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Table 2 Baseline characteristics of participants in the intention-to-treat cohort of randomized controlled trials included in the review.

From: Efficacy and Safety of Prophylactic Vaccines against Cervical HPV Infection and Diseases among Women: A Systematic Review & Meta-Analysis

Characteristics, n (%) Koutsky & Mao et al. § Harper et al. Villa et al. FUTURE I FUTURE II PATRICIA Muñoz et al.
  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) -- --
  1. † 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.
  2. * 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.