Trial Outcomes & Findings for Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001) (NCT NCT00543543)
NCT ID: NCT00543543
Last Updated: 2018-11-27
Results Overview
HPV Type 31/33/45/52/58-related high-grade Cervical Intraepithelial Neoplasia (CIN 2/3), Adenocarcinoma in Situ (AIS), Invasive Cervical Carcinoma, high-grade Vulvar Intraepithelial Neoplasia (VIN 2/3), high-grade Vaginal Intraepithelial Neoplasia (VaIN 2/3), vulvar cancer, or vaginal cancer were determined by clinical/pathologic criteria and positive Polymerase Chain Reaction (PCR) assay for virus subtype. This outcome measure reports data based on the protocol-specified plan of conducting hypothesis testing when at least 30 cases had accumulated. The cutoff date for this analysis was 10 April 2013. Disease incidence was defined as the number of primary efficacy cases per 10,000 person-years of follow-up in a treatment arm.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
14840 participants
Primary outcome timeframe
From Day 1 until >=30 cases accumulate, up to Month 54 in the base study
Results posted on
2018-11-27
Participant Flow
A total of 15,334 participants were screened and 14,840 were randomized into the study.
Participant milestones
| Measure |
Low-dose V503
V503 (9-Valent Human Papillomavirus \[HPV\] Vaccine) low-dose 0.5 mL injection in a 3-dose regimen in the base study.
|
Mid-dose V503
V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
|
High-dose V503
V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study.
|
Gardasil
Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
|
|---|---|---|---|---|
|
Base Study
STARTED
|
315
|
7106
|
310
|
7109
|
|
Base Study
Completed 3 Vaccinations
|
300
|
6928
|
297
|
6934
|
|
Base Study
COMPLETED
|
295
|
5854
|
296
|
5887
|
|
Base Study
NOT COMPLETED
|
20
|
1252
|
14
|
1222
|
|
Extension Study
STARTED
|
0
|
150
|
0
|
3050
|
|
Extension Study
COMPLETED
|
0
|
150
|
0
|
2824
|
|
Extension Study
NOT COMPLETED
|
0
|
0
|
0
|
226
|
Reasons for withdrawal
| Measure |
Low-dose V503
V503 (9-Valent Human Papillomavirus \[HPV\] Vaccine) low-dose 0.5 mL injection in a 3-dose regimen in the base study.
|
Mid-dose V503
V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
|
High-dose V503
V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study.
|
Gardasil
Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
|
|---|---|---|---|---|
|
Base Study
Adverse Event
|
1
|
11
|
0
|
5
|
|
Base Study
Lost to Follow-up
|
12
|
749
|
9
|
701
|
|
Base Study
Physician Decision
|
0
|
4
|
0
|
7
|
|
Base Study
Protocol Violation
|
0
|
6
|
0
|
6
|
|
Base Study
Withdrawal by Subject
|
7
|
482
|
5
|
503
|
|
Extension Study
Adverse Event
|
0
|
0
|
0
|
5
|
|
Extension Study
Lost to Follow-up
|
0
|
0
|
0
|
77
|
|
Extension Study
Physician Decision
|
0
|
0
|
0
|
7
|
|
Extension Study
Pregnancy
|
0
|
0
|
0
|
6
|
|
Extension Study
Protocol Violation
|
0
|
0
|
0
|
11
|
|
Extension Study
Withdrawal by Subject
|
0
|
0
|
0
|
120
|
Baseline Characteristics
Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001)
Baseline characteristics by cohort
| Measure |
Low-dose V503
n=315 Participants
V503 (9-Valent Human Papillomavirus \[HPV\] Vaccine) low-dose 0.5 mL injection in a 3-dose regimen in the base study.
|
Mid-dose V503
n=7106 Participants
V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
|
High-dose V503
n=310 Participants
V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study.
|
Gardasil
n=7109 Participants
Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
|
Total
n=14840 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
21.7 Years
STANDARD_DEVIATION 2.4 • n=5 Participants
|
21.9 Years
STANDARD_DEVIATION 2.5 • n=7 Participants
|
21.9 Years
STANDARD_DEVIATION 2.4 • n=5 Participants
|
21.8 Years
STANDARD_DEVIATION 2.5 • n=4 Participants
|
21.9 Years
STANDARD_DEVIATION 2.5 • n=21 Participants
|
|
Sex: Female, Male
Female
|
315 Participants
n=5 Participants
|
7106 Participants
n=7 Participants
|
310 Participants
n=5 Participants
|
7109 Participants
n=4 Participants
|
14840 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: From Day 1 until >=30 cases accumulate, up to Month 54 in the base studyPopulation: The Per-protocol Efficacy population included all participants who received all 3 vaccinations of mid-dose V503 or Gardasil within acceptable day ranges, were seronegative at Day 1 and PCR negative at Day 1 through Day 7 to the relevant HPV types, and had at least 1 follow-up visit following Month 7.
HPV Type 31/33/45/52/58-related high-grade Cervical Intraepithelial Neoplasia (CIN 2/3), Adenocarcinoma in Situ (AIS), Invasive Cervical Carcinoma, high-grade Vulvar Intraepithelial Neoplasia (VIN 2/3), high-grade Vaginal Intraepithelial Neoplasia (VaIN 2/3), vulvar cancer, or vaginal cancer were determined by clinical/pathologic criteria and positive Polymerase Chain Reaction (PCR) assay for virus subtype. This outcome measure reports data based on the protocol-specified plan of conducting hypothesis testing when at least 30 cases had accumulated. The cutoff date for this analysis was 10 April 2013. Disease incidence was defined as the number of primary efficacy cases per 10,000 person-years of follow-up in a treatment arm.
Outcome measures
| Measure |
Mid-dose V503
n=6016 Participants
V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
|
Gardasil
n=6017 Participants
Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
|
High-dose V503
V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study.
|
Gardasil
Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
|
|---|---|---|---|---|
|
Base Study: Combined Incidence of HPV Type 31/33/45/52/58-related Disease (Test of Hypothesis)
|
0.5 Cases per 10,000 person-years follow-up
|
15.8 Cases per 10,000 person-years follow-up
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Month 54 in the base studyPopulation: The Per-protocol Efficacy population included all participants who received all 3 vaccinations of mid-dose V503 or Gardasil within acceptable day ranges, were seronegative at Day 1 and PCR negative at Day 1 through Day 7 to the relevant HPV types, and had at least 1 follow-up visit following Month 7.
HPV Type 31/33/45/52/58-related high-grade Cervical Intraepithelial Neoplasia (CIN 2/3), Adenocarcinoma in Situ (AIS), Invasive Cervical Carcinoma, high-grade Vulvar Intraepithelial Neoplasia (VIN 2/3), high-grade Vaginal Intraepithelial Neoplasia (VaIN 2/3), vulvar cancer, or vaginal cancer were determined by clinical/pathologic criteria and positive Polymerase Chain Reaction (PCR) assay for virus subtype. This outcome measure reports cumulative study data through 10 March 2014. Disease incidence was defined as the number of primary efficacy cases per 10,000 person-years of follow-up in a treatment arm.
Outcome measures
| Measure |
Mid-dose V503
n=6016 Participants
V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
|
Gardasil
n=6017 Participants
Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
|
High-dose V503
V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study.
|
Gardasil
Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
|
|---|---|---|---|---|
|
Base Study: Combined Incidence of HPV Type 31/33/45/52/58-related Disease (End-of-study Update)
|
0.5 Cases per 10,000 person-years follow-up
|
19.0 Cases per 10,000 person-years follow-up
|
—
|
—
|
PRIMARY outcome
Timeframe: 4 weeks postdose 3 in the base studyPopulation: The Per-protocol Immunogenicity population included all participants who were not protocol violators, received all 3 vaccinations of mid-dose V503 or Gardasil within acceptable ranges, were seronegative at Day 1 and PCR negative from Day 1- Month 7 for the relevant HPV types, and had a Month 7 serum sample collected within an acceptable range
Serum antibodies to HPV types 6/11/16/18/31/33/45/52/58 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL. Statistical analysis was performed only for HPV types contained in both vaccines.
Outcome measures
| Measure |
Mid-dose V503
n=6792 Participants
V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
|
Gardasil
n=6795 Participants
Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
|
High-dose V503
V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study.
|
Gardasil
Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
|
|---|---|---|---|---|
|
Base Study: Geometric Mean Titers (GMTs) to HPV Types 6/11/16/18/31/33/45/52/58
Anti-HPV Type 6 (n=3993, 3975)
|
893.1 milli Merck U/mL
Interval 871.7 to 915.1
|
875.2 milli Merck U/mL
Interval 854.2 to 896.8
|
—
|
—
|
|
Base Study: Geometric Mean Titers (GMTs) to HPV Types 6/11/16/18/31/33/45/52/58
Anti-HPV Type 11 (n=3995, 3982)
|
666.3 milli Merck U/mL
Interval 649.6 to 683.4
|
830.0 milli Merck U/mL
Interval 809.2 to 851.4
|
—
|
—
|
|
Base Study: Geometric Mean Titers (GMTs) to HPV Types 6/11/16/18/31/33/45/52/58
Anti-HPV Type 16 (n=4032, 4062)
|
3131.1 milli Merck U/mL
Interval 3057.1 to 3206.9
|
3156.6 milli Merck U/mL
Interval 3082.3 to 3232.7
|
—
|
—
|
|
Base Study: Geometric Mean Titers (GMTs) to HPV Types 6/11/16/18/31/33/45/52/58
Anti-HPV Type 18 (n=4539, 4541)
|
804.6 milli Merck U/mL
Interval 782.7 to 827.1
|
678.7 milli Merck U/mL
Interval 660.2 to 697.7
|
—
|
—
|
|
Base Study: Geometric Mean Titers (GMTs) to HPV Types 6/11/16/18/31/33/45/52/58
Anti-HPV Type 31 (n=4466, 4377)
|
658.4 milli Merck U/mL
Interval 636.7 to 680.9
|
9.7 milli Merck U/mL
Interval 9.4 to 10.1
|
—
|
—
|
|
Base Study: Geometric Mean Titers (GMTs) to HPV Types 6/11/16/18/31/33/45/52/58
Anti-HPV Type 33 (n=4702, 4691)
|
415.9 milli Merck U/mL
Interval 405.6 to 426.4
|
NA milli Merck U/mL
The GMT value was \<4 milli Merck U/mL
|
—
|
—
|
|
Base Study: Geometric Mean Titers (GMTs) to HPV Types 6/11/16/18/31/33/45/52/58
Anti-HPV Type 45 (n=4792, 4750)
|
252.8 milli Merck U/mL
Interval 246.2 to 259.6
|
NA milli Merck U/mL
The GMT value was \<3 milli Merck U/mL
|
—
|
—
|
|
Base Study: Geometric Mean Titers (GMTs) to HPV Types 6/11/16/18/31/33/45/52/58
Anti-HPV Type 52 (n=4455, 4335)
|
379.7 milli Merck U/mL
Interval 371.6 to 388.0
|
NA milli Merck U/mL
The GMT value was \<3 milli Merck U/mL
|
—
|
—
|
|
Base Study: Geometric Mean Titers (GMTs) to HPV Types 6/11/16/18/31/33/45/52/58
Anti-HPV Type 58 (n=4486, 4446)
|
482.5 milli Merck U/mL
Interval 469.9 to 495.3
|
NA milli Merck U/mL
The GMT value was \<4 milli Merck U/mL
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Month 7 (low- and high-dose V503) or up to Month 54 (mid-dose V503 and Gardasil)Population: The analysis population included all participants who received \>=1 vaccination and had safety follow-up
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE.
Outcome measures
| Measure |
Mid-dose V503
n=310 Participants
V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
|
Gardasil
n=7071 Participants
Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
|
High-dose V503
n=305 Participants
V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study.
|
Gardasil
n=7078 Participants
Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
|
|---|---|---|---|---|
|
Base Study: Percentage of Participants With One or More Adverse Event
|
92.6 Percentage of participants
|
94.2 Percentage of participants
|
92.8 Percentage of participants
|
91.1 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to Day 5 after any vaccinationPopulation: The analysis population included all participants who received \>=1 vaccination and had safety follow-up
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. AEs such as redness, swelling, and pain/tenderness/soreness at the injection site were recorded.
Outcome measures
| Measure |
Mid-dose V503
n=310 Participants
V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
|
Gardasil
n=7071 Participants
Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
|
High-dose V503
n=305 Participants
V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study.
|
Gardasil
n=7078 Participants
Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
|
|---|---|---|---|---|
|
Base Study: Percentage of Participants With One or More Injection-site Adverse Event
|
87.7 Percentage of participants
|
90.7 Percentage of participants
|
90.5 Percentage of participants
|
84.9 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to Day 15 after any vaccinationPopulation: The analysis population included all participants who received \>=1 vaccination and had safety follow-up
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Systemic AEs were those not categorized as injection-site AEs.
Outcome measures
| Measure |
Mid-dose V503
n=310 Participants
V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
|
Gardasil
n=7071 Participants
Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
|
High-dose V503
n=305 Participants
V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study.
|
Gardasil
n=7078 Participants
Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
|
|---|---|---|---|---|
|
Base Study: Percentage of Participants With One or More Non-injection-site (Systemic) Adverse Event
|
53.5 Percentage of participants
|
55.8 Percentage of participants
|
51.1 Percentage of participants
|
54.9 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to Month 7 (low- and high-dose V503) or up to Month 54 (mid-dose V503 and Gardasil)Population: The analysis population included all participants who received \>=1 vaccination and had safety follow-up
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. An AE that is judged by the investigator to be "definitely related," "probably related," or "possibly related" to the study drug is defined as a vaccine-related AE.
Outcome measures
| Measure |
Mid-dose V503
n=310 Participants
V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
|
Gardasil
n=7071 Participants
Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
|
High-dose V503
n=305 Participants
V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study.
|
Gardasil
n=7078 Participants
Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
|
|---|---|---|---|---|
|
Base Study: Percentage of Participants With One or More Vaccine-related Adverse Event
|
90.0 Percentage of participants
|
92.2 Percentage of participants
|
92.8 Percentage of participants
|
87.6 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to Month 6Population: The analysis population included all participants who received \>=1 vaccination and had safety follow-up
An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse event.
Outcome measures
| Measure |
Mid-dose V503
n=310 Participants
V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
|
Gardasil
n=7071 Participants
Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
|
High-dose V503
n=305 Participants
V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study.
|
Gardasil
n=7078 Participants
Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
|
|---|---|---|---|---|
|
Base Study: Percentage of Participants With Study Medication Withdrawn Due to an Adverse Event
|
0.6 Percentage of participants
|
0.1 Percentage of participants
|
0.0 Percentage of participants
|
0.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Month 54 in the base studyPopulation: The Per-protocol Efficacy population included all participants who received all 3 vaccinations of mid-dose V503 or Gardasil within acceptable day ranges, were seronegative at Day 1 and PCR negative at Day 1 through Day 7 to the relevant HPV types, and had at least 1 follow-up visit following Month 7.
Combined Incidence of HPV Type 31/33/45/52/58-related persistent infection as determined by clinical/pathologic criteria and positive Polymerase Chain Reaction (PCR) assay for virus subtype. Persistent infection was defined as infection detected in samples from \>=2 consecutive visits 6 months (+/-1 month visit window) or longer apart. Incidence was defined as the number of cases of persistent infection per 10,000 person-years of follow-up in a treatment arm.
Outcome measures
| Measure |
Mid-dose V503
n=5941 Participants
V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
|
Gardasil
n=5955 Participants
Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
|
High-dose V503
V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study.
|
Gardasil
Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
|
|---|---|---|---|---|
|
Base Study: Combined Incidence of HPV Type 31/33/45/52/58-related Persistent Infection
|
21.5 Cases per 10,000 person-years follow-up
|
538.8 Cases per 10,000 person-years follow-up
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 weeks postdose 3Population: The Per-protocol Immunogenicity population included all participants who were not protocol violators, received all 3 vaccinations of mid-dose V503 or Gardasil within acceptable ranges, were seronegative at Day 1 and PCR negative from Day 1 - Month 7 for the relevant HPV types, and had a Month 7 serum sample collected within an acceptable range
Serum antibodies to HPV types were measured with a Competitive Luminex Immunoassay. The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30; HPV Type 11: ≥16; HPV Type 16: ≥20; HPV Type 18: ≥24; HPV Type 31: ≥10; HPV Types 33, 45, 52, and 58: ≥8.
Outcome measures
| Measure |
Mid-dose V503
n=6792 Participants
V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
|
Gardasil
n=6795 Participants
Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
|
High-dose V503
V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study.
|
Gardasil
Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
|
|---|---|---|---|---|
|
Base Study: Percentage of Participants Who Are Seropositive for HPV Types 6/11/16/18/31/33/45/52/58
Anti-HPV Type 31 (n=4466, 4377)
|
99.8 Percentage of participants
Interval 99.6 to 99.9
|
50.1 Percentage of participants
Interval 48.7 to 51.6
|
—
|
—
|
|
Base Study: Percentage of Participants Who Are Seropositive for HPV Types 6/11/16/18/31/33/45/52/58
Anti-HPV Type 33 (n=4702, 4691)
|
99.7 Percentage of participants
Interval 99.5 to 99.9
|
12.7 Percentage of participants
Interval 11.8 to 13.7
|
—
|
—
|
|
Base Study: Percentage of Participants Who Are Seropositive for HPV Types 6/11/16/18/31/33/45/52/58
Anti-HPV Type 45 (n=4792, 4750)
|
99.6 Percentage of participants
Interval 99.4 to 99.8
|
9.2 Percentage of participants
Interval 8.4 to 10.0
|
—
|
—
|
|
Base Study: Percentage of Participants Who Are Seropositive for HPV Types 6/11/16/18/31/33/45/52/58
Anti-HPV Type 52 (n=4455, 4335)
|
99.8 Percentage of participants
Interval 99.6 to 99.9
|
2.6 Percentage of participants
Interval 2.2 to 3.1
|
—
|
—
|
|
Base Study: Percentage of Participants Who Are Seropositive for HPV Types 6/11/16/18/31/33/45/52/58
Anti-HPV Type 58 (n=4486, 4446)
|
99.8 Percentage of participants
Interval 99.6 to 99.9
|
20.4 Percentage of participants
Interval 19.2 to 21.6
|
—
|
—
|
|
Base Study: Percentage of Participants Who Are Seropositive for HPV Types 6/11/16/18/31/33/45/52/58
Anti-HPV Type 6 (n=3993, 3975)
|
99.8 Percentage of participants
Interval 99.6 to 99.9
|
99.8 Percentage of participants
Interval 99.7 to 99.9
|
—
|
—
|
|
Base Study: Percentage of Participants Who Are Seropositive for HPV Types 6/11/16/18/31/33/45/52/58
Anti-HPV Type 11 (n=3995, 3982)
|
100 Percentage of participants
Interval 99.9 to 100.0
|
99.9 Percentage of participants
Interval 99.8 to 100.0
|
—
|
—
|
|
Base Study: Percentage of Participants Who Are Seropositive for HPV Types 6/11/16/18/31/33/45/52/58
Anti-HPV Type 16 (n=4032, 4062)
|
100 Percentage of participants
Interval 99.9 to 100.0
|
100 Percentage of participants
Interval 99.8 to 100.0
|
—
|
—
|
|
Base Study: Percentage of Participants Who Are Seropositive for HPV Types 6/11/16/18/31/33/45/52/58
Anti-HPV Type 18 (n=4539, 4541)
|
99.8 Percentage of participants
Interval 99.7 to 99.9
|
99.7 Percentage of participants
Interval 99.5 to 99.8
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 60: predose 4 in the Extension Study (Cohort 1)Population: All participants in Cohort 1 who received all 3 vaccinations of mid-dose V503 in the Base Study, were seronegative at Day 1 and PCR negative from Day 1 to Month 7 for the relevant HPV types, had no other violation that could interfere with evaluation of immune response, and provided post-dose 4 serum.
Serum antibodies to HPV types 6/11/16/18/31/33/45/52/58 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL. This outcome measure applied to Cohort 1 participants only.
Outcome measures
| Measure |
Mid-dose V503
n=150 Participants
V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
|
Gardasil
Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
|
High-dose V503
V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study.
|
Gardasil
Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
|
|---|---|---|---|---|
|
Extension Study: Geometric Mean Titers to HPV Types 6/11/16/18/31/33/45/52/58 at Predose 4
Anti-HPV Type 6 (n=101)
|
143.1 milli Merck U/mL
Interval 117.9 to 173.7
|
—
|
—
|
—
|
|
Extension Study: Geometric Mean Titers to HPV Types 6/11/16/18/31/33/45/52/58 at Predose 4
Anti-HPV Type 11 (n=112)
|
82.9 milli Merck U/mL
Interval 68.1 to 100.9
|
—
|
—
|
—
|
|
Extension Study: Geometric Mean Titers to HPV Types 6/11/16/18/31/33/45/52/58 at Predose 4
Anti-HPV Type 16 (n=128)
|
324.4 milli Merck U/mL
Interval 266.7 to 394.7
|
—
|
—
|
—
|
|
Extension Study: Geometric Mean Titers to HPV Types 6/11/16/18/31/33/45/52/58 at Predose 4
Anti-HPV Type 18 (n=142)
|
62.5 milli Merck U/mL
Interval 49.5 to 78.9
|
—
|
—
|
—
|
|
Extension Study: Geometric Mean Titers to HPV Types 6/11/16/18/31/33/45/52/58 at Predose 4
Anti-HPV Type 31 (n=135)
|
69.2 milli Merck U/mL
Interval 56.6 to 84.4
|
—
|
—
|
—
|
|
Extension Study: Geometric Mean Titers to HPV Types 6/11/16/18/31/33/45/52/58 at Predose 4
Anti-HPV Type 33 (n=141)
|
44.7 milli Merck U/mL
Interval 37.0 to 54.1
|
—
|
—
|
—
|
|
Extension Study: Geometric Mean Titers to HPV Types 6/11/16/18/31/33/45/52/58 at Predose 4
Anti-HPV Type 45 (n=148)
|
20.8 milli Merck U/mL
Interval 17.0 to 25.5
|
—
|
—
|
—
|
|
Extension Study: Geometric Mean Titers to HPV Types 6/11/16/18/31/33/45/52/58 at Predose 4
Anti-HPV Type 52 (n=134)
|
33.7 milli Merck U/mL
Interval 27.6 to 41.1
|
—
|
—
|
—
|
|
Extension Study: Geometric Mean Titers to HPV Types 6/11/16/18/31/33/45/52/58 at Predose 4
Anti-HPV Type 58 (n=132)
|
50.9 milli Merck U/mL
Interval 40.9 to 63.3
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 60 + 1 week: Day 7 postdose 4 in the Extension Study (Cohort 1)Population: All participants in Cohort 1 who received all 3 vaccinations of mid-dose V503 in the Base Study, were seronegative at Day 1 and PCR negative from Day 1 to Month 7 for the relevant HPV types, had no other violation that could interfere with evaluation of immune response, and provided post-dose 4 serum.
Serum antibodies to HPV types 6/11/16/18/31/33/45/52/58 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL. This outcome measure applied to Cohort 1 participants only.
Outcome measures
| Measure |
Mid-dose V503
n=150 Participants
V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
|
Gardasil
Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
|
High-dose V503
V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study.
|
Gardasil
Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
|
|---|---|---|---|---|
|
Extension Study: Geometric Mean Titers to HPV Types 6/11/16/18/31/33/45/52/58 at Day 7 Postdose 4
Anti-HPV Type 6 (n=109)
|
2180.5 milli Merck U/mL
Interval 1826.2 to 2603.7
|
—
|
—
|
—
|
|
Extension Study: Geometric Mean Titers to HPV Types 6/11/16/18/31/33/45/52/58 at Day 7 Postdose 4
Anti-HPV Type 11 (n=109)
|
2228.7 milli Merck U/mL
Interval 1852.5 to 2681.3
|
—
|
—
|
—
|
|
Extension Study: Geometric Mean Titers to HPV Types 6/11/16/18/31/33/45/52/58 at Day 7 Postdose 4
Anti-HPV Type 16 (n=126)
|
7986.3 milli Merck U/mL
Interval 6795.7 to 9385.6
|
—
|
—
|
—
|
|
Extension Study: Geometric Mean Titers to HPV Types 6/11/16/18/31/33/45/52/58 at Day 7 Postdose 4
Anti-HPV Type 18 (n=138)
|
2399.0 milli Merck U/mL
Interval 2049.4 to 2808.1
|
—
|
—
|
—
|
|
Extension Study: Geometric Mean Titers to HPV Types 6/11/16/18/31/33/45/52/58 at Day 7 Postdose 4
Anti-HPV Type 31 (n=131)
|
1462.2 milli Merck U/mL
Interval 1263.9 to 1691.5
|
—
|
—
|
—
|
|
Extension Study: Geometric Mean Titers to HPV Types 6/11/16/18/31/33/45/52/58 at Day 7 Postdose 4
Anti-HPV Type 33 (n=137)
|
1709.0 milli Merck U/mL
Interval 1466.7 to 1991.2
|
—
|
—
|
—
|
|
Extension Study: Geometric Mean Titers to HPV Types 6/11/16/18/31/33/45/52/58 at Day 7 Postdose 4
Anti-HPV Type 45 (n=144)
|
323.0 milli Merck U/mL
Interval 277.2 to 376.5
|
—
|
—
|
—
|
|
Extension Study: Geometric Mean Titers to HPV Types 6/11/16/18/31/33/45/52/58 at Day 7 Postdose 4
Anti-HPV Type 52 (n=131)
|
1078.1 milli Merck U/mL
Interval 907.2 to 1281.2
|
—
|
—
|
—
|
|
Extension Study: Geometric Mean Titers to HPV Types 6/11/16/18/31/33/45/52/58 at Day 7 Postdose 4
Anti-HPV Type 58 (n=129)
|
1801.8 milli Merck U/mL
Interval 1530.5 to 2121.2
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 61: 28 days postdose 4 in the Extension Study (Cohort 1)Population: All participants in Cohort 1 who received all 3 vaccinations of mid-dose V503 in the Base Study, were seronegative at Day 1 and PCR negative from Day 1 to Month 7 for the relevant HPV types, had no other violation that could interfere with evaluation of immune response, and provided post-dose 4 serum.
Serum antibodies to HPV types 6/11/16/18/31/33/45/52/58 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL. This outcome measure applied to Cohort 1 participants only.
Outcome measures
| Measure |
Mid-dose V503
n=150 Participants
V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
|
Gardasil
Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
|
High-dose V503
V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study.
|
Gardasil
Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
|
|---|---|---|---|---|
|
Extension Study: Geometric Mean Titers to HPV Types 6/11/16/18/31/33/45/52/58 at Day 28 Postdose 4
Anti-HPV Type 6 (n=109)
|
2585.0 milli Merck U/mL
Interval 2239.5 to 2983.8
|
—
|
—
|
—
|
|
Extension Study: Geometric Mean Titers to HPV Types 6/11/16/18/31/33/45/52/58 at Day 28 Postdose 4
Anti-HPV Type 11 (n=109)
|
2548.7 milli Merck U/mL
Interval 2191.4 to 2964.3
|
—
|
—
|
—
|
|
Extension Study: Geometric Mean Titers to HPV Types 6/11/16/18/31/33/45/52/58 at Day 28 Postdose 4
Anti-HPV Type 16 (n=123)
|
10904.3 milli Merck U/mL
Interval 9605.6 to 12378.7
|
—
|
—
|
—
|
|
Extension Study: Geometric Mean Titers to HPV Types 6/11/16/18/31/33/45/52/58 at Day 28 Postdose 4
Anti-HPV Type 18 (n=137)
|
2907.9 milli Merck U/mL
Interval 2531.1 to 3340.7
|
—
|
—
|
—
|
|
Extension Study: Geometric Mean Titers to HPV Types 6/11/16/18/31/33/45/52/58 at Day 28 Postdose 4
Anti-HPV Type 31 (n=130)
|
1745.4 milli Merck U/mL
Interval 1538.8 to 1979.8
|
—
|
—
|
—
|
|
Extension Study: Geometric Mean Titers to HPV Types 6/11/16/18/31/33/45/52/58 at Day 28 Postdose 4
Anti-HPV Type 33 (n=136)
|
2094.9 milli Merck U/mL
Interval 1848.7 to 2373.9
|
—
|
—
|
—
|
|
Extension Study: Geometric Mean Titers to HPV Types 6/11/16/18/31/33/45/52/58 at Day 28 Postdose 4
Anti-HPV Type 45 (n=143)
|
440.0 milli Merck U/mL
Interval 386.9 to 500.4
|
—
|
—
|
—
|
|
Extension Study: Geometric Mean Titers to HPV Types 6/11/16/18/31/33/45/52/58 at Day 28 Postdose 4
Anti-HPV Type 52 (n=129)
|
1131.5 milli Merck U/mL
Interval 991.6 to 1291.1
|
—
|
—
|
—
|
|
Extension Study: Geometric Mean Titers to HPV Types 6/11/16/18/31/33/45/52/58 at Day 28 Postdose 4
Anti-HPV Type 58 (n=127)
|
2024.6 milli Merck U/mL
Interval 1803.1 to 2273.2
|
—
|
—
|
—
|
Adverse Events
Base Study: Low-Dose V503
Serious events: 4 serious events
Other events: 278 other events
Deaths: 0 deaths
Base Study: Mid-dose V503
Serious events: 233 serious events
Other events: 6551 other events
Deaths: 0 deaths
Base Study: High-dose V503
Serious events: 5 serious events
Other events: 280 other events
Deaths: 0 deaths
Base Study: Gardasil
Serious events: 184 serious events
Other events: 6268 other events
Deaths: 0 deaths
Extension Study: Mid-dose V503 (Cohort 1)
Serious events: 1 serious events
Other events: 130 other events
Deaths: 0 deaths
Extension Study: Mid-dose V503 (Cohort 2)
Serious events: 25 serious events
Other events: 89 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Base Study: Low-Dose V503
n=310 participants at risk
V503 (9-Valent HPV Vaccine) low-dose 0.5 mL injection in a 3-dose regimen in the base study.
|
Base Study: Mid-dose V503
n=7071 participants at risk
V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) will receive a fourth V503 mid-dose vaccination in the extension study.
|
Base Study: High-dose V503
n=305 participants at risk
V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study.
|
Base Study: Gardasil
n=7078 participants at risk
Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) will be offered the V503 mid-dose 3-dose regimen in the extension study.
|
Extension Study: Mid-dose V503 (Cohort 1)
n=150 participants at risk
V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL fourth dose administration in Base Study participants who were randomized to receive a 3-dose regimen of V503 (9-Valent HPV) mid-dose 0.5 mL (Cohort 1).
|
Extension Study: Mid-dose V503 (Cohort 2)
n=3049 participants at risk
V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL 3-dose regimen administration on Base Study participants who were randomized to receive a 3-dose regimen of Gardasil (4-Valent HPV Vaccine) (Cohort 2).
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant palate neoplasm
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Cardiac disorders
Postural orthostatic tachycardia syndrome
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Congenital, familial and genetic disorders
Cleft lip and palate
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Congenital, familial and genetic disorders
Diverticulitis Meckel's
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.03%
2/7078 • Number of events 2 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Gastrointestinal disorders
Coeliac disease
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Gastrointestinal disorders
Omental infarction
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
General disorders
Accidental death
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
General disorders
Pyrexia
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
General disorders
Sudden death
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.03%
2/7078 • Number of events 2 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Immune system disorders
Allergy to vaccine
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Immune system disorders
Sarcoidosis
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Infections and infestations
Abscess jaw
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Infections and infestations
Appendicitis
|
0.32%
1/310 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.13%
9/7071 • Number of events 9 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.23%
16/7078 • Number of events 16 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.07%
2/3049 • Number of events 2 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.03%
2/7078 • Number of events 2 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Infections and infestations
Cholecystitis infective
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Infections and infestations
Chronic tonsillitis
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Infections and infestations
Dengue fever
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Infections and infestations
Enteritis infectious
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.03%
2/7071 • Number of events 2 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.03%
2/7078 • Number of events 2 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Infections and infestations
Haemorrhagic fever
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Infections and infestations
Influenza
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Infections and infestations
Post abortion infection
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.03%
2/7071 • Number of events 2 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.03%
2/7078 • Number of events 2 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Infections and infestations
Septic shock
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Infections and infestations
Tonsillitis streptococcal
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.03%
2/7071 • Number of events 2 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.33%
1/305 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.03%
2/7078 • Number of events 2 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Infections and infestations
Wound infection
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Injury, poisoning and procedural complications
Bladder injury
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.03%
1/3049 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Injury, poisoning and procedural complications
Fracture displacement
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 2 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.03%
2/7078 • Number of events 2 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.03%
2/7071 • Number of events 2 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Injury, poisoning and procedural complications
Neck injury
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Injury, poisoning and procedural complications
Poisoning
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 2 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Injury, poisoning and procedural complications
Spinal cord injury
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Injury, poisoning and procedural complications
Spinal cord injury cervical
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 2 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute promyelocytic leukaemia
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of the cervix
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.03%
1/3049 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ependymoma
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemic infiltration brain
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.03%
2/7071 • Number of events 2 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasal cavity cancer
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian neoplasm
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Respiratory papilloma
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Nervous system disorders
Benign intracranial hypertension
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Nervous system disorders
Diabetic coma
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Nervous system disorders
Facial paresis
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Nervous system disorders
Headache
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Nervous system disorders
Intracranial venous sinus thrombosis
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Nervous system disorders
Migraine
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Nervous system disorders
Multiple sclerosis
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.03%
2/7071 • Number of events 2 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.03%
1/3049 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Nervous system disorders
Neuritis
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Nervous system disorders
Orthostatic intolerance
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Nervous system disorders
Spondylitic myelopathy
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Nervous system disorders
Syncope
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.03%
2/7071 • Number of events 2 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.32%
1/310 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.51%
36/7071 • Number of events 38 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.33%
1/305 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.37%
26/7078 • Number of events 28 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.26%
8/3049 • Number of events 8 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous complete
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.03%
2/7078 • Number of events 2 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous incomplete
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Pregnancy, puerperium and perinatal conditions
Blighted ovum
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Pregnancy, puerperium and perinatal conditions
Cephalo-pelvic disproportion
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.06%
4/7071 • Number of events 4 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.08%
6/7078 • Number of events 6 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Pregnancy, puerperium and perinatal conditions
Cervix dystocia
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Pregnancy, puerperium and perinatal conditions
False labour
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Pregnancy, puerperium and perinatal conditions
Foetal death
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.33%
1/305 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Pregnancy, puerperium and perinatal conditions
Foetal distress syndrome
|
0.32%
1/310 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.06%
4/7071 • Number of events 4 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Pregnancy, puerperium and perinatal conditions
Foetal malposition
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Pregnancy, puerperium and perinatal conditions
Foetal malpresentation
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Pregnancy, puerperium and perinatal conditions
Gestational diabetes
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.03%
1/3049 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Pregnancy, puerperium and perinatal conditions
Labour complication
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Pregnancy, puerperium and perinatal conditions
Oligohydramnios
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.33%
1/305 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Pregnancy, puerperium and perinatal conditions
Premature labour
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Pregnancy, puerperium and perinatal conditions
Premature rupture of membranes
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.06%
4/7071 • Number of events 4 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.03%
2/7078 • Number of events 2 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Pregnancy, puerperium and perinatal conditions
Prolonged labour
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.03%
2/7071 • Number of events 2 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Pregnancy, puerperium and perinatal conditions
Uterine contractions during pregnancy
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Psychiatric disorders
Anorexia and bulimia syndrome
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Psychiatric disorders
Anorexia nervosa
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.04%
3/7071 • Number of events 3 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Psychiatric disorders
Depression
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.03%
2/7071 • Number of events 2 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Reproductive system and breast disorders
Bartholinitis
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.07%
5/7071 • Number of events 5 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.04%
3/7078 • Number of events 3 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Reproductive system and breast disorders
Cervix haemorrhage uterine
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.03%
2/7071 • Number of events 2 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Reproductive system and breast disorders
Fallopian tube cyst
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.03%
2/7078 • Number of events 2 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord polyp
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Surgical and medical procedures
Abortion induced
|
0.32%
1/310 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
1.0%
73/7071 • Number of events 76 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.66%
2/305 • Number of events 2 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.75%
53/7078 • Number of events 53 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.10%
3/3049 • Number of events 3 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Vascular disorders
Axillary vein thrombosis
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7078 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.01%
1/7071 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.03%
2/7071 • Number of events 2 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.03%
1/3049 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Hepatobiliary disorders
Cholestasis of pregnancy
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.03%
1/3049 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Nervous system disorders
Trigeminal nerve disorder
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.03%
1/3049 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.03%
1/3049 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.03%
1/3049 • Number of events 2 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.67%
1/150 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.03%
1/3049 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.03%
1/3049 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioma
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.03%
1/3049 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/310 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/305 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/7078 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.03%
1/3049 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
Other adverse events
| Measure |
Base Study: Low-Dose V503
n=310 participants at risk
V503 (9-Valent HPV Vaccine) low-dose 0.5 mL injection in a 3-dose regimen in the base study.
|
Base Study: Mid-dose V503
n=7071 participants at risk
V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) will receive a fourth V503 mid-dose vaccination in the extension study.
|
Base Study: High-dose V503
n=305 participants at risk
V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study.
|
Base Study: Gardasil
n=7078 participants at risk
Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) will be offered the V503 mid-dose 3-dose regimen in the extension study.
|
Extension Study: Mid-dose V503 (Cohort 1)
n=150 participants at risk
V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL fourth dose administration in Base Study participants who were randomized to receive a 3-dose regimen of V503 (9-Valent HPV) mid-dose 0.5 mL (Cohort 1).
|
Extension Study: Mid-dose V503 (Cohort 2)
n=3049 participants at risk
V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL 3-dose regimen administration on Base Study participants who were randomized to receive a 3-dose regimen of Gardasil (4-Valent HPV Vaccine) (Cohort 2).
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
7.1%
22/310 • Number of events 23 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
7.3%
513/7071 • Number of events 617 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
5.9%
18/305 • Number of events 20 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
6.5%
459/7078 • Number of events 551 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
1.3%
2/150 • Number of events 2 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.13%
4/3049 • Number of events 4 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
General disorders
Injection site erythema
|
32.3%
100/310 • Number of events 157 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
34.1%
2411/7071 • Number of events 3597 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
29.8%
91/305 • Number of events 140 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
25.6%
1810/7078 • Number of events 2564 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
22.0%
33/150 • Number of events 34 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.30%
9/3049 • Number of events 9 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
General disorders
Injection site pain
|
86.1%
267/310 • Number of events 684 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
89.9%
6360/7071 • Number of events 15383 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
89.5%
273/305 • Number of events 672 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
83.5%
5911/7078 • Number of events 13001 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
82.7%
124/150 • Number of events 128 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
1.9%
59/3049 • Number of events 94 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
General disorders
Injection site pruritus
|
5.8%
18/310 • Number of events 21 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
5.5%
389/7071 • Number of events 494 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
4.6%
14/305 • Number of events 16 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
4.0%
282/7078 • Number of events 341 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.67%
1/150 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.03%
1/3049 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
General disorders
Injection site swelling
|
32.3%
100/310 • Number of events 154 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
40.1%
2836/7071 • Number of events 4527 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
33.8%
103/305 • Number of events 168 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
28.8%
2035/7078 • Number of events 2988 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
32.7%
49/150 • Number of events 51 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.39%
12/3049 • Number of events 12 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
General disorders
Pyrexia
|
9.7%
30/310 • Number of events 35 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
6.6%
469/7071 • Number of events 563 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
5.6%
17/305 • Number of events 19 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
6.5%
463/7078 • Number of events 550 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
4.0%
6/150 • Number of events 6 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.23%
7/3049 • Number of events 7 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Infections and infestations
Influenza
|
6.5%
20/310 • Number of events 22 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
4.4%
312/7071 • Number of events 343 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
3.9%
12/305 • Number of events 12 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
4.2%
296/7078 • Number of events 314 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
2.7%
4/150 • Number of events 5 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.16%
5/3049 • Number of events 5 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Infections and infestations
Nasopharyngitis
|
3.2%
10/310 • Number of events 11 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
5.3%
376/7071 • Number of events 412 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
3.9%
12/305 • Number of events 13 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
5.5%
389/7078 • Number of events 420 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.67%
1/150 • Number of events 1 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/3049 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Nervous system disorders
Dizziness
|
5.5%
17/310 • Number of events 20 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
4.9%
346/7071 • Number of events 405 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
3.6%
11/305 • Number of events 13 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
4.3%
307/7078 • Number of events 368 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.00%
0/150 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.07%
2/3049 • Number of events 2 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
|
Nervous system disorders
Headache
|
21.0%
65/310 • Number of events 100 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
26.6%
1879/7071 • Number of events 3071 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
21.6%
66/305 • Number of events 106 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
24.8%
1756/7078 • Number of events 2788 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
21.3%
32/150 • Number of events 41 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
0.36%
11/3049 • Number of events 13 • Base Study: SAEs up to Month (M) 7 (low- and high-dose V503) or up to M54 (mid-dose V503 and Gardasil); non-serious AEs up to Day 15 after vaccination. Cohort 1: SAEs M60 to 61; non-serious AEs up to Day 15 after vaccination 4. Cohort 2: SAEs M60 to 67.
The analysis population included all participants who received \>=1 vaccination and had safety follow-up. Non-serious AEs were not solicited in Extension Cohort 2; however, some non-serious AEs were voluntarily reported.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.
- Publication restrictions are in place
Restriction type: OTHER