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. 2015 Mar 26;22(4):361–373. doi: 10.1128/CVI.00591-14

TABLE 3.

Efficacy against CIN1+, CIN2+, and CIN3+ associated with HPV-16 and/or -18, stratified by agea

Age stratum Endpoint HPV typeb Group TVC-naive
 TVC
n No. of cases Rate Efficacy (96.1% CI) n No. of cases Rate Efficacy (96.1% CI)
All CIN1+ HPV-16/18 Vaccine 5,449 3 0.02 96.5 (89.0, 99.4) 8,667 107 0.43 55.5 (43.2, 65.3)
Control 5,436 85 0.54 8,682 240 0.97
HPV-16 Vaccine 5,449 2 0.01 97.3 (89.3, 99.7) 8,667 90 0.36 54.5 (40.6, 65.4)
Control 5,436 73 0.46 8,682 198 0.80
HPV-18 Vaccine 5,449 1 0.01 94.5 (62.8, 99.9) 8,667 18 0.07 70.4 (48.0, 84.1)
Control 5,436 18 0.11 8,682 61 0.24
CIN2+ HPV-16/18 Vaccine 5,449 1c 0.01 98.4 (90.4, 100) 8,667 82 0.33 52.8 (37.5, 64.7)
Control 5,436 63 0.40 8,682 174 0.70
HPV-16 Vaccine 5,449 1c 0.01 98.2 (89.1, 100) 8,667 75 0.30 50.6 (33.5, 63.6)
Control 5,436 56 0.36 8,682 152 0.61
HPV-18 Vaccine 5,449 0 0.00 100 (61.3, 100) 8,667 8 0.03 75.7 (44.4, 90.8)
Control 5,436 12 0.08 8,682 33 0.13
CIN3+ HPV-16/18 Vaccine 5,449 0 0.00 100 (64.7, 100) 8,667 43 0.17 33.6 (−1.1, 56.9)
Control 5,436 13 0.08 8,682 65 0.26
HPV-16 Vaccine 5,449 0 0.00 100 (57.1, 100) 8,667 41 0.16 31.4 (−5.9, 56.0)
Control 5,436 11 0.07 8,682 60 0.24
HPV-18 Vaccine 5,449 0 0.00 100 (−170.8, 100) 8,667 2 0.01 77.7 (−14.7, 98.0)
Control 5,436 3 0.02 8,682 9 0.04
15–17 yr CIN1+ HPV-16/18 Vaccine 1,996 1 0.02 97.6 (85.0, 100) 2,880 28 0.32 73.6 (58.8, 83.7)
Control 2,022 42 0.68 2,891 106 1.22
HPV-16 Vaccine 1,996 1 0.02 97.0 (81.2, 99.9) 2,880 25 0.29 71.2 (53.7, 82.8)
Control 2,022 34 0.55 2,891 87 1.00
HPV-18 Vaccine 1,996 0 0.00 100 (64.1, 100) 2,880 4 0.05 87.5 (63.1, 97.0)
Control 2,022 13 0.21 2,891 32 0.36
CIN2+ HPV-16/18 Vaccine 1,996 1c 0.02 96.6 (78.5, 99.9) 2,880 19 0.22 72.8 (53.2, 85.0)
Control 2,022 30 0.49 2,891 70 0.80
HPV-16 Vaccine 1,996 1c 0.02 95.8 (72.5, 99.9) 2,880 18 0.21 69.9 (47.0, 83.8)
Control 2,022 24 0.39 2,891 60 0.69
HPV-18 Vaccine 1,996 0 0.00 100 (51.0, 100) 2,880 2 0.02 87.4 (43.5, 98.8)
Control 2,022 10 0.16 2,891 16 0.18
CIN3+ HPV-16/18 Vaccine 1,996 0 0.00 100 (23.2, 100) 2,880 6 0.07 74.9 (34.3, 92.1)
Control 2,022 7 0.11 2,891 24 0.27
HPV-16 Vaccine 1,996 0 0.00 100 (5.7, 100) 2,880 6 0.07 72.6 (27.3, 91.4)
Control 2,022 6 0.10 2,891 22 0.25
HPV-18 Vaccine 1,996 0 0.00 100 (−527.0, 100) 2,880 0 0.00 100 (−68.8, 100)
Control 2,022 2 0.03 2,891 4 0.05
18–20 yr CIN1+ HPV-16/18 Vaccine 1,090 0 0.00 100 (83.0, 100) 1,862 30 0.58 55.7 (29.6, 72.8)
Control 1,139 26 0.81 1,902 69 1.31
HPV-16 Vaccine 1,090 0 0.00 100 (81.5, 100) 1,862 23 0.44 60.3 (33.1, 77.2)
Control 1,139 24 0.75 1,902 59 1.12
HPV-18 Vaccine 1,090 0 0.00 100 (−183.7, 100) 1,862 7 0.13 52.3 (−29.8, 84.5)
Control 1,139 3 0.09 1,902 15 0.28
CIN2+ HPV-16/18 Vaccine 1,090 0 0.00 100 (78.5, 100) 1,862 21 0.40 61.9 (34.4, 78.7)
Control 1,139 21 0.66 1,902 56 1.06
HPV-16 Vaccine 1,090 0 0.00 100 (77.3, 100) 1,862 18 0.35 63.3 (34.3, 80.5)
Control 1,139 20 0.63 1,902 50 0.94
HPV-18 Vaccine 1,090 0 0.00 100 (−544.0, 100) 1,862 3 0.06 69.4 (−26.1, 95.1)
Control 1,139 2 0.06 1,902 10 0.19
CIN3+ HPV-16/18 Vaccine 1,090 0 0.00 100 (−75.1, 100) 1,862 10 0.19 51.4 (−11.9, 80.5)
Control 1,139 4 0.12 1,902 21 0.40
HPV-16 Vaccine 1,090 0 0.00 100 (−183.7, 100) 1,862 9 0.17 51.7 (−16.6, 81.7)
Control 1,139 3 0.09 1,902 19 0.36
HPV-18 Vaccine 1,090 0 0.00 100 (−5,157.1, 100) 1,862 1 0.02 65.9 (−372.9, 99.5)
Control 1,139 1 0.03 1,902 3 0.06
21–25 yr CIN1+ HPV-16/18 Vaccine 2,356 2 0.03 88.8 (50.0, 98.9) 3,916 49 0.45 25.3 (−12.0, 50.6)
Control 2,271 17 0.27 3,880 65 0.60
HPV-16 Vaccine 2,356 1 0.02 93.6 (55.9, 99.9) 3,916 42 0.39 19.9 (−25.3, 49.1)
Control 2,271 15 0.24 3,880 52 0.48
HPV-18 Vaccine 2,356 1 0.02 52.1 (−959.2, 99.4) 3,916 7 0.06 50.5 (−37.2, 84.0)
Control 2,271 2 0.03 3,880 14 0.13
CIN2+ HPV-16/18 Vaccine 2,356 0 0.00 100 (62.9, 100) 3,916 42 0.39 13.2 (−37.1, 45.3)
Control 2,271 12 0.19 3,880 48 0.44
HPV-16 Vaccine 2,356 0 0.00 100 (62.9, 100) 3,916 39 0.36 7.9 (−49.4, 43.3)
Control 2,271 12 0.19 3,880 42 0.39
HPV-18 Vaccine 2,356 0 0.00 3,916 3 0.03 57.5 (−98.7, 93.6)
Control 2,271 0 0.00 3,880 7 0.06
CIN3+ HPV-16/18 Vaccine 2,536 0 0.00 100 (−490.4, 100) 3,916 27 0.25 −34.1 (−160.6, 29.7)
Control 2,271 2 0.12 3,880 20 0.18
HPV-16 Vaccine 2,536 0 0.00 100 (−490.4, 100) 3,916 26 0.24 −35.9 (−168.6, 29.8)
Control 2,271 2 0.12 3,880 19 0.17
HPV-18 Vaccine 2,536 0 0.00 3,916 1 0.01 50.4 (−996.4, 99.4)
Control 2,271 0 0.00 3,880 2 0.02
a

n, number of evaluable women in each group; no. of cases, number of evaluable women reporting at least one event; rate, number of cases divided by sum of follow-up period (per 100 person-years), where follow-up period started on the day after the first vaccine dose; TVC, total vaccinated cohort; TVC-naive, total vaccinated cohort of women who at baseline had no DNA detected for 14 high-risk HPV types, were seronegative for HPV-16 and HPV-18, and had normal cytology results.

b

Women were infected with one or both HPV types (thus, the number of women with an HPV-16-associated lesion and the number with an HPV-18-associated lesion might not equal number with an HPV-16/18-associated lesion).

c

This young woman acquired the HPV-16 responsible for development of the lesion prior to completion of the full three-dose series (HPV-16 DNA was detected at months 6, 12, and 18; the CIN2 lesion was detected at month 21, and HPV-16 DNA was the only type in the lesion).