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Trial record 19 of 91 for:    cervarix

Human Papillomavirus (HPV) Vaccine (Cervarix TM) Efficacy, Immunogenicity & Safety Trial in Adult Japanese Women With GSK Biologicals HPV-16/18 Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00316693
Recruitment Status : Completed
First Posted : April 21, 2006
Results First Posted : December 16, 2009
Last Update Posted : September 3, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Prevention
Condition Infections, Papillomavirus
Interventions Biological: HPV-16/18 vaccine (Cervarix™)
Biological: Aimmugen™
Enrollment 1046
Recruitment Details  
Pre-assignment Details Six subjects enrolled in this study were not vaccinated and hence not reported as started in the participant flow table below.
Arm/Group Title Cervarix Group Aimmugen Group
Hide Arm/Group Description Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule. Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
Period Title: Overall Study
Started 519 521
Completed 442 436
Not Completed 77 85
Reason Not Completed
Adverse Event             6             1
Protocol Violation             1             0
Withdrawal by Subject             6             6
Lost to Follow-up             26             34
Other             38             44
Arm/Group Title Cervarix Group Aimmugen Group Total
Hide Arm/Group Description Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule. Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule. Total of all reporting groups
Overall Number of Baseline Participants 519 521 1040
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 519 participants 521 participants 1040 participants
22.4  (1.7) 22.5  (1.6) 22.5  (1.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 519 participants 521 participants 1040 participants
Female
519
 100.0%
521
 100.0%
1040
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Asian - Japanese heritage Number Analyzed 519 participants 521 participants 1040 participants
519
 100.0%
521
 100.0%
1040
 100.0%
1.Primary Outcome
Title Number of Subjects With Persistent Cervical Infection With Human Papillomavirus 16 (HPV-16) or Human Papillomavirus 18 (HPV-18)
Hide Description Persistent HPV-16 or HPV-18 infection is defined as at least 2 positive Human Papillomavirus (HPV) deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an approximate interval of 6 months (> 150 days) [as assessed in women who were, for the corresponding HPV type, seronegative at Month 0 and HPV DNA negative (by PCR) at Month 0 and Month 6].
Time Frame Throughout the study period (up to Month 24)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.
Arm/Group Title Cervarix Group Aimmugen Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 387 392
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16/18 Number Analyzed 387 participants 392 participants
0
   0.0%
15
   3.8%
HPV-16 Number Analyzed 332 participants 340 participants
0
   0.0%
11
   3.2%
HPV-18 Number Analyzed 346 participants 343 participants
0
   0.0%
5
   1.5%
2.Secondary Outcome
Title Number of Subjects With Incident Cervical Infection With Human Papillomavirus 16 (HPV-16) or Human Papillomavirus 18 (HPV-18)
Hide Description HPV-16 or HPV-18 incident infection is defined as at least one positive HPV-16 or HPV-18 deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assay in women who were, for the corresponding HPV type, seronegative at Month 0 and HPV DNA negative (by PCR) at Month 0 and Month 6.
Time Frame Up to Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.
Arm/Group Title Cervarix Group Aimmugen Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 408 406
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16/18 Number Analyzed 408 participants 406 participants
7
   1.7%
39
   9.6%
HPV-16 Number Analyzed 351 participants 353 participants
4
   1.1%
22
   6.2%
HPV-18 Number Analyzed 359 participants 355 participants
3
   0.8%
18
   5.1%
3.Secondary Outcome
Title Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Human Papillomavirus 16 (HPV-16) and/or Human Papillomavirus 18 (HPV-18) Cervical Infection
Hide Description Cytologically-confirmed abnormalities assessed include atypical squamous cells of undetermined significance (ASC-US), low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL), atypical squamous cells-can not exclude HSIL (ASC-H) and atypical glandular cells (AGC). These cytological abnormalities were assessed in women who were, for the corresponding Human Papillomavirus (HPV) type, seronegative at Month 0 and HPV deoxyribonucleic acid (DNA) negative (by polymerase chain reaction) at Month 0 and Month 6.
Time Frame Up to Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.
Arm/Group Title Cervarix Group Aimmugen Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 408 406
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16/18 Number Analyzed 408 participants 406 participants
1
   0.2%
12
   3.0%
HPV-16 Number Analyzed 351 participants 353 participants
0
   0.0%
8
   2.3%
HPV-18 Number Analyzed 359 participants 355 participants
1
   0.3%
4
   1.1%
4.Secondary Outcome
Title Number of Subjects With Histopathologically-confirmed Lesions Concurrently Associated With Human Papillomavirus 16 (HPV-16) and/or Human Papillomavirus (HPV-18) Cervical Infection
Hide Description Histopathologically-confirmed lesions assessed include cervical intraepithelial neoplasia of grade 1 (CIN1), grade 2 (CIN2), grade 3 (CIN3) and adenocarcinoma. These lesions were assessed in women who were, for the corresponding Human Papillomavirus (HPV) type, seronegative at Month 0 and HPV deoxyribonucleic acid (DNA) negative (by polymerase chain reaction) at Month 0 and Month 6.
Time Frame Up to Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.
Arm/Group Title Cervarix Group Aimmugen Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 408 407
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16/18 Number Analyzed 408 participants 407 participants
0
   0.0%
3
   0.7%
HPV-16 Number Analyzed 351 participants 353 participants
0
   0.0%
2
   0.6%
HPV-18 Number Analyzed 359 participants 356 participants
0
   0.0%
1
   0.3%
5.Secondary Outcome
Title Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types
Hide Description

Incident infection for oncogenic HPV types is defined as at least one positive oncogenic HPV type deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assay in women who were, for the corresponding HPV type, HPV DNA negative (by PCR) at Month 0 and Month 6.

Oncogenic (high risk [HR]) HPV types assessed include HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68.

Time Frame Up to Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.
Arm/Group Title Cervarix Group Aimmugen Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 446 436
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16 Number Analyzed 119 participants 398 participants
5
   4.2%
24
   6.0%
HPV-18 Number Analyzed 428 participants 407 participants
4
   0.9%
20
   4.9%
HPV-31 Number Analyzed 428 participants 416 participants
8
   1.9%
7
   1.7%
HPV-33 Number Analyzed 444 participants 435 participants
2
   0.5%
5
   1.1%
HPV-35 Number Analyzed 443 participants 432 participants
7
   1.6%
4
   0.9%
HPV-39 Number Analyzed 422 participants 418 participants
13
   3.1%
14
   3.3%
HPV-45 Number Analyzed 446 participants 433 participants
0
   0.0%
0
   0.0%
HPV-51 Number Analyzed 413 participants 412 participants
14
   3.4%
29
   7.0%
HPV-52 Number Analyzed 404 participants 383 participants
30
   7.4%
32
   8.4%
HPV-56 Number Analyzed 423 participants 414 participants
15
   3.5%
15
   3.6%
HPV-58 Number Analyzed 432 participants 411 participants
12
   2.8%
13
   3.2%
HPV-59 Number Analyzed 443 participants 427 participants
8
   1.8%
5
   1.2%
HPV-66 Number Analyzed 426 participants 410 participants
6
   1.4%
13
   3.2%
HPV-68 Number Analyzed 436 participants 424 participants
8
   1.8%
12
   2.8%
Any HR HPV types except HPV-16/18 Number Analyzed 446 participants 436 participants
90
  20.2%
113
  25.9%
Any HR HPV types Number Analyzed 446 participants 436 participants
98
  22.0%
134
  30.7%
6.Secondary Outcome
Title Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types
Hide Description

Persistent infection for oncogenic HPV types is defined as at least 2 positive HPV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an approximate interval of 6 months (> 150 days) [as assessed in women who were, for the corresponding HPV type, HPV DNA negative (by PCR) at Month 0 and Month 6].

Oncogenic (high risk [HR]) HPV types assessed include HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68.

Time Frame Up to Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.
Arm/Group Title Cervarix Group Aimmugen Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 424 422
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16 Number Analyzed 398 participants 384 participants
0
   0.0%
12
   3.1%
HPV-18 Number Analyzed 408 participants 394 participants
0
   0.0%
5
   1.3%
HPV-31 Number Analyzed 406 participants 403 participants
4
   1.0%
2
   0.5%
HPV-33 Number Analyzed 422 participants 421 participants
0
   0.0%
2
   0.5%
HPV-35 Number Analyzed 422 participants 418 participants
1
   0.2%
1
   0.2%
HPV-39 Number Analyzed 401 participants 406 participants
2
   0.5%
4
   1.0%
HPV-45 Number Analyzed 424 participants 419 participants
0
   0.0%
0
   0.0%
HPV-51 Number Analyzed 395 participants 398 participants
5
   1.3%
10
   2.5%
HPV-52 Number Analyzed 393 participants 371 participants
11
   2.8%
5
   1.3%
HPV-56 Number Analyzed 403 participants 400 participants
4
   1.0%
7
   1.8%
HPV-58 Number Analyzed 410 participants 399 participants
4
   1.0%
8
   2.0%
HPV-59 Number Analyzed 422 participants 413 participants
1
   0.2%
0
   0.0%
HPV-66 Number Analyzed 404 participants 396 participants
0
   0.0%
3
   0.8%
HPV-68 Number Analyzed 415 participants 410 participants
2
   0.5%
1
   0.2%
Any HR HPV types except HPV-16/18 Number Analyzed 424 participants 422 participants
27
   6.4%
39
   9.2%
Any HR HPV types Number Analyzed 424 participants 422 participants
27
   6.4%
53
  12.6%
7.Secondary Outcome
Title Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type
Hide Description

Cytologically-confirmed abnormalities assessed include ASC-US, LSIL, HSIL, ASC-H and AGC. These cytological abnormalities were assessed in women who were, for the corresponding HPV type (determined by PCR), HPV DNA negative (by PCR) at Month 0 and Month 6.

Oncogenic (high risk [HR]) HPV types assessed include HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68.

Time Frame Up to Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.
Arm/Group Title Cervarix Group Aimmugen Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 446 436
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16 Number Analyzed 419 participants 398 participants
0
   0.0%
9
   2.3%
HPV-18 Number Analyzed 428 participants 407 participants
1
   0.2%
4
   1.0%
HPV-31 Number Analyzed 428 participants 416 participants
2
   0.5%
0
   0.0%
HPV-33 Number Analyzed 444 participants 435 participants
1
   0.2%
2
   0.5%
HPV-35 Number Analyzed 443 participants 432 participants
2
   0.5%
1
   0.2%
HPV-39 Number Analyzed 422 participants 418 participants
3
   0.7%
5
   1.2%
HPV-45 Number Analyzed 446 participants 433 participants
0
   0.0%
0
   0.0%
HPV-51 Number Analyzed 413 participants 412 participants
4
   1.0%
5
   1.2%
HPV-52 Number Analyzed 404 participants 383 participants
6
   1.5%
7
   1.8%
HPV-56 Number Analyzed 423 participants 414 participants
5
   1.2%
6
   1.4%
HPV-58 Number Analyzed 432 participants 411 participants
4
   0.9%
10
   2.4%
HPV-59 Number Analyzed 443 participants 427 participants
3
   0.7%
3
   0.7%
HPV-66 Number Analyzed 426 participants 410 participants
1
   0.2%
3
   0.7%
HPV-68 Number Analyzed 436 participants 424 participants
3
   0.7%
5
   1.2%
Any HR HPV types except HPV-16/18 Number Analyzed 446 participants 436 participants
23
   5.2%
35
   8.0%
Any HR HPV types Number Analyzed 446 participants 436 participants
24
   5.4%
42
   9.6%
8.Secondary Outcome
Title Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type
Hide Description

Histopathologically-confirmed lesions assessed include cervical intraepithelial neoplasia of grade 1 (CIN1), grade 2 (CIN2), grade 3 (CIN3) and adenocarcinoma. These lesions were assessed in women who were, for the corresponding HPV type (determined by polymerase chain reaction)), HPV deoxyribonucleic acid (DNA) negative at Month 0 and Month 6.

Oncogenic (high risk [HR]) HPV types assessed include HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68.

Time Frame Up to Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.
Arm/Group Title Cervarix Group Aimmugen Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 446 438
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16 Number Analyzed 419 participants 400 participants
0
   0.0%
3
   0.8%
HPV-18 Number Analyzed 428 participants 409 participants
0
   0.0%
1
   0.2%
HPV-31 Number Analyzed 428 participants 417 participants
0
   0.0%
0
   0.0%
HPV-33 Number Analyzed 444 participants 437 participants
0
   0.0%
1
   0.2%
HPV-35 Number Analyzed 443 participants 434 participants
0
   0.0%
0
   0.0%
HPV-39 Number Analyzed 422 participants 419 participants
0
   0.0%
1
   0.2%
HPV-45 Number Analyzed 446 participants 435 participants
0
   0.0%
0
   0.0%
HPV-51 Number Analyzed 413 participants 413 participants
2
   0.5%
2
   0.5%
HPV-52 Number Analyzed 404 participants 385 participants
3
   0.7%
5
   1.3%
HPV-56 Number Analyzed 423 participants 415 participants
0
   0.0%
0
   0.0%
HPV-58 Number Analyzed 432 participants 413 participants
1
   0.2%
5
   1.2%
HPV-59 Number Analyzed 443 participants 429 participants
0
   0.0%
1
   0.2%
HPV-66 Number Analyzed 426 participants 412 participants
0
   0.0%
0
   0.0%
HPV-68 Number Analyzed 436 participants 425 participants
0
   0.0%
2
   0.5%
Any HR HPV types except HPV-16/18 Number Analyzed 446 participants 438 participants
6
   1.3%
14
   3.2%
Any HR HPV types Number Analyzed 446 participants 438 participants
6
   1.3%
17
   3.9%
9.Secondary Outcome
Title Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Titers Above the Cut-off Value
Hide Description Anti-HPV-16 antibody cut-off value assessed include 8 ELISA units per milliliter (EL.U/mL) and anti-HPV-18 antibody cut-off value assessed include 7 EL.U/mL.
Time Frame At Months 0 (pre-vaccination), 6, 7, 12, 18 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity.
Arm/Group Title Cervarix Group Aimmugen Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 411 393
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16 (pre-vaccination) Number Analyzed 411 participants 393 participants
64
  15.6%
51
  13.0%
HPV-16 (Month 6) Number Analyzed 411 participants 393 participants
411
 100.0%
55
  14.0%
HPV-16 (Month 7) Number Analyzed 410 participants 387 participants
410
 100.0%
52
  13.4%
HPV-16 (Month 12) Number Analyzed 373 participants 334 participants
373
 100.0%
46
  13.8%
HPV-16 (Month 18) Number Analyzed 356 participants 307 participants
356
 100.0%
39
  12.7%
HPV-16 (Month 24) Number Analyzed 351 participants 295 participants
351
 100.0%
38
  12.9%
HPV-18 (pre-vaccination) Number Analyzed 410 participants 390 participants
61
  14.9%
48
  12.3%
HPV-18 (Month 6) Number Analyzed 410 participants 388 participants
410
 100.0%
53
  13.7%
HPV-18 (Month 7) Number Analyzed 409 participants 385 participants
409
 100.0%
54
  14.0%
HPV-18 (Month 12) Number Analyzed 372 participants 329 participants
372
 100.0%
55
  16.7%
HPV-18 (Month 18) Number Analyzed 355 participants 302 participants
355
 100.0%
40
  13.2%
HPV-18 (Month 24) Number Analyzed 350 participants 288 participants
350
 100.0%
38
  13.2%
10.Secondary Outcome
Title Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Hide Description Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).
Time Frame At Months 0, 6, 7, 12, 18 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity.
Arm/Group Title Cervarix Group Aimmugen Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 411 393
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-HPV-16 (Month 0) Number Analyzed 411 participants 393 participants
5.5
(5.1 to 5.9)
5.3
(4.9 to 5.7)
Anti-HPV-16 (Month 6) Number Analyzed 411 participants 393 participants
708.4
(650.1 to 772.0)
5.4
(4.9 to 5.8)
Anti-HPV-16 (Month 7) Number Analyzed 410 participants 387 participants
7441.0
(6854.3 to 8077.8)
5.3
(4.9 to 5.8)
Anti-HPV-16 (Month 12) Number Analyzed 373 participants 334 participants
2877.7
(2623.1 to 3156.9)
5.3
(4.9 to 5.8)
Anti-HPV-16 (Month 18) Number Analyzed 356 participants 307 participants
1864.8
(1694.5 to 2052.2)
5.3
(4.8 to 5.8)
Anti-HPV-16 (Month 24) Number Analyzed 351 participants 295 participants
1532.2
(1395.1 to 1682.7)
5.4
(4.9 to 5.9)
Anti-HPV-18 (Month 0) Number Analyzed 410 participants 390 participants
4.5
(4.2 to 4.8)
4.4
(4.1 to 4.7)
Anti-HPV-18 (Month 6) Number Analyzed 410 participants 388 participants
504.6
(464.6 to 548.1)
4.4
(4.1 to 4.7)
Anti-HPV-18 (Month 7) Number Analyzed 409 participants 385 participants
3805.4
(3515.6 to 4119.1)
4.5
(4.2 to 4.8)
Anti-HPV-18 (Month 12) Number Analyzed 372 participants 329 participants
1330.7
(1210.2 to 1463.2)
4.5
(4.2 to 4.8)
Anti-HPV-18 (Month 18) Number Analyzed 355 participants 302 participants
782.0
(703.4 to 869.5)
4.4
(4.1 to 4.7)
Anti-HPV-18 (Month 24) Number Analyzed 350 participants 288 participants
627.8
(566.3 to 696.0)
4.4
(4.1 to 4.8)
11.Secondary Outcome
Title Number of Subjects Reporting Solicited Local and General Symptoms
Hide Description Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include arthralgia, fatigue, fever (above 37.5 degree Celsius), gastrointestinal symptoms, headache, myalgia, rash and urticaria.
Time Frame Within 7 days after each and any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
Arm/Group Title Cervarix Group Aimmugen Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 512 511
Measure Type: Count of Participants
Unit of Measure: Participants
Pain Number Analyzed 512 participants 510 participants
508
  99.2%
214
  42.0%
Redness Number Analyzed 512 participants 510 participants
455
  88.9%
287
  56.3%
Swelling Number Analyzed 512 participants 510 participants
401
  78.3%
165
  32.4%
Arthralgia Number Analyzed 512 participants 511 participants
123
  24.0%
61
  11.9%
Fatigue Number Analyzed 512 participants 511 participants
341
  66.6%
300
  58.7%
Fever Number Analyzed 512 participants 511 participants
41
   8.0%
28
   5.5%
Gastro-intestinal symptoms Number Analyzed 512 participants 511 participants
172
  33.6%
167
  32.7%
Headache Number Analyzed 512 participants 511 participants
250
  48.8%
222
  43.4%
Myalgia Number Analyzed 512 participants 511 participants
262
  51.2%
128
  25.0%
Rash Number Analyzed 512 participants 511 participants
33
   6.4%
24
   4.7%
Urticaria Number Analyzed 512 participants 511 participants
16
   3.1%
20
   3.9%
12.Secondary Outcome
Title Number of Subjects Reporting Unsolicited Adverse Events (AE)
Hide Description Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time Frame Within 30 days after any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated Cohort.
Arm/Group Title Cervarix Group Aimmugen Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 519 521
Measure Type: Count of Participants
Unit of Measure: Participants
294
  56.6%
266
  51.1%
13.Secondary Outcome
Title Number of Subjects Reporting Serious Adverse Events (SAE)
Hide Description SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Time Frame Throughout the study period (up to Month 24)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated Cohort.
Arm/Group Title Cervarix Group Aimmugen Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 519 521
Measure Type: Count of Participants
Unit of Measure: Participants
18
   3.5%
19
   3.6%
14.Secondary Outcome
Title Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs)
Hide Description NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSC include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Time Frame Throughout the study period (up to Month 24)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated Cohort.
Arm/Group Title Cervarix Group Aimmugen Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 519 521
Measure Type: Count of Participants
Unit of Measure: Participants
NOCDs
5
   1.0%
6
   1.2%
MSCs
91
  17.5%
107
  20.5%
15.Secondary Outcome
Title Outcome of Any Reported Pregnancies
Hide Description Information on any subject who became pregnant while participating in this study was collected. The outcomes of the pregnancies are reported below.
Time Frame Throughout the study period (up to Month 24)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on those subjects reporting pregnancy during the study period.
Arm/Group Title Cervarix Group Aimmugen Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 46 43
Measure Type: Count of Participants
Unit of Measure: Participants
Normal infant
20
  43.5%
19
  44.2%
Premature birth
1
   2.2%
0
   0.0%
Elective termination
14
  30.4%
16
  37.2%
Spontaneous abortion
5
  10.9%
3
   7.0%
Lost to follow-up
1
   2.2%
0
   0.0%
Pregnancy ongoing
5
  10.9%
5
  11.6%
16.Secondary Outcome
Title Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
Hide Description

Hematological parameters assessed in blood samples include hemoglobin, haematocrit, mean corpuscular (MC) hemoglobin, mean corpuscular (MC) hemoglobin concentration, mean corpuscular (MC) volume, platelet count, red blood cell count, white blood cell count.

Abnormalities reported include values outside the normal ranges: values higher than normal are designated as "Above" and values lower than normal as "Below" while "Unknown" stands for values not determined.

Time Frame At Month 0 and Month 7
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated Cohort.
Arm/Group Title Cervarix Group Aimmugen Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 519 521
Measure Type: Count of Participants
Unit of Measure: Participants
Hemoglobin Normal [Month 0]
499
  96.1%
498
  95.6%
Hemoglobin Above [Month 0]
1
   0.2%
2
   0.4%
Hemoglobin Below [Month 0]
18
   3.5%
21
   4.0%
Hemoglobin Unknown [Month 0]
1
   0.2%
0
   0.0%
Hemoglobin Normal [Month 7]
448
  86.3%
444
  85.2%
Hemoglobin Above [Month 7]
7
   1.3%
7
   1.3%
Hemoglobin Below [Month 7]
12
   2.3%
22
   4.2%
Hemoglobin Unknown [Month 7]
52
  10.0%
48
   9.2%
Hematocrit Normal [Month 0]
501
  96.5%
506
  97.1%
Hematocrit Above [Month 0]
3
   0.6%
5
   1.0%
Hematocrit Below [Month 0]
14
   2.7%
10
   1.9%
Hematocrit Unknown [Month 0]
1
   0.2%
0
   0.0%
Hematocrit Normal [Month 7]
448
  86.3%
456
  87.5%
Hematocrit Above [Month 7]
11
   2.1%
4
   0.8%
Hematocrit Below [Month 7]
8
   1.5%
13
   2.5%
Hematocrit Unknown [Month 7]
52
  10.0%
48
   9.2%
Platelet count Normal [Month 0]
504
  97.1%
514
  98.7%
Platelet count Above [Month 0]
13
   2.5%
5
   1.0%
Platelet count Below [Month 0]
0
   0.0%
2
   0.4%
Platelet count Unknown [Month 0]
2
   0.4%
0
   0.0%
Platelet count Normal [Month 7]
456
  87.9%
461
  88.5%
Platelet count Above [Month 7]
9
   1.7%
10
   1.9%
Platelet count Below [Month 7]
1
   0.2%
2
   0.4%
Platelet count Unknown [Month 7]
53
  10.2%
48
   9.2%
Red Blood Cells count Normal [Month 0]
514
  99.0%
515
  98.8%
Red Blood Cells count Above [Month 0]
2
   0.4%
4
   0.8%
Red Blood Cells count Below [Month 0]
2
   0.4%
2
   0.4%
Red Blood Cells count Unknown [Month 0]
1
   0.2%
0
   0.0%
Red Blood Cells count Normal [Month 7]
457
  88.1%
463
  88.9%
Red Blood Cells count Above [Month 7]
6
   1.2%
5
   1.0%
Red Blood Cells count Below [Month 7]
4
   0.8%
5
   1.0%
Red Blood Cells count Unknown [Month 7]
52
  10.0%
48
   9.2%
White Blood Cells count Normal [Month 0]
496
  95.6%
499
  95.8%
White Blood Cells count Above [Month 0]
12
   2.3%
14
   2.7%
White Blood Cells count Below [Month 0]
10
   1.9%
8
   1.5%
White Blood Cells count Unknown [Month 0]
1
   0.2%
0
   0.0%
White Blood Cells count Normal [Month 7]
440
  84.8%
453
  86.9%
White Blood Cells count Above [Month 7]
23
   4.4%
16
   3.1%
White Blood Cells count Below [Month 7]
4
   0.8%
4
   0.8%
White Blood Cells count Unknown [Month 7]
52
  10.0%
48
   9.2%
MC hemoglobin Normal [Month 0]
489
  94.2%
491
  94.2%
MC hemoglobin Above [Month 0]
0
   0.0%
0
   0.0%
MC hemoglobin Below [Month 0]
29
   5.6%
30
   5.8%
MC hemoglobin Unknown [Month 0]
1
   0.2%
0
   0.0%
MC hemoglobin Normal [Month 7]
441
  85.0%
439
  84.3%
MC hemoglobin Above [Month 7]
0
   0.0%
0
   0.0%
MC hemoglobin Below [Month 7]
26
   5.0%
34
   6.5%
MC hemoglobin Unknown [Month 7]
52
  10.0%
48
   9.2%
MC hemoglobin concentration Normal [Month 0]
495
  95.4%
488
  93.7%
MC hemoglobin concentration Above [Month 0]
0
   0.0%
0
   0.0%
MC hemoglobin concentration Below [Month 0]
23
   4.4%
33
   6.3%
MC hemoglobin concentration Unknown [Month 0]
1
   0.2%
0
   0.0%
MC hemoglobin concentration Normal [Month 7]
442
  85.2%
434
  83.3%
MC hemoglobin concentration Above [Month 7]
0
   0.0%
0
   0.0%
MC hemoglobin concentration Below [Month 7]
25
   4.8%
39
   7.5%
MC hemoglobin concentration Unknown [Month 7]
52
  10.0%
48
   9.2%
MC volume Normal [Month 0]
504
  97.1%
505
  96.9%
MC volume Above [Month 0]
1
   0.2%
0
   0.0%
MC volume Below [Month 0]
13
   2.5%
16
   3.1%
MC volume Unknown [Month 0]
1
   0.2%
0
   0.0%
MC volume Normal [Month 7]
457
  88.1%
456
  87.5%
MC volume Above [Month 7]
2
   0.4%
1
   0.2%
MC volume Below [Month 7]
8
   1.5%
16
   3.1%
MC volume Unknown [Month 7]
52
  10.0%
48
   9.2%
17.Secondary Outcome
Title Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Hide Description

Biochemical parameters were assessed in blood samples. Abnormalities reported include values outside the normal ranges: values higher than normal are designated as "Above" and values lower than normal as "Below" while "Unknown" stands for values not determined.

Abbreviations: aminotransferase (ALT), aspartate aminotransferase (ASP), C reactive protein (CRP), gamma-glutamyl-transferase (GGT) and lactate dehydrogenase (LDH).

Time Frame At Month 0 and Month 7
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated Cohort.
Arm/Group Title Cervarix Group Aimmugen Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 519 521
Measure Type: Count of Participants
Unit of Measure: Participants
Albumin Normal [Month 0]
519
 100.0%
521
 100.0%
Albumin Above [Month 0]
0
   0.0%
0
   0.0%
Albumin Below [Month 0]
0
   0.0%
0
   0.0%
Albumin Unknown [Month 0]
0
   0.0%
0
   0.0%
Albumin Normal [Month 7]
466
  89.8%
472
  90.6%
Albumin Above [Month 7]
0
   0.0%
0
   0.0%
Albumin Below [Month 7]
1
   0.2%
2
   0.4%
Albumin Unknown [Month 7]
52
  10.0%
47
   9.0%
Albumin/Globulin ratio Normal [Month 0]
483
  93.1%
488
  93.7%
Albumin/Globulin ratio Above [Month 0]
20
   3.9%
20
   3.8%
Albumin/Globulin ratio Below [Month 0]
16
   3.1%
13
   2.5%
Albumin/Globulin ratio Unknown [Month 0]
0
   0.0%
0
   0.0%
Albumin/Globulin ratio Normal [Month 7]
421
  81.1%
443
  85.0%
Albumin/Globulin ratio Above [Month 7]
30
   5.8%
19
   3.6%
Albumin/Globulin ratio Below [Month 7]
16
   3.1%
12
   2.3%
Albumin/Globulin ratio Unknown [Month 7]
52
  10.0%
47
   9.0%
Alkaline phosphatase Normal [Month 0]
500
  96.3%
497
  95.4%
Alkaline phosphatase Above [Month 0]
3
   0.6%
4
   0.8%
Alkaline phosphatase Below [Month 0]
16
   3.1%
20
   3.8%
Alkaline phosphatase Unknown [Month 0]
0
   0.0%
0
   0.0%
Alkaline phosphatase Normal [Month 7]
451
  86.9%
453
  86.9%
Alkaline phosphatase Above [Month 7]
4
   0.8%
3
   0.6%
Alkaline phosphatase Below [Month 7]
12
   2.3%
18
   3.5%
Alkaline phosphatase Unknown [Month 7]
52
  10.0%
47
   9.0%
ALT Normal [Month 0]
510
  98.3%
518
  99.4%
ALT Above [Month 0]
8
   1.5%
3
   0.6%
ALT Below [Month 0]
1
   0.2%
0
   0.0%
ALT Unknown [Month 0]
0
   0.0%
0
   0.0%
ALT Normal [Month 7]
457
  88.1%
471
  90.4%
ALT Above [Month 7]
9
   1.7%
3
   0.6%
ALT Below [Month 7]
1
   0.2%
0
   0.0%
ALT Unknown [Month 7]
52
  10.0%
47
   9.0%
AST Normal [Month 0]
516
  99.4%
520
  99.8%
AST Above [Month 0]
3
   0.6%
1
   0.2%
AST Below [Month 0]
0
   0.0%
0
   0.0%
AST Unknown [Month 0]
0
   0.0%
0
   0.0%
AST Normal [Month 7]
464
  89.4%
472
  90.6%
AST Above [Month 7]
3
   0.6%
0
   0.0%
AST Below [Month 7]
0
   0.0%
2
   0.4%
AST Unknown [Month 7]
52
  10.0%
47
   9.0%
Blood Urea Nitrogen Normal [Month 0]
450
  86.7%
466
  89.4%
Blood Urea Nitrogen Above [Month 0]
7
   1.3%
3
   0.6%
Blood Urea Nitrogen Below [Month 0]
62
  11.9%
52
  10.0%
Blood Urea Nitrogen Unknown [Month 0]
0
   0.0%
0
   0.0%
Blood Urea Nitrogen Normal [Month 7]
417
  80.3%
434
  83.3%
Blood Urea Nitrogen Above [Month 7]
3
   0.6%
1
   0.2%
Blood Urea Nitrogen Below [Month 7]
47
   9.1%
39
   7.5%
Blood Urea Nitrogen Unknown [Month 7]
52
  10.0%
47
   9.0%
Calcium Normal [Month 0]
516
  99.4%
519
  99.6%
Calcium Above [Month 0]
3
   0.6%
2
   0.4%
Calcium Below [Month 0]
0
   0.0%
0
   0.0%
Calcium Unknown [Month 0]
0
   0.0%
0
   0.0%
Calcium Normal [Month 7]
461
  88.8%
468
  89.8%
Calcium Above [Month 7]
3
   0.6%
4
   0.8%
Calcium Below [Month 7]
3
   0.6%
2
   0.4%
Calcium Unknown [Month 7]
52
  10.0%
47
   9.0%
Total cholesterol Normal [Month 0]
407
  78.4%
402
  77.2%
Total cholesterol Above [Month 0]
42
   8.1%
34
   6.5%
Total cholesterol Below [Month 0]
70
  13.5%
85
  16.3%
Total cholesterol Unknown [Month 0]
0
   0.0%
0
   0.0%
Total cholesterol Normal [Month 7]
355
  68.4%
367
  70.4%
Total cholesterol Above [Month 7]
36
   6.9%
36
   6.9%
Total cholesterol Below [Month 7]
76
  14.6%
71
  13.6%
Total cholesterol Unknown [Month 7]
52
  10.0%
47
   9.0%
Chlorine Normal [Month 0]
518
  99.8%
518
  99.4%
Chlorine Above [Month 0]
0
   0.0%
1
   0.2%
Chlorine Below [Month 0]
1
   0.2%
2
   0.4%
Chlorine Unknown [Month 0]
0
   0.0%
0
   0.0%
Chlorine Normal [Month 7]
466
  89.8%
472
  90.6%
Chlorine Above [Month 7]
0
   0.0%
0
   0.0%
Chlorine Below [Month 7]
1
   0.2%
2
   0.4%
Chlorine Unknown [Month 7]
52
  10.0%
47
   9.0%
Creatinine phosphokinase Normal [Month 0]
456
  87.9%
454
  87.1%
Creatinine phosphokinase Above [Month 0]
13
   2.5%
13
   2.5%
Creatinine phosphokinase Below [Month 0]
50
   9.6%
54
  10.4%
Creatinine phosphokinase Unknown [Month 0]
0
   0.0%
0
   0.0%
Creatinine phosphokinase Normal [Month 7]
412
  79.4%
420
  80.6%
Creatinine phosphokinase Above [Month 7]
10
   1.9%
7
   1.3%
Creatinine phosphokinase Below [Month 7]
45
   8.7%
47
   9.0%
Creatinine phosphokinase Unknown [Month 7]
52
  10.0%
47
   9.0%
Creatinine Normal [Month 0]
510
  98.3%
509
  97.7%
Creatinine Above [Month 0]
2
   0.4%
4
   0.8%
Creatinine Below [Month 0]
7
   1.3%
8
   1.5%
Creatinine Unknown [Month 0]
0
   0.0%
0
   0.0%
Creatinine Normal [Month 7]
453
  87.3%
466
  89.4%
Creatinine Above [Month 7]
3
   0.6%
2
   0.4%
Creatinine Below [Month 7]
11
   2.1%
6
   1.2%
Creatinine Unknown [Month 7]
52
  10.0%
47
   9.0%
Direct bilirubin Normal [Month 0]
500
  96.3%
494
  94.8%
Direct bilirubin Above [Month 0]
19
   3.7%
27
   5.2%
Direct bilirubin Below [Month 0]
0
   0.0%
0
   0.0%
Direct bilirubin Unknown [Month 0]
0
   0.0%
0
   0.0%
Direct bilirubin Normal [Month 7]
457
  88.1%
458
  87.9%
Direct bilirubin Above [Month 7]
10
   1.9%
16
   3.1%
Direct bilirubin Below [Month 7]
0
   0.0%
0
   0.0%
Direct bilirubin Unknown [Month 7]
52
  10.0%
47
   9.0%
GGT Normal [Month 0]
510
  98.3%
515
  98.8%
GGT Above [Month 0]
9
   1.7%
6
   1.2%
GGT Below [Month 0]
0
   0.0%
0
   0.0%
GGT Unknown [Month 0]
0
   0.0%
0
   0.0%
GGT Normal [Month 7]
459
  88.4%
471
  90.4%
GGT Above [Month 7]
8
   1.5%
3
   0.6%
GGT Below [Month 7]
0
   0.0%
0
   0.0%
GGT Unknown [Month 7]
52
  10.0%
47
   9.0%
Glucose Normal [Month 0]
468
  90.2%
464
  89.1%
Glucose Above [Month 0]
10
   1.9%
11
   2.1%
Glucose Below [Month 0]
41
   7.9%
47
   9.0%
Glucose Unknown [Month 0]
0
   0.0%
0
   0.0%
Glucose Normal [Month 7]
409
  78.8%
423
  81.2%
Glucose Above [Month 7]
15
   2.9%
18
   3.5%
Glucose Below [Month 7]
43
   8.3%
34
   6.5%
Glucose Unknown [Month 7]
52
  10.0%
47
   9.0%
Potassium Normal [Month 0]
509
  98.1%
509
  97.7%
Potassium Above [Month 0]
10
   1.9%
11
   2.1%
Potassium Below [Month 0]
0
   0.0%
1
   0.2%
Potassium Unknown [Month 0]
0
   0.0%
0
   0.0%
Potassium Normal [Month 7]
462
  89.0%
470
  90.2%
Potassium Above [Month 7]
5
   1.0%
4
   0.8%
Potassium Below [Month 7]
0
   0.0%
0
   0.0%
Potassium Unknown [Month 7]
52
  10.0%
47
   9.0%
Leucine Amino Peptidase Normal [Month 0]
510
  98.3%
512
  98.3%
Leucine Amino Peptidase Above [Month 0]
4
   0.8%
1
   0.2%
Leucine Amino Peptidase Below [Month 0]
5
   1.0%
8
   1.5%
Leucine Amino Peptidase Unknown [Month 0]
0
   0.0%
0
   0.0%
Leucine Amino Peptidase Normal [Month 7]
460
  88.6%
462
  88.7%
Leucine Amino Peptidase Above [Month 7]
2
   0.4%
9
   1.7%
Leucine Amino Peptidase Below [Month 7]
5
   1.0%
3
   0.6%
Leucine Amino Peptidase Unknown [Month 7]
52
  10.0%
47
   9.0%
LDH Normal [Month 0]
486
  93.6%
491
  94.2%
LDH Above [Month 0]
2
   0.4%
1
   0.2%
LDH Below [Month 0]
31
   6.0%
29
   5.6%
LDH Unknown [Month 0]
0
   0.0%
0
   0.0%
LDH Normal [Month 7]
433
  83.4%
437
  83.9%
LDH Above [Month 7]
5
   1.0%
2
   0.4%
LDH Below [Month 7]
29
   5.6%
35
   6.7%
LDH Unknown [Month 7]
52
  10.0%
47
   9.0%
Sodium Normal [Month 0]
519
 100.0%
521
 100.0%
Sodium Above [Month 0]
0
   0.0%
0
   0.0%
Sodium Below [Month 0]
0
   0.0%
0
   0.0%
Sodium Unknown [Month 0]
0
   0.0%
0
   0.0%
Sodium Normal [Month 7]
466
  89.8%
474
  91.0%
Sodium Above [Month 7]
1
   0.2%
0
   0.0%
Sodium Below [Month 7]
0
   0.0%
0
   0.0%
Sodium Unknown [Month 7]
52
  10.0%
47
   9.0%
Total bilirubin Normal [Month 0]
472
  90.9%
466
  89.4%
Total bilirubin Above [Month 0]
47
   9.1%
55
  10.6%
Total bilirubin Below [Month 0]
0
   0.0%
0
   0.0%
Total bilirubin Unknown [Month 0]
0
   0.0%
0
   0.0%
Total bilirubin Normal [Month 7]
440
  84.8%
443
  85.0%
Total bilirubin Above [Month 7]
27
   5.2%
31
   6.0%
Total bilirubin Below [Month 7]
0
   0.0%
0
   0.0%
Total bilirubin Unknown [Month 7]
52
  10.0%
47
   9.0%
Triglycerides Normal [Month 0]
318
  61.3%
324
  62.2%
Triglycerides Above [Month 0]
24
   4.6%
21
   4.0%
Triglycerides Below [Month 0]
177
  34.1%
176
  33.8%
Triglycerides Unknown [Month 0]
0
   0.0%
0
   0.0%
Triglycerides Normal [Month 7]
275
  53.0%
290
  55.7%
Triglycerides Above [Month 7]
28
   5.4%
26
   5.0%
Triglycerides Below [Month 7]
164
  31.6%
158
  30.3%
Triglycerides Unknown [Month 7]
52
  10.0%
47
   9.0%
Total protein Normal [Month 0]
510
  98.3%
509
  97.7%
Total protein Above [Month 0]
6
   1.2%
10
   1.9%
Total protein Below [Month 0]
3
   0.6%
2
   0.4%
Total protein Unknown [Month 0]
0
   0.0%
0
   0.0%
Total protein Normal [Month 7]
454
  87.5%
463
  88.9%
Total protein Above [Month 7]
1
   0.2%
2
   0.4%
Total protein Below [Month 7]
12
   2.3%
9
   1.7%
Total protein Unknown [Month 7]
52
  10.0%
47
   9.0%
Uric acid Normal [Month 0]
515
  99.2%
520
  99.8%
Uric acid Above [Month 0]
4
   0.8%
1
   0.2%
Uric acid Below [Month 0]
0
   0.0%
0
   0.0%
Uric acid Unknown [Month 0]
0
   0.0%
0
   0.0%
Uric acid Normal [Month 7]
465
  89.6%
473
  90.8%
Uric acid Above [Month 7]
2
   0.4%
1
   0.2%
Uric acid Below [Month 7]
0
   0.0%
0
   0.0%
Uric acid Unknown [Month 7]
52
  10.0%
47
   9.0%
pH Normal [Month 0]
466
  89.8%
462
  88.7%
pH Above [Month 0]
52
  10.0%
59
  11.3%
pH Below [Month 0]
0
   0.0%
0
   0.0%
pH Unknown [Month 0]
1
   0.2%
0
   0.0%
pH Normal [Month 7]
438
  84.4%
442
  84.8%
pH Above [Month 7]
28
   5.4%
32
   6.1%
pH Below [Month 7]
0
   0.0%
0
   0.0%
pH Unknown [Month 7]
53
  10.2%
47
   9.0%
CRP Normal [Month 0]
106
  20.4%
70
  13.4%
CRP Above [Month 0]
12
   2.3%
11
   2.1%
CRP Below [Month 0]
0
   0.0%
0
   0.0%
CRP Unknown [Month 0]
401
  77.3%
440
  84.5%
CRP Normal [Month 7]
126
  24.3%
96
  18.4%
CRP Above [Month 7]
20
   3.9%
16
   3.1%
CRP Below [Month 7]
0
   0.0%
0
   0.0%
CRP Unknown [Month 7]
373
  71.9%
409
  78.5%
18.Secondary Outcome
Title Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Hide Description

Abnormalities in concentrations (expressed as milligrams per deciliter [mg/dL]) are presented categorical as follows:

Protein: <10 (-)*; 10-25 (+-)*; 25-85 (+); 85-250 (2+); 250-800 (3+).

Glucose: <30 (-)*; 30-60 (+-)*; 60-125 (+); 125-250 (2+); 250-750 (3+).

Urobilinogen: <1.5 (+-)*; 1.5-3.5 (+); 3.5-7 (2+); 7-14 (3+).

Bilirubin: <0.35 (-)*; 0.35-1.5 (+); 1.5-5 (2+); 5-12 (3+).

Occult blood: <0.015 (-)*; 0.015-0.045 (+-); 0.045-015 (+); 0.15-0.75 (2+); >0.75 (3+).

Ketone body: <2.5 (-)*; 2.5-7.5 (+-); 7.5-30 (+); 30-70 (2+); 70-125 (3+).

Normal ranges indicated by asterix*.

Time Frame At Month 0 and Month 7
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated cohort.
Arm/Group Title Cervarix Group Aimmugen Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 519 521
Measure Type: Count of Participants
Unit of Measure: Participants
Protein (-) [Month 0]
496
  95.6%
492
  94.4%
Protein (+-) [Month 0]
10
   1.9%
11
   2.1%
Protein (+) [Month 0]
9
   1.7%
16
   3.1%
Protein (2+) [Month 0]
2
   0.4%
1
   0.2%
Protein (3+) [Month 0]
1
   0.2%
1
   0.2%
Protein (Unknown) [Month 0]
1
   0.2%
0
   0.0%
Protein (-) [Month 7]
444
  85.5%
448
  86.0%
Protein (+-) [Month 7]
10
   1.9%
11
   2.1%
Protein (+) [Month 7]
11
   2.1%
14
   2.7%
Protein (2+) [Month 7]
1
   0.2%
1
   0.2%
Protein (3+) [Month 7]
0
   0.0%
0
   0.0%
Protein (Unknown) [Month 7]
53
  10.2%
47
   9.0%
Glucose (-) [Month 0]
513
  98.8%
520
  99.8%
Glucose (+-) [Month 0]
3
   0.6%
0
   0.0%
Glucose (+) [Month 0]
0
   0.0%
0
   0.0%
Glucose (2+) [Month 0]
0
   0.0%
1
   0.2%
Glucose (3+) [Month 0]
2
   0.4%
0
   0.0%
Glucose (Unknown) [Month 0]
1
   0.2%
0
   0.0%
Glucose (-) [Month 7]
459
  88.4%
471
  90.4%
Glucose (+-) [Month 7]
2
   0.4%
2
   0.4%
Glucose (+) [Month 7]
2
   0.4%
1
   0.2%
Glucose (2+) [Month 7]
3
   0.6%
0
   0.0%
Glucose (3+) [Month 7]
0
   0.0%
0
   0.0%
Glucose (Unknown) [Month 7]
53
  10.2%
47
   9.0%
Urobilinogen (-) [Month 0]
0
   0.0%
0
   0.0%
Urobilinogen (+-) [Month 0]
506
  97.5%
502
  96.4%
Urobilinogen (+) [Month 0]
11
   2.1%
15
   2.9%
Urobilinogen (2+) [Month 0]
1
   0.2%
2
   0.4%
Urobilinogen (3+) [Month 0]
0
   0.0%
2
   0.4%
Urobilinogen (Unknown) [Month 0]
1
   0.2%
0
   0.0%
Urobilinogen (-) [Month 7]
0
   0.0%
0
   0.0%
Urobilinogen (+-) [Month 7]
460
  88.6%
460
  88.3%
Urobilinogen (+) [Month 7]
6
   1.2%
12
   2.3%
Urobilinogen (2+) [Month 7]
0
   0.0%
1
   0.2%
Urobilinogen (3+) [Month 7]
0
   0.0%
1
   0.2%
Urobilinogen (Unknown) [Month 7]
53
  10.2%
47
   9.0%
Occult Blood (-) [Month 0]
483
  93.1%
495
  95.0%
Occult Blood (+-) [Month 0]
11
   2.1%
7
   1.3%
Occult Blood (+) [Month 0]
11
   2.1%
9
   1.7%
Occult Blood (2+) [Month 0]
9
   1.7%
8
   1.5%
Occult Blood (3+) [Month 0]
4
   0.8%
2
   0.4%
Occult Blood (Unknown) [Month 0]
1
   0.2%
0
   0.0%
Occult Blood (-) [Month 7]
393
  75.7%
398
  76.4%
Occult Blood (+-) [Month 7]
22
   4.2%
28
   5.4%
Occult Blood (+) [Month 7]
19
   3.7%
20
   3.8%
Occult Blood (2+) [Month 7]
22
   4.2%
18
   3.5%
Occult Blood (3+) [Month 7]
10
   1.9%
10
   1.9%
Occult Blood (Unknown) [Month 7]
53
  10.2%
47
   9.0%
Ketone Body (-) [Month 0]
501
  96.5%
506
  97.1%
Ketone Body (+-) [Month 0]
0
   0.0%
0
   0.0%
Ketone Body (+) [Month 0]
9
   1.7%
8
   1.5%
Ketone Body (2+) [Month 0]
7
   1.3%
6
   1.2%
Ketone Body (3+) [Month 0]
1
   0.2%
1
   0.2%
Ketone Body (Unknown) [Month 0]
1
   0.2%
0
   0.0%
Ketone Body (-) [Month 7]
452
  87.1%
460
  88.3%
Ketone Body (+-) [Month 7]
0
   0.0%
0
   0.0%
Ketone Body (+) [Month 7]
10
   1.9%
10
   1.9%
Ketone Body (2+) [Month 7]
3
   0.6%
3
   0.6%
Ketone Body (3+) [Month 7]
1
   0.2%
1
   0.2%
Ketone Body (Unknown) [Month 7]
53
  10.2%
47
   9.0%
Bilirubin (-) [Month 0]
517
  99.6%
520
  99.8%
Bilirubin (+-) [Month 0]
0
   0.0%
0
   0.0%
Bilirubin (+) [Month 0]
1
   0.2%
1
   0.2%
Bilirubin (2+) [Month 0]
0
   0.0%
0
   0.0%
Bilirubin (3+) [Month 0]
0
   0.0%
0
   0.0%
Bilirubin (Unknown) [Month 0]
1
   0.2%
0
   0.0%
Bilirubin (-) [Month 7]
466
  89.8%
474
  91.0%
Bilirubin (+-) [Month 7]
0
   0.0%
0
   0.0%
Bilirubin (+) [Month 7]
0
   0.0%
0
   0.0%
Bilirubin (2+) [Month 7]
0
   0.0%
0
   0.0%
Bilirubin (3+) [Month 7]
0
   0.0%
0
   0.0%
Bilirubin (Unknown) [Month 7]
53
  10.2%
47
   9.0%
Time Frame - For serious adverse events: thoughout the study period (up to Month 24). - For other adverse events: -- during the 30-day (non-systematically assessed) or -- during the 7-day (systematically assessed) follow-up period after any vaccination.
Adverse Event Reporting Description

Total number of subjects at risk corresponds to

  • all subjects in the Total Vaccinated Cohort for serious events and non-systematically assessed other events;
  • those subjects in the Total Vaccinated Cohort with at least one documented dose.
 
Arm/Group Title Cervarix Group Aimmugen Group
Hide Arm/Group Description Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule. Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
All-Cause Mortality
Cervarix Group Aimmugen Group
Affected / at Risk (%) Affected / at Risk (%)
Total   1/519 (0.19%)   0/521 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Cervarix Group Aimmugen Group
Affected / at Risk (%) Affected / at Risk (%)
Total   18/519 (3.47%)   19/521 (3.65%) 
Gastrointestinal disorders     
Acute abdomen * 1  0/519 (0.00%)  1/521 (0.19%) 
Enterocolitis * 1  0/519 (0.00%)  1/521 (0.19%) 
Gastritis * 1  0/519 (0.00%)  1/521 (0.19%) 
General disorders     
Fatigue * 1  0/519 (0.00%)  1/521 (0.19%) 
Hepatobiliary disorders     
Hepatitis acute * 1  1/519 (0.19%)  1/521 (0.19%) 
Infections and infestations     
Acute tonsillitis * 1  0/519 (0.00%)  2/521 (0.38%) 
Appendicitis * 1  1/519 (0.19%)  1/521 (0.19%) 
Mastitis postpartum * 1  0/519 (0.00%)  1/521 (0.19%) 
Pneumonia * 2  0/519 (0.00%)  1/521 (0.19%) 
Pyelonephritis acute * 2  1/519 (0.19%)  0/521 (0.00%) 
Injury, poisoning and procedural complications     
Avulsion fracture * 1  0/519 (0.00%)  1/521 (0.19%) 
Brain contusion * 1  1/519 (0.19%)  0/521 (0.00%) 
Contusion * 1  0/519 (0.00%)  1/521 (0.19%) 
Eyeball rupture * 1  1/519 (0.19%)  0/521 (0.00%) 
Ligament injury * 1  1/519 (0.19%)  0/521 (0.00%) 
Ligament rupture * 1  0/519 (0.00%)  1/521 (0.19%) 
Road traffic accident * 2  1/519 (0.19%)  0/521 (0.00%) 
Skull fracture * 2  1/519 (0.19%)  0/521 (0.00%) 
Nervous system disorders     
Moyamoya disease * 1  0/519 (0.00%)  1/521 (0.19%) 
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous * 1  3/519 (0.58%)  3/521 (0.58%) 
Abortion threatened * 1  1/519 (0.19%)  1/521 (0.19%) 
Threatened labour * 1  1/519 (0.19%)  1/521 (0.19%) 
Abortion missed * 1  1/519 (0.19%)  0/521 (0.00%) 
Abortion spontaneous incomplete * 1  1/519 (0.19%)  0/521 (0.00%) 
Psychiatric disorders     
Borderline personality disorder * 1  1/519 (0.19%)  0/521 (0.00%) 
Completed suicide * 1  1/519 (0.19%)  0/521 (0.00%) 
Depression * 1  1/519 (0.19%)  0/521 (0.00%) 
Panic disorder * 2  1/519 (0.19%)  0/521 (0.00%) 
Schizophrenia * 2  0/519 (0.00%)  1/521 (0.19%) 
Reproductive system and breast disorders     
Ovarian haemorrhage * 1  1/519 (0.19%)  0/521 (0.00%) 
Polycystic ovaries * 2  0/519 (0.00%)  1/521 (0.19%) 
Respiratory, thoracic and mediastinal disorders     
Allergic granulomatous angiitis * 1  1/519 (0.19%)  0/521 (0.00%) 
Pneumothorax * 2  1/519 (0.19%)  0/521 (0.00%) 
1
Term from vocabulary, MedDRA (Unspecified)
2
Term from vocabulary, MedDRA
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cervarix Group Aimmugen Group
Affected / at Risk (%) Affected / at Risk (%)
Total   512/519 (98.65%)   459/521 (88.10%) 
General disorders     
Pain  1  508/512 (99.22%)  214/510 (41.96%) 
Redness  1  455/512 (88.87%)  287/510 (56.27%) 
Swelling  1  401/512 (78.32%)  165/510 (32.35%) 
Arthralgia  1  123/512 (24.02%)  61/511 (11.94%) 
Fatigue  1  341/512 (66.60%)  300/511 (58.71%) 
Fever  1  41/512 (8.01%)  28/511 (5.48%) 
Gastrointestinal symptoms  1  172/512 (33.59%)  167/511 (32.68%) 
Headache  1  250/512 (48.83%)  222/511 (43.44%) 
Myalgia  1  262/512 (51.17%)  128/511 (25.05%) 
Rash  1  33/512 (6.45%)  24/511 (4.70%) 
Injection site pruritus * 2  83/519 (15.99%)  15/521 (2.88%) 
Injection site warmth * 2  69/519 (13.29%)  6/521 (1.15%) 
Infections and infestations     
Nasopharyngitis * 2  110/519 (21.19%)  91/521 (17.47%) 
Nervous system disorders     
Headache * 2  19/519 (3.66%)  27/521 (5.18%) 
1
Term from vocabulary, MedDRA
2
Term from vocabulary, MedDRA (Unspecified)
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Publications:
Konno R et al. Efficacy, immunogenicity and safety of HPV 16/18 AS04-adjuvanted vaccine in Japanese women. Abstract presented at European Research Organization on Genital Infection and Neoplasia 2010 (EUROGIN). Monte Carlo, Monaco, 17-20 February 2010.
Konno R et al. Interim analysis of clinical trial of HPV-16/18-AS04 vaccine in Japan. Abstract presented at the 25th International Papillomavirus Conference, Malmö, Sweden, 8-14 May 2009.
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00316693     History of Changes
Other Study ID Numbers: 104798
First Submitted: April 19, 2006
First Posted: April 21, 2006
Results First Submitted: November 12, 2009
Results First Posted: December 16, 2009
Last Update Posted: September 3, 2018