Trial Outcomes & Findings for Efficacy, Immunogenicity and Safety of GSK Biologicals' HPV GSK 580299 Vaccine in Healthy Chinese Female Subjects (NCT NCT00779766)
NCT ID: NCT00779766
Last Updated: 2019-06-10
Results Overview
CIN1+ = CIN 1, 2, and 3, low/high-grade cervical glandular intraepithelial neoplasia (L/HCGIN), adenocarcinoma in-situ (AIS) or invasive cervical cancer. Persistent infection (6-month+ definition) = 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 interval of approximately 6 months. The analyses were done on subjects HPV DNA negative at baseline (Month 0) and Month 6 and seronegative at baseline (Month 0) or on subjects DNA negative at baseline (Month 0) and Month 6, regardless of initial serostatus.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
6081 participants
Primary outcome timeframe
At Month 24
Results posted on
2019-06-10
Participant Flow
This record provides the end-of-study analysis, including analyses at Month 24, 48, 57 and 72.
Out of the 6081 subjects enrolled, 2 did not have any subject or vaccine number allocated and 28 did not receive any study vaccine dose, hence only 6051 subjects started the study.
Participant milestones
| Measure |
Cervarix Group
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Placebo Group
Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Month 24
STARTED
|
3026
|
3025
|
|
Month 24
COMPLETED
|
2694
|
2693
|
|
Month 24
NOT COMPLETED
|
332
|
332
|
|
Month 48
STARTED
|
2703
|
2727
|
|
Month 48
COMPLETED
|
2529
|
2559
|
|
Month 48
NOT COMPLETED
|
174
|
168
|
|
Month 72
STARTED
|
2319
|
2347
|
|
Month 72
COMPLETED
|
2134
|
2158
|
|
Month 72
NOT COMPLETED
|
185
|
189
|
Reasons for withdrawal
| Measure |
Cervarix Group
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Placebo Group
Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Month 24
Serious Adverse Event
|
2
|
3
|
|
Month 24
Adverse Event
|
3
|
3
|
|
Month 24
Protocol Violation
|
3
|
1
|
|
Month 24
Withdrawal by Subject
|
159
|
127
|
|
Month 24
Migrated/moved from study area
|
138
|
162
|
|
Month 24
Lost to Follow-up
|
9
|
9
|
|
Month 24
Other
|
18
|
27
|
|
Month 48
Withdrawal by Subject
|
68
|
63
|
|
Month 48
Migrated/moved from study area
|
76
|
75
|
|
Month 48
Lost to Follow-up
|
29
|
30
|
|
Month 48
Other
|
1
|
0
|
|
Month 72
Withdrawal by Subject
|
55
|
71
|
|
Month 72
Migrated/moved from study area
|
124
|
109
|
|
Month 72
Lost to Follow-up
|
6
|
8
|
|
Month 72
Other
|
0
|
1
|
Baseline Characteristics
Efficacy, Immunogenicity and Safety of GSK Biologicals' HPV GSK 580299 Vaccine in Healthy Chinese Female Subjects
Baseline characteristics by cohort
| Measure |
Cervarix Group
n=3026 Participants
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Placebo Group
n=3025 Participants
Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Total
n=6051 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
23.0 Years
STANDARD_DEVIATION 1.70 • n=5 Participants
|
23.0 Years
STANDARD_DEVIATION 1.75 • n=7 Participants
|
23.0 Years
STANDARD_DEVIATION 1.73 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3026 Participants
n=5 Participants
|
3025 Participants
n=7 Participants
|
6051 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 - Chinese Heritage
|
3026 Participants
n=5 Participants
|
3025 Participants
n=7 Participants
|
6051 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Month 24Population: The analysis was performed on the According-To-Protocol (ATP) cohort for efficacy, which included all evaluable subjects for whom efficacy data were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.
CIN1+ = CIN 1, 2, and 3, low/high-grade cervical glandular intraepithelial neoplasia (L/HCGIN), adenocarcinoma in-situ (AIS) or invasive cervical cancer. Persistent infection (6-month+ definition) = 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 interval of approximately 6 months. The analyses were done on subjects HPV DNA negative at baseline (Month 0) and Month 6 and seronegative at baseline (Month 0) or on subjects DNA negative at baseline (Month 0) and Month 6, regardless of initial serostatus.
Outcome measures
| Measure |
Cervarix Group
n=2775 Participants
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Placebo Group
n=2764 Participants
Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 24
Sero negative, DNA negative HPV-16/18
|
1 Subjects
|
17 Subjects
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 24
Sero negative, DNA negative HPV-16
|
1 Subjects
|
15 Subjects
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 24
Sero negative, DNA negative HPV-18
|
0 Subjects
|
3 Subjects
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 24
DNA negative, HPV-16/18
|
1 Subjects
|
27 Subjects
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 24
DNA negative, HPV-16
|
1 Subjects
|
21 Subjects
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 24
DNA negative, HPV-18
|
0 Subjects
|
7 Subjects
|
PRIMARY outcome
Timeframe: At Month 48Population: The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.
CIN1+ = CIN 1, 2, and 3, low/high-grade cervical glandular intraepithelial neoplasia (L/HCGIN), adenocarcinoma in-situ (AIS) or invasive cervical cancer. Persistent infection (6-month+ definition) = 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 interval of approximately 6 months. The analyses were done on subjects HPV DNA negative at baseline (Month 0) and Month 6 and seronegative at baseline (Month 0) or on subjects DNA negative at baseline (Month 0) and Month 6, regardless of initial serostatus.
Outcome measures
| Measure |
Cervarix Group
n=2803 Participants
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Placebo Group
n=2799 Participants
Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 48
Sero negative, DNA negative HPV-16/18
|
2 Participants
|
45 Participants
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 48
Sero negative, DNA negative HPV-16
|
2 Participants
|
33 Participants
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 48
Sero negative, DNA negative HPV-18
|
0 Participants
|
14 Participants
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 48
DNA negative, HPV-16/18
|
2 Participants
|
61 Participants
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 48
DNA negative, HPV-16
|
2 Participants
|
45 Participants
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 48
DNA negative, HPV-18
|
0 Participants
|
18 Participants
|
PRIMARY outcome
Timeframe: At Month 57Population: The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.
CIN1+ = CIN 1, 2, and 3, low/high-grade cervical glandular intraepithelial neoplasia (L/HCGIN), adenocarcinoma in-situ (AIS) or invasive cervical cancer. Persistent infection (6-month+ definition) = 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 interval of approximately 6 months. The analyses were done on subjects HPV DNA negative at baseline (Month 0) and Month 6 and seronegative at baseline (Month 0) or on subjects DNA negative at baseline (Month 0) and Month 6, regardless of initial serostatus.
Outcome measures
| Measure |
Cervarix Group
n=2805 Participants
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Placebo Group
n=2802 Participants
Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 57
Sero negative, DNA negative HPV-16/18
|
2 Participants
|
60 Participants
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 57
Sero negative, DNA negative HPV-16
|
2 Participants
|
43 Participants
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 57
Sero negative, DNA negative HPV-18
|
0 Participants
|
19 Participants
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 57
DNA negative HPV-16/18
|
2 Participants
|
78 Participants
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 57
DNA negative HPV-16
|
2 Participants
|
57 Participants
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 57
DNA negative HPV-18
|
0 Participants
|
23 Participants
|
PRIMARY outcome
Timeframe: At Month 72Population: The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.
CIN1+ = CIN 1, 2, and 3, low/high-grade cervical glandular intraepithelial neoplasia (L/HCGIN), adenocarcinoma in-situ (AIS) or invasive cervical cancer. Persistent infection (6-month+ definition) = 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 interval of approximately 6 months. The analyses were done on subjects HPV DNA negative at baseline (Month 0) and Month 6 and seronegative at baseline (Month 0) or on subjects DNA negative at baseline (Month 0) and Month 6, regardless of initial serostatus.
Outcome measures
| Measure |
Cervarix Group
n=2804 Participants
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Placebo Group
n=2801 Participants
Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 72
Sero negative, DNA negative HPV-16/18
|
2 Participants
|
69 Participants
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 72
Sero negative, DNA negative HPV-16
|
2 Participants
|
50 Participants
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 72
Sero negative, DNA negative HPV-18
|
0 Participants
|
21 Participants
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 72
DNA negative HPV-16/18
|
2 Participants
|
91 Participants
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 72
DNA negative HPV-16
|
2 Participants
|
68 Participants
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 72
DNA negative HPV-18
|
0 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: At Months 24,48, 57 and 72Population: The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.
HPV-16 and/or HPV-18 incident infection is defined as at least one positive HPV-16 or HPV-18 DNA PCR assay at the time point considered. - DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) - Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.
Outcome measures
| Measure |
Cervarix Group
n=2807 Participants
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Placebo Group
n=2802 Participants
Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18
Sero negative, DNA negative HPV-16 M72
|
21 Participants
|
103 Participants
|
|
Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18
Sero negative, DNA negative HPV-16/18 M24
|
15 Participants
|
49 Participants
|
|
Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18
Sero negative, DNA negative HPV-16 M24
|
9 Participants
|
30 Participants
|
|
Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18
Sero negative, DNA negative HPV-18 M24
|
7 Participants
|
21 Participants
|
|
Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18
DNA negative HPV-16/18 M24
|
20 Participants
|
70 Participants
|
|
Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18
DNA negative HPV-16 M24
|
13 Participants
|
43 Participants
|
|
Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18
DNA negative HPV-18 M24
|
8 Participants
|
30 Participants
|
|
Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18
Sero negative, DNA negative HPV-16/18 M48
|
22 Participants
|
96 Participants
|
|
Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18
Sero negative, DNA negative HPV-16 M48
|
13 Participants
|
62 Participants
|
|
Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18
Sero negative, DNA negative HPV-18 M48
|
10 Participants
|
39 Participants
|
|
Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18
DNA negative HPV-16/18 M48
|
1 Participants
|
21 Participants
|
|
Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18
DNA negative HPV-18 M48
|
0 Participants
|
5 Participants
|
|
Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18
DNA negative HPV-16 M48
|
1 Participants
|
16 Participants
|
|
Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18
Sero negative, DNA negative HPV-16/18 M57
|
29 Participants
|
142 Participants
|
|
Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18
Sero negative, DNA negative HPV-16 M57
|
16 Participants
|
92 Participants
|
|
Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18
Sero negative, DNA negative HPV-18 M57
|
14 Participants
|
57 Participants
|
|
Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18
DNA negative HPV-16/18 M57
|
43 Participants
|
189 Participants
|
|
Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18
DNA negative HPV-16 M57
|
26 Participants
|
127 Participants
|
|
Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18
DNA negative HPV-18 M57
|
18 Participants
|
74 Participants
|
|
Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18
Sero negative, DNA negative HPV-16/18 M72
|
34 Participants
|
156 Participants
|
|
Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18
Sero negative, DNA negative HPV-18 M72
|
14 Participants
|
63 Participants
|
|
Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18
DNA negative HPV-16/18 M72
|
49 Participants
|
204 Participants
|
|
Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18
DNA negative HPV-16 M72
|
32 Participants
|
139 Participants
|
|
Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18
DNA negative HPV-18 M72
|
18 Participants
|
81 Participants
|
SECONDARY outcome
Timeframe: At Months 24, 48, 57 and 72Population: The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.
Persistent HPV-16 and/or HPV-18 infection (6-month+ definition) = 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 two positive DNA samples, over an interval of approximately 6 months. Subjects had at least 5 months of follow-up after Month 12. DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by ELISA Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.
Outcome measures
| Measure |
Cervarix Group
n=2762 Participants
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Placebo Group
n=2748 Participants
Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18
Sero negative, DNA negative HPV-16/18 M24
|
1 Participants
|
15 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18
Sero negative, DNA negative HPV-16 M24
|
1 Participants
|
13 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18
Sero negative, DNA negative HPV-18 M24
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18
Overall HPV-16/18 M24
|
1 Participants
|
24 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18
Overall HPV-16 M24
|
1 Participants
|
18 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18
Overall HPV-18 M24
|
0 Participants
|
7 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18
Sero negative, DNA negative HPV-16/18 M48
|
2 Participants
|
39 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18
Sero negative, DNA negative HPV-16 M48
|
2 Participants
|
30 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18
Sero negative, DNA negative HPV-18 M48
|
0 Participants
|
11 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18
Overall HPV-16/18 M48
|
2 Participants
|
53 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18
Overall HPV-16 M48
|
2 Participants
|
40 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18
Overall HPV-18 M48
|
0 Participants
|
15 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18
Sero negative, DNA negative HPV-16/18 M57
|
2 Participants
|
54 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18
Sero negative, DNA negative HPV-16 M57
|
2 Participants
|
39 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18
Sero negative, DNA negative HPV-18 M57
|
0 Participants
|
17 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18
Overall HPV-16/18 M57
|
2 Participants
|
70 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18
Overall HPV-16 M57
|
2 Participants
|
51 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18
Overall HPV-18 M57
|
0 Participants
|
21 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18
Sero negative, DNA negative HPV-16/18 M72
|
2 Participants
|
63 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18
Sero negative, DNA negative HPV-16 M72
|
2 Participants
|
46 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18
Sero negative, DNA negative HPV-18 M72
|
0 Participants
|
19 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18
Overall HPV-16/18 M72
|
2 Participants
|
83 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18
Overall HPV-16 M72
|
2 Participants
|
62 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18
Overall HPV-18 M72
|
0 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: At Months 24, 48, 57 and 72Population: The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.
Persistent infection (12-month+ definition) is defined as the detection of the same HPV type(s) (by PCR) in cervical samples at all available time points over an interval of approximately 12 months. Subjects had at least 10 months of follow-up after Month 12. DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA). Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.
Outcome measures
| Measure |
Cervarix Group
n=2702 Participants
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Placebo Group
n=2709 Participants
Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18
Overall, HPV-16/18 M72
|
1 Subjects
|
38 Subjects
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18
Sero negative, DNA negative HPV-16/18 M24
|
0 Subjects
|
2 Subjects
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18
Sero negative, DNA negative HPV-16 M24
|
0 Subjects
|
2 Subjects
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18
Sero negative, DNA negative HPV-18 M24
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18
Overall, HPV-16/18 M24
|
0 Subjects
|
2 Subjects
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18
Overall, HPV-16 M24
|
0 Subjects
|
2 Subjects
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18
Overall, HPV-18 M24
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18
Sero negative, DNA negative HPV-16/18 M48
|
1 Subjects
|
21 Subjects
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18
Sero negative, DNA negative HPV-16 M48
|
1 Subjects
|
16 Subjects
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18
Sero negative, DNA negative HPV-18 M48
|
0 Subjects
|
5 Subjects
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18
Overall, HPV-16/18 M48
|
1 Subjects
|
22 Subjects
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18
Overall, HPV-16 M48
|
1 Subjects
|
17 Subjects
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18
Overall, HPV-18 M48
|
0 Subjects
|
5 Subjects
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18
Sero negative, DNA negative HPV-16/18 M57
|
1 Subjects
|
32 Subjects
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18
Sero negative, DNA negative HPV-16 M57
|
1 Subjects
|
24 Subjects
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18
Sero negative, DNA negative HPV-18 M57
|
0 Subjects
|
8 Subjects
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18
Overall, HPV-16/18 M57
|
1 Subjects
|
37 Subjects
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18
Overall, HPV-16 M57
|
1 Subjects
|
29 Subjects
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18
Overall, HPV-18 M57
|
0 Subjects
|
8 Subjects
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18
Sero negative, DNA negative HPV-16/18 M72
|
1 Subjects
|
32 Subjects
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18
Sero negative, DNA negative HPV-16 M72
|
1 Subjects
|
24 Subjects
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18
Sero negative, DNA negative HPV-18 M72
|
0 Subjects
|
8 Subjects
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18
Overall, HPV-16 M72
|
1 Subjects
|
30 Subjects
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18
Overall, HPV-18 M72
|
0 Subjects
|
8 Subjects
|
SECONDARY outcome
Timeframe: At Months 24, 48, 57 and 72Population: The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.
Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus. HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Outcome measures
| Measure |
Cervarix Group
n=2812 Participants
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Placebo Group
n=2812 Participants
Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-39 M48
|
80 Subjects
|
78 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-45 M48
|
13 Subjects
|
25 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-51 M48
|
117 Subjects
|
131 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-52 M48
|
168 Subjects
|
176 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-56 M48
|
63 Subjects
|
70 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-58 M48
|
56 Subjects
|
62 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-59 M48
|
35 Subjects
|
44 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-66 M48
|
74 Subjects
|
73 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-68 M48
|
59 Subjects
|
61 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-31/33/45 M48
|
62 Subjects
|
119 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-16/18/31/33/45 M48
|
89 Subjects
|
239 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HRW-HPV M48
|
536 Subjects
|
591 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HR-HPV M48
|
552 Subjects
|
646 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-16 M57
|
26 Subjects
|
127 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-18 M57
|
18 Subjects
|
74 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-31 M57
|
33 Subjects
|
74 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-33 M57
|
40 Subjects
|
69 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-35 M57
|
49 Subjects
|
55 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-39 M57
|
136 Subjects
|
121 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-45 M57
|
18 Subjects
|
38 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-51 M57
|
152 Subjects
|
187 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-52 M57
|
227 Subjects
|
264 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-18 M48
|
13 Subjects
|
50 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-31 M48
|
29 Subjects
|
59 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-33 M48
|
29 Subjects
|
52 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-35 M48
|
35 Subjects
|
38 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-16 M24
|
13 Subjects
|
43 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-18 M24
|
8 Subjects
|
30 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-31 M24
|
14 Subjects
|
25 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-33 M24
|
19 Subjects
|
22 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-35 M24
|
17 Subjects
|
15 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-39 M24
|
42 Subjects
|
32 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-45 M24
|
8 Subjects
|
17 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-51 M24
|
69 Subjects
|
57 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-52 M24
|
90 Subjects
|
87 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-56 M24
|
34 Subjects
|
37 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-58 M24
|
28 Subjects
|
34 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-59 M24
|
16 Subjects
|
20 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-66 M24
|
37 Subjects
|
33 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-68 M24
|
33 Subjects
|
32 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-31/33/45 M24
|
36 Subjects
|
60 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-16/18/31/33/45 M24
|
54 Subjects
|
126 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HRW-HPV M24
|
313 Subjects
|
324 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HR-HPV M24
|
323 Subjects
|
364 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-16 M48
|
18 Subjects
|
88 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-56 M57
|
93 Subjects
|
106 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-58 M57
|
77 Subjects
|
99 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-59 M57
|
47 Subjects
|
62 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-66 M57
|
96 Subjects
|
111 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-68 M57
|
91 Subjects
|
95 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-31/33/45 M57
|
80 Subjects
|
159 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-16/18/31/33/45 M57
|
120 Subjects
|
329 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HRW-HPV M57
|
692 Subjects
|
800 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HR-HPV M57
|
710 Subjects
|
862 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-16 M72
|
32 Subjects
|
139 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-18 M72
|
18 Subjects
|
81 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-31 M72
|
35 Subjects
|
86 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-33 M72
|
43 Subjects
|
75 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-35 M72
|
53 Subjects
|
65 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-39 M72
|
154 Subjects
|
133 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-45 M72
|
18 Subjects
|
40 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-51 M72
|
166 Subjects
|
204 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-52 M72
|
251 Subjects
|
284 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-56 M72
|
104 Subjects
|
113 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-58 M72
|
83 Subjects
|
111 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-59 M72
|
52 Subjects
|
65 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-66 M72
|
103 Subjects
|
124 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-68 M72
|
101 Subjects
|
107 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-31/33/45 M72
|
85 Subjects
|
175 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HPV-16/18/31/33/45 M72
|
131 Subjects
|
356 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HRW-HPV M72
|
744 Subjects
|
852 Subjects
|
|
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
HR-HPV M72
|
764 Subjects
|
914 Subjects
|
SECONDARY outcome
Timeframe: At Months 24, 48, 57 and 72Population: The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.
Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus. HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Outcome measures
| Measure |
Cervarix Group
n=2767 Participants
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Placebo Group
n=2756 Participants
Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-16 M24
|
1 Participants
|
18 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-18 M24
|
0 Participants
|
7 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-31 M24
|
5 Participants
|
6 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-33 M24
|
7 Participants
|
8 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-35 M24
|
4 Participants
|
7 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-39 M24
|
11 Participants
|
9 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-45 M24
|
1 Participants
|
5 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-51 M24
|
21 Participants
|
14 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-52 M24
|
36 Participants
|
23 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-56 M24
|
13 Participants
|
5 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-58 M24
|
8 Participants
|
12 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-59 M24
|
6 Participants
|
7 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-66 M24
|
5 Participants
|
8 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-68 M24
|
11 Participants
|
7 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-31/33/45 M24
|
12 Participants
|
19 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-16/18/31/33/45 M24
|
13 Participants
|
42 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HRW-HPV M24
|
114 Participants
|
98 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HR-HPV M24
|
115 Participants
|
116 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-16 M48
|
2 Participants
|
40 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-18 M48
|
0 Participants
|
15 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-31 M48
|
10 Participants
|
23 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-33 M48
|
12 Participants
|
19 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-35 M48
|
13 Participants
|
15 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-39 M48
|
34 Participants
|
29 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-45 M48
|
7 Participants
|
7 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-51 M48
|
49 Participants
|
42 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-52 M48
|
84 Participants
|
72 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-56 M48
|
25 Participants
|
29 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-58 M48
|
25 Participants
|
29 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-59 M48
|
14 Participants
|
13 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-66 M48
|
19 Participants
|
25 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-68 M48
|
21 Participants
|
20 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-31/33/45 M48
|
27 Participants
|
46 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-16/18/31/33/45 M48
|
29 Participants
|
97 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HRW-HPV M48
|
257 Participants
|
275 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HR-HPV M48
|
258 Participants
|
312 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-16 M57
|
2 Participants
|
51 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-18 M57
|
0 Participants
|
21 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-31 M57
|
10 Participants
|
29 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-33 M57
|
13 Participants
|
25 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-35 M57
|
17 Participants
|
18 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-39 M57
|
47 Participants
|
41 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-45 M57
|
7 Participants
|
8 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-51 M57
|
59 Participants
|
58 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-52 M57
|
109 Participants
|
97 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-56 M57
|
32 Participants
|
36 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-58 M57
|
32 Participants
|
40 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-59 M57
|
15 Participants
|
15 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-66 M57
|
31 Participants
|
29 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-68 M57
|
28 Participants
|
30 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-31/33/45 M57
|
28 Participants
|
59 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-16/18/31/33/45 M57
|
30 Participants
|
126 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HRW-HPV M57
|
319 Participants
|
357 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HR-HPV M57
|
320 Participants
|
400 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-16 M72
|
2 Participants
|
62 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-18 M72
|
0 Participants
|
24 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-31 M72
|
11 Participants
|
31 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-33 M72
|
16 Participants
|
30 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-35 M72
|
19 Participants
|
18 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-39 M72
|
63 Participants
|
50 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-45 M72
|
8 Participants
|
10 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-51 M72
|
69 Participants
|
73 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-52 M72
|
128 Participants
|
117 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-56 M72
|
43 Participants
|
41 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-58 M72
|
38 Participants
|
49 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-59 M72
|
16 Participants
|
16 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-66 M72
|
36 Participants
|
37 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-68 M72
|
32 Participants
|
36 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-31/33/45 M72
|
33 Participants
|
68 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HPV-16/18/31/33/45 M72
|
35 Participants
|
146 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HRW-HPV M72
|
381 Participants
|
418 Participants
|
|
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
HR-HPV M72
|
382 Participants
|
466 Participants
|
SECONDARY outcome
Timeframe: At Months 24,48, 57 and 72Population: The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.
Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus. HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Outcome measures
| Measure |
Cervarix Group
n=2706 Participants
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Placebo Group
n=2717 Participants
Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-16 M24
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-18 M24
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-31 M24
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-33 M24
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-35 M24
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-39 M24
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-45 M24
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-51 M24
|
6 Participants
|
2 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-52 M24
|
7 Participants
|
5 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-56 M24
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-58 M24
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-59 M24
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-66 M24
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-68 M24
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-31/33/45 M24
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-16/18/31/33/45 M24
|
3 Participants
|
3 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HRW-HPV M24
|
21 Participants
|
14 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HR-HPV M24
|
21 Participants
|
15 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-16 M48
|
1 Participants
|
17 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-18 M48
|
0 Participants
|
5 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-31 M48
|
3 Participants
|
11 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-33 M48
|
6 Participants
|
6 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-35 M48
|
5 Participants
|
7 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-39 M48
|
12 Participants
|
16 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-45 M48
|
4 Participants
|
1 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-51 M48
|
20 Participants
|
16 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-52 M48
|
41 Participants
|
40 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-56 M48
|
11 Participants
|
5 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-58 M48
|
4 Participants
|
9 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-59 M48
|
5 Participants
|
2 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-66 M48
|
8 Participants
|
7 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-68 M48
|
9 Participants
|
4 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-31/33/45 M48
|
12 Participants
|
18 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-16/18/31/33/45 M48
|
13 Participants
|
40 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HRW-HPV M48
|
122 Participants
|
119 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HR-HPV M48
|
122 Participants
|
137 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-16 M57
|
1 Participants
|
29 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-18 M57
|
0 Participants
|
8 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-31 M57
|
3 Participants
|
16 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-33 M57
|
8 Participants
|
9 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-35 M57
|
11 Participants
|
9 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-39 M57
|
25 Participants
|
22 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-45 M57
|
5 Participants
|
2 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-51 M57
|
28 Participants
|
24 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-52 M57
|
70 Participants
|
63 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-56 M57
|
14 Participants
|
11 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-58 M57
|
15 Participants
|
18 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-59 M57
|
7 Participants
|
2 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-66 M57
|
17 Participants
|
10 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-68 M57
|
12 Participants
|
12 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-31/33/45 M57
|
15 Participants
|
27 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-16/18/31/33/45 M57
|
16 Participants
|
63 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HRW-HPV M57
|
192 Participants
|
188 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HR-HPV M57
|
192 Participants
|
215 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-16 M72
|
1 Participants
|
30 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-18 M72
|
0 Participants
|
8 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-31 M72
|
3 Participants
|
16 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-33 M72
|
9 Participants
|
9 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-35 M72
|
12 Participants
|
9 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-39 M72
|
25 Participants
|
22 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-45 M72
|
5 Participants
|
2 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-51 M72
|
28 Participants
|
25 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-52 M72
|
72 Participants
|
65 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-56 M72
|
14 Participants
|
12 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-58 M72
|
15 Participants
|
18 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-59 M72
|
8 Participants
|
2 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-66 M72
|
17 Participants
|
10 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-68 M72
|
12 Participants
|
12 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-31/33/45 M72
|
16 Participants
|
27 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HPV-16/18/31/33/45 M72
|
17 Participants
|
64 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HRW-HPV M72
|
196 Participants
|
192 Participants
|
|
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
HR-HPV M72
|
196 Participants
|
219 Participants
|
SECONDARY outcome
Timeframe: At Months 24, 48, 57 and 72Population: The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.
Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus. US).
Outcome measures
| Measure |
Cervarix Group
n=2803 Participants
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Placebo Group
n=2802 Participants
Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection
Overall, HPV-16 M24
|
3 Participants
|
17 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection
Sero negative, DNA negative HPV-16/18 M24
|
1 Participants
|
16 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection
Sero negative, DNA negative HPV-16 M24
|
1 Participants
|
12 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection
Sero negative, DNA negative HPV-18 M24
|
0 Participants
|
5 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection
Overall, HPV-16/18 M24
|
3 Participants
|
24 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection
Overall, HPV-18 M24
|
0 Participants
|
8 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection
Sero negative, DNA negative HPV-16/18 M48
|
2 Participants
|
39 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection
Sero negative, DNA negative HPV-16 M48
|
2 Participants
|
28 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection
Sero negative, DNA negative HPV-18 M48
|
0 Participants
|
12 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection
Overall, HPV-16/18 M48
|
5 Participants
|
53 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection
Overall, HPV-16 M48
|
4 Participants
|
39 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection
Overall, HPV-18 M48
|
1 Participants
|
16 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection
Sero negative, DNA negative HPV-16/18 M57
|
4 Participants
|
53 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection
Sero negative, DNA negative HPV-16 M57
|
3 Participants
|
38 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection
Sero negative, DNA negative HPV-18 M57
|
1 Participants
|
16 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection
Overall, HPV-16/18 M57
|
10 Participants
|
71 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection
Overall, HPV-16 M57
|
7 Participants
|
52 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection
Overall, HPV-18 M57
|
3 Participants
|
21 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection
Sero negative, DNA negative HPV-16/18 M72
|
5 Participants
|
60 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection
Sero negative, DNA negative HPV-16 M72
|
4 Participants
|
44 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection
Sero negative, DNA negative HPV-18 M72
|
1 Participants
|
17 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection
Overall, HPV-16/18 M72
|
12 Participants
|
83 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection
Overall, HPV-16 M72
|
9 Participants
|
62 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection
Overall, HPV-18 M72
|
3 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: At Months 24, 48, 57 and 72Population: The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.
Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US). Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus. HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Outcome measures
| Measure |
Cervarix Group
n=2808 Participants
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Placebo Group
n=2812 Participants
Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-16 M24
|
3 Participants
|
17 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-18 M24
|
0 Participants
|
8 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-31 M24
|
5 Participants
|
7 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-33 M24
|
5 Participants
|
7 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-35 M24
|
6 Participants
|
4 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-39 M24
|
11 Participants
|
8 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-45 M24
|
4 Participants
|
5 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-51 M24
|
19 Participants
|
17 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-52 M24
|
29 Participants
|
16 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-56 M24
|
9 Participants
|
13 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-58 M24
|
9 Participants
|
11 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-59 M24
|
8 Participants
|
4 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-66 M24
|
12 Participants
|
9 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-68 M24
|
10 Participants
|
10 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-31/33/45 M24
|
13 Participants
|
18 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-16/18/31/33/45 M24
|
15 Participants
|
42 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HRW-HPV M24
|
88 Participants
|
90 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HR-HPV M24
|
90 Participants
|
105 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-16 M48
|
4 Participants
|
39 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-18 M48
|
1 Participants
|
16 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-31 M48
|
10 Participants
|
21 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-33 M48
|
11 Participants
|
20 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-35 M48
|
12 Participants
|
15 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-39 M48
|
29 Participants
|
21 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-45 M48
|
6 Participants
|
6 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-51 M48
|
42 Participants
|
47 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-52 M48
|
54 Participants
|
45 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-56 M48
|
25 Participants
|
27 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-58 M48
|
20 Participants
|
20 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-59 M48
|
17 Participants
|
10 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-66 M48
|
27 Participants
|
20 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-68 M48
|
22 Participants
|
19 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-31/33/45 M48
|
24 Participants
|
41 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-16/18/31/33/45 M48
|
28 Participants
|
92 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HRW-HPV M48
|
196 Participants
|
212 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HR-HPV M48
|
199 Participants
|
238 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-16 M57
|
7 Participants
|
52 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-18 M57
|
3 Participants
|
21 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-31 M57
|
12 Participants
|
28 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-33 M57
|
15 Participants
|
29 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-35 M57
|
18 Participants
|
19 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-39 M57
|
40 Participants
|
31 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-45 M57
|
9 Participants
|
12 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-51 M57
|
57 Participants
|
64 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-52 M57
|
71 Participants
|
74 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-56 M57
|
39 Participants
|
43 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-58 M57
|
34 Participants
|
42 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-59 M57
|
19 Participants
|
15 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-66 M57
|
39 Participants
|
39 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-68 M57
|
28 Participants
|
30 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-31/33/45 M57
|
32 Participants
|
61 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-16/18/31/33/45 M57
|
41 Participants
|
127 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HRW-HPV M57
|
127 Participants
|
274 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HR-HPV M57
|
278 Participants
|
343 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-16 M72
|
9 Participants
|
62 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-18 M72
|
3 Participants
|
25 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-31 M72
|
12 Participants
|
32 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-33 M72
|
17 Participants
|
32 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-35 M72
|
20 Participants
|
21 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-39 M72
|
49 Participants
|
35 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-45 M72
|
9 Participants
|
12 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-51 M72
|
64 Participants
|
78 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-52 M72
|
83 Participants
|
81 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-56 M72
|
46 Participants
|
51 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-58 M72
|
36 Participants
|
49 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-59 M72
|
20 Participants
|
17 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-66 M72
|
42 Participants
|
46 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-68 M72
|
30 Participants
|
37 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-31/33/45 M72
|
34 Participants
|
66 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HPV-16/18/31/33/45 M72
|
45 Participants
|
144 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HRW-HPV M72
|
309 Participants
|
352 Participants
|
|
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
HR-HPV M72
|
313 Participants
|
386 Participants
|
SECONDARY outcome
Timeframe: At Months 24, 48, 57 and 72Population: The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.
CIN1+ = CIN grades 1, 2, and3, low-grade cervical glandular intraepithelial neoplasia (LCGIN), high grade cervical glandular intraepithelial neoplasia (HCGIN), adenocarcinoma in-situ (AIS) or invasive cervical cancer. DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.
Outcome measures
| Measure |
Cervarix Group
n=2805 Participants
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Placebo Group
n=2802 Participants
Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection
Overall, HPV-16/18 M24
|
0 Participants
|
5 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection
Sero negative, DNA negative HPV-16/18 M24
|
0 Participants
|
4 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection
Sero negative, DNA negative HPV-16 M24
|
0 Participants
|
4 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection
Sero negative, DNA negative HPV-18 M24
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection
Overall, HPV-16 M24
|
0 Participants
|
5 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection
Overall, HPV-18 M24
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection
Sero negative, DNA negative HPV-16/18 M48
|
1 Participants
|
12 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection
Sero negative, DNA negative HPV-16 M48
|
1 Participants
|
8 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection
Sero negative, DNA negative HPV-18 M48
|
0 Participants
|
4 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection
Overall, HPV-16/18 M48
|
1 Participants
|
14 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection
Overall, HPV-16 M48
|
1 Participants
|
10 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection
Overall, HPV-18 M48
|
0 Participants
|
4 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection
Sero negative, DNA negative HPV-16/18 M57
|
1 Participants
|
15 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection
Sero negative, DNA negative HPV-16 M57
|
1 Participants
|
10 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection
Sero negative, DNA negative HPV-18 M57
|
0 Participants
|
5 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection
Overall, HPV-16/18 M57
|
1 Participants
|
18 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection
Overall, HPV-16 M57
|
1 Participants
|
13 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection
Overall, HPV-18 M57
|
0 Participants
|
5 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection
Sero negative, DNA negative HPV-16/18 M72
|
1 Participants
|
15 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection
Sero negative, DNA negative HPV-16 M72
|
1 Participants
|
10 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection
Sero negative, DNA negative HPV-18 M72
|
0 Participants
|
5 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection
Overall, HPV-16/18 M72
|
1 Participants
|
18 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection
Overall, HPV-16 M72
|
1 Participants
|
13 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection
Overall, HPV-18 M72
|
0 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: At Months 24, 48, 57 and 72Population: The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.
CIN2+ = CIN grades 2 and 3, LCGIN, HCGIN, AIS or invasive cervical cancer. DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.
Outcome measures
| Measure |
Cervarix Group
n=2805 Participants
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Placebo Group
n=2802 Participants
Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection
Sero negative, DNA negative HPV-16/18 M72
|
1 Participants
|
8 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection
Sero negative, DNA negative HPV-16 M72
|
1 Participants
|
8 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection
Sero negative, DNA negative HPV-18 M72
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection
Overall, HPV-16/18 M72
|
1 Participants
|
10 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection
Overall, HPV-16 M72
|
1 Participants
|
10 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection
Overall, HPV-18 M72
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection
Sero negative, DNA negative HPV-16/18 M24
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection
Sero negative, DNA negative HPV-16 M24
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection
Sero negative, DNA negative HPV-18 M24
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection
Overall, HPV-16/18 M24
|
0 Participants
|
4 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection
Overall, HPV-16 M24
|
0 Participants
|
4 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection
Overall, HPV-18 M24
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection
Sero negative, DNA negative HPV-16/18 M48
|
1 Participants
|
6 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection
Sero negative, DNA negative HPV-16 M48
|
1 Participants
|
6 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection
Sero negative, DNA negative HPV-18 M48
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection
Overall, HPV-16/18 M48
|
1 Participants
|
7 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection
Overall, HPV-16 M48
|
1 Participants
|
7 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection
Overall, HPV-18 M48
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection
Sero negative, DNA negative HPV-16/18 M57
|
1 Participants
|
8 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection
Sero negative, DNA negative HPV-16 M57
|
1 Participants
|
8 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection
Sero negative, DNA negative HPV-18 M57
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection
Overall, HPV-16/18 M57
|
1 Participants
|
10 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection
Overall, HPV-16 M57
|
1 Participants
|
10 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection
Overall, HPV-18 M57
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Months 24, 48, 57 and 72Population: The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.
CIN1+ = CIN grades 1, 2 and 3, LCGIN, HCGIN, AIS or invasive cervical cancer. Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus. HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Outcome measures
| Measure |
Cervarix Group
n=2810 Participants
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Placebo Group
n=2812 Participants
Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-16 M24
|
0 Participants
|
5 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-18 M24
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-31 M24
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-33 M24
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-35 M24
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-39 M24
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-45 M24
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-51 M24
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-52 M24
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-56 M24
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-58 M24
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-59 M24
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-66 M24
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-68 M24
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-31/33/45 M24
|
3 Participants
|
3 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-16/18/31/33/45 M24
|
3 Participants
|
8 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HRW-HPV M24
|
11 Participants
|
14 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HR-HPV M24
|
11 Participants
|
17 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-16 M48
|
1 Participants
|
10 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-18 M48
|
0 Participants
|
4 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-31 M48
|
0 Participants
|
4 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-33 M48
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-35 M48
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-39 M48
|
4 Participants
|
1 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-45 M48
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-51 M48
|
1 Participants
|
8 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-52 M48
|
7 Participants
|
9 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-56 M48
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-58 M48
|
4 Participants
|
4 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-59 M48
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-66 M48
|
6 Participants
|
3 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-68 M48
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-31/33/45 M48
|
5 Participants
|
7 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-16/18/31/33/45 M48
|
6 Participants
|
21 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HRW-HPV M48
|
27 Participants
|
35 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HR-HPV M48
|
27 Participants
|
44 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-16 M57
|
1 Participants
|
13 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-18 M57
|
0 Participants
|
5 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-31 M57
|
0 Participants
|
6 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-33 M57
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-35 M57
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-39 M57
|
7 Participants
|
1 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-45 M57
|
3 Participants
|
3 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-51 M57
|
2 Participants
|
9 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-52 M57
|
11 Participants
|
11 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-56 M57
|
2 Participants
|
4 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-58 M57
|
4 Participants
|
9 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-59 M57
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-66 M57
|
6 Participants
|
5 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-68 M57
|
3 Participants
|
3 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-31/33/45 M57
|
5 Participants
|
10 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-16/18/31/33/45 M57
|
6 Participants
|
27 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HRW-HPV M57
|
37 Participants
|
49 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HR-HPV M57
|
37 Participants
|
60 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-16 M72
|
1 Participants
|
13 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-18 M72
|
0 Participants
|
5 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-31 M72
|
0 Participants
|
6 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-33 M72
|
5 Participants
|
3 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-35 M72
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-39 M72
|
7 Participants
|
1 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-45 M72
|
3 Participants
|
3 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-51 M72
|
3 Participants
|
9 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-52 M72
|
11 Participants
|
12 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-56 M72
|
2 Participants
|
4 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-58 M72
|
6 Participants
|
9 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-59 M72
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-66 M72
|
6 Participants
|
8 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-68 M72
|
3 Participants
|
3 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-31/33/45 M72
|
7 Participants
|
11 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-16/18/31/33/45 M72
|
8 Participants
|
28 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HRW-HPV M72
|
42 Participants
|
53 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
HR-HPV M72
|
42 Participants
|
64 Participants
|
SECONDARY outcome
Timeframe: At Months 24, 48, 57 and 72Population: The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.
CIN2+ = CIN grades 2 and 3, LCGIN, HCGIN, AIS or invasive cervical cancer. Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus. HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Outcome measures
| Measure |
Cervarix Group
n=2810 Participants
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Placebo Group
n=2812 Participants
Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-68 M57
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-31/33/45 M57
|
1 Participants
|
7 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-59 M72
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-66 M72
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-68 M72
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-31/33/45 M72
|
2 Participants
|
8 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-16/18/31/33/45 M72
|
3 Participants
|
18 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HRW-HPV M72
|
13 Participants
|
17 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HR-HPV M72
|
13 Participants
|
26 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-16/18/31/33/45 M57
|
2 Participants
|
17 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HRW-HPV M57
|
10 Participants
|
16 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HR-HPV M57
|
10 Participants
|
25 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-16 M72
|
1 Participants
|
10 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-18 M72
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-31 M72
|
0 Participants
|
4 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-33 M72
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-35 M72
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-39 M72
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-45 M72
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-51 M72
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-52 M72
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-56 M72
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-58 M72
|
5 Participants
|
5 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-66 M57
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-31 M24
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-33 M24
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-35 M24
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-39 M24
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-45 M24
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-51 M24
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-52 M24
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-56 M24
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-58 M24
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-59 M24
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-66 M24
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-68 M24
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-31/33/45 M24
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-16/18/31/33/45 M24
|
1 Participants
|
5 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HRW-HPV M24
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HR-HPV M24
|
2 Participants
|
6 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-16 M48
|
1 Participants
|
7 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-18 M48
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-31 M48
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-33 M48
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-35 M48
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-39 M48
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-45 M48
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-51 M48
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-52 M48
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-56 M48
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-58 M48
|
4 Participants
|
2 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-59 M48
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-66 M48
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-68 M48
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-31/33/45 M48
|
1 Participants
|
4 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-16/18/31/33/45 M48
|
2 Participants
|
11 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HRW-HPV M48
|
8 Participants
|
9 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HR-HPV M48
|
8 Participants
|
15 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-16 M57
|
1 Participants
|
10 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-18 M57
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-31 M57
|
0 Participants
|
4 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-33 M57
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-35 M57
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-39 M57
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-45 M57
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-51 M57
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-52 M57
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-56 M57
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-58 M57
|
4 Participants
|
5 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-59 M57
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-16 M24
|
0 Participants
|
4 Participants
|
|
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
HPV-18 M24
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days (Days 0-6) after vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Solicited local symptoms assessed were pain, redness and swelling. Any = solicited local symptom reported irrespective of intensity grade, Grade 3 Pain = pain that prevented normal activity, Grade 3 Swelling or Redness = swelling or redness above (\>) 50 millimeter (mm). All local symptoms were considered as related to the study vaccination.
Outcome measures
| Measure |
Cervarix Group
n=3005 Participants
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Placebo Group
n=3001 Participants
Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms
Any Pain - Across doses
|
2634 Participants
|
2166 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms
Grade 3 Pain - Across doses
|
211 Participants
|
64 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms
Any Pain - Dose 1
|
2439 Participants
|
1815 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms
Grade 3 Pain - Dose 1
|
105 Participants
|
23 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms
Any Redness - Dose 1
|
512 Participants
|
326 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms
Grade 3 Redness - Dose 1
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms
Any Redness - Dose 2
|
350 Participants
|
182 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms
Grade 3 Redness - Dose 2
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms
Any Redness - Dose 3
|
432 Participants
|
173 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms
Grade 3 Redness - Dose 3
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms
Any Redness - Across Doses
|
838 Participants
|
517 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms
Grade 3 Redness - Across Doses
|
5 Participants
|
1 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms
Any Swelling - Dose 1
|
514 Participants
|
215 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms
Grade 3 Swelling - Dose 1
|
34 Participants
|
4 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms
Any Swelling - Dose 2
|
323 Participants
|
120 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms
Grade 3 Swelling - Dose 2
|
19 Participants
|
2 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms
Any Swelling - Dose 3
|
447 Participants
|
149 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms
Grade 3 Swelling - Dose 3
|
10 Participants
|
1 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms
Any Swelling - Across Doses
|
853 Participants
|
408 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms
Grade 3 Swelling - Across Doses
|
48 Participants
|
5 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms
Any Pain - Dose 2
|
1650 Participants
|
1062 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms
Grade 3 Pain - Dose 2
|
53 Participants
|
17 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms
Any Pain - Dose 3
|
1499 Participants
|
918 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms
Grade 3 Pain - Dose 3
|
86 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: Within 7 days (Days 0-6) after vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Solicited local symptoms assessed were pain, redness and swelling. Any = solicited local symptom reported irrespective of intensity grade Grade 3 Pain = pain that prevented normal activity Grade 3 Swelling or Redness = swelling/redness above (\>) 50 millimeter (mm). All local symptoms were considered as related to the study vaccination.
Outcome measures
| Measure |
Cervarix Group
n=1879 Participants
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Placebo Group
n=1831 Participants
Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Grade 3 Swelling - Dose 3
|
7 Participants
|
1 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Any Swelling - Across doses
|
493 Participants
|
228 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Grade 3 Swelling - Across doses
|
28 Participants
|
4 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Any Pain - Dose 1
|
1519 Participants
|
1079 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Grade 3 Pain - Dose 1
|
65 Participants
|
11 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Any Pain - Dose 2
|
1029 Participants
|
627 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Grade 3 Pain - Dose 2
|
35 Participants
|
10 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Any Pain - Dose 3
|
923 Participants
|
530 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Grade 3 Pain - Dose 3
|
54 Participants
|
14 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Any Pain - Across doses
|
1633 Participants
|
1286 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Grade 3 Pain - Across doses
|
131 Participants
|
22 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Any Redness - Dose 1
|
290 Participants
|
174 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Grade 3 Redness - Dose 1
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Any Redness - Dose 2
|
201 Participants
|
99 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Grade 3 Redness - Dose 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Any Redness - Dose 3
|
240 Participants
|
95 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Grade 3 Redness - Dose 3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Any Redness - Across doses
|
486 Participants
|
280 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Grade 3 Redness - Across doses
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Any Swelling - Dose 1
|
293 Participants
|
138 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Grade 3 Swelling - Dose 1
|
18 Participants
|
4 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Any Swelling - Dose 2
|
196 Participants
|
65 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Grade 3 Swelling - Dose 2
|
12 Participants
|
1 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Any Swelling - Dose 3
|
248 Participants
|
85 Participants
|
SECONDARY outcome
Timeframe: Within 7 days (Days 0-6) after vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Solicited local symptoms assessed were pain, redness and swelling. Any = solicited local symptom reported irrespective of intensity grade Grade 3 Pain = pain that prevented normal activity, Grade 3 Swelling or Redness = swelling/redness above (\>) 50 millimeter (mm). All local symptoms were considered as related to the study vaccination.
Outcome measures
| Measure |
Cervarix Group
n=1124 Participants
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Placebo Group
n=1167 Participants
Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Pain - Dose 1
|
919 Participants
|
733 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Redness - Dose 3
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Swelling - Dose 1
|
16 Participants
|
0 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Swelling - Dose 3
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Pain - Dose 1
|
40 Participants
|
11 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Pain - Dose 2
|
620 Participants
|
434 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Pain - Dose 2
|
18 Participants
|
7 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Pain - Dose 3
|
576 Participants
|
386 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Pain - Dose 3
|
32 Participants
|
12 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Pain - Across doses
|
1000 Participants
|
877 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Pain - Across doses
|
80 Participants
|
30 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Redness - Dose 1
|
222 Participants
|
151 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Redness - Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Redness - Dose 2
|
148 Participants
|
83 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Redness - Dose 2
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Redness - Dose 3
|
192 Participants
|
78 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Redness - Across doses
|
351 Participants
|
236 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Redness - Across doses
|
4 Participants
|
0 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Swelling - Dose 1
|
220 Participants
|
112 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Swelling - Dose 2
|
126 Participants
|
55 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Swelling - Dose 2
|
7 Participants
|
1 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Swelling - Dose 3
|
199 Participants
|
64 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Swelling - Across doses
|
359 Participants
|
179 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Swelling - Across doses
|
20 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Within 7 days (Days 0-6) after vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Solicited local symptoms assessed were pain, redness and swelling. Any = solicited local symptom reported irrespective of intensity grade, Grade 3 Redness, Swelling = redness/swelling above 50 millimeter All local symptoms were considered as related to the study vaccination
Outcome measures
| Measure |
Cervarix Group
n=151 Participants
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Placebo Group
n=127 Participants
Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Swelling - Dose 3
|
29 Participants
|
5 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Swelling - Dose 3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Swelling - Across doses
|
58 Participants
|
21 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Pain - Dose 1
|
123 Participants
|
82 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Pain - Dose 1
|
5 Participants
|
0 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Pain - Dose 2
|
78 Participants
|
55 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Pain - Dose 2
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Pain - Dose 3
|
74 Participants
|
43 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Pain - Dose 3
|
5 Participants
|
1 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Pain - Across doses
|
133 Participants
|
97 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Pain - Across doses
|
11 Participants
|
3 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Redness - Dose 1
|
41 Participants
|
16 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Redness - Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Redness - Dose 2
|
24 Participants
|
11 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Redness - Dose 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Redness - Dose 3
|
23 Participants
|
6 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Redness - Dose 3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Redness - Across doses
|
55 Participants
|
28 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Redness - Across doses
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Swelling - Dose 1
|
40 Participants
|
14 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Swelling - Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Swelling - Dose 2
|
21 Participants
|
8 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Swelling - Dose 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Swelling - Across doses
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days (Days 0-6) after vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, fever (= axillary temperature above 37.0 degrees Celsius) and urticaria. Any = any solicited general symptom reported irrespective of intensity grade and relationship to vaccination, Related = symptoms assessed by the investigator as causally related to study vaccination, Grade 3 symptoms = prevented normal activity, Grade 3 urticaria = distributed on at least 4 body areas.
Outcome measures
| Measure |
Cervarix Group
n=3005 Participants
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Placebo Group
n=3001 Participants
Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Related Arthralgia - Dose 3
|
61 Participants
|
26 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Any Gastrointestinal - Across doses
|
409 Participants
|
473 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Any Gastrointestinal - Dose 1
|
295 Participants
|
368 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Any Gastrointestinal - Dose 2
|
123 Participants
|
111 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Any Gastrointestinal - Dose 3
|
64 Participants
|
61 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Grade 3 Gastrointestinal - Dose 1
|
10 Participants
|
18 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Grade 3 Gastrointestinal - Dose 2
|
2 Participants
|
5 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Grade 3 Gastrointestinal - Dose 3
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Grade 3 Gastrointestinal - Across doses
|
15 Participants
|
22 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Related Gastrointestinal - Dose 1
|
177 Participants
|
200 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Related Gastrointestinal - Dose 2
|
79 Participants
|
65 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Related Gastrointestinal - Dose 3
|
50 Participants
|
43 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Related Gastrointestinal - Across doses
|
267 Participants
|
275 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Any Headache - Dose 1
|
476 Participants
|
509 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Any Headache - Dose 2
|
229 Participants
|
208 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Any Headache - Dose 3
|
191 Participants
|
146 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Any Headache - Across doses
|
684 Participants
|
682 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Grade 3 Headache - Dose 1
|
332 Participants
|
347 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Grade 3 Headache - Dose 2
|
5 Participants
|
4 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Grade 3 Headache - Dose 3
|
6 Participants
|
5 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Grade 3 Headache - Across doses
|
25 Participants
|
20 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Related Headache - Dose 1
|
332 Participants
|
347 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Related Headache - Dose 2
|
180 Participants
|
161 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Related Headache - Dose 3
|
164 Participants
|
107 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Related Headache - Across doses
|
526 Participants
|
505 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Any Myalgia - Dose 1
|
362 Participants
|
249 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Grade 3 Rash - Dose 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Any Arthralgia - Dose 1
|
199 Participants
|
163 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Grade 3 Rash - Dose 3
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Any Arthralgia - Dose 2
|
63 Participants
|
51 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Any Arthralgia - Dose 3
|
67 Participants
|
32 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Any Arthralgia - Across doses
|
270 Participants
|
213 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Grade 3 Arthralgia - Dose 1
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Grade 3 Arthralgia - Dose 2
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Grade 3 Arthralgia - Dose 3
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Grade 3 Arthralgia - Across doses
|
2 Participants
|
4 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Related Arthralgia - Dose 1
|
143 Participants
|
109 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Related Arthralgia - Dose 2
|
51 Participants
|
32 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Related Arthralgia - Across doses
|
210 Participants
|
149 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Any Fatigue - Dose 1
|
817 Participants
|
769 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Any Fatigue - Dose 2
|
447 Participants
|
367 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Any Fatigue - Across doses
|
1142 Participants
|
1018 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Any Fatigue - Dose 3
|
443 Participants
|
309 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Grade 3 Fatigue - Dose 1
|
14 Participants
|
18 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Grade 3 Fatigue - Dose 2
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Grade 3 Fatigue - Dose 3
|
5 Participants
|
5 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Any Myalgia - Dose 2
|
118 Participants
|
73 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Any Myalgia - Dose 3
|
175 Participants
|
109 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Any Myalgia - Across doses
|
523 Participants
|
360 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Grade 3 Myalgia - Dose 1
|
5 Participants
|
2 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Grade 3 Myalgia - Dose 2
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Grade 3 Myalgia - Dose 3
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Grade 3 Myalgia - Across doses
|
9 Participants
|
5 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Related Myalgia - Dose 1
|
303 Participants
|
188 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Related Myalgia - Across doses
|
449 Participants
|
287 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Any Rash - Dose 1
|
28 Participants
|
42 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Any Rash - Dose 2
|
9 Participants
|
13 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Any Rash - Dose 3
|
12 Participants
|
7 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Any Rash - Across doses
|
47 Participants
|
59 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Grade 3 Rash - Dose 1
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Grade 3 Rash - Across doses
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Related Rash - Dose 1
|
15 Participants
|
19 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Related Rash - Dose 2
|
1 Participants
|
9 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Related Rash - Dose 3
|
5 Participants
|
5 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Related Rash - Across doses
|
21 Participants
|
33 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
>37.0°C Fever - Dose 1
|
480 Participants
|
433 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
>37.0°C Fever - Dose 2
|
232 Participants
|
236 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
>37.0°C Fever - Dose 3
|
182 Participants
|
175 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
>37.0°C Fever - Across doses
|
744 Participants
|
697 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
>39.0°C Fever - Dose 1
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
>39.0°C Fever - Dose 2
|
6 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
>39.0°C Fever - Dose 3
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
>39.0°C Fever - Across doses
|
11 Participants
|
2 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Related Fever - Dose 1
|
386 Participants
|
344 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Related Fever - Dose 2
|
175 Participants
|
168 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Related Fever - Dose 3
|
124 Participants
|
117 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Related Fever - Across doses
|
588 Participants
|
539 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Any Urticaria - Dose 1
|
22 Participants
|
20 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Any Urticaria - Dose 2
|
6 Participants
|
6 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Any Urticaria - Dose 3
|
4 Participants
|
4 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Any Urticaria - Across doses
|
29 Participants
|
28 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Grade 3 Urticaria - Dose 1
|
4 Participants
|
2 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Grade 3 Urticaria - Dose 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Grade 3 Urticaria - Dose 3
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Grade 3 Urticaria - Across doses
|
5 Participants
|
3 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Related Urticaria - Dose 1
|
10 Participants
|
12 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Related Urticaria - Dose 2
|
6 Participants
|
5 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Related Urticaria - Dose 3
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Related Urticaria - Across doses
|
16 Participants
|
16 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Grade 3 Fatigue - Across doses
|
26 Participants
|
29 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Related Fatigue - Dose 1
|
634 Participants
|
581 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Related Fatigue - Dose 2
|
51 Participants
|
32 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Related Fatigue - Dose 3
|
390 Participants
|
256 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Related Fatigue - Across doses
|
968 Participants
|
833 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Related Myalgia - Dose 2
|
98 Participants
|
57 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Related Myalgia - Dose 3
|
153 Participants
|
92 Participants
|
SECONDARY outcome
Timeframe: Within 7 days (Days 0-6) after vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, fever (= axillary temperature above 37.0°C) and urticaria. Any = any solicited general symptom reported irrespective of intensity grade and relationship to vaccination Related = symptoms assessed by the investigator as causally related to study vaccination Grade 3 symptoms = symptoms that prevented normal activity Grade 3 urticaria = urticaria distributed on at least 4 body areas.
Outcome measures
| Measure |
Cervarix Group
n=1879 Participants
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Placebo Group
n=1831 Participants
Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Related Arthralgia - Dose 1
|
89 Participants
|
62 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Related Arthralgia - Dose 2
|
29 Participants
|
20 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Related Arthralgia - Dose 3
|
37 Participants
|
16 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Related Arthralgia - Across doses
|
128 Participants
|
87 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Any Fatigue - Dose 1
|
509 Participants
|
443 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Any Fatigue - Dose 3
|
278 Participants
|
165 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Related Fatigue - Dose 3
|
248 Participants
|
135 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Any Gastrointestinal - Dose 2
|
66 Participants
|
65 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Grade 3 Arthralgia - Dose 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Any Arthralgia - Dose 1
|
124 Participants
|
96 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Any Arthralgia - Dose 2
|
33 Participants
|
34 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Any Arthralgia - Dose 3
|
40 Participants
|
18 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Any Arthralgia - Across doses
|
164 Participants
|
128 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Grade 3 Arthralgia - Dose 1
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Grade 3 Arthralgia - Dose 3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Grade 3 Arthralgia - Across doses
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Related Fatigue - Dose 2
|
223 Participants
|
185 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Any Fatigue - Dose 2
|
255 Participants
|
219 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Any Fatigue - Across doses
|
711 Participants
|
588 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Related Fatigue - Across doses
|
592 Participants
|
471 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Any Headache - Dose 2
|
118 Participants
|
120 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Grade 3 Fatigue - Dose 1
|
10 Participants
|
13 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Grade 3 Fatigue - Dose 2
|
4 Participants
|
3 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Grade 3 Fatigue - Dose 3
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Grade 3 Fatigue - Across doses
|
16 Participants
|
18 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Related Fatigue - Dose 1
|
386 Participants
|
321 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Related Gastrointestinal - Dose 1
|
114 Participants
|
122 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Grade 3 Gastrointestinal - Across doses
|
6 Participants
|
10 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Related Gastrointestinal - Dose 2
|
40 Participants
|
40 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Related Gastrointestinal - Dose 3
|
25 Participants
|
27 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Grade 3 Headache - Dose 1
|
7 Participants
|
10 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Grade 3 Urticaria - Dose 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Grade 3 Urticaria - Dose 3
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Related Gastrointestinal - Across doses
|
154 Participants
|
170 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Any Gastrointestinal - Dose 1
|
182 Participants
|
227 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Any Gastrointestinal - Dose 3
|
33 Participants
|
35 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Any Gastrointestinal - Across doses
|
240 Participants
|
287 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Grade 3 Gastrointestinal - Dose 1
|
5 Participants
|
9 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Grade 3 Gastrointestinal - Dose 2
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Grade 3 Gastrointestinal - Dose 3
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Grade 3 Urticaria - Across doses
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Related Urticaria - Dose 1
|
7 Participants
|
8 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Grade 3 Headache - Dose 2
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Any Headache - Dose 1
|
284 Participants
|
315 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Related Urticaria - Dose 2
|
5 Participants
|
4 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Any Headache - Dose 3
|
111 Participants
|
85 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Any Headache - Across doses
|
408 Participants
|
404 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Related Urticaria - Dose 3
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Related Urticaria - Across doses
|
11 Participants
|
11 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Grade 3 Headache - Dose 3
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Grade 3 Headache - Across doses
|
11 Participants
|
12 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Related Headache - Dose 1
|
186 Participants
|
212 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Related Headache - Dose 2
|
89 Participants
|
96 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Related Headache - Dose 3
|
97 Participants
|
60 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Related Headache - Across doses
|
300 Participants
|
298 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Any Myalgia - Dose 1
|
233 Participants
|
154 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Any Myalgia - Dose 2
|
73 Participants
|
38 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Any Myalgia - Dose 3
|
114 Participants
|
74 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Any Myalgia - Across doses
|
328 Participants
|
214 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Grade 3 Myalgia - Dose 1
|
4 Participants
|
2 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Grade 3 Myalgia - Dose 2
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Grade 3 Myalgia - Dose 3
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Grade 3 Myalgia - Across doses
|
4 Participants
|
3 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Related Myalgia - Dose 1
|
194 Participants
|
117 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Related Myalgia - Dose 2
|
59 Participants
|
33 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Related Myalgia - Dose 3
|
100 Participants
|
62 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Related Myalgia - Across doses
|
280 Participants
|
173 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Any Rash - Dose 1
|
19 Participants
|
26 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Any Rash - Dose 2
|
6 Participants
|
7 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Any Rash - Dose 3
|
7 Participants
|
7 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Any Rash - Across doses
|
32 Participants
|
37 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Grade 3 Rash - Dose 1
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Grade 3 Rash - Dose 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Grade 3 Rash - Dose 3
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Grade 3 Rash - Across doses
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Related Rash - Dose 1
|
8 Participants
|
11 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Related Rash - Dose 2
|
1 Participants
|
6 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Related Rash - Dose 3
|
2 Participants
|
5 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Related Rash - Across doses
|
11 Participants
|
22 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
>37.0°C Fever - Dose 1
|
296 Participants
|
261 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
>37.0°C Fever - Dose 2
|
146 Participants
|
149 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
>37.0°C Fever - Dose 3
|
107 Participants
|
108 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
>37.0°C Fever - Across doses
|
464 Participants
|
427 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
>39.0°C Fever - Dose 1
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
>39.0°C Fever - Dose 2
|
4 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
>39.0°C Fever - Dose 3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
>39.0°C Fever - Across doses
|
6 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Related Fever - Dose 1
|
226 Participants
|
211 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Related Fever - Dose 2
|
106 Participants
|
109 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Related Fever - Dose 3
|
74 Participants
|
72 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Related Fever - Across doses
|
355 Participants
|
333 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Any Urticaria - Dose 1
|
13 Participants
|
15 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Any Urticaria - Dose 2
|
5 Participants
|
4 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Any Urticaria - Dose 3
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Any Urticaria - Across doses
|
18 Participants
|
19 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Grade 3 Urticaria - Dose 1
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Within 7 days (Days 0-6) after vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, fever (= axillary temperature above 37.0°C) and urticaria. Any = any solicited general symptom reported irrespective of intensity grade and relationship to vaccination Related = symptoms assessed by the investigator as causally related to study vaccination Grade 3 symptoms = symptoms that prevented normal activity Grade 3 urticaria = urticaria distributed on at least 4 body areas
Outcome measures
| Measure |
Cervarix Group
n=1124 Participants
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Placebo Group
n=1167 Participants
Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Myalgia - Dose 3
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Arthralgia - Dose 1
|
75 Participants
|
67 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Arthralgia - Dose 2
|
30 Participants
|
17 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Arthralgia - Dose 3
|
27 Participants
|
14 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Arthralgia - Across doses
|
106 Participants
|
85 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Arthralgia - Dose 1
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Arthralgia - Dose 2
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Arthralgia - Dose 3
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Arthralgia - Across doses
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Arthralgia - Dose 1
|
54 Participants
|
47 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Arthralgia - Dose 2
|
22 Participants
|
12 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Arthralgia - Dose 3
|
24 Participants
|
10 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Arthralgia - Across doses
|
82 Participants
|
62 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Fatigue - Dose 1
|
307 Participants
|
325 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Fatigue - Dose 2
|
191 Participants
|
147 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Fatigue - Dose 3
|
27 Participants
|
14 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Fatigue - Across doses
|
430 Participants
|
429 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Fatigue - Dose 1
|
4 Participants
|
5 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Fatigue - Dose 2
|
5 Participants
|
3 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Fatigue - Dose 3
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Fatigue - Across doses
|
10 Participants
|
11 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Fatigue - Dose 1
|
247 Participants
|
259 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Fatigue - Dose 2
|
170 Participants
|
118 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Fatigue - Dose 3
|
142 Participants
|
120 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Fatigue - Across doses
|
375 Participants
|
361 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Gastrointestinal - Dose 1
|
112 Participants
|
140 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Gastrointestinal - Dose 2
|
57 Participants
|
46 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Gastrointestinal - Dose 3
|
31 Participants
|
26 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Gastrointestinal - Across doses
|
168 Participants
|
185 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Gastrointestinal - Dose 1
|
5 Participants
|
9 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Gastrointestinal - Dose 2
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Gastrointestinal - Dose 3
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Gastrointestinal - Across doses
|
9 Participants
|
12 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Gastrointestinal - Dose 1
|
62 Participants
|
78 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Gastrointestinal - Dose 2
|
39 Participants
|
25 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Gastrointestinal - Dose 3
|
25 Participants
|
16 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Gastrointestinal - Across doses
|
112 Participants
|
105 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Headache - Dose 1
|
191 Participants
|
193 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Headache - Dose 2
|
111 Participants
|
88 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Headache - Dose 3
|
80 Participants
|
61 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Headache - Across doses
|
275 Participants
|
277 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Headache - Dose 1
|
7 Participants
|
3 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Headache - Dose 2
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Headache - Dose 3
|
4 Participants
|
3 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Headache - Across doses
|
14 Participants
|
8 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Headache - Dose 1
|
145 Participants
|
134 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Headache - Dose 2
|
91 Participants
|
65 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Headache - Dose 3
|
67 Participants
|
47 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Headache - Across doses
|
225 Participants
|
206 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Myalgia - Dose 1
|
129 Participants
|
94 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Myalgia - Dose 2
|
45 Participants
|
35 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Myalgia - Dose 3
|
61 Participants
|
35 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Myalgia - Across doses
|
195 Participants
|
145 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Myalgia - Dose 1
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Myalgia - Dose 2
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Myalgia - Across doses
|
5 Participants
|
2 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Myalgia - Dose 1
|
109 Participants
|
70 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Myalgia - Dose 2
|
39 Participants
|
24 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Myalgia - Dose 3
|
53 Participants
|
30 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Myalgia - Across doses
|
169 Participants
|
113 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Rash - Dose 1
|
9 Participants
|
16 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Rash - Dose 2
|
3 Participants
|
6 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Rash - Dose 3
|
5 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Rash - Across doses
|
15 Participants
|
22 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Rash - Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Rash - Dose 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Rash - Dose 3
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Rash - Across doses
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Rash - Dose 1
|
7 Participants
|
8 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Rash - Dose 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Rash - Dose 3
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Rash - Across doses
|
10 Participants
|
11 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
>37.0°C Fever - Dose 1
|
183 Participants
|
172 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
>37.0°C Fever - Dose 2
|
85 Participants
|
87 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
>37.0°C Fever - Dose 3
|
73 Participants
|
67 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
>37.0°C Fever - Across doses
|
278 Participants
|
270 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
>39.0°C Fever - Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
>39.0°C Fever - Dose 2
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
>39.0°C Fever - Dose 3
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
>39.0°C Fever - Across doses
|
5 Participants
|
2 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Fever - Dose 1
|
159 Participants
|
133 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Fever - Dose 2
|
68 Participants
|
59 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Fever - Dose 3
|
49 Participants
|
45 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Fever - Across doses
|
232 Participants
|
206 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Urticaria - Dose 1
|
9 Participants
|
5 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Urticaria - Dose 2
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Urticaria - Dose 3
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Urticaria - Across doses
|
11 Participants
|
9 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Urticaria - Dose 1
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Urticaria - Dose 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Urticaria - Dose 3
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Urticaria - Across doses
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Urticaria - Dose 1
|
3 Participants
|
4 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Urticaria - Dose 2
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Urticaria - Dose 3
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Urticaria - Across doses
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Within 7 days (Days 0-6) after vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, fever (= axillary temperature above 37.0°C) and urticaria. Any = any solicited general symptom reported irrespective of intensity grade and relationship to vaccination Related = symptoms assessed by the investigator as causally related to study vaccination Grade 3 symptoms = symptoms that prevented normal activity Grade 3 urticaria = urticaria distributed on at least 4 body areas
Outcome measures
| Measure |
Cervarix Group
n=151 Participants
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Placebo Group
n=127 Participants
Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Fatigue - Across doses
|
58 Participants
|
47 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Gastrointestinal - Dose 1
|
14 Participants
|
20 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Gastrointestinal - Dose 2
|
10 Participants
|
5 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Gastrointestinal - Dose 3
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Gastrointestinal - Across doses
|
22 Participants
|
24 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Gastrointestinal - Dose 1
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Gastrointestinal - Dose 2
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Gastrointestinal - Dose 3
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Gastrointestinal - Across doses
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Gastrointestinal - Dose 1
|
7 Participants
|
8 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Gastrointestinal - Dose 2
|
7 Participants
|
3 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Gastrointestinal - Dose 3
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Gastrointestinal - Across doses
|
14 Participants
|
12 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Headache - Dose 1
|
25 Participants
|
20 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Headache - Dose 2
|
17 Participants
|
9 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Headache - Dose 3
|
8 Participants
|
6 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Headache - Across doses
|
36 Participants
|
31 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Headache - Dose 1
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Headache - Dose 2
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Headache - Dose 3
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Headache - Across doses
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Headache - Dose 1
|
15 Participants
|
11 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Headache - Dose 2
|
16 Participants
|
7 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Headache - Dose 3
|
7 Participants
|
5 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Headache - Across doses
|
29 Participants
|
22 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Myalgia - Dose 1
|
17 Participants
|
10 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Myalgia - Dose 2
|
5 Participants
|
4 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Myalgia - Dose 3
|
7 Participants
|
2 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Myalgia - Across doses
|
25 Participants
|
15 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Myalgia - Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Myalgia - Dose 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Myalgia - Dose 3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Myalgia - Across doses
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Myalgia - Dose 1
|
11 Participants
|
9 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Myalgia - Dose 2
|
5 Participants
|
4 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Myalgia - Dose 3
|
7 Participants
|
1 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Myalgia - Across doses
|
19 Participants
|
13 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Rash - Dose 1
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Rash - Dose 2
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Rash - Dose 3
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Rash - Across doses
|
4 Participants
|
2 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Rash - Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Rash - Dose 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Rash - Dose 3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Rash - Across doses
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Rash - Dose 1
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Rash - Dose 2
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Rash - Dose 3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Rash - Across doses
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
>37.0°C Fever - Dose 1
|
16 Participants
|
18 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
>37.0°C Fever - Dose 2
|
11 Participants
|
12 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
>37.0°C Fever - Dose 3
|
15 Participants
|
3 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
>37.0°C Fever - Across doses
|
32 Participants
|
26 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
>39.0°C Fever - Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
>39.0°C Fever - Dose 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
>39.0°C Fever - Dose 3
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
>39.0°C Fever - Across doses
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Fever - Dose 1
|
13 Participants
|
13 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Fever - Dose 2
|
8 Participants
|
7 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Fever - Dose 3
|
8 Participants
|
2 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Fever - Across doses
|
23 Participants
|
18 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Urticaria - Dose 1
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Urticaria - Dose 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Urticaria - Dose 3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Urticaria - Across doses
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Urticaria - Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Urticaria - Dose 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Urticaria - Dose 3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Urticaria - Across doses
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Urticaria - Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Urticaria - Dose 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Urticaria - Dose 3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Urticaria - Across doses
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Arthralgia - Dose 1
|
12 Participants
|
8 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Arthralgia - Dose 2
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Arthralgia - Dose 3
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Arthralgia - Across doses
|
14 Participants
|
10 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Arthralgia - Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Arthralgia - Dose 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Arthralgia - Dose 3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Arthralgia - Across doses
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Arthralgia - Dose 1
|
7 Participants
|
5 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Arthralgia - Dose 2
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Arthralgia - Dose 3
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Arthralgia - Across doses
|
8 Participants
|
6 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Fatigue - Dose 1
|
44 Participants
|
46 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Fatigue - Dose 2
|
29 Participants
|
18 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Fatigue - Dose 3
|
24 Participants
|
14 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Any Fatigue - Across doses
|
66 Participants
|
53 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Fatigue - Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Fatigue - Dose 2
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Fatigue - Dose 3
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Grade 3 Fatigue - Across doses
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Fatigue - Dose 1
|
35 Participants
|
36 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Fatigue - Dose 2
|
26 Participants
|
13 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Related Fatigue - Dose 3
|
20 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Within Days 0-29 after vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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. Related = event assessed by the investigator as causally related to study vaccination Grade 3 = event that prevented normal activity
Outcome measures
| Measure |
Cervarix Group
n=3026 Participants
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Placebo Group
n=3025 Participants
Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Unsolicited Adverse Events (AEs)
Any AEs
|
793 Participants
|
775 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Unsolicited Adverse Events (AEs)
Grade 3 AEs
|
18 Participants
|
18 Participants
|
|
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Unsolicited Adverse Events (AEs)
Related AEs
|
35 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: Within Days 0-29 after vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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 |
Cervarix Group
n=1892 Participants
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Placebo Group
n=1843 Participants
Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects With Unsolicited Adverse Events for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
|
497 Participants
|
468 Participants
|
SECONDARY outcome
Timeframe: Within Days 0-29 after vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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 |
Cervarix Group
n=1131 Participants
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Placebo Group
n=1179 Participants
Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects With Unsolicited Adverse Events for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
|
295 Participants
|
307 Participants
|
SECONDARY outcome
Timeframe: Within Days 0-29 after vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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 |
Cervarix Group
n=151 Participants
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Placebo Group
n=128 Participants
Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects With Unsolicited Adverse Events for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
|
32 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: From Day 0 to Month 72Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Outcome measures
| Measure |
Cervarix Group
n=3026 Participants
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Placebo Group
n=3025 Participants
Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
56 Participants
|
81 Participants
|
SECONDARY outcome
Timeframe: From Day 0 to Month 72Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Medically significant conditions were defined as: adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.
Outcome measures
| Measure |
Cervarix Group
n=3026 Participants
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Placebo Group
n=3025 Participants
Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects With Medically Significant Conditions (MSC) Regardless of Causal Relationship to Vaccination and Intensity
|
186 Participants
|
185 Participants
|
SECONDARY outcome
Timeframe: From Day 0 to Month 72Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Medically significant conditions were defined as: adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.
Outcome measures
| Measure |
Cervarix Group
n=1892 Participants
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Placebo Group
n=1843 Participants
Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects With Medically Significant Conditions Regardless of Causal Relationship to Vaccination and Intensity for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
|
122 Participants
|
110 Participants
|
SECONDARY outcome
Timeframe: From Day 0 to Month 72Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Medically significant conditions were defined as: adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.
Outcome measures
| Measure |
Cervarix Group
n=1131 Participants
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Placebo Group
n=1179 Participants
Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects With Medically Significant Conditions Regardless of Causal Relationship to Vaccination and Intensity for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
|
64 Participants
|
75 Participants
|
SECONDARY outcome
Timeframe: From Day 0 to Month 72Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Medically significant conditions were defined as: adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.
Outcome measures
| Measure |
Cervarix Group
n=151 Participants
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Placebo Group
n=128 Participants
Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects With Medically Significant Conditions Regardless of Causal Relationship to Vaccination and Intensity for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
|
10 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: From Day 0 to Month 72Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Outcomes of pregnancies were Live infant NO apparent congenital anomaly (ACA), Live infant CA, Elective termination NO ACA, Elective termination CA, Ectopic pregnancy, Spontaneous abortion NO ACA, Stillbirth NO ACA, Stillbirth CA, Lost to follow up and Pregnancy ongoing.
Outcome measures
| Measure |
Cervarix Group
n=837 Participants
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Placebo Group
n=853 Participants
Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies
Live infant NO ACA
|
648 Participants
|
657 Participants
|
|
Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies
Live infant CA
|
5 Participants
|
0 Participants
|
|
Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies
Elective termination NO ACA
|
139 Participants
|
158 Participants
|
|
Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies
Elective termination CA
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies
Ectopic pregnancy
|
7 Participants
|
7 Participants
|
|
Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies
Spontaneous abortion NO ACA
|
16 Participants
|
13 Participants
|
|
Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies
Stillbirth NO ACA
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies
Stillbirth CA
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies
Lost to follow up
|
20 Participants
|
13 Participants
|
|
Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies
Pregnancy ongoing
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Day 0 to Month 72Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Outcomes of pregnancies were Live infant NO apparent congenital anomaly (ACA), Live infant CA, Elective termination NO ACA, Elective termination CA, Ectopic pregnancy, Spontaneous abortion NO ACA, Stillbirth NO ACA, Stillbirth CA, Lost to follow up, Pregnancy ongoing and MIssing.
Outcome measures
| Measure |
Cervarix Group
n=555 Participants
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Placebo Group
n=529 Participants
Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Live infant NO ACA
|
436 Participants
|
411 Participants
|
|
Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Live infant CA
|
5 Participants
|
0 Participants
|
|
Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Elective termination NO ACA
|
87 Participants
|
97 Participants
|
|
Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Elective termination CA
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Ectopic pregnancy
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Spontaneous abortion NO ACA
|
10 Participants
|
8 Participants
|
|
Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Spontaneous abortion CA [Month 24]
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Stillbirth NO ACA
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Stillbirth CA
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Lost to follow up
|
14 Participants
|
9 Participants
|
|
Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Pregnancy ongoing
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Missing
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Day 0 to Month 72Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Outcomes of pregnancies were Live infant NO apparent congenital anomaly (ACA), Live infant CA, Elective termination NO ACA, Elective termination CA, Ectopic pregnancy, Spontaneous abortion NO ACA, Stillbirth NO ACA, Stillbirth CA, Lost to follow up, Pregnancy ongoing and Missing.
Outcome measures
| Measure |
Cervarix Group
n=282 Participants
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Placebo Group
n=324 Participants
Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Live infant NO ACA
|
212 Participants
|
246 Participants
|
|
Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Live infant CA
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Elective termination NO ACA
|
52 Participants
|
61 Participants
|
|
Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Elective termination CA
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Ectopic pregnancy
|
5 Participants
|
4 Participants
|
|
Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Spontaneous abortion NO ACA
|
6 Participants
|
5 Participants
|
|
Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Stillbirth NO ACA
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Stillbirth CA
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Lost to follow up
|
6 Participants
|
4 Participants
|
|
Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Pregnancy ongoing
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Missing
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Day 0 to Month 72Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Outcomes of pregnancies were Live infant NO apparent congenital anomaly (ACA), Live infant CA, Elective termination NO ACA, Elective termination CA, Ectopic pregnancy, Spontaneous abortion NO ACA, Stillbirth NO ACA, Stillbirth CA, Lost to follow up and Pregnancy ongoing.
Outcome measures
| Measure |
Cervarix Group
n=40 Participants
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Placebo Group
n=39 Participants
Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Live infant NO ACA
|
29 Participants
|
26 Participants
|
|
Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Live infant CA
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Elective termination NO ACA
|
6 Participants
|
12 Participants
|
|
Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Elective termination CA
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Ectopic pregnancy
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Spontaneous abortion NO ACA
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Stillbirth NO ACA
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Stillbirth CA
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Lost to follow up
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Pregnancy ongoing
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Missing
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: at Months 0 (PRE), 7, 12, 24, 36, 48 and 72Population: The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects in the immunogenicity subset for whom data concerning immunogenicity endpoint measures were available at the specified time points.
HPV-16 assay cut-off value was defined as greater than or equal to (≥) 8 ELISA units per millilitre (EL.U/mL) at PRE vaccination, Month 7, 12 and 24 and ≥ 19 EL.U/mL at Month 36, 48 and 72. Seronegative (Sero-) subjects are subjects who had an antibody concentration below 8 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration ≥ 8 EL.U/mL prior to vaccination.
Outcome measures
| Measure |
Cervarix Group
n=236 Participants
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Placebo Group
n=220 Participants
Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status
≥8 EL.U/mL, sero- [pre-vaccination]
|
0 Participants
|
0 Participants
|
|
Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status
≥8 EL.U/mL, sero+ [pre-vaccination]
|
103 Participants
|
105 Participants
|
|
Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status
≥8 EL.U/mL, sero- [Month 7]
|
236 Participants
|
17 Participants
|
|
Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status
≥8 EL.U/mL, sero+ [Month 7]
|
103 Participants
|
97 Participants
|
|
Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status
≥8 EL.U/mL, sero-, [Month12]
|
222 Participants
|
39 Participants
|
|
Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status
≥8 EL.U/mL, sero+, [Month12]
|
99 Participants
|
93 Participants
|
|
Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status
≥8 EL.U/mL, sero-, [Month24]
|
207 Participants
|
31 Participants
|
|
Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status
≥8 EL.U/mL, sero+, [Month24]
|
94 Participants
|
85 Participants
|
|
Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status
≥19 EL.U/mL, sero-, [Month 36]
|
183 Participants
|
4 Participants
|
|
Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status
≥19 EL.U/mL, sero+, [Month 36]
|
76 Participants
|
44 Participants
|
|
Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status
≥19 EL.U/mL, sero-, [Month 48]
|
195 Participants
|
12 Participants
|
|
Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status
≥19 EL.U/mL, sero+, [Month 48]
|
83 Participants
|
48 Participants
|
|
Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status
≥19 EL.U/mL, sero-, [Month 72]
|
153 Participants
|
10 Participants
|
|
Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status
≥19 EL.U/mL, sero+, [Month 72]
|
65 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: at Months 0 (PRE), 7, 12, 24, 36, 48 and 72Population: The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects in the immunogenicity subset for whom data concerning immunogenicity endpoint measures were available at the specified time points.
HPV-18 assay cut-off value was defined as ≥ 7 EL.U/mL at PRE vaccination, Month 7, 12 and 24 and ≥ 18 EL.U/mL at Month 36, 48 and 72. Seronegative (Sero-) subjects are subjects who had an antibody concentration below 7 EL.U/mL and 18 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration ≥ 7 EL.U/mL and 18 EL.U/mL prior to vaccination.
Outcome measures
| Measure |
Cervarix Group
n=279 Participants
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Placebo Group
n=278 Participants
Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status
≥ 7 EL.U/mL, sero- PRE
|
0 Participants
|
0 Participants
|
|
Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status
≥ 7 EL.U/mL, sero+ PRE
|
60 Participants
|
47 Participants
|
|
Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status
≥ 7 EL.U/mL, sero- [Month 7]
|
278 Participants
|
14 Participants
|
|
Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status
≥ 7 EL.U/mL, sero+ [Month 7]
|
60 Participants
|
39 Participants
|
|
Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status
≥ 7 EL.U/mL, sero- [Month 12]
|
263 Participants
|
34 Participants
|
|
Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status
≥ 7 EL.U/mL, sero+ [Month 12]
|
57 Participants
|
32 Participants
|
|
Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status
≥ 7 EL.U/mL, sero- [Month 24]
|
249 Participants
|
63 Participants
|
|
Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status
≥ 7 EL.U/mL, sero+ [Month 24]
|
51 Participants
|
33 Participants
|
|
Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status
≥ 18 EL.U/mL, sero- [Month 36]
|
218 Participants
|
13 Participants
|
|
Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status
≥ 18 EL.U/mL, sero+ [Month 36]
|
41 Participants
|
22 Participants
|
|
Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status
≥ 18 EL.U/mL, sero- [Month 48]
|
231 Participants
|
14 Participants
|
|
Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status
≥ 18 EL.U/mL, sero+ [Month 48]
|
47 Participants
|
23 Participants
|
|
Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status
≥ 18 EL.U/mL, sero- [Month 72]
|
183 Participants
|
14 Participants
|
|
Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status
≥ 18 EL.U/mL, sero+ [Month 72]
|
37 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: at Months 0 (PRE), 7, 12, 24, 36, 48 and 72Population: The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects in the immunogenicity subset for whom data concerning immunogenicity endpoint measures were available at the specified time points.
Titers were expressed as geometric mean titers calculated on all subjects, HPV-16 assay cut-off value was defined as greater than or equal to 8 EL.U/mL at Months 0, 7, 12 and 24 and greater than or equal to 19 EL.U/mL at Months 36, 48 and 72. HPV-18 assay cut-off value was defined as ≥ 7 EL.U/mL at Month 0, 7, 12 and 24 and ≥ 18 EL.U/mL at Months 36, 48 and 72. Seronegative (Sero-) subjects are subjects who had an antibody concentration below the assay cut-off value prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration ≥ the assay cut-off value prior to vaccination.
Outcome measures
| Measure |
Cervarix Group
n=279 Participants
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Placebo Group
n=362 Participants
Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status
HPV-16, sero- [pre-vaccination]
|
4.0 Titers
Interval 4.0 to 4.0
|
4.0 Titers
Interval 4.0 to 4.0
|
|
Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status
HPV-16, sero- [Month 7]
|
6964.3 Titers
Interval 6164.3 to 7868.2
|
4.6 Titers
Interval 4.2 to 5.1
|
|
Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status
HPV-16, sero-, [Month 12]
|
3451.3 Titers
Interval 3055.5 to 3898.4
|
5.0 Titers
Interval 4.7 to 5.4
|
|
Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status
HPV-16, sero-, [Month 24]
|
1253.2 Titers
Interval 1120.6 to 1401.5
|
4.7 Titers
Interval 4.5 to 5.0
|
|
Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status
HPV-16, sero-, [Month 36]
|
1074.6 Titers
Interval 958.0 to 1205.4
|
9.8 Titers
Interval 9.5 to 10.1
|
|
Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status
HPV-16, sero-, [Month 48]
|
828.4 Titers
Interval 728.4 to 942.2
|
10.7 Titers
Interval 9.9 to 11.5
|
|
Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status
HPV-16, sero-, [Month 72]
|
678.1 Titers
Interval 552.9 to 831.5
|
10.5 Titers
Interval 9.7 to 11.4
|
|
Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status
HPV-16, sero+ [pre-vaccination]
|
27.4 Titers
Interval 22.7 to 33.0
|
25.2 Titers
Interval 21.1 to 30.1
|
|
Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status
HPV-16, sero+ [Month 7]
|
5672.0 Titers
Interval 4661.9 to 6900.9
|
25.6 Titers
Interval 20.6 to 31.9
|
|
Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status
HPV-16, sero+, [Month 12]
|
3219.8 Titers
Interval 2593.3 to 3997.7
|
28.5 Titers
Interval 23.2 to 35.1
|
|
Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status
HPV-16, sero+, [Month 24]
|
1317.7 Titers
Interval 1094.4 to 1586.5
|
19.7 Titers
Interval 16.1 to 24.1
|
|
Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status
HPV-16, sero+, [Month 36]
|
1290.3 Titers
Interval 1071.7 to 1553.5
|
24.6 Titers
Interval 19.4 to 31.2
|
|
Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status
HPV-16, sero+, [Month 48]
|
1006.0 Titers
Interval 817.9 to 1237.2
|
25.1 Titers
Interval 20.1 to 31.4
|
|
Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status
HPV-16, sero+, [Month 72]
|
724.4 Titers
Interval 503.1 to 1043.0
|
17.3 Titers
Interval 13.5 to 22.3
|
|
Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status
HPV-18, sero- [pre-vaccination]
|
3.5 Titers
Interval 3.5 to 3.5
|
3.5 Titers
Interval 3.5 to 3.5
|
|
Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status
HPV-18, sero-, [Month 24]
|
711.7 Titers
Interval 629.6 to 804.6
|
5.0 Titers
Interval 4.6 to 5.4
|
|
Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status
HPV-18, sero- [Month 7]
|
3357.4 Titers
Interval 2974.7 to 3789.4
|
3.9 Titers
Interval 3.6 to 4.2
|
|
Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status
HPV-18, sero-, [Month 12]
|
1318.9 Titers
Interval 1166.2 to 1491.4
|
4.2 Titers
Interval 4.0 to 4.5
|
|
Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status
HPV-18, sero-, [Month 36]
|
525.1 Titers
Interval 467.2 to 590.3
|
9.7 Titers
Interval 9.3 to 10.1
|
|
Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status
HPV-18, sero-, [Month 48]
|
387.7 Titers
Interval 342.6 to 438.8
|
9.8 Titers
Interval 9.3 to 10.3
|
|
Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status
HPV-18, sero-, [Month 72]
|
343.7 Titers
Interval 291.9 to 404.8
|
10.1 Titers
Interval 9.4 to 11.0
|
|
Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status
HPV-18, sero+ [pre-vaccination]
|
19.9 Titers
Interval 16.4 to 24.1
|
25.8 Titers
Interval 19.5 to 34.1
|
|
Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status
HPV-18, sero+ [Month 7]
|
3200.2 Titers
Interval 2690.8 to 3806.1
|
24.2 Titers
Interval 15.8 to 36.9
|
|
Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status
HPV-18, sero+, [Month 12]
|
1152.9 Titers
Interval 932.3 to 1425.6
|
20.2 Titers
Interval 13.7 to 30.0
|
|
Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status
HPV-18, sero+, [Month 24]
|
831.6 Titers
Interval 659.5 to 1048.7
|
21.9 Titers
Interval 15.1 to 31.8
|
|
Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status
HPV-18, sero+, [Month 36]
|
601.8 Titers
Interval 465.4 to 778.0
|
33.4 Titers
Interval 22.4 to 49.8
|
|
Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status
HPV-18, sero+, [Month 48]
|
523.0 Titers
Interval 403.8 to 677.5
|
25.5 Titers
Interval 18.3 to 35.4
|
|
Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status
HPV-18, sero+, [Month 72]
|
420.0 Titers
Interval 278.9 to 632.4
|
28.3 Titers
Interval 19.0 to 42.1
|
Adverse Events
Cervarix Group
Serious events: 56 serious events
Other events: 2786 other events
Deaths: 0 deaths
Placebo Group
Serious events: 81 serious events
Other events: 2548 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Cervarix Group
n=3026 participants at risk
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Placebo Group
n=3025 participants at risk
Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Infections and infestations
Appendicitis
|
0.13%
4/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.40%
12/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
General disorders
Ectopic pregnancy
|
0.20%
6/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.20%
6/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion missed
|
0.17%
5/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.10%
3/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.17%
5/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.10%
3/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Reproductive system and breast disorders
Breast cyst
|
0.03%
1/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.03%
1/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
General disorders
Ectopic pregnancy with intrauterine device
|
0.03%
1/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.03%
1/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.03%
1/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.03%
1/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Reproductive system and breast disorders
Ovarian cyst torsion
|
0.03%
1/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.03%
1/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.03%
1/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous complete
|
0.07%
2/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.17%
5/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Pregnancy, puerperium and perinatal conditions
Premature baby
|
0.03%
1/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.17%
5/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Surgical and medical procedures
Abortion induced
|
0.03%
1/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.07%
2/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.00%
0/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.10%
3/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.03%
1/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.07%
2/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.07%
2/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.03%
1/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Pregnancy, puerperium and perinatal conditions
Umbilical cord around neck
|
0.03%
1/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.07%
2/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Gastrointestinal disorders
Cholelithiasis
|
0.00%
0/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.07%
2/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Infections and infestations
Chronic tonsillitis
|
0.00%
0/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.07%
2/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Congenital, familial and genetic disorders
Cleft lip and palate
|
0.07%
2/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.00%
0/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.07%
2/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.07%
2/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Congenital, familial and genetic disorders
Congenital torticollis
|
0.07%
2/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.00%
0/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Pregnancy, puerperium and perinatal conditions
Foetal death
|
0.03%
1/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.03%
1/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.03%
1/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.03%
1/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Pregnancy, puerperium and perinatal conditions
Low birth weight baby
|
0.03%
1/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.03%
1/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Infections and infestations
Neonatal pneumonia
|
0.03%
1/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.03%
1/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory distress syndrome
|
0.03%
1/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.03%
1/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.03%
1/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.03%
1/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Pregnancy, puerperium and perinatal conditions
Premature separation of placenta
|
0.07%
2/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.00%
0/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Pregnancy, puerperium and perinatal conditions
Stillbirth
|
0.00%
0/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.07%
2/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Teratoma
|
0.03%
1/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.03%
1/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Injury, poisoning and procedural complications
Abdominal injury
|
0.03%
1/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.00%
0/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion
|
0.00%
0/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.03%
1/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous incomplete
|
0.00%
0/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.03%
1/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion threatened
|
0.03%
1/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.00%
0/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoma benign
|
0.00%
0/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.03%
1/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Surgical and medical procedures
Amputation
|
0.03%
1/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.00%
0/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.03%
1/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.00%
0/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.03%
1/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Angiomyolipoma
|
0.00%
0/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.03%
1/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.03%
1/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.03%
1/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.00%
0/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.03%
1/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.00%
0/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign gastric neoplasm
|
0.00%
0/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.03%
1/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Pregnancy, puerperium and perinatal conditions
Blighted ovum
|
0.03%
1/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.00%
0/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.03%
1/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.00%
0/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast fibroma
|
0.00%
0/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.03%
1/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.03%
1/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.03%
1/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Congenital, familial and genetic disorders
Chondrodystrophy
|
0.03%
1/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.00%
0/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.03%
1/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.00%
0/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
General disorders
Cyst
|
0.00%
0/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.03%
1/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Gastrointestinal disorders
Diaphragmatic hernia
|
0.00%
0/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.03%
1/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.03%
1/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.03%
1/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Pregnancy, puerperium and perinatal conditions
Foetal distress syndrome
|
0.03%
1/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.00%
0/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric neoplasm
|
0.00%
0/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.03%
1/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.03%
1/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.03%
1/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Pregnancy, puerperium and perinatal conditions
Gestational diabetes
|
0.00%
0/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.03%
1/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Pregnancy, puerperium and perinatal conditions
Gestational hypertension
|
0.00%
0/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.03%
1/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.03%
1/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.00%
0/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.03%
1/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Blood and lymphatic system disorders
Hypersplenism
|
0.00%
0/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.03%
1/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Renal and urinary disorders
IgA nephropathy
|
0.03%
1/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.00%
0/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Pregnancy, puerperium and perinatal conditions
Imminent abortion
|
0.03%
1/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.00%
0/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.03%
1/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.00%
0/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Injury, poisoning and procedural complications
Iris injury
|
0.03%
1/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.00%
0/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.03%
1/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.00%
0/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.03%
1/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.00%
0/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.03%
1/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.00%
0/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.03%
1/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Reproductive system and breast disorders
Pelvic adhesions
|
0.03%
1/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.00%
0/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Infections and infestations
Pelvic infection
|
0.00%
0/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.03%
1/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.03%
1/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.00%
0/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour
|
0.03%
1/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.00%
0/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Pregnancy, puerperium and perinatal conditions
Placental insufficiency
|
0.03%
1/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.00%
0/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.03%
1/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.00%
0/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia
|
0.00%
0/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.03%
1/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Congenital, familial and genetic disorders
Pulmonary hypoplasia
|
0.00%
0/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.03%
1/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Renal and urinary disorders
Renal disorder
|
0.00%
0/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.03%
1/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.03%
1/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.03%
1/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.03%
1/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.00%
0/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.03%
1/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.00%
0/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.03%
1/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.00%
0/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Congenital, familial and genetic disorders
Trisomy 21
|
0.00%
0/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.03%
1/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Renal and urinary disorders
Urethral cyst
|
0.00%
0/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.03%
1/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Reproductive system and breast disorders
Uterine cyst
|
0.00%
0/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.03%
1/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.03%
1/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.00%
0/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Vascular disorders
Vascular rupture
|
0.00%
0/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.03%
1/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Injury, poisoning and procedural complications
Wound
|
0.03%
1/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
0.00%
0/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
Other adverse events
| Measure |
Cervarix Group
n=3026 participants at risk
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Placebo Group
n=3025 participants at risk
Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
9.1%
276/3026 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
9.6%
290/3025 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
General disorders
Pain
|
87.7%
2634/3005 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
72.2%
2166/3001 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
27.9%
838/3005 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
17.2%
517/3001 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
General disorders
Swelling
|
28.4%
853/3005 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
13.6%
408/3001 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.0%
270/3005 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
7.1%
213/3001 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
General disorders
Fatigue
|
38.0%
1142/3005 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
33.9%
1018/3001 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Gastrointestinal disorders
Gastrointestinal
|
13.6%
409/3005 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
15.8%
473/3001 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Nervous system disorders
Headache
|
23.0%
691/3005 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
23.0%
690/3001 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
17.4%
523/3005 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
12.0%
360/3001 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
|
General disorders
Pyrexia
|
24.9%
749/3005 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
23.4%
703/3001 • SAEs: up to Month 72. Unsolicited AEs: Within Days 0-29 after vaccination. Solicited local and general symptoms: Within 7 days (Days 0-6) after vaccination
Safety data presented here were assessed for all vaccinated subjects for whom data were available at the time of the event-triggered analysis irrespective of the initial (Month 0) HPV-16 or HPV-18 serostatus and DNA status.
|
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