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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.