|
|
Study [reference] |
Protocol |
Number of study sites |
Countries included |
Year of study enrolment |
Funding source | Inclusion criteria | Exclusion criteria |
Vaccine type |
Control |
Women enrolled (TVC) |
Women assessed (TVC) |
Length of follow-up |
| Age years | Sexual partners | Any of the following |
|
| GSK [11, 12, 28] | NCT00120848
Phase II trial | 27 | Brazil, Canada, and USA | 2001 | GSK | 15–25 | ≤6 | Abnormal cervical cytology,
HPV16/18 seropositivity,
DNA positivity for 14 oncogenic HPV types,
history of abnormal Pap test. | B | Aluminium containing placebo | 560 V
553 P | 505 V
497 P | 5.9 years (average)
6.4 years (maximum) |
|
| PATRICIA [13, 27] | NCT00122681
Phase III trial | 135 | 14 (Asia-Pacific, Europe, Latin America, and North America) | 2004-2005 | GSK | 15–25 | ≤6 | History of abnormal Pap test,
pregnancy or breastfeeding,
chronic disease, autoimmune disease, immunodeficiency. | B | HAV vaccine | 9319 V
9325 P | 8694 V
8708 P | 4 years
(average) |
|
| Konno et al. [29] | NCT00316693
Phase II trial | 13 | Japan | 2006 | GSK | 20–25 | Not specified | History of abnormal Pap test or genital warts,
pregnancy,
previous vaccination with HPV or HAV vaccine,
MPL administration,
hepatitis A infection. | B | HAV vaccine | 519 V
521 P | 501 V
501 P | 13.6 months in Konno 2010 |
|
| FUTURE I [16, 26, 30] | NCT00092521
Phase III trial | 62 | 16 (Asia-Pacific, Europe, and America) | 2001–2003 | Merck | 16–24 | ≤4 | History of abnormal Pap test or genital warts,
pregnancy,
being not healthy. | Q | Aluminium containing placebo | 2723 V
2732 P | 7980 V
7236 P
Follow-up FUTURE I + FUTURE II trial | 3.6 years (average)
4.9 years (maximum) |
|
| FUTURE II [17, 26, 30] | NCT00092534
Phase III trial | 90 | 13 (as above) | 2002-2003 | Merck | 15–26 | ≤4 | History of abnormal Pap test or genital warts,
pregnancy,
being not healthy. | Q | Aluminium containing placebo | 6087 V
6080 P | As above | As above |
|
