Trial Outcomes & Findings for V501 Efficacy Study in Women Aged 18 to 26 (V501-027) (NCT NCT00378560)

NCT ID: NCT00378560

Last Updated: 2017-04-17

Results Overview

Participants with HPV 6, 11, 16 or 18 persistent infection, and genital disease (e.g., cervical, vaginal or vulval intraepithelial neoplasia, or cancer, adenocarcinoma in situ and genital warts) per 100 person-years of follow up.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 1021 participants
• Primary outcome timeframe: Over 30 months
• Results posted on: 2017-04-17

Participant Flow

Study was conducted at 14 sites in Japan from 2006 to 2009.

There were no specific criteria.

Participant milestones

Measure	V501 V501; Gardasil, 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6	Placebo Placebo 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
Overall Study STARTED	509	512
Overall Study Vaccinated	509	512
Overall Study COMPLETED	453	454
Overall Study NOT COMPLETED	56	58

Reasons for withdrawal

Measure	V501 V501; Gardasil, 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6	Placebo Placebo 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
Overall Study Adverse Event	1	0
Overall Study Lost to Follow-up	24	29
Overall Study Protocol Violation	2	0
Overall Study Withdrawal by Subject	17	21
Overall Study Moved	4	3
Overall Study Pregnancy	7	5
Overall Study Laboratory test values abnormal	1	0

Baseline Characteristics

V501 Efficacy Study in Women Aged 18 to 26 (V501-027)

Baseline characteristics by cohort

Measure	V501 n=509 Participants V501; Gardasil, 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6	Placebo n=512 Participants Placebo 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6	Total n=1021 Participants Total of all reporting groups
Age, Continuous	22.7 years STANDARD_DEVIATION 2.1 • n=5 Participants	22.9 years STANDARD_DEVIATION 2.1 • n=7 Participants	22.8 years STANDARD_DEVIATION 2.1 • n=5 Participants
Sex: Female, Male Female	509 Participants n=5 Participants	512 Participants n=7 Participants	1021 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Body Weight	52.1 Kilograms STANDARD_DEVIATION 8.2 • n=5 Participants	51.7 Kilograms STANDARD_DEVIATION 7.3 • n=7 Participants	51.9 Kilograms STANDARD_DEVIATION 7.8 • n=5 Participants

PRIMARY outcome

Timeframe: Over 30 months

Population: Includes participants who were not general protocol violators, received all 3 vaccinations, and were seronegative at Day 1 and PCR negative through Month 7 for the relevant HPV type

Participants with HPV 6, 11, 16 or 18 persistent infection, and genital disease (e.g., cervical, vaginal or vulval intraepithelial neoplasia, or cancer, adenocarcinoma in situ and genital warts) per 100 person-years of follow up.

Outcome measures

Measure	V501 n=419 Participants V501; Gardasil, 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6	Placebo n=422 Participants Placebo 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
Combined Incidence of Persistent Human Papillomavirus (HPV) 6, 11, 16 and 18 Infection or HPV 6, 11, 16 and 18 Related-Disease as Determined by Clinical/Pathologic Criteria and Positive Polymerase Chain Reaction (PCR) Assay for Virus Subtype	0.4 Incidence per 100 person-years Interval 61.2 to 97.7	3.1 Incidence per 100 person-years Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: At one month after completed vaccination series (Month 7)

Population: Includes participants who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and had a Month 7 serum sample collected within an acceptable time range

Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers (GMTs) by vaccine group.

The limit of detection of the assay was 7 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "7.0".

Outcome measures

Measure	V501 n=386 Participants V501; Gardasil, 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6	Placebo n=365 Participants Placebo 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 6)	390.8 Geometric Mean Titers Interval 357.7 to 426.9	7.0 Geometric Mean Titers Interval 7.0 to 7.0

SECONDARY outcome

Timeframe: At one month after completed vaccination series (Month 7)

Population: Includes participants who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and had a Month 7 serum sample collected within an acceptable time range

Month 7 HPV cLIA Geometric Mean Titers by vaccine group.

The limit of detection of the assay was 8 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "8.0".

Outcome measures

Measure	V501 n=386 Participants V501; Gardasil, 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6	Placebo n=365 Participants Placebo 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 11)	579.8 Geometric Mean Titers Interval 538.1 to 624.8	8.0 Geometric Mean Titers Interval 8.0 to 8.0

SECONDARY outcome

Timeframe: At one month after completed vaccination series (Month 7)

Population: Includes participants who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and had a Month 7 serum sample collected within an acceptable time range

Month 7 HPV cLIA Geometric Mean Titers by vaccine group.

The limit of detection of the assay was 11 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "11.0".

Outcome measures

Measure	V501 n=357 Participants V501; Gardasil, 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6	Placebo n=365 Participants Placebo 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 16)	2396.4 Geometric Mean Titers Interval 2201.3 to 2608.8	11.0 Geometric Mean Titers Interval 11.0 to 11.0

SECONDARY outcome

Timeframe: At one month after completed vaccination series (Month 7)

Population: Includes participants who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and had a Month 7 serum sample collected within an acceptable time range

Month 7 HPV cLIA Geometric Mean Titers by vaccine group.

The limit of detection of the assay was 10 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "10.0".

Outcome measures

Measure	V501 n=389 Participants V501; Gardasil, 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6	Placebo n=386 Participants Placebo 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 18)	369.0 Geometric Mean Titers Interval 335.9 to 405.4	10.0 Geometric Mean Titers Interval 10.0 to 10.0

Adverse Events

V501

Serious events: 39 serious events

Other events: 435 other events

Deaths: 0 deaths

Placebo

Serious events: 65 serious events

Other events: 396 other events

Deaths: 0 deaths

Serious adverse events

Measure	V501 n=480 participants at risk V501; Gardasil, 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6	Placebo n=468 participants at risk Placebo 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Ear and labyrinth disorders Vertigo	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Gastrointestinal disorders Ascites	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Gastrointestinal disorders Enterocolitis	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Gastrointestinal disorders Peritonitis	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
General disorders Hernia	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Infections and infestations Appendicitis	0.42% 2/480 • Number of events 2 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Infections and infestations Gastroenteritis	0.42% 2/480 • Number of events 2 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Infections and infestations Herpes simplex	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Infections and infestations Meningitis aseptic	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Infections and infestations Ovarian abscess	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Infections and infestations Pneumonia	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.43% 2/468 • Number of events 2 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Infections and infestations Pyelonephritis	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Infections and infestations Pyelonephritis acute	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Infections and infestations Tonsillitis	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Injury, poisoning and procedural complications Drug toxicity	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Injury, poisoning and procedural complications Hand fracture	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Injury, poisoning and procedural complications Ligament injury	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Injury, poisoning and procedural complications Neck injury	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian neoplasm	0.42% 2/480 • Number of events 2 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Nervous system disorders Depressed level of consciousness	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Nervous system disorders Myasthenia gravis	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 2 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Psychiatric disorders Depression	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Reproductive system and breast disorders Cervical dysplasia	4.2% 20/480 • Number of events 20 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	9.8% 46/468 • Number of events 46 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Surgical and medical procedures Abortion induced	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.64% 3/468 • Number of events 3 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Surgical and medical procedures Ovarian cystectomy	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Surgical and medical procedures Tonsillectomy	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Surgical and medical procedures Tooth extraction	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma stage 0	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Nervous system disorders Loss of consciousness	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.

Other adverse events

Measure	V501 n=480 participants at risk V501; Gardasil, 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6	Placebo n=468 participants at risk Placebo 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
Blood and lymphatic system disorders Anaemia	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.43% 2/468 • Number of events 2 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Cardiac disorders Palpitations	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.43% 2/468 • Number of events 2 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Ear and labyrinth disorders Vertigo	0.42% 2/480 • Number of events 2 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Eye disorders Asthenopia	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Eye disorders Conjunctivitis	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.43% 2/468 • Number of events 2 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Eye disorders Conjunctivitis allergic	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Eye disorders Dry eye	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Eye disorders Eye pruritus	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Eye disorders Keratitis	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Gastrointestinal disorders Abdominal distension	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Gastrointestinal disorders Abdominal pain	1.5% 7/480 • Number of events 7 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.64% 3/468 • Number of events 3 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Gastrointestinal disorders Abdominal pain lower	0.62% 3/480 • Number of events 3 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	1.1% 5/468 • Number of events 5 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Gastrointestinal disorders Abdominal pain upper	1.9% 9/480 • Number of events 12 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	1.7% 8/468 • Number of events 11 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Gastrointestinal disorders Constipation	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	1.3% 6/468 • Number of events 6 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Gastrointestinal disorders Diarrhoea	2.5% 12/480 • Number of events 12 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	1.9% 9/468 • Number of events 10 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Gastrointestinal disorders Dyspepsia	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Gastrointestinal disorders Enterocolitis	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Gastrointestinal disorders Faeces discoloured	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Gastrointestinal disorders Frequent bowel movements	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Gastrointestinal disorders Gastritis	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Gastrointestinal disorders Hyperchlorhydria	0.42% 2/480 • Number of events 2 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Gastrointestinal disorders Irritable bowel syndrome	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Gastrointestinal disorders Nausea	2.3% 11/480 • Number of events 11 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	2.8% 13/468 • Number of events 15 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Gastrointestinal disorders Stomach discomfort	1.2% 6/480 • Number of events 6 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.43% 2/468 • Number of events 2 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Gastrointestinal disorders Stomatitis	1.2% 6/480 • Number of events 6 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Gastrointestinal disorders Toothache	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.64% 3/468 • Number of events 3 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Gastrointestinal disorders Vomiting	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.64% 3/468 • Number of events 3 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
General disorders Chest pain	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
General disorders Face oedema	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
General disorders Feeling hot	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
General disorders Injection site anaesthesia	0.42% 2/480 • Number of events 3 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.64% 3/468 • Number of events 3 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
General disorders Injection site bruising	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.64% 3/468 • Number of events 3 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
General disorders Injection site discolouration	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
General disorders Injection site discomfort	1.7% 8/480 • Number of events 12 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.64% 3/468 • Number of events 3 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
General disorders Injection site erythema	30.6% 147/480 • Number of events 206 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	21.2% 99/468 • Number of events 154 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
General disorders Injection site haemorrhage	3.1% 15/480 • Number of events 16 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
General disorders Injection site induration	0.42% 2/480 • Number of events 2 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
General disorders Injection site movement impairment	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
General disorders Injection site pain	82.7% 397/480 • Number of events 867 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	67.5% 316/468 • Number of events 626 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
General disorders Injection site paraesthesia	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.43% 2/468 • Number of events 2 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
General disorders Injection site pruritus	5.2% 25/480 • Number of events 29 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	2.4% 11/468 • Number of events 12 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
General disorders Injection site rash	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
General disorders Injection site reaction	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.43% 2/468 • Number of events 2 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
General disorders Injection site swelling	25.6% 123/480 • Number of events 188 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	12.2% 57/468 • Number of events 84 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
General disorders Injection site warmth	0.62% 3/480 • Number of events 4 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.64% 3/468 • Number of events 3 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
General disorders Malaise	2.9% 14/480 • Number of events 16 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	3.4% 16/468 • Number of events 18 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
General disorders Puncture site pain	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
General disorders Pyrexia	8.1% 39/480 • Number of events 40 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	6.0% 28/468 • Number of events 29 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
General disorders Swelling	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
General disorders Venipuncture site swelling	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Immune system disorders Seasonal allergy	0.42% 2/480 • Number of events 2 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Infections and infestations Bronchitis	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Infections and infestations Cystitis	0.42% 2/480 • Number of events 2 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	1.5% 7/468 • Number of events 7 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Infections and infestations Dental caries	0.42% 2/480 • Number of events 2 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.43% 2/468 • Number of events 2 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Infections and infestations Folliculitis	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Infections and infestations Gastroenteritis	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.43% 2/468 • Number of events 2 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Infections and infestations Herpes simplex	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Infections and infestations Laryngopharyngitis	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Infections and infestations Lymph gland infection	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Infections and infestations Nasopharyngitis	10.8% 52/480 • Number of events 59 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	11.1% 52/468 • Number of events 60 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Infections and infestations Otitis media	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Infections and infestations Pharyngitis	0.42% 2/480 • Number of events 3 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Infections and infestations Purulence	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Infections and infestations Rash pustular	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Infections and infestations Rhinitis	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 2 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Infections and infestations Subcutaneous abscess	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Infections and infestations Tonsillitis	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.64% 3/468 • Number of events 3 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Infections and infestations Vaginal candidiasis	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Infections and infestations Viral infection	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Injury, poisoning and procedural complications Arthropod sting	0.42% 2/480 • Number of events 2 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.64% 3/468 • Number of events 5 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Injury, poisoning and procedural complications Contusion	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Injury, poisoning and procedural complications Excoriation	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Injury, poisoning and procedural complications Eye injury	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Injury, poisoning and procedural complications Injury corneal	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Injury, poisoning and procedural complications Ligament injury	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Injury, poisoning and procedural complications Skin laceration	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Investigations Alanine aminotransferase increased	0.62% 3/480 • Number of events 3 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	1.3% 6/468 • Number of events 6 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Investigations Aspartate aminotransferase increased	0.42% 2/480 • Number of events 2 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.43% 2/468 • Number of events 2 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Investigations Blood bilirubin increased	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 2 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Investigations Blood pressure decreased	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Investigations C-reactive protein increased	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Investigations Glucose urine present	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.43% 2/468 • Number of events 2 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Investigations Haematocrit decreased	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.64% 3/468 • Number of events 3 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Investigations Haemoglobin decreased	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.85% 4/468 • Number of events 4 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Investigations Platelet count decreased	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Investigations Platelet count increased	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.64% 3/468 • Number of events 3 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Investigations Protein total decreased	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.43% 2/468 • Number of events 2 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Investigations Protein urine present	0.42% 2/480 • Number of events 2 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	1.3% 6/468 • Number of events 6 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Investigations Red blood cell count decreased	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Investigations Weight decreased	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.64% 3/468 • Number of events 3 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Investigations Weight increased	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Investigations White blood cell count decreased	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Investigations White blood cell count increased	0.83% 4/480 • Number of events 4 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.43% 2/468 • Number of events 2 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Metabolism and nutrition disorders Anorexia	0.42% 2/480 • Number of events 2 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.64% 3/468 • Number of events 3 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Musculoskeletal and connective tissue disorders Arthralgia	0.42% 2/480 • Number of events 2 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.85% 4/468 • Number of events 4 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Musculoskeletal and connective tissue disorders Back pain	0.42% 2/480 • Number of events 2 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Musculoskeletal and connective tissue disorders Muscle tightness	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Musculoskeletal and connective tissue disorders Muscle twitching	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.83% 4/480 • Number of events 4 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.43% 2/468 • Number of events 3 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Musculoskeletal and connective tissue disorders Myalgia	0.42% 2/480 • Number of events 2 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Musculoskeletal and connective tissue disorders Neck pain	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Musculoskeletal and connective tissue disorders Pain in extremity	0.62% 3/480 • Number of events 3 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Musculoskeletal and connective tissue disorders Pain in jaw	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Musculoskeletal and connective tissue disorders Sensation of heaviness	0.42% 2/480 • Number of events 2 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Musculoskeletal and connective tissue disorders Shoulder pain	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Nervous system disorders Balance disorder	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Nervous system disorders Dizziness	1.0% 5/480 • Number of events 5 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	1.3% 6/468 • Number of events 8 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Nervous system disorders Dizziness postural	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Nervous system disorders Headache	12.9% 62/480 • Number of events 74 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	10.7% 50/468 • Number of events 67 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Nervous system disorders Hyperaesthesia	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Nervous system disorders Hypoaesthesia	0.42% 2/480 • Number of events 2 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.64% 3/468 • Number of events 3 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Nervous system disorders Migraine	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.43% 2/468 • Number of events 2 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Nervous system disorders Somnolence	0.42% 2/480 • Number of events 2 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.64% 3/468 • Number of events 4 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Nervous system disorders Tremor	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Psychiatric disorders Adjustment disorder	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Psychiatric disorders Anxiety	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Psychiatric disorders Depression	0.42% 2/480 • Number of events 2 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Psychiatric disorders Dysphoria	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Psychiatric disorders Insomnia	0.42% 2/480 • Number of events 2 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Renal and urinary disorders Neurogenic bladder	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Renal and urinary disorders Pollakiuria	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Reproductive system and breast disorders Cervix haemorrhage uterine	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Reproductive system and breast disorders Dysmenorrhoea	3.3% 16/480 • Number of events 17 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	6.0% 28/468 • Number of events 34 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Reproductive system and breast disorders Genital pruritus female	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Reproductive system and breast disorders Menstruation irregular	0.42% 2/480 • Number of events 2 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Reproductive system and breast disorders Metrorrhagia	0.42% 2/480 • Number of events 2 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.85% 4/468 • Number of events 4 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Reproductive system and breast disorders Vaginal discharge	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Respiratory, thoracic and mediastinal disorders Cough	0.42% 2/480 • Number of events 2 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.43% 2/468 • Number of events 2 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Respiratory, thoracic and mediastinal disorders Hyperventilation	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.42% 2/480 • Number of events 3 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Respiratory, thoracic and mediastinal disorders Nasal discomfort	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Respiratory, thoracic and mediastinal disorders Oropharyngeal swelling	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	0.83% 4/480 • Number of events 4 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	1.3% 6/468 • Number of events 6 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Respiratory, thoracic and mediastinal disorders Productive cough	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.42% 2/480 • Number of events 2 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.62% 3/480 • Number of events 3 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Respiratory, thoracic and mediastinal disorders Sneezing	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Skin and subcutaneous tissue disorders Acne	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Skin and subcutaneous tissue disorders Comedone	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.43% 2/468 • Number of events 2 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.62% 3/480 • Number of events 3 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.21% 1/480 • Number of events 2 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Skin and subcutaneous tissue disorders Dermatitis contact	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Skin and subcutaneous tissue disorders Dry skin	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.85% 4/468 • Number of events 4 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Skin and subcutaneous tissue disorders Eczema	0.62% 3/480 • Number of events 3 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.64% 3/468 • Number of events 3 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Skin and subcutaneous tissue disorders Ingrowing nail	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Skin and subcutaneous tissue disorders Pruritus	0.83% 4/480 • Number of events 4 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Skin and subcutaneous tissue disorders Purpura	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Skin and subcutaneous tissue disorders Rash	0.21% 1/480 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.43% 2/468 • Number of events 5 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Skin and subcutaneous tissue disorders Urticaria	0.42% 2/480 • Number of events 2 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Skin and subcutaneous tissue disorders Urticaria generalised	0.42% 2/480 • Number of events 2 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.00% 0/468 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Surgical and medical procedures Tooth extraction	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.
Vascular disorders Hypotension	0.00% 0/480 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.	0.21% 1/468 • Number of events 1 • Serious adverse event data were collected over the entire duration of the study. Other non-serious adverse event data were collected from Day 1 to Day 15 following vaccination. The number of subjects at risk included randomized participants who had follow-up after at least one dose of vaccine. Unlike many countries, in Japan high-grade cervical intraepithelial neoplasias (eg, cervical dysplasia) are often treated in the hospital and are thus categorized as serious adverse events.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp

Phone: 1-800-672-6372

Results disclosure agreements

• Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER