Trial Outcomes & Findings for Human Papillomavirus (HPV) Vaccine (Cervarix TM) Efficacy, Immunogenicity & Safety Trial in Adult Japanese Women With GSK Biologicals HPV-16/18 Vaccine (NCT NCT00316693)
NCT ID: NCT00316693
Last Updated: 2018-09-04
Results Overview
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) \[as assessed in women who were, for the corresponding HPV type, seronegative at Month 0 and HPV DNA negative (by PCR) at Month 0 and Month 6\].
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
1046 participants
Primary outcome timeframe
Throughout the study period (up to Month 24)
Results posted on
2018-09-04
Participant Flow
Six subjects enrolled in this study were not vaccinated and hence not reported as started in the participant flow table below.
Participant milestones
| Measure |
Cervarix Group
Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
|
Aimmugen Group
Subjects received 3 doses of Aimmugen™ (Hepatitis A \[HAV\] vaccine) according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Overall Study
STARTED
|
519
|
521
|
|
Overall Study
COMPLETED
|
442
|
436
|
|
Overall Study
NOT COMPLETED
|
77
|
85
|
Reasons for withdrawal
| Measure |
Cervarix Group
Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
|
Aimmugen Group
Subjects received 3 doses of Aimmugen™ (Hepatitis A \[HAV\] vaccine) according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
6
|
6
|
|
Overall Study
Lost to Follow-up
|
26
|
34
|
|
Overall Study
Other
|
38
|
44
|
Baseline Characteristics
Human Papillomavirus (HPV) Vaccine (Cervarix TM) Efficacy, Immunogenicity & Safety Trial in Adult Japanese Women With GSK Biologicals HPV-16/18 Vaccine
Baseline characteristics by cohort
| Measure |
Cervarix Group
n=519 Participants
Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
|
Aimmugen Group
n=521 Participants
Subjects received 3 doses of Aimmugen™ (Hepatitis A \[HAV\] vaccine) according to a 0, 1, 6-month schedule.
|
Total
n=1040 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
22.4 years
STANDARD_DEVIATION 1.7 • n=5 Participants
|
22.5 years
STANDARD_DEVIATION 1.6 • n=7 Participants
|
22.5 years
STANDARD_DEVIATION 1.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
519 Participants
n=5 Participants
|
521 Participants
n=7 Participants
|
1040 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - Japanese heritage
|
519 Participants
n=5 Participants
|
521 Participants
n=7 Participants
|
1040 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Throughout the study period (up to Month 24)Population: Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.
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) \[as assessed in women who were, for the corresponding HPV type, seronegative at Month 0 and HPV DNA negative (by PCR) at Month 0 and Month 6\].
Outcome measures
| Measure |
Aimmugen Group
n=392 Participants
Subjects received 3 doses of Aimmugen™ (Hepatitis A \[HAV\] vaccine) according to a 0, 1, 6-month schedule.
|
Cervarix Group
n=387 Participants
Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects With Persistent Cervical Infection With Human Papillomavirus 16 (HPV-16) or Human Papillomavirus 18 (HPV-18)
HPV-16/18
|
15 Participants
|
0 Participants
|
|
Number of Subjects With Persistent Cervical Infection With Human Papillomavirus 16 (HPV-16) or Human Papillomavirus 18 (HPV-18)
HPV-16
|
11 Participants
|
0 Participants
|
|
Number of Subjects With Persistent Cervical Infection With Human Papillomavirus 16 (HPV-16) or Human Papillomavirus 18 (HPV-18)
HPV-18
|
5 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Month 24Population: Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.
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.
Outcome measures
| Measure |
Aimmugen Group
n=406 Participants
Subjects received 3 doses of Aimmugen™ (Hepatitis A \[HAV\] vaccine) according to a 0, 1, 6-month schedule.
|
Cervarix Group
n=408 Participants
Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects With Incident Cervical Infection With Human Papillomavirus 16 (HPV-16) or Human Papillomavirus 18 (HPV-18)
HPV-16/18
|
39 Participants
|
7 Participants
|
|
Number of Subjects With Incident Cervical Infection With Human Papillomavirus 16 (HPV-16) or Human Papillomavirus 18 (HPV-18)
HPV-16
|
22 Participants
|
4 Participants
|
|
Number of Subjects With Incident Cervical Infection With Human Papillomavirus 16 (HPV-16) or Human Papillomavirus 18 (HPV-18)
HPV-18
|
18 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to Month 24Population: Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.
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.
Outcome measures
| Measure |
Aimmugen Group
n=406 Participants
Subjects received 3 doses of Aimmugen™ (Hepatitis A \[HAV\] vaccine) according to a 0, 1, 6-month schedule.
|
Cervarix Group
n=408 Participants
Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Human Papillomavirus 16 (HPV-16) and/or Human Papillomavirus 18 (HPV-18) Cervical Infection
HPV-16/18
|
12 Participants
|
1 Participants
|
|
Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Human Papillomavirus 16 (HPV-16) and/or Human Papillomavirus 18 (HPV-18) Cervical Infection
HPV-16
|
8 Participants
|
0 Participants
|
|
Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Human Papillomavirus 16 (HPV-16) and/or Human Papillomavirus 18 (HPV-18) Cervical Infection
HPV-18
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to Month 24Population: Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.
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.
Outcome measures
| Measure |
Aimmugen Group
n=407 Participants
Subjects received 3 doses of Aimmugen™ (Hepatitis A \[HAV\] vaccine) according to a 0, 1, 6-month schedule.
|
Cervarix Group
n=408 Participants
Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects With Histopathologically-confirmed Lesions Concurrently Associated With Human Papillomavirus 16 (HPV-16) and/or Human Papillomavirus (HPV-18) Cervical Infection
HPV-16/18
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically-confirmed Lesions Concurrently Associated With Human Papillomavirus 16 (HPV-16) and/or Human Papillomavirus (HPV-18) Cervical Infection
HPV-16
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically-confirmed Lesions Concurrently Associated With Human Papillomavirus 16 (HPV-16) and/or Human Papillomavirus (HPV-18) Cervical Infection
HPV-18
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Month 24Population: Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.
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.
Outcome measures
| Measure |
Aimmugen Group
n=436 Participants
Subjects received 3 doses of Aimmugen™ (Hepatitis A \[HAV\] vaccine) according to a 0, 1, 6-month schedule.
|
Cervarix Group
n=446 Participants
Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types
HPV-16
|
24 Participants
|
5 Participants
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types
HPV-18
|
20 Participants
|
4 Participants
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types
HPV-31
|
7 Participants
|
8 Participants
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types
HPV-33
|
5 Participants
|
2 Participants
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types
HPV-35
|
4 Participants
|
7 Participants
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types
HPV-39
|
14 Participants
|
13 Participants
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types
HPV-45
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types
HPV-51
|
29 Participants
|
14 Participants
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types
HPV-52
|
32 Participants
|
30 Participants
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types
HPV-56
|
15 Participants
|
15 Participants
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types
HPV-58
|
13 Participants
|
12 Participants
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types
HPV-59
|
5 Participants
|
8 Participants
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types
HPV-66
|
13 Participants
|
6 Participants
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types
HPV-68
|
12 Participants
|
8 Participants
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types
Any HR HPV types except HPV-16/18
|
113 Participants
|
90 Participants
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types
Any HR HPV types
|
134 Participants
|
98 Participants
|
SECONDARY outcome
Timeframe: Up to Month 24Population: Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.
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.
Outcome measures
| Measure |
Aimmugen Group
n=422 Participants
Subjects received 3 doses of Aimmugen™ (Hepatitis A \[HAV\] vaccine) according to a 0, 1, 6-month schedule.
|
Cervarix Group
n=424 Participants
Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types
HPV-16
|
12 Participants
|
0 Participants
|
|
Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types
HPV-18
|
5 Participants
|
0 Participants
|
|
Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types
HPV-31
|
2 Participants
|
4 Participants
|
|
Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types
HPV-33
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types
HPV-35
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types
HPV-39
|
4 Participants
|
2 Participants
|
|
Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types
HPV-45
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types
HPV-51
|
10 Participants
|
5 Participants
|
|
Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types
HPV-52
|
5 Participants
|
11 Participants
|
|
Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types
HPV-56
|
7 Participants
|
4 Participants
|
|
Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types
HPV-58
|
8 Participants
|
4 Participants
|
|
Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types
HPV-59
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types
HPV-66
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types
HPV-68
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types
Any HR HPV types except HPV-16/18
|
39 Participants
|
27 Participants
|
|
Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types
Any HR HPV types
|
53 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: Up to Month 24Population: Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.
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.
Outcome measures
| Measure |
Aimmugen Group
n=436 Participants
Subjects received 3 doses of Aimmugen™ (Hepatitis A \[HAV\] vaccine) according to a 0, 1, 6-month schedule.
|
Cervarix Group
n=446 Participants
Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type
HPV-66
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type
HPV-16
|
9 Participants
|
0 Participants
|
|
Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type
HPV-18
|
4 Participants
|
1 Participants
|
|
Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type
HPV-31
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type
HPV-33
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type
HPV-35
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type
HPV-39
|
5 Participants
|
3 Participants
|
|
Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type
HPV-45
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type
HPV-51
|
5 Participants
|
4 Participants
|
|
Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type
HPV-52
|
7 Participants
|
6 Participants
|
|
Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type
HPV-56
|
6 Participants
|
5 Participants
|
|
Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type
HPV-58
|
10 Participants
|
4 Participants
|
|
Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type
HPV-59
|
3 Participants
|
3 Participants
|
|
Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type
HPV-68
|
5 Participants
|
3 Participants
|
|
Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type
Any HR HPV types except HPV-16/18
|
35 Participants
|
23 Participants
|
|
Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type
Any HR HPV types
|
42 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Up to Month 24Population: Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.
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.
Outcome measures
| Measure |
Aimmugen Group
n=438 Participants
Subjects received 3 doses of Aimmugen™ (Hepatitis A \[HAV\] vaccine) according to a 0, 1, 6-month schedule.
|
Cervarix Group
n=446 Participants
Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type
HPV-51
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type
HPV-52
|
5 Participants
|
3 Participants
|
|
Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type
HPV-56
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type
HPV-58
|
5 Participants
|
1 Participants
|
|
Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type
HPV-59
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type
HPV-39
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type
HPV-45
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type
HPV-16
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type
HPV-18
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type
HPV-31
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type
HPV-33
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type
HPV-35
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type
HPV-66
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type
HPV-68
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type
Any HR HPV types except HPV-16/18
|
14 Participants
|
6 Participants
|
|
Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type
Any HR HPV types
|
17 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: At Months 0 (pre-vaccination), 6, 7, 12, 18 and 24Population: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity.
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.
Outcome measures
| Measure |
Aimmugen Group
n=393 Participants
Subjects received 3 doses of Aimmugen™ (Hepatitis A \[HAV\] vaccine) according to a 0, 1, 6-month schedule.
|
Cervarix Group
n=411 Participants
Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Titers Above the Cut-off Value
HPV-16 (pre-vaccination)
|
51 Participants
|
64 Participants
|
|
Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Titers Above the Cut-off Value
HPV-16 (Month 6)
|
55 Participants
|
411 Participants
|
|
Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Titers Above the Cut-off Value
HPV-16 (Month 7)
|
52 Participants
|
410 Participants
|
|
Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Titers Above the Cut-off Value
HPV-16 (Month 12)
|
46 Participants
|
373 Participants
|
|
Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Titers Above the Cut-off Value
HPV-16 (Month 18)
|
39 Participants
|
356 Participants
|
|
Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Titers Above the Cut-off Value
HPV-16 (Month 24)
|
38 Participants
|
351 Participants
|
|
Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Titers Above the Cut-off Value
HPV-18 (pre-vaccination)
|
48 Participants
|
61 Participants
|
|
Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Titers Above the Cut-off Value
HPV-18 (Month 6)
|
53 Participants
|
410 Participants
|
|
Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Titers Above the Cut-off Value
HPV-18 (Month 7)
|
54 Participants
|
409 Participants
|
|
Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Titers Above the Cut-off Value
HPV-18 (Month 12)
|
55 Participants
|
372 Participants
|
|
Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Titers Above the Cut-off Value
HPV-18 (Month 18)
|
40 Participants
|
355 Participants
|
|
Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Titers Above the Cut-off Value
HPV-18 (Month 24)
|
38 Participants
|
350 Participants
|
SECONDARY outcome
Timeframe: At Months 0, 6, 7, 12, 18 and 24Population: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity.
Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).
Outcome measures
| Measure |
Aimmugen Group
n=393 Participants
Subjects received 3 doses of Aimmugen™ (Hepatitis A \[HAV\] vaccine) according to a 0, 1, 6-month schedule.
|
Cervarix Group
n=411 Participants
Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Anti-HPV-16 (Month 0)
|
5.3 EL.U/mL
Interval 4.9 to 5.7
|
5.5 EL.U/mL
Interval 5.1 to 5.9
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Anti-HPV-16 (Month 6)
|
5.4 EL.U/mL
Interval 4.9 to 5.8
|
708.4 EL.U/mL
Interval 650.1 to 772.0
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Anti-HPV-16 (Month 7)
|
5.3 EL.U/mL
Interval 4.9 to 5.8
|
7441.0 EL.U/mL
Interval 6854.3 to 8077.8
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Anti-HPV-16 (Month 12)
|
5.3 EL.U/mL
Interval 4.9 to 5.8
|
2877.7 EL.U/mL
Interval 2623.1 to 3156.9
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Anti-HPV-16 (Month 18)
|
5.3 EL.U/mL
Interval 4.8 to 5.8
|
1864.8 EL.U/mL
Interval 1694.5 to 2052.2
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Anti-HPV-16 (Month 24)
|
5.4 EL.U/mL
Interval 4.9 to 5.9
|
1532.2 EL.U/mL
Interval 1395.1 to 1682.7
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Anti-HPV-18 (Month 0)
|
4.4 EL.U/mL
Interval 4.1 to 4.7
|
4.5 EL.U/mL
Interval 4.2 to 4.8
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Anti-HPV-18 (Month 6)
|
4.4 EL.U/mL
Interval 4.1 to 4.7
|
504.6 EL.U/mL
Interval 464.6 to 548.1
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Anti-HPV-18 (Month 7)
|
4.5 EL.U/mL
Interval 4.2 to 4.8
|
3805.4 EL.U/mL
Interval 3515.6 to 4119.1
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Anti-HPV-18 (Month 12)
|
4.5 EL.U/mL
Interval 4.2 to 4.8
|
1330.7 EL.U/mL
Interval 1210.2 to 1463.2
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Anti-HPV-18 (Month 18)
|
4.4 EL.U/mL
Interval 4.1 to 4.7
|
782.0 EL.U/mL
Interval 703.4 to 869.5
|
|
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Anti-HPV-18 (Month 24)
|
4.4 EL.U/mL
Interval 4.1 to 4.8
|
627.8 EL.U/mL
Interval 566.3 to 696.0
|
SECONDARY outcome
Timeframe: Within 7 days after each and any vaccinationPopulation: Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
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.
Outcome measures
| Measure |
Aimmugen Group
n=511 Participants
Subjects received 3 doses of Aimmugen™ (Hepatitis A \[HAV\] vaccine) according to a 0, 1, 6-month schedule.
|
Cervarix Group
n=512 Participants
Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Gastro-intestinal symptoms
|
167 Participants
|
172 Participants
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Headache
|
222 Participants
|
250 Participants
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Myalgia
|
128 Participants
|
262 Participants
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Rash
|
24 Participants
|
33 Participants
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Urticaria
|
20 Participants
|
16 Participants
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Pain
|
214 Participants
|
508 Participants
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Redness
|
287 Participants
|
455 Participants
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Swelling
|
165 Participants
|
401 Participants
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Arthralgia
|
61 Participants
|
123 Participants
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Fatigue
|
300 Participants
|
341 Participants
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Fever
|
28 Participants
|
41 Participants
|
SECONDARY outcome
Timeframe: Within 30 days after any vaccinationPopulation: Analysis was performed on the Total Vaccinated Cohort.
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.
Outcome measures
| Measure |
Aimmugen Group
n=521 Participants
Subjects received 3 doses of Aimmugen™ (Hepatitis A \[HAV\] vaccine) according to a 0, 1, 6-month schedule.
|
Cervarix Group
n=519 Participants
Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects Reporting Unsolicited Adverse Events (AE)
|
266 Participants
|
294 Participants
|
SECONDARY outcome
Timeframe: Throughout the study period (up to Month 24)Population: Analysis was performed on the Total Vaccinated Cohort.
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.
Outcome measures
| Measure |
Aimmugen Group
n=521 Participants
Subjects received 3 doses of Aimmugen™ (Hepatitis A \[HAV\] vaccine) according to a 0, 1, 6-month schedule.
|
Cervarix Group
n=519 Participants
Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects Reporting Serious Adverse Events (SAE)
|
19 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Throughout the study period (up to Month 24)Population: Analysis was performed on the Total Vaccinated Cohort.
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.
Outcome measures
| Measure |
Aimmugen Group
n=521 Participants
Subjects received 3 doses of Aimmugen™ (Hepatitis A \[HAV\] vaccine) according to a 0, 1, 6-month schedule.
|
Cervarix Group
n=519 Participants
Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs)
MSCs
|
107 Participants
|
91 Participants
|
|
Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs)
NOCDs
|
6 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Throughout the study period (up to Month 24)Population: Analysis was performed on those subjects reporting pregnancy during the study period.
Information on any subject who became pregnant while participating in this study was collected. The outcomes of the pregnancies are reported below.
Outcome measures
| Measure |
Aimmugen Group
n=43 Participants
Subjects received 3 doses of Aimmugen™ (Hepatitis A \[HAV\] vaccine) according to a 0, 1, 6-month schedule.
|
Cervarix Group
n=46 Participants
Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Outcome of Any Reported Pregnancies
Lost to follow-up
|
0 Participants
|
1 Participants
|
|
Outcome of Any Reported Pregnancies
Normal infant
|
19 Participants
|
20 Participants
|
|
Outcome of Any Reported Pregnancies
Premature birth
|
0 Participants
|
1 Participants
|
|
Outcome of Any Reported Pregnancies
Elective termination
|
16 Participants
|
14 Participants
|
|
Outcome of Any Reported Pregnancies
Spontaneous abortion
|
3 Participants
|
5 Participants
|
|
Outcome of Any Reported Pregnancies
Pregnancy ongoing
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: At Month 0 and Month 7Population: Analysis was performed on the Total Vaccinated Cohort.
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.
Outcome measures
| Measure |
Aimmugen Group
n=521 Participants
Subjects received 3 doses of Aimmugen™ (Hepatitis A \[HAV\] vaccine) according to a 0, 1, 6-month schedule.
|
Cervarix Group
n=519 Participants
Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
Hematocrit Normal [Month 0]
|
506 Participants
|
501 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
Hematocrit Below [Month 7]
|
13 Participants
|
8 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
Platelet count Below [Month 0]
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
Platelet count Unknown [Month 0]
|
0 Participants
|
2 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
Platelet count Above [Month 7]
|
10 Participants
|
9 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
Platelet count Below [Month 7]
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
Red Blood Cells count Normal [Month 0]
|
515 Participants
|
514 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
Red Blood Cells count Unknown [Month 7]
|
48 Participants
|
52 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
White Blood Cells count Normal [Month 0]
|
499 Participants
|
496 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
White Blood Cells count Below [Month 0]
|
8 Participants
|
10 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
White Blood Cells count Normal [Month 7]
|
453 Participants
|
440 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
White Blood Cells count Above [Month 7]
|
16 Participants
|
23 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
White Blood Cells count Unknown [Month 7]
|
48 Participants
|
52 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
MC hemoglobin Normal [Month 0]
|
491 Participants
|
489 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
MC hemoglobin Above [Month 0]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
MC hemoglobin Below [Month 0]
|
30 Participants
|
29 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
MC hemoglobin Unknown [Month 0]
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
MC hemoglobin Normal [Month 7]
|
439 Participants
|
441 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
MC hemoglobin Above [Month 7]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
MC hemoglobin Below [Month 7]
|
34 Participants
|
26 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
MC hemoglobin Unknown [Month 7]
|
48 Participants
|
52 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
MC hemoglobin concentration Normal [Month 0]
|
488 Participants
|
495 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
MC hemoglobin concentration Above [Month 0]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
MC hemoglobin concentration Below [Month 0]
|
33 Participants
|
23 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
MC hemoglobin concentration Unknown [Month 0]
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
MC hemoglobin concentration Normal [Month 7]
|
434 Participants
|
442 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
MC hemoglobin concentration Above [Month 7]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
MC hemoglobin concentration Below [Month 7]
|
39 Participants
|
25 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
MC volume Normal [Month 0]
|
505 Participants
|
504 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
MC volume Unknown [Month 0]
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
MC volume Normal [Month 7]
|
456 Participants
|
457 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
MC volume Above [Month 7]
|
1 Participants
|
2 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
MC volume Unknown [Month 7]
|
48 Participants
|
52 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
Platelet count Unknown [Month 7]
|
48 Participants
|
53 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
Red Blood Cells count Above [Month 0]
|
4 Participants
|
2 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
Red Blood Cells count Below [Month 0]
|
2 Participants
|
2 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
Red Blood Cells count Unknown [Month 0]
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
Red Blood Cells count Normal [Month 7]
|
463 Participants
|
457 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
Red Blood Cells count Above [Month 7]
|
5 Participants
|
6 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
Red Blood Cells count Below [Month 7]
|
5 Participants
|
4 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
White Blood Cells count Above [Month 0]
|
14 Participants
|
12 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
White Blood Cells count Unknown [Month 0]
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
White Blood Cells count Below [Month 7]
|
4 Participants
|
4 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
Hemoglobin Normal [Month 0]
|
498 Participants
|
499 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
Hemoglobin Above [Month 0]
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
Hemoglobin Below [Month 0]
|
21 Participants
|
18 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
Hemoglobin Unknown [Month 0]
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
Hemoglobin Normal [Month 7]
|
444 Participants
|
448 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
Hemoglobin Above [Month 7]
|
7 Participants
|
7 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
Hemoglobin Below [Month 7]
|
22 Participants
|
12 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
Hemoglobin Unknown [Month 7]
|
48 Participants
|
52 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
Hematocrit Above [Month 0]
|
5 Participants
|
3 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
Hematocrit Below [Month 0]
|
10 Participants
|
14 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
Hematocrit Unknown [Month 0]
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
Hematocrit Normal [Month 7]
|
456 Participants
|
448 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
Hematocrit Above [Month 7]
|
4 Participants
|
11 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
Hematocrit Unknown [Month 7]
|
48 Participants
|
52 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
Platelet count Normal [Month 0]
|
514 Participants
|
504 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
Platelet count Above [Month 0]
|
5 Participants
|
13 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
Platelet count Normal [Month 7]
|
461 Participants
|
456 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
MC hemoglobin concentration Unknown [Month 7]
|
48 Participants
|
52 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
MC volume Above [Month 0]
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
MC volume Below [Month 0]
|
16 Participants
|
13 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
MC volume Below [Month 7]
|
16 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: At Month 0 and Month 7Population: Analysis was performed on the Total Vaccinated Cohort.
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).
Outcome measures
| Measure |
Aimmugen Group
n=521 Participants
Subjects received 3 doses of Aimmugen™ (Hepatitis A \[HAV\] vaccine) according to a 0, 1, 6-month schedule.
|
Cervarix Group
n=519 Participants
Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
GGT Below [Month 0]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
GGT Unknown [Month 0]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Albumin Above [Month 0]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Albumin Below [Month 0]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Albumin Unknown [Month 0]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Albumin Normal [Month 7]
|
472 Participants
|
466 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Albumin Below [Month 7]
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Alkaline phosphatase Normal [Month 0]
|
497 Participants
|
500 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Chlorine Normal [Month 0]
|
518 Participants
|
518 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Alkaline phosphatase Above [Month 0]
|
4 Participants
|
3 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Alkaline phosphatase Below [Month 0]
|
20 Participants
|
16 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Alkaline phosphatase Unknown [Month 0]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Alkaline phosphatase Above [Month 7]
|
3 Participants
|
4 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Total protein Above [Month 0]
|
10 Participants
|
6 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Total protein Below [Month 0]
|
2 Participants
|
3 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Total protein Unknown [Month 0]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
ALT Above [Month 7]
|
3 Participants
|
9 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
ALT Below [Month 7]
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
ALT Unknown [Month 7]
|
47 Participants
|
52 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
AST Normal [Month 0]
|
520 Participants
|
516 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
AST Above [Month 0]
|
1 Participants
|
3 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
AST Below [Month 0]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
AST Unknown [Month 0]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
AST Normal [Month 7]
|
472 Participants
|
464 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Blood Urea Nitrogen Above [Month 7]
|
1 Participants
|
3 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Blood Urea Nitrogen Below [Month 7]
|
39 Participants
|
47 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Blood Urea Nitrogen Unknown [Month 7]
|
47 Participants
|
52 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Calcium Below [Month 0]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Calcium Unknown [Month 0]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Calcium Normal [Month 7]
|
468 Participants
|
461 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Total cholesterol Unknown [Month 7]
|
47 Participants
|
52 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Calcium Above [Month 7]
|
4 Participants
|
3 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Calcium Below [Month 7]
|
2 Participants
|
3 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Calcium Unknown [Month 7]
|
47 Participants
|
52 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Total cholesterol Below [Month 0]
|
85 Participants
|
70 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Chlorine Above [Month 0]
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Chlorine Below [Month 0]
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Chlorine Unknown [Month 0]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Chlorine Normal [Month 7]
|
472 Participants
|
466 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Chlorine Above [Month 7]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Chlorine Below [Month 7]
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Chlorine Unknown [Month 7]
|
47 Participants
|
52 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Creatinine phosphokinase Above [Month 0]
|
13 Participants
|
13 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Creatinine phosphokinase Below [Month 0]
|
54 Participants
|
50 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Creatinine phosphokinase Above [Month 7]
|
7 Participants
|
10 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Creatinine Below [Month 0]
|
8 Participants
|
7 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Creatinine Unknown [Month 0]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Creatinine Normal [Month 7]
|
466 Participants
|
453 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Creatinine Above [Month 7]
|
2 Participants
|
3 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Creatinine Below [Month 7]
|
6 Participants
|
11 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Creatinine Unknown [Month 7]
|
47 Participants
|
52 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Direct bilirubin Normal [Month 0]
|
494 Participants
|
500 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Direct bilirubin Below [Month 0]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Direct bilirubin Unknown [Month 0]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Direct bilirubin Above [Month 7]
|
16 Participants
|
10 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Direct bilirubin Below [Month 7]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Direct bilirubin Unknown [Month 7]
|
47 Participants
|
52 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
GGT Normal [Month 0]
|
515 Participants
|
510 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
GGT Normal [Month 7]
|
471 Participants
|
459 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
GGT Above [Month 7]
|
3 Participants
|
8 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
GGT Below [Month 7]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
GGT Unknown [Month 7]
|
47 Participants
|
52 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Glucose Normal [Month 0]
|
464 Participants
|
468 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Glucose Above [Month 0]
|
11 Participants
|
10 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Glucose Below [Month 0]
|
47 Participants
|
41 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Glucose Unknown [Month 0]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Glucose Normal [Month 7]
|
423 Participants
|
409 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Potassium Normal [Month 0]
|
509 Participants
|
509 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Potassium Normal [Month 7]
|
470 Participants
|
462 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Potassium Unknown [Month 7]
|
47 Participants
|
52 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Leucine Amino Peptidase Normal [Month 0]
|
512 Participants
|
510 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Leucine Amino Peptidase Above [Month 0]
|
1 Participants
|
4 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Leucine Amino Peptidase Below [Month 0]
|
8 Participants
|
5 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Leucine Amino Peptidase Unknown [Month 0]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Leucine Amino Peptidase Normal [Month 7]
|
462 Participants
|
460 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
LDH Normal [Month 7]
|
437 Participants
|
433 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
LDH Above [Month 7]
|
2 Participants
|
5 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
LDH Below [Month 7]
|
35 Participants
|
29 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
LDH Unknown [Month 7]
|
47 Participants
|
52 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Sodium Normal [Month 0]
|
521 Participants
|
519 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Sodium Above [Month 0]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Sodium Below [Month 0]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Sodium Unknown [Month 0]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Sodium Normal [Month 7]
|
474 Participants
|
466 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Sodium Above [Month 7]
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Sodium Below [Month 7]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Total bilirubin Below [Month 0]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Total bilirubin Unknown [Month 0]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Total bilirubin Above [Month 7]
|
31 Participants
|
27 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Total bilirubin Below [Month 7]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Total bilirubin Unknown [Month 7]
|
47 Participants
|
52 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Triglycerides Normal [Month 0]
|
324 Participants
|
318 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Triglycerides Above [Month 0]
|
21 Participants
|
24 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Triglycerides Below [Month 0]
|
176 Participants
|
177 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Triglycerides Above [Month 7]
|
26 Participants
|
28 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Triglycerides Below [Month 7]
|
158 Participants
|
164 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Triglycerides Unknown [Month 7]
|
47 Participants
|
52 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Total protein Normal [Month 0]
|
509 Participants
|
510 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Uric acid Above [Month 0]
|
1 Participants
|
4 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Uric acid Below [Month 0]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Uric acid Normal [Month 7]
|
473 Participants
|
465 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Uric acid Above [Month 7]
|
1 Participants
|
2 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Uric acid Below [Month 7]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Uric acid Unknown [Month 7]
|
47 Participants
|
52 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
pH Above [Month 0]
|
59 Participants
|
52 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
CRP Below [Month 0]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
CRP Normal [Month 7]
|
96 Participants
|
126 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
CRP Above [Month 7]
|
16 Participants
|
20 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
CRP Below [Month 7]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Albumin Above [Month 7]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Albumin Unknown [Month 7]
|
47 Participants
|
52 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Albumin/Globulin ratio Normal [Month 0]
|
488 Participants
|
483 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Albumin/Globulin ratio Above [Month 0]
|
20 Participants
|
20 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Albumin/Globulin ratio Below [Month 0]
|
13 Participants
|
16 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Albumin/Globulin ratio Unknown [Month 0]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Albumin/Globulin ratio Normal [Month 7]
|
443 Participants
|
421 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Albumin/Globulin ratio Above [Month 7]
|
19 Participants
|
30 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Albumin/Globulin ratio Below [Month 7]
|
12 Participants
|
16 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Albumin/Globulin ratio Unknown [Month 7]
|
47 Participants
|
52 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Alkaline phosphatase Normal [Month 7]
|
453 Participants
|
451 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Alkaline phosphatase Below [Month 7]
|
18 Participants
|
12 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Alkaline phosphatase Unknown [Month 7]
|
47 Participants
|
52 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
ALT Normal [Month 0]
|
518 Participants
|
510 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
ALT Above [Month 0]
|
3 Participants
|
8 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
ALT Below [Month 0]
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Albumin Normal [Month 0]
|
521 Participants
|
519 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
ALT Unknown [Month 0]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
ALT Normal [Month 7]
|
471 Participants
|
457 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
AST Above [Month 7]
|
0 Participants
|
3 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
AST Below [Month 7]
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
AST Unknown [Month 7]
|
47 Participants
|
52 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Blood Urea Nitrogen Normal [Month 0]
|
466 Participants
|
450 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Blood Urea Nitrogen Above [Month 0]
|
3 Participants
|
7 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Blood Urea Nitrogen Below [Month 0]
|
52 Participants
|
62 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Blood Urea Nitrogen Unknown [Month 0]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Blood Urea Nitrogen Normal [Month 7]
|
434 Participants
|
417 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Calcium Normal [Month 0]
|
519 Participants
|
516 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Calcium Above [Month 0]
|
2 Participants
|
3 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Total cholesterol Normal [Month 0]
|
402 Participants
|
407 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Total cholesterol Above [Month 0]
|
34 Participants
|
42 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Total cholesterol Unknown [Month 0]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Total cholesterol Normal [Month 7]
|
367 Participants
|
355 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Total cholesterol Above [Month 7]
|
36 Participants
|
36 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Total cholesterol Below [Month 7]
|
71 Participants
|
76 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Creatinine phosphokinase Normal [Month 0]
|
454 Participants
|
456 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Creatinine phosphokinase Unknown [Month 0]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Creatinine phosphokinase Normal [Month 7]
|
420 Participants
|
412 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Creatinine phosphokinase Below [Month 7]
|
47 Participants
|
45 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Creatinine phosphokinase Unknown [Month 7]
|
47 Participants
|
52 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Creatinine Normal [Month 0]
|
509 Participants
|
510 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Creatinine Above [Month 0]
|
4 Participants
|
2 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Direct bilirubin Above [Month 0]
|
27 Participants
|
19 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Direct bilirubin Normal [Month 7]
|
458 Participants
|
457 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
GGT Above [Month 0]
|
6 Participants
|
9 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Glucose Above [Month 7]
|
18 Participants
|
15 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Glucose Below [Month 7]
|
34 Participants
|
43 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Glucose Unknown [Month 7]
|
47 Participants
|
52 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Potassium Above [Month 0]
|
11 Participants
|
10 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Potassium Below [Month 0]
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Potassium Unknown [Month 0]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Potassium Above [Month 7]
|
4 Participants
|
5 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Potassium Below [Month 7]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Leucine Amino Peptidase Above [Month 7]
|
9 Participants
|
2 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Leucine Amino Peptidase Below [Month 7]
|
3 Participants
|
5 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Leucine Amino Peptidase Unknown [Month 7]
|
47 Participants
|
52 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
LDH Normal [Month 0]
|
491 Participants
|
486 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
LDH Above [Month 0]
|
1 Participants
|
2 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
LDH Below [Month 0]
|
29 Participants
|
31 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
LDH Unknown [Month 0]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Sodium Unknown [Month 7]
|
47 Participants
|
52 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Total bilirubin Normal [Month 0]
|
466 Participants
|
472 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Total bilirubin Above [Month 0]
|
55 Participants
|
47 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Total bilirubin Normal [Month 7]
|
443 Participants
|
440 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Triglycerides Unknown [Month 0]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Triglycerides Normal [Month 7]
|
290 Participants
|
275 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Total protein Normal [Month 7]
|
463 Participants
|
454 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Total protein Above [Month 7]
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Total protein Below [Month 7]
|
9 Participants
|
12 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Total protein Unknown [Month 7]
|
47 Participants
|
52 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Uric acid Normal [Month 0]
|
520 Participants
|
515 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Uric acid Unknown [Month 0]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
pH Normal [Month 0]
|
462 Participants
|
466 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
pH Below [Month 0]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
pH Unknown [Month 0]
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
pH Normal [Month 7]
|
442 Participants
|
438 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
pH Above [Month 7]
|
32 Participants
|
28 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
pH Below [Month 7]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
pH Unknown [Month 7]
|
47 Participants
|
53 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
CRP Normal [Month 0]
|
70 Participants
|
106 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
CRP Above [Month 0]
|
11 Participants
|
12 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
CRP Unknown [Month 0]
|
440 Participants
|
401 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
CRP Unknown [Month 7]
|
409 Participants
|
373 Participants
|
SECONDARY outcome
Timeframe: At Month 0 and Month 7Population: Analysis was performed on the Total Vaccinated cohort.
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\*.
Outcome measures
| Measure |
Aimmugen Group
n=521 Participants
Subjects received 3 doses of Aimmugen™ (Hepatitis A \[HAV\] vaccine) according to a 0, 1, 6-month schedule.
|
Cervarix Group
n=519 Participants
Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Protein (+-) [Month 0]
|
11 Participants
|
10 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Protein (+) [Month 0]
|
16 Participants
|
9 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Protein (2+) [Month 0]
|
1 Participants
|
2 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Protein (3+) [Month 7]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Protein (Unknown) [Month 7]
|
47 Participants
|
53 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Glucose (+) [Month 0]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Glucose (3+) [Month 0]
|
0 Participants
|
2 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Glucose (+) [Month 7]
|
1 Participants
|
2 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Glucose (2+) [Month 7]
|
0 Participants
|
3 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Urobilinogen (Unknown) [Month 0]
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Urobilinogen (-) [Month 7]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Occult Blood (Unknown) [Month 7]
|
47 Participants
|
53 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Protein (-) [Month 0]
|
492 Participants
|
496 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Protein (3+) [Month 0]
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Protein (Unknown) [Month 0]
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Protein (-) [Month 7]
|
448 Participants
|
444 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Protein (+-) [Month 7]
|
11 Participants
|
10 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Protein (+) [Month 7]
|
14 Participants
|
11 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Protein (2+) [Month 7]
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Glucose (-) [Month 0]
|
520 Participants
|
513 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Glucose (+-) [Month 0]
|
0 Participants
|
3 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Glucose (2+) [Month 0]
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Glucose (Unknown) [Month 0]
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Glucose (-) [Month 7]
|
471 Participants
|
459 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Glucose (+-) [Month 7]
|
2 Participants
|
2 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Glucose (3+) [Month 7]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Glucose (Unknown) [Month 7]
|
47 Participants
|
53 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Urobilinogen (-) [Month 0]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Urobilinogen (+-) [Month 0]
|
502 Participants
|
506 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Urobilinogen (+) [Month 0]
|
15 Participants
|
11 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Urobilinogen (2+) [Month 0]
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Urobilinogen (3+) [Month 0]
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Urobilinogen (+-) [Month 7]
|
460 Participants
|
460 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Urobilinogen (+) [Month 7]
|
12 Participants
|
6 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Urobilinogen (2+) [Month 7]
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Urobilinogen (3+) [Month 7]
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Urobilinogen (Unknown) [Month 7]
|
47 Participants
|
53 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Occult Blood (-) [Month 0]
|
495 Participants
|
483 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Occult Blood (+-) [Month 0]
|
7 Participants
|
11 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Occult Blood (+) [Month 0]
|
9 Participants
|
11 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Occult Blood (2+) [Month 0]
|
8 Participants
|
9 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Occult Blood (3+) [Month 0]
|
2 Participants
|
4 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Occult Blood (Unknown) [Month 0]
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Occult Blood (-) [Month 7]
|
398 Participants
|
393 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Occult Blood (+-) [Month 7]
|
28 Participants
|
22 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Occult Blood (+) [Month 7]
|
20 Participants
|
19 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Occult Blood (2+) [Month 7]
|
18 Participants
|
22 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Occult Blood (3+) [Month 7]
|
10 Participants
|
10 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Ketone Body (-) [Month 0]
|
506 Participants
|
501 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Ketone Body (+-) [Month 0]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Ketone Body (+) [Month 0]
|
8 Participants
|
9 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Ketone Body (2+) [Month 0]
|
6 Participants
|
7 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Ketone Body (3+) [Month 0]
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Ketone Body (Unknown) [Month 0]
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Ketone Body (-) [Month 7]
|
460 Participants
|
452 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Ketone Body (+-) [Month 7]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Ketone Body (+) [Month 7]
|
10 Participants
|
10 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Ketone Body (2+) [Month 7]
|
3 Participants
|
3 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Ketone Body (3+) [Month 7]
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Ketone Body (Unknown) [Month 7]
|
47 Participants
|
53 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Bilirubin (-) [Month 0]
|
520 Participants
|
517 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Bilirubin (+-) [Month 0]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Bilirubin (+) [Month 0]
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Bilirubin (2+) [Month 0]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Bilirubin (3+) [Month 0]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Bilirubin (Unknown) [Month 0]
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Bilirubin (-) [Month 7]
|
474 Participants
|
466 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Bilirubin (+-) [Month 7]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Bilirubin (+) [Month 7]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Bilirubin (2+) [Month 7]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Bilirubin (3+) [Month 7]
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Bilirubin (Unknown) [Month 7]
|
47 Participants
|
53 Participants
|
Adverse Events
Cervarix Group
Serious events: 18 serious events
Other events: 512 other events
Deaths: 1 deaths
Aimmugen Group
Serious events: 19 serious events
Other events: 459 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cervarix Group
n=519 participants at risk
Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
|
Aimmugen Group
n=521 participants at risk
Subjects received 3 doses of Aimmugen™ (Hepatitis A \[HAV\] vaccine) according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.58%
3/519 • - 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.
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.
|
0.58%
3/521 • - 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.
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.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion threatened
|
0.19%
1/519 • - 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.
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.
|
0.19%
1/521 • - 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.
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.
|
|
Infections and infestations
Acute tonsillitis
|
0.00%
0/519 • - 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.
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.
|
0.38%
2/521 • - 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.
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.
|
|
Infections and infestations
Appendicitis
|
0.19%
1/519 • - 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.
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.
|
0.19%
1/521 • - 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.
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.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.19%
1/519 • - 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.
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.
|
0.19%
1/521 • - 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.
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.
|
|
Pregnancy, puerperium and perinatal conditions
Threatened labour
|
0.19%
1/519 • - 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.
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.
|
0.19%
1/521 • - 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.
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.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion missed
|
0.19%
1/519 • - 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.
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.
|
0.00%
0/521 • - 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.
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.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous incomplete
|
0.19%
1/519 • - 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.
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.
|
0.00%
0/521 • - 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.
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.
|
|
Gastrointestinal disorders
Acute abdomen
|
0.00%
0/519 • - 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.
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.
|
0.19%
1/521 • - 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic granulomatous angiitis
|
0.19%
1/519 • - 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.
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.
|
0.00%
0/521 • - 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.
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.
|
|
Injury, poisoning and procedural complications
Avulsion fracture
|
0.00%
0/519 • - 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.
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.
|
0.19%
1/521 • - 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.
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.
|
|
Psychiatric disorders
Borderline personality disorder
|
0.19%
1/519 • - 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.
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.
|
0.00%
0/521 • - 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.
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.
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.19%
1/519 • - 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.
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.
|
0.00%
0/521 • - 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.
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.
|
|
Psychiatric disorders
Completed suicide
|
0.19%
1/519 • - 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.
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.
|
0.00%
0/521 • - 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.
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.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/519 • - 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.
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.
|
0.19%
1/521 • - 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.
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.
|
|
Psychiatric disorders
Depression
|
0.19%
1/519 • - 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.
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.
|
0.00%
0/521 • - 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.
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.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/519 • - 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.
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.
|
0.19%
1/521 • - 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.
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.
|
|
Injury, poisoning and procedural complications
Eyeball rupture
|
0.19%
1/519 • - 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.
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.
|
0.00%
0/521 • - 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.
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.
|
|
General disorders
Fatigue
|
0.00%
0/519 • - 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.
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.
|
0.19%
1/521 • - 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.
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.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/519 • - 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.
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.
|
0.19%
1/521 • - 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.
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.
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.19%
1/519 • - 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.
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.
|
0.00%
0/521 • - 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.
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.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/519 • - 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.
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.
|
0.19%
1/521 • - 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.
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.
|
|
Infections and infestations
Mastitis postpartum
|
0.00%
0/519 • - 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.
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.
|
0.19%
1/521 • - 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.
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.
|
|
Nervous system disorders
Moyamoya disease
|
0.00%
0/519 • - 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.
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.
|
0.19%
1/521 • - 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.
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.
|
|
Reproductive system and breast disorders
Ovarian haemorrhage
|
0.19%
1/519 • - 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.
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.
|
0.00%
0/521 • - 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.
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.
|
|
Psychiatric disorders
Panic disorder
|
0.19%
1/519 • - 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.
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.
|
0.00%
0/521 • - 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.
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.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/519 • - 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.
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.
|
0.19%
1/521 • - 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.19%
1/519 • - 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.
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.
|
0.00%
0/521 • - 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.
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.
|
|
Reproductive system and breast disorders
Polycystic ovaries
|
0.00%
0/519 • - 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.
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.
|
0.19%
1/521 • - 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.
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.
|
|
Infections and infestations
Pyelonephritis acute
|
0.19%
1/519 • - 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.
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.
|
0.00%
0/521 • - 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.
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.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.19%
1/519 • - 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.
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.
|
0.00%
0/521 • - 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.
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.
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/519 • - 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.
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.
|
0.19%
1/521 • - 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.
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.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.19%
1/519 • - 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.
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.
|
0.00%
0/521 • - 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.
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.
|
Other adverse events
| Measure |
Cervarix Group
n=519 participants at risk
Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
|
Aimmugen Group
n=521 participants at risk
Subjects received 3 doses of Aimmugen™ (Hepatitis A \[HAV\] vaccine) according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
General disorders
Pain
|
99.2%
508/512 • - 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.
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.
|
42.0%
214/510 • - 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.
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.
|
|
General disorders
Redness
|
88.9%
455/512 • - 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.
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.
|
56.3%
287/510 • - 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.
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.
|
|
General disorders
Swelling
|
78.3%
401/512 • - 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.
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.
|
32.4%
165/510 • - 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.
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.
|
|
General disorders
Arthralgia
|
24.0%
123/512 • - 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.
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.
|
11.9%
61/511 • - 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.
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.
|
|
General disorders
Fatigue
|
66.6%
341/512 • - 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.
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.
|
58.7%
300/511 • - 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.
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.
|
|
General disorders
Fever
|
8.0%
41/512 • - 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.
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.
|
5.5%
28/511 • - 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.
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.
|
|
General disorders
Gastrointestinal symptoms
|
33.6%
172/512 • - 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.
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.
|
32.7%
167/511 • - 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.
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.
|
|
General disorders
Headache
|
48.8%
250/512 • - 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.
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.
|
43.4%
222/511 • - 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.
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.
|
|
General disorders
Myalgia
|
51.2%
262/512 • - 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.
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.
|
25.0%
128/511 • - 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.
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.
|
|
General disorders
Rash
|
6.4%
33/512 • - 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.
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.
|
4.7%
24/511 • - 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.
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.
|
|
Infections and infestations
Nasopharyngitis
|
21.2%
110/519 • - 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.
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.
|
17.5%
91/521 • - 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.
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.
|
|
General disorders
Injection site pruritus
|
16.0%
83/519 • - 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.
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.
|
2.9%
15/521 • - 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.
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.
|
|
General disorders
Injection site warmth
|
13.3%
69/519 • - 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.
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.
|
1.2%
6/521 • - 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.
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.
|
|
Nervous system disorders
Headache
|
3.7%
19/519 • - 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.
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.
|
5.2%
27/521 • - 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.
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.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER