
24 (3) |
19 (3) |
-- |
-- |
-- |
-- |
118 (4) |
135 (5) |
258 (4) |
224 (4) |
478 (5) |
475 (5) |
-- |
-- |
|
Contraceptive use |
||||||||||||||
|
Barrier |
-- |
-- |
-- |
-- |
63 (23) |
76 (28) |
872 (32) |
874 (32) |
-- |
-- |
-- |
-- |
441 (23) |
425 (22) |
|
Hormonal |
-- |
-- |
-- |
-- |
161 (58) |
157 (57) |
1568 (58) |
1539 (57) |
3613 (60) |
3614 (60) |
5544 (59) |
5662 (61) |
596 (31) |
591 (31) |
|
Behavioral |
-- |
-- |
-- |
-- |
48 (17) |
48 (17) |
487 (18) |
498 (18) |
-- |
-- |
-- |
-- |
165 (9) |
184 (10) |
|
Other |
-- |
-- |
-- |
-- |
21 (8) |
17 (6) |
125 (5) |
138 (5) |
-- |
-- |
-- |
-- |
748 (39) |
749 (39) |
|
Cytological status at entry |
||||||||||||||
|
Normal |
656 (88) |
655 (87) |
-- |
-- |
-- |
-- |
2360 (89) |
2326 (88) |
5222 (87) |
5242 (89) |
8395 (90) |
8450 (91) |
-- |
-- |
|
Abnormal |
84 (11) |
96 (13) |
-- |
-- |
-- |
-- |
288 (11) |
316 (12) |
697 (12) |
654 (11) |
908 (10) |
860 (10) |
-- |
-- |
|
|
||||||||||||||
|
† Seropositive or DNA positive to HPV 16 or 18 on day 1. †† Reported as "number of sexual partners in past year" in PATRICIA study. § Participant characteristics were presented for the per-protocol population only. * Never smoker category includes participants who never smoke or smoked for ≤6 months (current/past); Former smoker category includes participants who smoked ≥6 months (current/past) in PATRICIA trial. |
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|
Lu et al. BMC Infectious Diseases 2011 11:13 doi:10.1186/1471-2334-11-13 |
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