Trial Outcomes & Findings for Study to Evaluate the Efficacy of the Human Papillomavirus Vaccine in Healthy Adult Women of 26 Years of Age and Older (NCT NCT00294047)
NCT ID: NCT00294047
Last Updated: 2020-01-02
Results Overview
CIN1+ = CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Persistent HPV infection = detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. * DNA- and sero-/+: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and 6 and seronegative/positive (sero-/+) at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) * Overall: subjects DNA- at Month 0 and 6 for the corresponding HPV-type, regardless of initial serostatus
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
5752 participants
Primary outcome timeframe
Up to Month 48
Results posted on
2020-01-02
Participant Flow
Some subjects completed the study at Months 36 and 48 as they did not want to participate to the extensions up to Month 84, but they were included in the safety analysis for these subsequent timepoints.
Enrolment was stratified by (1) age, with the majority of subjects in age strata 26 - 35 years and 36 - 45 years (about 45% each) and about 10% in the age stratum 46+ years, and (2) previous HPV history (in each age stratum, the number of women with a history of HPV infection/treatment was limited to approximately 15%).
Participant milestones
| Measure |
Cervarix Group
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|---|---|---|
|
Month 48
STARTED
|
2881
|
2871
|
|
Month 48
Participated up to Month 48
|
2305
|
2281
|
|
Month 48
COMPLETED
|
2456
|
2438
|
|
Month 48
NOT COMPLETED
|
425
|
433
|
|
Month 84
STARTED
|
2877
|
2870
|
|
Month 84
COMPLETED
|
1904
|
1881
|
|
Month 84
NOT COMPLETED
|
973
|
989
|
Reasons for withdrawal
| Measure |
Cervarix Group
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|---|---|---|
|
Month 48
Adverse Event
|
28
|
13
|
|
Month 48
Protocol Violation
|
4
|
4
|
|
Month 48
Withdrawal by Subject
|
111
|
115
|
|
Month 48
Lost to Follow-up
|
272
|
287
|
|
Month 48
Other
|
10
|
14
|
|
Month 84
Adverse Event
|
4
|
2
|
|
Month 84
Protocol Violation
|
1
|
1
|
|
Month 84
Withdrawal by Subject
|
33
|
31
|
|
Month 84
Lost to Follow-up
|
187
|
190
|
|
Month 84
Absent Cervix
|
2
|
0
|
|
Month 84
Work related reasons
|
4
|
2
|
|
Month 84
Center closed, subject did not transfer
|
1
|
0
|
|
Month 84
Family problems
|
2
|
2
|
|
Month 84
Lack of time
|
3
|
1
|
|
Month 84
Personal reason
|
2
|
4
|
|
Month 84
Subject does not want male physician
|
1
|
0
|
|
Month 84
Transport reimbursement delayed
|
0
|
1
|
|
Month 84
Unable to reach study site
|
1
|
0
|
|
Month 84
Under investigation locally
|
1
|
0
|
|
Month 84
Visit missed
|
0
|
1
|
|
Month 84
No consent for Month 84 Follow-up
|
731
|
754
|
Baseline Characteristics
Study to Evaluate the Efficacy of the Human Papillomavirus Vaccine in Healthy Adult Women of 26 Years of Age and Older
Baseline characteristics by cohort
| Measure |
Cervarix Group
n=2881 Participants
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
n=2871 Participants
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Total
n=5752 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.0 Years
STANDARD_DEVIATION 7.24 • n=5 Participants
|
37.0 Years
STANDARD_DEVIATION 7.32 • n=7 Participants
|
37.0 Years
STANDARD_DEVIATION 7.28 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2881 Participants
n=5 Participants
|
2871 Participants
n=7 Participants
|
5752 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Month 48Population: The According-To-Protocol cohort for efficacy included subjects 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, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
CIN1+ = CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Persistent HPV infection = detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. * DNA- and sero-/+: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and 6 and seronegative/positive (sero-/+) at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) * Overall: subjects DNA- at Month 0 and 6 for the corresponding HPV-type, regardless of initial serostatus
Outcome measures
| Measure |
Cervarix Group
n=2224 Participants
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
n=2190 Participants
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|---|---|---|
|
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection.
HPV-16/18, DNA- and sero- subjects
|
7 Participants
|
36 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection.
HPV-16, DNA- and sero- subjects
|
5 Participants
|
27 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection.
HPV-18, DNA- and sero- subjects
|
2 Participants
|
10 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection.
HPV-16/18, DNA- and sero+ subjects
|
2 Participants
|
14 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection.
HPV-16, DNA- and sero+ subjects
|
1 Participants
|
9 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection.
HPV-18, DNA- and sero+ subjects
|
1 Participants
|
5 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection.
HPV-16/18, overall
|
9 Participants
|
51 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection.
HPV-16, overall
|
6 Participants
|
36 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection.
HPV-18, overall
|
3 Participants
|
16 Participants
|
PRIMARY outcome
Timeframe: Up to Month 48Population: The According-To-Protocol cohort for efficacy included subjects 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, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
CIN1+ = CIN grades 1, 2 and 3, AIS and invasive cervical cancer. Persistent cervical HPV infection (6-month definition) = detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. * DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0). * Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.
Outcome measures
| Measure |
Cervarix Group
n=2224 Participants
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
n=2190 Participants
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|---|---|---|
|
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).
HPV-16/18, DNA- and sero- subjects
|
7 Participants
|
36 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).
HPV-16, DNA- and sero- subjects
|
5 Participants
|
27 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).
HPV-18, DNA- and sero- subjects
|
2 Participants
|
10 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).
HPV-16/18, DNA- and sero+ subjects
|
2 Participants
|
12 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).
HPV-16, DNA- and sero+ subjects
|
1 Participants
|
8 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).
HPV-18, DNA- and sero+ subjects
|
1 Participants
|
4 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).
HPV-16/18, overall
|
9 Participants
|
49 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).
HPV-16, overall
|
6 Participants
|
35 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).
HPV-18, overall
|
3 Participants
|
15 Participants
|
PRIMARY outcome
Timeframe: Up to Month 84Population: The According-To-Protocol cohort for efficacy included subjects 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, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
CIN1+ = CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Persistent HPV infection = detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. - DNA- and sero-/+: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and 6 and seronegative/positive (sero-/+) at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) - Overall: subjects DNA- at Month 0 and 6 for the corresponding HPV-type, regardless of initial serostatus
Outcome measures
| Measure |
Cervarix Group
n=2168 Participants
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
n=2147 Participants
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|---|---|---|
|
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection.
HPV-16/18, DNA- and sero- subjects
|
7 Participants
|
71 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection.
HPV-16, DNA- and sero- subjects
|
5 Participants
|
53 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection.
HPV-18, DNA- and sero- subjects
|
3 Participants
|
20 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection.
HPV-16/18, DNA- and sero+ subjects
|
3 Participants
|
16 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection.
HPV-16, DNA- and sero+ subjects
|
2 Participants
|
10 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection.
HPV-18, DNA- and sero+ subjects
|
1 Participants
|
6 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection.
HPV-16/18, overall
|
10 Participants
|
90 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection.
HPV-16, overall
|
7 Participants
|
63 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection.
HPV-18, overall
|
4 Participants
|
29 Participants
|
PRIMARY outcome
Timeframe: Up to Month 84Population: The According-To-Protocol cohort for efficacy included subjects 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, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
CIN1+ = CIN grades 1, 2 and 3, AIS and invasive cervical cancer. Persistent cervical HPV infection (6-month definition) = detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. - DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.
Outcome measures
| Measure |
Cervarix Group
n=2168 Participants
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
n=2147 Participants
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|---|---|---|
|
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).
HPV-16/18, DNA- and sero- subjects
|
7 Participants
|
71 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).
HPV-16, DNA- and sero- subjects
|
5 Participants
|
53 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).
HPV-18, DNA- and sero- subjects
|
2 Participants
|
20 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).
HPV-16/18, DNA- and sero+ subjects
|
3 Participants
|
14 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).
HPV-16, DNA- and sero+ subjects
|
2 Participants
|
9 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).
HPV-18, DNA- and sero+ subjects
|
1 Participants
|
5 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).
HPV-16/18, overall
|
10 Participants
|
88 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).
HPV-16, overall
|
7 Participants
|
62 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).
HPV-18, overall
|
3 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: Up to Month 48Population: The According-To-Protocol cohort for efficacy included subjects 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, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Detection was done in: * DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0). * Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.
Outcome measures
| Measure |
Cervarix Group
n=2178 Participants
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
n=2152 Participants
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|---|---|---|
|
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
HPV-16/18, DNA- and sero- subjects
|
6 Participants
|
34 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
HPV-16, DNA- and sero- subjects
|
5 Participants
|
26 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
HPV-18, DNA- and sero- subjects
|
1 Participants
|
8 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
HPV-16/18, DNA- and sero+ subjects
|
2 Participants
|
11 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
HPV-16, DNA- and sero+ subjects
|
1 Participants
|
8 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
HPV-18, DNA- and sero+ subjects
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
HPV-16/18, overall
|
8 Participants
|
45 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
HPV-16, overall
|
6 Participants
|
34 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
HPV-18, overall
|
2 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Up to Month 48Population: The According-To-Protocol cohort for efficacy included subjects 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, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
Persistent cervical HPV infection (12-month definition) was defined as the detection of the same HPV type(s) PCR in cervical samples at all available time points over approximately a 12-month interval (evaluations are planned at approximately 6-month intervals). * DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0). * Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.
Outcome measures
| Measure |
Cervarix Group
n=2146 Participants
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
n=2124 Participants
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|---|---|---|
|
Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
HPV-16/18, DNA- and sero- subjects
|
2 Participants
|
18 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
HPV-16, DNA- and sero- subjects
|
1 Participants
|
12 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
HPV-18, DNA- and sero- subjects
|
1 Participants
|
6 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
HPV-16/18, DNA- and sero+ subjects
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
HPV-16, DNA- and sero+ subjects
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
HPV-18, DNA- and sero+ subjects
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
HPV-16/18, overall
|
2 Participants
|
21 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
HPV-16, overall
|
1 Participants
|
14 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
HPV-18, overall
|
1 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Up to Month 48Population: The According-To-Protocol cohort for efficacy included subjects 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, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
Persistent cervical HPV infection (6-month definition) = detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Detection was done in subjects HPV DNA- for the corresponding HPV type at baseline (at month 0 and Month 6) regardless of initial serostatus. HPV-HRW=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18. HPV-HR=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=2179 Participants
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
n=2154 Participants
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|---|---|---|
|
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-16
|
6 Participants
|
34 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-18
|
2 Participants
|
11 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-31
|
4 Participants
|
19 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-33
|
8 Participants
|
6 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-35
|
8 Participants
|
13 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-39
|
20 Participants
|
11 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-45
|
4 Participants
|
17 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-51
|
27 Participants
|
26 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-52
|
33 Participants
|
38 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-56
|
16 Participants
|
20 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-58
|
12 Participants
|
8 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-59
|
12 Participants
|
11 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-66
|
27 Participants
|
27 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-68
|
15 Participants
|
23 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-31/45
|
8 Participants
|
35 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-31/45/33/52/58
|
58 Participants
|
83 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-39/45/59/68
|
50 Participants
|
60 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-31/33/35/52/58
|
63 Participants
|
80 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-31/45/33/52/58/35/39/51/56/59
|
132 Participants
|
146 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-HRW
|
163 Participants
|
185 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-HR
|
170 Participants
|
217 Participants
|
SECONDARY outcome
Timeframe: Up to Month 48Population: The According-To-Protocol cohort for efficacy included subjects 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, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
Persistent HPV infection (12-month definition) = detection of the same HPV type(s) by PCR in cervical samples at available time points over approximately a 12-month interval (evaluations are planned at approximately 6-month intervals). Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. subjects HPV DNA- for the corresponding HPV type at Month 0 6, regardless of initial serostatus. HPV-HRW=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HPV-HR=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 , 68
Outcome measures
| Measure |
Cervarix Group
n=2147 Participants
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
n=2126 Participants
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|---|---|---|
|
Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-16
|
1 Participants
|
14 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-18
|
1 Participants
|
7 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-31
|
2 Participants
|
10 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-33
|
5 Participants
|
5 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-35
|
3 Participants
|
8 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-39
|
12 Participants
|
5 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-45
|
4 Participants
|
8 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-51
|
11 Participants
|
14 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-52
|
21 Participants
|
23 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-56
|
4 Participants
|
8 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-58
|
8 Participants
|
7 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-59
|
4 Participants
|
3 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-66
|
10 Participants
|
8 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-68
|
7 Participants
|
13 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-31/45
|
6 Participants
|
17 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-31/45/33/52/58
|
39 Participants
|
49 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-39/45/59/68
|
27 Participants
|
29 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-31/33/35/52/58
|
38 Participants
|
51 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-31/45/33/52/58/35/39/51/56/59
|
70 Participants
|
84 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-HRW
|
86 Participants
|
105 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-HR
|
88 Participants
|
122 Participants
|
SECONDARY outcome
Timeframe: Up to Month 48Population: The According-To-Protocol cohort for efficacy included subjects 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, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
CIN2+ was defined as CIN grades 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done in: * DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0). * Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline. Note: Results for seropositive status were not analysed.
Outcome measures
| Measure |
Cervarix Group
n=2224 Participants
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
n=2190 Participants
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|---|---|---|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-16/18, DNA- and sero- subjects
|
0 Participants
|
4 Participants
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-16, DNA- and sero- subjects
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-18, DNA- and sero- subjects
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-16/18, overall
|
0 Participants
|
6 Participants
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-16, overall
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-18, overall
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to Month 48Population: The According-To-Protocol cohort for efficacy included subjects 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, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done in: * DNA- and sero-/+: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0). * Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.
Outcome measures
| Measure |
Cervarix Group
n=2224 Participants
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
n=2190 Participants
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|---|---|---|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-16/18, DNA- and sero- subjects
|
1 Participants
|
7 Participants
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-16, DNA- and sero- subjects
|
0 Participants
|
5 Participants
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-18, DNA- and sero- subjects
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-16/18, DNA- and sero+ subjects
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-16, DNA- and sero+ subjects
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-18, DNA- and sero+ subjects
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-16/18, overall
|
1 Participants
|
11 Participants
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-16, overall
|
0 Participants
|
6 Participants
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-18, overall
|
1 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to Month 48Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus.
Outcome measures
| Measure |
Cervarix Group
n=2740 Participants
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
n=2737 Participants
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|---|---|---|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-16/18
|
35 Participants
|
56 Participants
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-16
|
24 Participants
|
42 Participants
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-18
|
13 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Up to Month 48Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done on all subjects irrespective of their baseline HPV DNA status.
Outcome measures
| Measure |
Cervarix Group
n=2740 Participants
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
n=2737 Participants
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|---|---|---|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Irrespective of HPV Cervical Infection and Irrespective of Baseline HPV DNA Status
|
152 Participants
|
178 Participants
|
SECONDARY outcome
Timeframe: Up to Month 48Population: The According-To-Protocol cohort for efficacy included subjects 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, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US). Detection was done in: * DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0). * Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline. Results for seropositive status were not analysed.
Outcome measures
| Measure |
Cervarix Group
n=2224 Participants
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
n=2190 Participants
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|---|---|---|
|
Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection
HPV-16/18, DNA- and sero- subjects
|
2 Participants
|
31 Participants
|
|
Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection
HPV-16, DNA- and sero- subjects
|
2 Participants
|
24 Participants
|
|
Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection
HPV-18, DNA- and sero- subjects
|
0 Participants
|
8 Participants
|
|
Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection
HPV-16/18, overall
|
5 Participants
|
38 Participants
|
|
Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection
HPV-16
|
4 Participants
|
27 Participants
|
|
Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection
HPV-18
|
1 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Up to Month 48Population: The According-To-Protocol cohort for efficacy included subjects 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, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Detection was done in subjects who were HPV DNA negative for the corresponding HPV type at baseline (at month 0 and Month 6) regardless of initial serostatus. HRW-HPV= All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HPV-HR= 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=2225 Participants
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
n=2192 Participants
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|---|---|---|
|
Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations
HPV-16
|
4 Participants
|
27 Participants
|
|
Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations
HPV-18
|
1 Participants
|
12 Participants
|
|
Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations
HPV-31
|
4 Participants
|
12 Participants
|
|
Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations
HPV-33
|
4 Participants
|
4 Participants
|
|
Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations
HPV-35
|
4 Participants
|
10 Participants
|
|
Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations
HPV-39
|
10 Participants
|
11 Participants
|
|
Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations
HPV-45
|
3 Participants
|
17 Participants
|
|
Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations
HPV-51
|
21 Participants
|
18 Participants
|
|
Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations
HPV-52
|
19 Participants
|
19 Participants
|
|
Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations
HPV-56
|
9 Participants
|
19 Participants
|
|
Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations
HPV-58
|
12 Participants
|
6 Participants
|
|
Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations
HPV-59
|
4 Participants
|
15 Participants
|
|
Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations
HPV-66
|
13 Participants
|
26 Participants
|
|
Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations
HPV-68
|
8 Participants
|
8 Participants
|
|
Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations
HPV-31/45
|
7 Participants
|
28 Participants
|
|
Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations
HPV-31/45/33/52/58
|
40 Participants
|
54 Participants
|
|
Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations
HPV-39/45/59/68
|
24 Participants
|
48 Participants
|
|
Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations
HPV-31/33/35/52/58
|
41 Participants
|
49 Participants
|
|
Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations
HPV-31/45/33/52/58/35/39/51/56/59
|
79 Participants
|
107 Participants
|
|
Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations
HPV-HRW
|
94 Participants
|
126 Participants
|
|
Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations
HPV-HR
|
96 Participants
|
148 Participants
|
SECONDARY outcome
Timeframe: Up to Month 48Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
Detection was done on all subjects irrespective of their baseline HPV DNA status.
Outcome measures
| Measure |
Cervarix Group
n=2740 Participants
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
n=2737 Participants
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|---|---|---|
|
Number of Subjects With Histopathologically Confirmed Reduction of Local Cervical Therapy
|
76 Participants
|
84 Participants
|
SECONDARY outcome
Timeframe: Up to Month 48Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
Detection was done on all subjects irrespective of their baseline HPV DNA status.
Outcome measures
| Measure |
Cervarix Group
n=2741 Participants
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
n=2738 Participants
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|---|---|---|
|
Number of Subjects With First Colposcopy
|
392 Participants
|
422 Participants
|
SECONDARY outcome
Timeframe: Up to Month 48Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus.
Outcome measures
| Measure |
Cervarix Group
n=2772 Participants
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
n=2779 Participants
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|---|---|---|
|
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection
HPV-16/18
|
90 Participants
|
158 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection
HPV-16
|
64 Participants
|
118 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection
HPV-18
|
30 Participants
|
52 Participants
|
SECONDARY outcome
Timeframe: Up to Month 48Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus. The lesion was assigned to an HPV type found in the lesion if (1) the same HPV type was found in at least 1 of the 2 (closest) preceding cytology samples, or (2) none of the HPV types found in the lesion were found in any of the 2 preceding cytology samples (isolate HPV types)
Outcome measures
| Measure |
Cervarix Group
n=2772 Participants
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
n=2779 Participants
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|---|---|---|
|
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).
HPV-16/18
|
89 Participants
|
155 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).
HPV-16
|
63 Participants
|
117 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).
HPV-18
|
29 Participants
|
49 Participants
|
SECONDARY outcome
Timeframe: At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84Population: The According-To-Protocol cohort for immunogenicity included subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. The 15% subset of women enrolled with prior history of HPV disease/infection was included.
Seroconversion was defined as the appearance of antibodies (i.e.; titre greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. HPV-16 assay cut-off value was defined as greater than or equal to 8 ELISA units per millilitre (EL.U/mL). 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 equal to or above 8 EL.U/mL prior to vaccination. Immuno subset=subjects from selected sites N≥1000, at least 250 per region
Outcome measures
| Measure |
Cervarix Group
n=406 Participants
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
n=374 Participants
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|---|---|---|
|
Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset.
Sero+ at Month 60
|
99 Participants
|
79 Participants
|
|
Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset.
Sero+ at Month 72
|
99 Participants
|
57 Participants
|
|
Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset.
Sero+ at Month 84
|
95 Participants
|
51 Participants
|
|
Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset.
Sero- before vaccination
|
0 Participants
|
0 Participants
|
|
Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset.
Sero- at Month 7
|
406 Participants
|
13 Participants
|
|
Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset.
Sero- at Month 12
|
384 Participants
|
28 Participants
|
|
Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset.
Sero- at Month 18
|
377 Participants
|
9 Participants
|
|
Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset.
Sero- at Month 24
|
392 Participants
|
11 Participants
|
|
Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset.
Sero- at Month 36
|
361 Participants
|
23 Participants
|
|
Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset.
Sero- at Month 48
|
345 Participants
|
31 Participants
|
|
Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset.
Sero- at Month 60
|
275 Participants
|
11 Participants
|
|
Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset.
Sero- at Month 72
|
276 Participants
|
5 Participants
|
|
Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset.
Sero- at Month 84
|
273 Participants
|
2 Participants
|
|
Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset.
Sero+ before vaccination
|
170 Participants
|
179 Participants
|
|
Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset.
Sero+ at Month 7
|
170 Participants
|
166 Participants
|
|
Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset.
Sero+ at Month 12
|
154 Participants
|
151 Participants
|
|
Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset.
Sero+ at Month 24
|
158 Participants
|
144 Participants
|
|
Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset.
Sero+ at Month 18
|
147 Participants
|
136 Participants
|
|
Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset.
Sero+ at Month 36
|
137 Participants
|
131 Participants
|
|
Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset.
Sero+ at Month 48
|
132 Participants
|
135 Participants
|
SECONDARY outcome
Timeframe: At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84Population: The According-To-Protocol cohort for immunogenicity included subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. The 15% subset of women enrolled with prior history of HPV disease/infection was included.
Seroconversion was defined as the appearance of antibodies (i.e.; titre greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. HPV-18 assay cut-off value was defined as greater than or equal to 7 ELISA units per millilitre (EL.U/mL). Seronegative (Sero-) subjects are subjects who had an antibody concentration below 7 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 7 EL.U/mL prior to vaccination. Immuno subset=subjects from selected sites N≥1000, at least 250 per region
Outcome measures
| Measure |
Cervarix Group
n=405 Participants
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
n=379 Participants
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|---|---|---|
|
Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset.
Sero+ at Month 60
|
101 Participants
|
58 Participants
|
|
Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset.
Sero- before vaccination
|
0 Participants
|
0 Participants
|
|
Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset.
Sero- at Month 7
|
405 Participants
|
12 Participants
|
|
Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset.
Sero- at Month 12
|
375 Participants
|
16 Participants
|
|
Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset.
Sero- at Month 18
|
366 Participants
|
12 Participants
|
|
Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset.
Sero- at Month 24
|
387 Participants
|
14 Participants
|
|
Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset.
Sero- at Month 36
|
346 Participants
|
14 Participants
|
|
Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset.
Sero- at Month 48
|
336 Participants
|
16 Participants
|
|
Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset.
Sero- at Month 60
|
266 Participants
|
11 Participants
|
|
Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset.
Sero- at Month 72
|
261 Participants
|
3 Participants
|
|
Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset.
Sero- at month 84
|
257 Participants
|
3 Participants
|
|
Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset.
Sero+ before vaccination
|
163 Participants
|
164 Participants
|
|
Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset.
Sero+ at Month 7
|
163 Participants
|
146 Participants
|
|
Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset.
Sero+ at Month 12
|
154 Participants
|
133 Participants
|
|
Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset.
Sero+ at Month 18
|
149 Participants
|
118 Participants
|
|
Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset.
Sero+ at Month 24
|
153 Participants
|
114 Participants
|
|
Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset.
Sero+ at Month 36
|
142 Participants
|
92 Participants
|
|
Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset.
Sero+ at Month 48
|
133 Participants
|
94 Participants
|
|
Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset.
Sero+ at Month 72
|
103 Participants
|
32 Participants
|
|
Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset.
Sero+ at Month 84
|
98 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84Population: The According-To-Protocol cohort for immunogenicity included subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. The 15% subset of women enrolled with prior history of HPV disease/infection was included.
GMCs were expressed in ELISA units per milliliter (EL.U/mL). 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 equal to or above 8 EL.U/mL prior to vaccination. Immuno subset=subjects from selected sites (N≥1000, at least 250 per region)
Outcome measures
| Measure |
Cervarix Group
n=406 Participants
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
n=374 Participants
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|---|---|---|
|
Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset.
Sero- at Month 24
|
827.8 EL.U/mL
Interval 745.2 to 919.5
|
4.2 EL.U/mL
Interval 4.1 to 4.4
|
|
Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset.
Sero-before vaccination
|
NA EL.U/mL
Not calculable as no subject had HPV-16 antibody concentration equal to or above the assay cut-off value.
|
NA EL.U/mL
Not calculable as no subject had HPV-16 antibody concentration equal to or above the assay cut-off value.
|
|
Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset.
Sero- at Month 7
|
5412.9 EL.U/mL
Interval 4934.3 to 5938.0
|
4.3 EL.U/mL
Interval 4.1 to 4.4
|
|
Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset.
Sero- at Month 12
|
1542.5 EL.U/mL
Interval 1393.2 to 1707.8
|
4.4 EL.U/mL
Interval 4.2 to 4.5
|
|
Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset.
Sero- at Month 18
|
992.6 EL.U/mL
Interval 893.9 to 1102.2
|
4.1 EL.U/mL
Interval 4.0 to 4.2
|
|
Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset.
Sero- at Month 36
|
612.9 EL.U/mL
Interval 550.1 to 682.8
|
4.5 EL.U/mL
Interval 4.2 to 4.7
|
|
Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset.
Sero- at Month 48
|
546.2 EL.U/mL
Interval 490.4 to 608.2
|
4.6 EL.U/mL
Interval 4.4 to 4.9
|
|
Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset.
Sero- at Month 60
|
447.1 EL.U/mL
Interval 394.3 to 507.0
|
4.3 EL.U/mL
Interval 4.1 to 4.5
|
|
Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset.
Sero- at Month 72
|
412.8 EL.U/mL
Interval 364.0 to 468.1
|
9.8 EL.U/mL
Interval 9.5 to 10.0
|
|
Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset.
Sero- at Month 84
|
381.0 EL.U/mL
Interval 334.7 to 433.8
|
9.6 EL.U/mL
Interval 9.4 to 9.9
|
|
Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset.
Sero+ before vaccination
|
39.3 EL.U/mL
Interval 33.6 to 45.9
|
38.6 EL.U/mL
Interval 33.2 to 44.9
|
|
Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset.
Sero+ at Month 7
|
5845.5 EL.U/mL
Interval 5113.8 to 6682.0
|
33.4 EL.U/mL
Interval 28.2 to 39.5
|
|
Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset.
Sero+ at month 12
|
2705.8 EL.U/mL
Interval 2313.2 to 3165.1
|
38.0 EL.U/mL
Interval 32.0 to 45.3
|
|
Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset.
Sero+ at Month 18
|
2104.7 EL.U/mL
Interval 1780.5 to 2487.8
|
30.5 EL.U/mL
Interval 25.2 to 36.9
|
|
Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset.
Sero+ at Month 24
|
1883.5 EL.U/mL
Interval 1599.4 to 2218.1
|
29.6 EL.U/mL
Interval 24.5 to 35.7
|
|
Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset.
Sero+ at month 36
|
1363.8 EL.U/mL
Interval 1138.2 to 1634.2
|
30.6 EL.U/mL
Interval 25.3 to 37.0
|
|
Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset.
Sero+ at Month 48
|
1261.2 EL.U/mL
Interval 1048.4 to 1517.1
|
34.3 EL.U/mL
Interval 28.8 to 40.8
|
|
Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset.
Sero+ at Month 60
|
943.0 EL.U/mL
Interval 749.2 to 1187.0
|
24.7 EL.U/mL
Interval 19.2 to 31.7
|
|
Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset.
Sero+ at Month 72
|
1053.7 EL.U/mL
Interval 841.0 to 1320.3
|
25.6 EL.U/mL
Interval 20.7 to 31.5
|
|
Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset.
Sero+ at Month 84
|
954.3 EL.U/mL
Interval 755.3 to 1205.8
|
23.9 EL.U/mL
Interval 19.3 to 29.5
|
SECONDARY outcome
Timeframe: At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84Population: The According-To-Protocol cohort for immunogenicity included subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. The 15% subset of women enrolled with prior history of HPV disease/infection was included.
GMCs were expressed in ELISA units per milliliter (EL.U/mL). Seronegative (Sero-) subjects are subjects who had an antibody concentration below 7 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 7 EL.U/mL prior to vaccination. Immuno subset=subjects from selected sites (N≥1000, at least 250 per region)
Outcome measures
| Measure |
Cervarix Group
n=405 Participants
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
n=379 Participants
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|---|---|---|
|
Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset.
Sero- before vaccination
|
NA EL.U/mL
Not calculable as no subject had HPV-18 antibody concentration equal to or above the assay cut-off value.
|
NA EL.U/mL
Not calculable as no subject had HPV-18 antibody concentration equal to or above the assay cut-off value.
|
|
Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset.
Sero- at Month 7
|
2567.7 EL.U/mL
Interval 2339.5 to 2818.2
|
3.7 EL.U/mL
Interval 3.6 to 3.9
|
|
Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset.
Sero- at Month 12
|
645.3 EL.U/mL
Interval 576.6 to 722.1
|
3.7 EL.U/mL
Interval 3.6 to 3.9
|
|
Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset.
Sero- at Month 18
|
402.6 EL.U/mL
Interval 359.7 to 450.6
|
3.7 EL.U/mL
Interval 3.6 to 3.8
|
|
Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset.
Sero- at Month 24
|
321.7 EL.U/mL
Interval 286.9 to 360.7
|
3.7 EL.U/mL
Interval 3.6 to 3.9
|
|
Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset.
Sero- at Month 36
|
245.9 EL.U/mL
Interval 218.5 to 276.8
|
3.7 EL.U/mL
Interval 3.6 to 3.8
|
|
Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset.
Sero- at Month 48
|
228.5 EL.U/mL
Interval 201.9 to 258.7
|
3.7 EL.U/mL
Interval 3.6 to 3.8
|
|
Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset.
Sero- at Month 60
|
174.3 EL.U/mL
Interval 151.2 to 200.8
|
3.8 EL.U/mL
Interval 3.6 to 4.0
|
|
Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset.
Sero- at Month 72
|
177.7 EL.U/mL
Interval 154.1 to 204.8
|
9.2 EL.U/mL
Interval 9.0 to 9.5
|
|
Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset.
Sero- at Month 84
|
166.2 EL.U/mL
Interval 143.4 to 192.7
|
9.1 EL.U/mL
Interval 9.0 to 9.3
|
|
Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset.
Sero+ before vaccination
|
23.0 EL.U/mL
Interval 19.9 to 26.7
|
24.2 EL.U/mL
Interval 20.6 to 28.4
|
|
Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset.
Sero+ at Month 7
|
2933.9 EL.U/mL
Interval 2557.1 to 3366.3
|
21.9 EL.U/mL
Interval 18.1 to 26.5
|
|
Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset.
Sero+ at Month 12
|
936.2 EL.U/mL
Interval 796.4 to 1100.4
|
23.6 EL.U/mL
Interval 19.4 to 28.7
|
|
Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset.
Sero+ at Month 18
|
661.3 EL.U/mL
Interval 560.9 to 779.7
|
19.5 EL.U/mL
Interval 15.7 to 24.2
|
|
Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset.
Sero+ at Month 24
|
573.6 EL.U/mL
Interval 487.7 to 674.6
|
16.6 EL.U/mL
Interval 13.5 to 20.5
|
|
Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset.
Sero+ at Month 36
|
423.1 EL.U/mL
Interval 357.9 to 500.1
|
16.4 EL.U/mL
Interval 12.9 to 20.7
|
|
Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset.
Sero+ at Month 48
|
392.3 EL.U/mL
Interval 328.9 to 468.0
|
15.9 EL.U/mL
Interval 12.7 to 19.9
|
|
Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset.
Sero+ at Month 60
|
306.0 EL.U/mL
Interval 245.7 to 380.9
|
12.9 EL.U/mL
Interval 9.8 to 16.9
|
|
Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset.
Sero+ at Month 72
|
324.8 EL.U/mL
Interval 264.3 to 399.1
|
16.2 EL.U/mL
Interval 13.3 to 19.6
|
|
Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset.
Sero+ at Month 84
|
302.2 EL.U/mL
Interval 243.4 to 375.2
|
16.5 EL.U/mL
Interval 13.4 to 20.4
|
SECONDARY outcome
Timeframe: Prior to vaccination and at Months 7, 12, 18, 24, 48 and 84.Population: The According-To-Protocol cohort for immunogenicity included subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. The 15% subset of women enrolled with prior history of HPV disease/infection was included.
Seroconversion was defined as the appearance of antibodies (i.e.; titre greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. HPV-16/18 assay cut-off value was defined as greater than or equal to 40 Estimated dose 50% (ED50). Sero- subjects are subjects who had an antibody concentration below 40 ED50 prior to vaccination. Sero+ subjects are subjects who had an antibody concentration equal to or above 50 ED50 prior to vaccination. ED50 = the estimated serum dilution reducing the signal generated by viral infection by 50%
Outcome measures
| Measure |
Cervarix Group
n=38 Participants
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
n=37 Participants
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|---|---|---|
|
Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects.
HPV-18 sero- [at Month 24]
|
36 Participants
|
1 Participants
|
|
Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects.
HPV-18 sero- [at Month 48]
|
29 Participants
|
0 Participants
|
|
Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects.
HPV-16 sero- [pre-vaccination]
|
0 Participants
|
0 Participants
|
|
Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects.
HPV-16 sero- [at Month 7]
|
37 Participants
|
1 Participants
|
|
Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects.
HPV-16 sero- [at Month 12]
|
37 Participants
|
0 Participants
|
|
Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects.
HPV-16 sero- [at Month 18]
|
36 Participants
|
0 Participants
|
|
Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects.
HPV-16 sero- [at Month 24]
|
35 Participants
|
2 Participants
|
|
Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects.
HPV-16 sero- [at Month 48]
|
27 Participants
|
1 Participants
|
|
Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects.
HPV-16 sero- [at Month 84]
|
19 Participants
|
1 Participants
|
|
Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects.
HPV-16 sero+ [pre-vaccination]
|
4 Participants
|
1 Participants
|
|
Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects.
HPV-16 sero+ [at Month 7]
|
4 Participants
|
1 Participants
|
|
Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects.
HPV-16 sero+ [at Month 12]
|
4 Participants
|
1 Participants
|
|
Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects.
HPV-16 sero+ [at Month 18]
|
4 Participants
|
1 Participants
|
|
Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects.
HPV-16 sero+ [at Month 24]
|
4 Participants
|
0 Participants
|
|
Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects.
HPV-16 sero+ [at Month 48]
|
3 Participants
|
0 Participants
|
|
Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects.
HPV-16 sero+ [at Month 84]
|
3 Participants
|
1 Participants
|
|
Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects.
HPV-18 sero- [pre-vaccination]
|
0 Participants
|
0 Participants
|
|
Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects.
HPV-18 sero- [at Month 7]
|
38 Participants
|
0 Participants
|
|
Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects.
HPV-18 sero- [at Month 12]
|
38 Participants
|
0 Participants
|
|
Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects.
HPV-18 sero- [at Month 18]
|
37 Participants
|
0 Participants
|
|
Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects.
HPV-18 sero- [at Month 84]
|
22 Participants
|
0 Participants
|
|
Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects.
HPV-18 sero+ [pre-vaccination]
|
3 Participants
|
3 Participants
|
|
Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects.
HPV-18 sero+ [at Month 7]
|
3 Participants
|
2 Participants
|
|
Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects.
HPV-18 sero+ [at Month 12]
|
3 Participants
|
2 Participants
|
|
Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects.
HPV-18 sero+ [at Month 18]
|
3 Participants
|
2 Participants
|
|
Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects.
HPV-18 sero+ [at Month 24]
|
3 Participants
|
2 Participants
|
|
Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects.
HPV-18 sero+ [at Month 48]
|
1 Participants
|
1 Participants
|
|
Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects.
HPV-18 sero+ [at Month 84]
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Prior to vaccination and at Months 7, 12, 18, 24, 48 and 84.Population: The According-To-Protocol cohort for immunogenicity included subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. The 15% subset of women enrolled with prior history of HPV disease/infection was included.
Titers are expressed as geometric mean antibody titers (GMTs). Seronegative (Sero-) subjects are subjects who had an antibody titer below 40 ED50 prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody titer equal to or above 40 ED50 prior to vaccination. ED50 = Estimated dose 50%, the estimated serum dilution reducing the signal generated by viral infection by 50%
Outcome measures
| Measure |
Cervarix Group
n=38 Participants
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
n=37 Participants
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects.
HPV-16 sero- [pre-vaccination]
|
NA Titers
Not calculable as no subject had HPV-16 antibody titer equal to or above the assay cut-off value.
|
NA Titers
Not calculable as no subject had HPV-16 antibody titer equal to or above the assay cut-off value.
|
|
Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects.
HPV-16 sero- [at Month 7]
|
11663.5 Titers
Interval 7507.2 to 18120.8
|
20.8 Titers
Interval 19.2 to 22.4
|
|
Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects.
HPV-16 sero- [at Month 12]
|
5597.7 Titers
Interval 3688.3 to 8495.6
|
NA Titers
Not calculable as no subject had HPV-16 antibody titer equal to or above the assay cut-off value.
|
|
Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects.
HPV-16 sero- [at Month 18]
|
2175.2 Titers
Interval 1390.8 to 3401.9
|
NA Titers
Not calculable as no subject had HPV-16 antibody titer equal to or above the assay cut-off value.
|
|
Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects.
HPV-16 sero- [at Month 24]
|
1941.7 Titers
Interval 1193.0 to 3160.4
|
22.3 Titers
Interval 18.6 to 26.6
|
|
Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects.
HPV-16 sero- [at Month 48]
|
828.9 Titers
Interval 488.4 to 1406.7
|
21.4 Titers
Interval 18.7 to 24.5
|
|
Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects.
HPV-16 sero- [at Month 84]
|
1213.4 Titers
Interval 1213.4 to 2779.1
|
NA Titers
Not calculable as no subject had HPV-16 antibody titer equal to or above the assay cut-off value.
|
|
Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects.
HPV-16 sero+ [pre-vaccination]
|
139.3 Titers
Interval 32.7 to 594.2
|
45.0 Titers
Data were not calculable because of too few subjects.
|
|
Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects.
HPV-16 sero+ [at Month 7]
|
20283.2 Titers
Interval 2428.3 to 169422.0
|
107.0 Titers
Data were not calculable because of too few subjects.
|
|
Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects.
HPV-16 sero+ [at Month 12]
|
19484.3 Titers
Interval 7049.3 to 53854.2
|
99.0 Titers
Data were not calculable because of too few subjects.
|
|
Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects.
HPV-16 sero+ [at Month 18]
|
4393.3 Titers
Interval 798.4 to 24175.0
|
93.0 Titers
Data were not calculable because of too few subjects.
|
|
Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects.
HPV-16 sero+ [at Month 24]
|
9459.1 Titers
Interval 2168.4 to 41263.7
|
NA Titers
Not calculable as no subject had HPV-16 antibody titer equal to or above the assay cut-off value.
|
|
Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects.
HPV-16 sero+ [at Month 48]
|
4187.2 Titers
Interval 676.4 to 25921.6
|
NA Titers
Not calculable as no subject had HPV-16 antibody titer equal to or above the assay cut-off value.
|
|
Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects.
HPV-16 sero+ [at Month 84]
|
5837.0 Titers
Interval 5837.0 to 35354.6
|
NA Titers
Not calculable as no subject had HPV-16 antibody titer equal to or above the assay cut-off value.
|
|
Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects.
HPV-18 sero- [pre-vaccination]
|
NA Titers
Not calculable as no subject had HPV-18 antibody titer equal to or above the assay cut-off value.
|
NA Titers
Not calculable as no subject had HPV-18 antibody titer equal to or above the assay cut-off value.
|
|
Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects.
HPV-18 sero- [at Month 7]
|
7959.6 Titers
Interval 4648.0 to 13630.7
|
NA Titers
Not calculable as no subject had HPV-18 antibody titer equal to or above the assay cut-off value.
|
|
Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects.
HPV-18 sero- [at Month 12]
|
1979.9 Titers
Interval 1201.6 to 3262.5
|
NA Titers
Not calculable as no subject had HPV-18 antibody titer equal to or above the assay cut-off value.
|
|
Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects.
HPV-18 sero- [at Month 18]
|
1334.6 Titers
Interval 793.3 to 2245.3
|
NA Titers
Not calculable as no subject had HPV-18 antibody titer equal to or above the assay cut-off value.
|
|
Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects.
HPV-18 sero- [at Month 24]
|
826.6 Titers
Interval 493.6 to 1384.1
|
21.4 Titers
Interval 18.7 to 24.5
|
|
Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects.
HPV-18 sero- [at Month 48]
|
386.1 Titers
Interval 203.9 to 731.1
|
NA Titers
Not calculable as no subject had HPV-18 antibody titer equal to or above the assay cut-off value.
|
|
Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects.
HPV-18 sero- [at Month 84]
|
491.2 Titers
Interval 232.9 to 1036.0
|
NA Titers
Not calculable as no subject had HPV-18 antibody titer equal to or above the assay cut-off value.
|
|
Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects.
HPV-18 sero+ [pre-vaccination]
|
84.7 Titers
Interval 9.2 to 782.4
|
115.5 Titers
Interval 21.5 to 621.0
|
|
Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects.
HPV-18 sero+ [at Month 7]
|
3014.5 Titers
Interval 446.3 to 20361.5
|
163.4 Titers
Interval 0.8 to 31959.2
|
|
Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects.
HPV-18 sero+ [at Month 12]
|
3377.8 Titers
Interval 2563.9 to 4450.1
|
167.3 Titers
Interval 0.8 to 35164.4
|
|
Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects.
HPV-18 sero+ [at Month 18]
|
3125.8 Titers
Interval 595.8 to 16398.4
|
254.9 Titers
Interval 0.4 to 172814.0
|
|
Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects.
HPV-18 sero+ [at Month 24]
|
2493.0 Titers
Interval 261.2 to 23793.7
|
154.9 Titers
Interval 0.4 to 53341.9
|
|
Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects.
HPV-18 sero+ [at Month 48]
|
545.0 Titers
Data were not calculable because of too few subjects.
|
86.0 Titers
Interval 0.0 to 9662500000.0
|
|
Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects.
HPV-18 sero+ [at Month 84]
|
NA Titers
Data were not calculable because of too few subjects.
|
968.0 Titers
Data were not calculable because of too few subjects.
|
SECONDARY outcome
Timeframe: Within 7 days (Days 0-6) after vaccinationPopulation: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented and symptom sheets completed.
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling was defined as redness/swelling above 50 millimeter (mm).
Outcome measures
| Measure |
Cervarix Group
n=2830 Participants
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
n=2831 Participants
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|---|---|---|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Any pain
|
2411 Participants
|
1862 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Grade 3 pain
|
303 Participants
|
73 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Any redness
|
1058 Participants
|
530 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Grade 3 redness
|
44 Participants
|
5 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Any swelling
|
1080 Participants
|
428 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Grade 3 swelling
|
97 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Within 7 days (Days 0-6) after vaccinationPopulation: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented and symptom sheets completed.
Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (Fever = axillary temperature above 37.5 degrees Celsius (°C)). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = axillary temperature above 39.0°C.
Outcome measures
| Measure |
Cervarix Group
n=2832 Participants
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
n=2832 Participants
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Any arthralgia
|
580 Participants
|
439 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Grade3 arthralgia
|
30 Participants
|
24 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Related arthralgia
|
323 Participants
|
225 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Any fatigue
|
1116 Participants
|
916 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 fatigue
|
78 Participants
|
53 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Related fatigue
|
678 Participants
|
545 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Any fever
|
308 Participants
|
248 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 fever
|
17 Participants
|
8 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Related fever
|
181 Participants
|
159 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Any gastrointestinal
|
664 Participants
|
592 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 gastrointestinal
|
60 Participants
|
54 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Related gastrointestinal
|
335 Participants
|
312 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Any headache
|
1165 Participants
|
1074 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 headache
|
76 Participants
|
72 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Related headache
|
666 Participants
|
598 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Any myalgia
|
878 Participants
|
622 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 myalgia
|
46 Participants
|
32 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Related myalgia
|
541 Participants
|
391 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Any rash
|
185 Participants
|
124 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 rash
|
1 Participants
|
7 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Related rash
|
88 Participants
|
61 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Any urticaria
|
258 Participants
|
201 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 urticaria
|
21 Participants
|
18 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Related urticaria
|
84 Participants
|
79 Participants
|
SECONDARY outcome
Timeframe: Within 30 days (Days 0 - 29) post-vaccination period.Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
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. Grade 3 unsolicited AE = an event that prevented normal activity. A related AE = event assessed by the investigator as causally related to the study vaccination.
Outcome measures
| Measure |
Cervarix Group
n=2877 Participants
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
n=2870 Participants
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Any AEs
|
1153 Participants
|
1164 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Grade 3 AEs
|
208 Participants
|
184 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Related AEs
|
246 Participants
|
191 Participants
|
SECONDARY outcome
Timeframe: Up to Month 48 and up to Month 84Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
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. A related SAE was defined as an event assessed by the investigator as causally related to the study vaccination.
Outcome measures
| Measure |
Cervarix Group
n=2877 Participants
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
n=2870 Participants
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|---|---|---|
|
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).
Any SAEs, M48
|
286 Participants
|
266 Participants
|
|
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).
Related SAEs, M48
|
5 Participants
|
8 Participants
|
|
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).
Any SAEs, M84
|
291 Participants
|
269 Participants
|
|
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).
Related SAEs, M84
|
5 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Up to Month 84Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Outcome measures
| Measure |
Cervarix Group
n=2877 Participants
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
n=2870 Participants
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|---|---|---|
|
Number of Subjects Reporting Related or Fatal Serious Adverse Event.
Fatal AEs
|
13 Participants
|
5 Participants
|
|
Number of Subjects Reporting Related or Fatal Serious Adverse Event.
Related SAEs
|
5 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Up to Month 84Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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. Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Outcome measures
| Measure |
Cervarix Group
n=2877 Participants
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
n=2870 Participants
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|---|---|---|
|
Number of Subjects Reporting Any AE/SAE Leading to Premature Discontinuation of the Study.
|
28 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Up to Month 48Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
NOCDs include autoimmune disorders, asthma and type I diabetes.
Outcome measures
| Measure |
Cervarix Group
n=2877 Participants
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
n=2870 Participants
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|---|---|---|
|
Number of Subjects Reporting New Onset of Chronic Disease (NOCDs).
|
143 Participants
|
165 Participants
|
SECONDARY outcome
Timeframe: Up to Month 48Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
Outcome measures
| Measure |
Cervarix Group
n=2877 Participants
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
n=2870 Participants
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|---|---|---|
|
Number of Subjects Reporting New Onset of Autoimmune Disease (NOADs).
|
24 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Up to Month 48Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
Medically significant conditions were defined as: 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=2877 Participants
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
n=2870 Participants
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|---|---|---|
|
Number of Subjects Reporting Medically Significant Conditions (MAEs).
|
1170 Participants
|
1140 Participants
|
SECONDARY outcome
Timeframe: Up to Month 48Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
Pregnancy outcomes are live infant, premature live infant, elective termination, ectopic pregnancy, spontaneous abortion, lost to follow-up and pregnancy ongoing. For each category it was specified if the infant presents congenital anomaly (CA) or no apparent congenital anomaly (No ACA).
Outcome measures
| Measure |
Cervarix Group
n=359 Participants
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
n=357 Participants
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|---|---|---|
|
Number of Subjects With Pregnancies and Their Outcomes.
Live infant No ACA, M48
|
259 Participants
|
249 Participants
|
|
Number of Subjects With Pregnancies and Their Outcomes.
Live infant CA, M48
|
4 Participants
|
7 Participants
|
|
Number of Subjects With Pregnancies and Their Outcomes.
Elective termination No ACA, M48
|
19 Participants
|
24 Participants
|
|
Number of Subjects With Pregnancies and Their Outcomes.
Elective termination CA, M48
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Pregnancies and Their Outcomes.
Ectopic pregnancy, M48
|
5 Participants
|
6 Participants
|
|
Number of Subjects With Pregnancies and Their Outcomes.
Spontaneous abortion No ACA, M48
|
69 Participants
|
66 Participants
|
|
Number of Subjects With Pregnancies and Their Outcomes.
Spontaneous abortion CA, M48
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Pregnancies and Their Outcomes.
Stillbirth No ACA, M48
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Pregnancies and Their Outcomes.
Lost to follow-up, M48
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to Month 48Population: The According-To-Protocol cohort for efficacy included subjects 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, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done on subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline. TAA: Type assignment algorithm. The lesion was assigned to an HPV type found in the lesion if 1. the same HPV type was found in at least one of the two (closest) preceding cytology samples, or 2. none of the HPV types found in the lesion were found in any of the two preceding cytology samples (isolate HPV types)
Outcome measures
| Measure |
Cervarix Group
n=2224 Participants
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
n=2190 Participants
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|---|---|---|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the Type Assignment Algorithm (TAA)
HPV-16/18 DNA-
|
1 Participants
|
9 Participants
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the Type Assignment Algorithm (TAA)
HPV-16 DNA-
|
0 Participants
|
5 Participants
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the Type Assignment Algorithm (TAA)
HPV-18 DNA-
|
1 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to Month 84Population: The According-To-Protocol cohort for efficacy included subjects 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, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Detection was done in: - DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.
Outcome measures
| Measure |
Cervarix Group
n=2124 Participants
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
n=2109 Participants
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|---|---|---|
|
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
HPV-16/18, DNA- and sero- subjects
|
6 Participants
|
67 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
HPV-16, DNA- and sero- subjects
|
5 Participants
|
51 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
HPV-18, DNA- and sero- subjects
|
1 Participants
|
17 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
HPV-16/18, DNA- and sero+ subjects
|
3 Participants
|
13 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
HPV-16, DNA- and sero+ subjects
|
2 Participants
|
9 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
HPV-18, DNA- and sero+ subjects
|
1 Participants
|
4 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
HPV-16/18, overall
|
9 Participants
|
82 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
HPV-16, overall
|
7 Participants
|
60 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
HPV-18, overall
|
2 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Up to Month 84Population: The According-To-Protocol cohort for efficacy included subjects 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, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
Persistent cervical HPV infection (12-month definition) was defined as the detection of the same HPV type(s) PCR in cervical samples at all available time points over approximately a 12-month interval (evaluations are planned at approximately 6-month intervals). - DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.
Outcome measures
| Measure |
Cervarix Group
n=2093 Participants
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
n=2081 Participants
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|---|---|---|
|
Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
HPV-16/18, DNA- and sero- subjects
|
2 Participants
|
37 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
HPV-16, DNA- and sero- subjects
|
1 Participants
|
27 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
HPV-18, DNA- and sero- subjects
|
1 Participants
|
10 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
HPV-16/18, DNA- and sero+ subjects
|
0 Participants
|
5 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
HPV-16, DNA- and sero+ subjects
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
HPV-18, DNA- and sero+ subjects
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
HPV-16/18, overall
|
2 Participants
|
43 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
HPV-16, overall
|
1 Participants
|
30 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
HPV-18, overall
|
1 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Up to Month 84Population: The According-To-Protocol cohort for efficacy included subjects 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, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
Persistent cervical HPV infection (6-month definition) = detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Detection was done in subjects HPV DNA- for the corresponding HPV type at baseline (at month 0 and Month 6) regardless of initial serostatus. HPV-HRW=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18. HPV-HR=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=2125 Participants
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
n=2111 Participants
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|---|---|---|
|
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-16
|
7 Participants
|
60 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-18
|
2 Participants
|
23 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-31
|
10 Participants
|
29 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-33
|
12 Participants
|
9 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-35
|
11 Participants
|
17 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-39
|
34 Participants
|
26 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-45
|
9 Participants
|
30 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-51
|
48 Participants
|
42 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-52
|
54 Participants
|
56 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-56
|
28 Participants
|
30 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-58
|
24 Participants
|
19 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-59
|
22 Participants
|
21 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-66
|
45 Participants
|
49 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-68
|
31 Participants
|
33 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-31/45
|
19 Participants
|
57 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-31/45/33/52/58
|
98 Participants
|
128 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-39/45/59/68
|
92 Participants
|
102 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-31/33/35/52/58
|
101 Participants
|
118 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-31/45/33/52/58/35/39/51/56/59
|
206 Participants
|
220 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-HRW
|
255 Participants
|
274 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-HR
|
262 Participants
|
330 Participants
|
SECONDARY outcome
Timeframe: Up to Month 84Population: The According-To-Protocol cohort for efficacy included subjects 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, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. subjects HPV DNA- for the corresponding HPV type at Month 0 6, regardless of initial serostatus. HPV-HRW=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HPV-HR=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 , 68
Outcome measures
| Measure |
Cervarix Group
n=2094 Participants
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
n=2083 Participants
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|---|---|---|
|
Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-16
|
1 Participants
|
30 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-18
|
1 Participants
|
13 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-31
|
7 Participants
|
17 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-33
|
9 Participants
|
7 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-35
|
5 Participants
|
9 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-39
|
20 Participants
|
10 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-45
|
7 Participants
|
13 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-51
|
23 Participants
|
26 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-52
|
34 Participants
|
31 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-56
|
11 Participants
|
15 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-58
|
14 Participants
|
13 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-59
|
7 Participants
|
10 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-66
|
22 Participants
|
16 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-68
|
13 Participants
|
22 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-31/45
|
14 Participants
|
28 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-31/45/33/52/58
|
65 Participants
|
75 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-39/45/59/68
|
46 Participants
|
54 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-31/33/35/52/58
|
64 Participants
|
72 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-31/45/33/52/58/35/39/51/56/59
|
118 Participants
|
129 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-HRW
|
145 Participants
|
160 Participants
|
|
Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.
HPV-HR
|
147 Participants
|
194 Participants
|
SECONDARY outcome
Timeframe: Up to Month 84Population: The According-To-Protocol cohort for efficacy included subjects 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, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
CIN2+ was defined as CIN grades 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done in: - DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline. Note: Results for seropositive status were not analysed.
Outcome measures
| Measure |
Cervarix Group
n=2168 Participants
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
n=2146 Participants
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|---|---|---|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-16/18, DNA- and sero- subjects
|
1 Participants
|
6 Participants
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-16, DNA- and sero- subjects
|
1 Participants
|
5 Participants
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-18, DNA- and sero- subjects
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-16/18, overall
|
1 Participants
|
8 Participants
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-16, overall
|
1 Participants
|
5 Participants
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-18, overall
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to Month 84Population: The According-To-Protocol cohort for efficacy included subjects 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, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done in: - DNA- and sero-/+: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.
Outcome measures
| Measure |
Cervarix Group
n=2168 Participants
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
n=2146 Participants
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|---|---|---|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-16/18, DNA- and sero- subjects
|
2 Participants
|
12 Participants
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-16, DNA- and sero- subjects
|
1 Participants
|
9 Participants
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-18, DNA- and sero- subjects
|
2 Participants
|
4 Participants
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-16/18, DNA- and sero+ subjects
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-16, DNA- and sero+ subjects
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-18, DNA- and sero+ subjects
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-16/18, overall
|
2 Participants
|
16 Participants
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-16, overall
|
1 Participants
|
10 Participants
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-18, overall
|
2 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Up to Month 84Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
Outcome measures
| Measure |
Cervarix Group
n=2733 Participants
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
n=2735 Participants
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|---|---|---|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-16/18
|
37 Participants
|
66 Participants
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-16
|
26 Participants
|
49 Participants
|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
HPV-18
|
14 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Up to Month 84Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done on all subjects irrespective of their baseline HPV DNA status.
Outcome measures
| Measure |
Cervarix Group
n=2733 Participants
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
n=2735 Participants
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|---|---|---|
|
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Irrespective of HPV Cervical Infection and Irrespective of Baseline HPV DNA Status
|
179 Participants
|
229 Participants
|
SECONDARY outcome
Timeframe: Up to Month 84Population: The According-To-Protocol cohort for efficacy included subjects 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, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US). Detection was done in: - DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline. Results for seropositive status were not analysed.
Outcome measures
| Measure |
Cervarix Group
n=2168 Participants
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
n=2146 Participants
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|---|---|---|
|
Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection
HPV-16
|
5 Participants
|
38 Participants
|
|
Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection
HPV-18
|
1 Participants
|
19 Participants
|
|
Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection
HPV-16/18, DNA- and sero- subjects
|
3 Participants
|
47 Participants
|
|
Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection
HPV-16, DNA- and sero- subjects
|
3 Participants
|
34 Participants
|
|
Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection
HPV-18, DNA- and sero- subjects
|
0 Participants
|
14 Participants
|
|
Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection
HPV-16/18, overall
|
6 Participants
|
56 Participants
|
SECONDARY outcome
Timeframe: Up to Month 48Population: The According-To-Protocol cohort for efficacy included subjects 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, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Detection was done in subjects who were HPV DNA negative for the corresponding HPV type at baseline (at month 0 and Month 6) regardless of initial serostatus. HRW-HPV= All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HPV-HR= 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=2169 Participants
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
n=2148 Participants
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|---|---|---|
|
Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations
HPV-16
|
5 Participants
|
38 Participants
|
|
Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations
HPV-18
|
1 Participants
|
19 Participants
|
|
Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations
HPV-31
|
5 Participants
|
23 Participants
|
|
Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations
HPV-33
|
6 Participants
|
8 Participants
|
|
Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations
HPV-35
|
7 Participants
|
13 Participants
|
|
Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations
HPV-39
|
21 Participants
|
23 Participants
|
|
Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations
HPV-45
|
5 Participants
|
23 Participants
|
|
Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations
HPV-51
|
38 Participants
|
34 Participants
|
|
Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations
HPV-52
|
25 Participants
|
22 Participants
|
|
Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations
HPV-56
|
15 Participants
|
28 Participants
|
|
Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations
HPV-58
|
19 Participants
|
13 Participants
|
|
Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations
HPV-59
|
9 Participants
|
22 Participants
|
|
Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations
HPV-66
|
22 Participants
|
43 Participants
|
|
Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations
HPV-68
|
15 Participants
|
15 Participants
|
|
Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations
HPV-31/45
|
10 Participants
|
44 Participants
|
|
Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations
HPV-31/45/33/52/58
|
56 Participants
|
78 Participants
|
|
Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations
HPV-39/45/59/68
|
49 Participants
|
74 Participants
|
|
Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations
HPV-31/33/35/52/58
|
56 Participants
|
70 Participants
|
|
Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations
HPV-31/45/33/52/58/35/39/51/56/59
|
119 Participants
|
160 Participants
|
|
Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations
HPV-HRW
|
143 Participants
|
192 Participants
|
|
Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations
HPV-HR
|
145 Participants
|
223 Participants
|
SECONDARY outcome
Timeframe: Up to Month 84Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
Detection was done on all subjects irrespective of their baseline HPV DNA status.
Outcome measures
| Measure |
Cervarix Group
n=2733 Participants
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
n=2735 Participants
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|---|---|---|
|
Number of Subjects With Histopathologically Confirmed Reduction of Local Cervical Therapy
|
88 Participants
|
110 Participants
|
SECONDARY outcome
Timeframe: Up to Month 84Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
Detection was done on all subjects irrespective of their baseline HPV DNA status.
Outcome measures
| Measure |
Cervarix Group
n=2734 Participants
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
n=2736 Participants
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|---|---|---|
|
Number of Subjects With First Colposcopy
|
506 Participants
|
560 Participants
|
SECONDARY outcome
Timeframe: Up to Month 84Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus.
Outcome measures
| Measure |
Cervarix Group
n=2768 Participants
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
n=2778 Participants
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|---|---|---|
|
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection
HPV-16/18
|
93 Participants
|
209 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection
HPV-16
|
66 Participants
|
152 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection
HPV-18
|
32 Participants
|
71 Participants
|
SECONDARY outcome
Timeframe: Up to Month 84Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus. The lesion was assigned to an HPV type found in the lesion if (1) the same HPV type was found in at least 1 of the 2 (closest) preceding cytology samples, or (2) none of the HPV types found in the lesion were found in any of the 2 preceding cytology samples (isolate HPV types)
Outcome measures
| Measure |
Cervarix Group
n=2768 Participants
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
n=2778 Participants
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|---|---|---|
|
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).
HPV-16/18
|
92 Participants
|
206 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).
HPV-16
|
65 Participants
|
151 Participants
|
|
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).
HPV-18
|
30 Participants
|
68 Participants
|
Adverse Events
Cervarix Group
Serious events: 291 serious events
Other events: 2543 other events
Deaths: 0 deaths
Aluminium Hydroxide Group
Serious events: 269 serious events
Other events: 2236 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cervarix Group
n=2881 participants at risk
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
n=2871 participants at risk
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous complete
|
0.66%
19/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.56%
16/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous incomplete
|
0.66%
19/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.45%
13/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Infections and infestations
Appendicitis
|
0.45%
13/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.42%
12/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.45%
13/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.42%
12/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.45%
13/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.31%
9/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion missed
|
0.35%
10/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.38%
11/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.17%
5/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.31%
9/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Pregnancy, puerperium and perinatal conditions
Blighted ovum
|
0.21%
6/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.24%
7/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion threatened
|
0.14%
4/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.24%
7/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.17%
5/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.21%
6/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Infections and infestations
Dengue fever
|
0.31%
9/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia
|
0.24%
7/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.07%
2/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.10%
3/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.17%
5/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Infections and infestations
Gastroenteritis
|
0.17%
5/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.10%
3/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Infections and infestations
Urinary tract infection
|
0.17%
5/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.10%
3/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.07%
2/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.10%
3/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Infections and infestations
Pyelonephritis
|
0.21%
6/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Vascular disorders
Hypertension
|
0.14%
4/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.07%
2/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Psychiatric disorders
Suicide attempt
|
0.17%
5/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.10%
3/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.10%
3/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.10%
3/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.07%
2/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.10%
3/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.07%
2/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.07%
2/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.10%
3/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.10%
3/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.07%
2/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.10%
3/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.14%
4/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.10%
3/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Pregnancy, puerperium and perinatal conditions
Premature labour
|
0.07%
2/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.07%
2/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.07%
2/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.07%
2/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Infections and infestations
Pyelonephritis acute
|
0.10%
3/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.07%
2/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.07%
2/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Psychiatric disorders
Depression
|
0.07%
2/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Immune system disorders
Drug hypersensitivity
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.07%
2/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Reproductive system and breast disorders
Dysfunctional uterine bleeding
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.10%
3/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.07%
2/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Gastrointestinal disorders
Gastritis
|
0.07%
2/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.07%
2/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.07%
2/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.07%
2/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Infections and infestations
Pneumonia
|
0.07%
2/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.07%
2/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Pregnancy, puerperium and perinatal conditions
Ruptured ectopic pregnancy
|
0.07%
2/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Ear and labyrinth disorders
Vertigo
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.07%
2/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Cardiac disorders
Angina unstable
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Pregnancy, puerperium and perinatal conditions
Arrested labour
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Reproductive system and breast disorders
Bartholin's cyst
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Gastrointestinal disorders
Diarrhoea infectious
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Pregnancy, puerperium and perinatal conditions
Gestational hypertension
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Endocrine disorders
Goitre
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Infections and infestations
Salpingitis
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Cardiac disorders
Sinus bradycardia
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.10%
3/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.10%
3/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Nervous system disorders
Migraine
|
0.17%
5/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.14%
4/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.10%
3/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.10%
3/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Psychiatric disorders
Completed suicide
|
0.10%
3/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.10%
3/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.07%
2/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis
|
0.07%
2/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.07%
2/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Infections and infestations
Bronchopneumonia
|
0.07%
2/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.07%
2/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Nervous system disorders
Headache
|
0.07%
2/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.07%
2/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.07%
2/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.07%
2/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.07%
2/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.07%
2/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.07%
2/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Reproductive system and breast disorders
Ovarian cyst torsion
|
0.07%
2/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Pregnancy, puerperium and perinatal conditions
Premature delivery
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.07%
2/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Infections and infestations
Sinusitis
|
0.07%
2/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.07%
2/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.07%
2/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion complete
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Surgical and medical procedures
Abortion induced
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Infections and infestations
Abscess
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Endocrine disorders
Addison's disease
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of the cervix
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoma benign
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Reproductive system and breast disorders
Adnexal torsion
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Infections and infestations
Amniotic cavity infection
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Injury, poisoning and procedural complications
Anaesthetic complication pulmonary
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anaplastic astrocytoma
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Cardiac disorders
Angina pectoris
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Eye disorders
Angle closure glaucoma
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Psychiatric disorders
Anorexia nervosa
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Vascular disorders
Arteriosclerosis
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Musculoskeletal and connective tissue disorders
Arthritis reactive
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Infections and infestations
Atypical pneumonia
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Reproductive system and breast disorders
Bartholinitis
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Nervous system disorders
Basal ganglia haemorrhage
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Endocrine disorders
Basedow's disease
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Injury, poisoning and procedural complications
Bone fissure
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage II
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Congenital, familial and genetic disorders
Bronchogenic cyst
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Infections and infestations
Burn infection
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Renal and urinary disorders
Calculus bladder
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Cardiac disorders
Cardiac valve disease
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Nervous system disorders
Cerebral cyst
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix cancer metastatic
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
General disorders
Chest pain
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Infections and infestations
Chlamydial infection
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Metabolism and nutrition disorders
Cholesterosis
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Infections and infestations
Chronic tonsillitis
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Immune system disorders
Colitis ulcerative
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Reproductive system and breast disorders
Colpocele
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Psychiatric disorders
Conversion disorder
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
General disorders
Cyst
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Infections and infestations
Cystitis klebsiella
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Psychiatric disorders
Depression suicidal
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Nervous system disorders
Diabetic coma
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Reproductive system and breast disorders
Endosalpingiosis
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Gastrointestinal disorders
Epiploic appendagitis
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroma
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Pregnancy, puerperium and perinatal conditions
Foetal death
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Reproductive system and breast disorders
Genital prolapse
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Infections and infestations
Genitourinary tract infection
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma multiforme
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Gastrointestinal disorders
Haematemesis
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Pregnancy, puerperium and perinatal conditions
Haemorrhage in pregnancy
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Gastrointestinal disorders
Haemorrhoids thrombosed
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Infections and infestations
Hepatitis C
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Infections and infestations
Herpes virus infection
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Social circumstances
Homicide
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Pregnancy, puerperium and perinatal conditions
Hyperemesis gravidarum
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vaginal adenocarcinoma
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Immune system disorders
Hypersensitivity
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Cardiac disorders
Hypertensive heart disease
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
General disorders
Ill-defined disorder
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
General disorders
Incarcerated hernia
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Infections and infestations
Infection
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Nervous system disorders
Intracranial haematoma
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Hepatobiliary disorders
Jaundice
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Musculoskeletal and connective tissue disorders
Joint instability
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liposarcoma
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Musculoskeletal and connective tissue disorders
Lupus-like syndrome
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Infections and infestations
Lyme disease
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Eye disorders
Macular oedema
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mediastinum neoplasm
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Reproductive system and breast disorders
Menometrorrhagia
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Nervous system disorders
Monoparesis
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cyst
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal disorder
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasopharyngeal cancer
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Nervous system disorders
Vertebral artery dissection
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
General disorders
Oedema
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
General disorders
Oedema peripheral
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Gastrointestinal disorders
Oedematous pancreatitis
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Infections and infestations
Opisthorchiasis
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian germ cell teratoma benign
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian neoplasm
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Infections and infestations
Paronychia
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Infections and infestations
Pasteurella infection
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Infections and infestations
Pelvic abscess
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Infections and infestations
Vestibular neuronitis
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Reproductive system and breast disorders
Pelvic prolapse
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Musculoskeletal and connective tissue disorders
Periostitis
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Injury, poisoning and procedural complications
Wound
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Infections and infestations
Pilonidal cyst
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Pregnancy, puerperium and perinatal conditions
Placenta accreta
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Blood and lymphatic system disorders
Placental transfusion syndrome
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Infections and infestations
Pneumonia streptococcal
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Reproductive system and breast disorders
Polycystic ovaries
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Infections and infestations
Postoperative abscess
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Reproductive system and breast disorders
Polymyalgia rheumatica
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Pregnancy, puerperium and perinatal conditions
Postpartum haemorrhage
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Pregnancy, puerperium and perinatal conditions
Premature rupture of membranes
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Psychiatric disorders
Psychotic disorder
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Congenital, familial and genetic disorders
Pyloric stenosis
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Infections and infestations
Pyonephrosis
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Gastrointestinal disorders
Pyrexia
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Infections and infestations
Renal abscess
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Renal and urinary disorders
Renal colic
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Renal and urinary disorders
Renal failure acute
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal oncocytoma
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Pregnancy, puerperium and perinatal conditions
Retained products of conception
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Eye disorders
Retinal vein thrombosis
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Immune system disorders
Sarcoidosis
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Nervous system disorders
Sedation
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Infections and infestations
Sepsis
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Pregnancy, puerperium and perinatal conditions
Stillbirth
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Nervous system disorders
Tension headache
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Teratoma
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Pregnancy, puerperium and perinatal conditions
Threatened labour
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Endocrine disorders
Thyroid cyst
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Gastrointestinal disorders
Tooth impacted
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Infections and infestations
Typhoid fever
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Injury, poisoning and procedural complications
Ulnar nerve injury
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Pregnancy, puerperium and perinatal conditions
Prolonged labour
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.07%
2/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Infections and infestations
Viral infection
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Renal and urinary disorders
Urinary retention
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Injury, poisoning and procedural complications
Urinary retention postoperative
|
0.03%
1/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.00%
0/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Reproductive system and breast disorders
Uterine atony
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Reproductive system and breast disorders
Uterine cyst
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
Reproductive system and breast disorders
Uterovaginal prolapse
|
0.00%
0/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
0.03%
1/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
Other adverse events
| Measure |
Cervarix Group
n=2881 participants at risk
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
Aluminium Hydroxide Group
n=2871 participants at risk
Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
|
|---|---|---|
|
Nervous system disorders
Headache
|
7.0%
203/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
7.7%
222/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
General disorders
Pain
|
83.7%
2411/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
64.9%
1862/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
General disorders
Redness
|
36.7%
1058/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
18.5%
530/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
General disorders
Swelling
|
37.5%
1080/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
14.9%
428/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
General disorders
Arthralgia
|
20.1%
580/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
15.3%
439/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
General disorders
Fatigue
|
38.7%
1116/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
31.9%
916/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
General disorders
Fever
|
10.7%
308/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
8.6%
248/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
General disorders
Gastrointestinal
|
23.0%
664/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
20.6%
592/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
General disorders
Headache
|
40.4%
1165/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
37.4%
1074/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
General disorders
Myalgia
|
30.5%
878/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
21.7%
622/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
General disorders
Rash
|
6.4%
185/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
4.3%
124/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
|
General disorders
Urticaria
|
9.0%
258/2881 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
7.0%
201/2871 • SAEs: from the beginning of the study up to Month 84. Unsolicited AEs: within 30 days (Days 0-29) post-vaccination period). Solicited AEs: During the 7-day (Days 0-6) post-vaccination period.
|
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