Trial Outcomes & Findings for A Study of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (V503-002) (NCT NCT00943722)
NCT ID: NCT00943722
Last Updated: 2022-10-03
Results Overview
Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using a competitive luminex immunoassay (cLIA). Titers were reported in milli Merck Units/mL.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
3074 participants
Primary outcome timeframe
4 weeks post-vaccination 3 (Month 7)
Results posted on
2022-10-03
Participant Flow
The base study was a 12-month study that collected immunogenicity data through Month 7 and safety data through Month 12.
Extension study 1 (EXT1) collected data to Month 36. Extension study 2 (EXT2) collected long-term data through \~Month 126. No study vaccine was administered. Per protocol, participants enrolled in the 16- to 26-year-old arm in the base study were not included in the extension study. Per protocol, the extension study included data from 9- to 15-year-old females regardless of lot administered (arm: "Extension Study: 9- to 15- Year Old Females").
Participant milestones
| Measure |
Base Study: 9- to 15-Year-Old Females (Lot 1)
9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
|
Base Study: 9- to 15-Year-Old Females (Lot 2)
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 2.
|
Base Study: 9- to 15-Year-Old Females (Lot 3)
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 3.
|
Base Study: 9- to 15-Year-Old Males (Lot 1)
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
|
Base Study: 16- to 26-Year-Old Females (Lot 1)
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
|
Extension Study: 9- to 15-Year-Old Females
In the base study, participants received the 9vHPV L1 VLP vaccine (0.5 mL intramuscular injection) at Day 1, Month 2, and Month 6 and were evaluated through Month 12. In the extension studies, the participants were followed up for safety and immunogenicity up to Month 36 (EXT1) and for immunogenicity, effectiveness, and safety up to Month 126 (EXT2).
|
Extension Study: 9- to 15-Year-Old Males
In the base study, participants received the 9vHPV L1 VLP vaccine (0.5 mL intramuscular injection) at Day 1, Month 2, and Month 6 and were evaluated through Month 12. In the extension studies, the participants were followed up for safety and immunogenicity up to Month 36 (EXT1) and for immunogenicity, effectiveness, and safety up to Month 126 (EXT2)
|
|---|---|---|---|---|---|---|---|
|
Base Study
STARTED
|
648
|
643
|
644
|
669
|
470
|
0
|
0
|
|
Base Study
Vaccination 1
|
646
|
642
|
644
|
666
|
468
|
0
|
0
|
|
Base Study
Vaccination 2
|
637
|
633
|
638
|
658
|
462
|
0
|
0
|
|
Base Study
Vaccination 3
|
635
|
627
|
637
|
653
|
455
|
0
|
0
|
|
Base Study
At Least One Dose With Protocol-specified Safety Follow-up
|
643
|
639
|
641
|
662
|
466
|
0
|
0
|
|
Base Study
COMPLETED
|
623
|
621
|
631
|
647
|
444
|
0
|
0
|
|
Base Study
NOT COMPLETED
|
25
|
22
|
13
|
22
|
26
|
0
|
0
|
|
First Extension Study: EXT 1
STARTED
|
0
|
0
|
0
|
0
|
0
|
1604
|
568
|
|
First Extension Study: EXT 1
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1489
|
527
|
|
First Extension Study: EXT 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
115
|
41
|
|
Second Extension Study: EXT 2
STARTED
|
0
|
0
|
0
|
0
|
0
|
971
|
301
|
|
Second Extension Study: EXT 2
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
720
|
202
|
|
Second Extension Study: EXT 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
251
|
99
|
Reasons for withdrawal
| Measure |
Base Study: 9- to 15-Year-Old Females (Lot 1)
9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
|
Base Study: 9- to 15-Year-Old Females (Lot 2)
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 2.
|
Base Study: 9- to 15-Year-Old Females (Lot 3)
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 3.
|
Base Study: 9- to 15-Year-Old Males (Lot 1)
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
|
Base Study: 16- to 26-Year-Old Females (Lot 1)
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
|
Extension Study: 9- to 15-Year-Old Females
In the base study, participants received the 9vHPV L1 VLP vaccine (0.5 mL intramuscular injection) at Day 1, Month 2, and Month 6 and were evaluated through Month 12. In the extension studies, the participants were followed up for safety and immunogenicity up to Month 36 (EXT1) and for immunogenicity, effectiveness, and safety up to Month 126 (EXT2).
|
Extension Study: 9- to 15-Year-Old Males
In the base study, participants received the 9vHPV L1 VLP vaccine (0.5 mL intramuscular injection) at Day 1, Month 2, and Month 6 and were evaluated through Month 12. In the extension studies, the participants were followed up for safety and immunogenicity up to Month 36 (EXT1) and for immunogenicity, effectiveness, and safety up to Month 126 (EXT2)
|
|---|---|---|---|---|---|---|---|
|
Base Study
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Base Study
Lost to Follow-up
|
12
|
8
|
10
|
8
|
11
|
0
|
0
|
|
Base Study
Physician Decision
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Base Study
Pregnancy
|
0
|
0
|
1
|
0
|
2
|
0
|
0
|
|
Base Study
Protocol Violation
|
0
|
1
|
0
|
0
|
2
|
0
|
0
|
|
Base Study
Withdrawal by Subject
|
12
|
13
|
2
|
13
|
8
|
0
|
0
|
|
Base Study
Month 12 visit not completed
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
|
First Extension Study: EXT 1
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
First Extension Study: EXT 1
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
38
|
10
|
|
First Extension Study: EXT 1
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
32
|
10
|
|
First Extension Study: EXT 1
Disposition Unknown
|
0
|
0
|
0
|
0
|
0
|
44
|
21
|
|
Second Extension Study: EXT 2
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Second Extension Study: EXT 2
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
111
|
46
|
|
Second Extension Study: EXT 2
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
1
|
3
|
|
Second Extension Study: EXT 2
Pregnancy
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Second Extension Study: EXT 2
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
137
|
50
|
Baseline Characteristics
A Study of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (V503-002)
Baseline characteristics by cohort
| Measure |
Base Study: 9- to 15-Year-Old Females (Lot 1)
n=648 Participants
9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
|
Base Study: 9- to 15-Year-Old Females (Lot 2)
n=643 Participants
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 2.
|
Base Study: 9- to 15-Year-Old Females (Lot 3)
n=644 Participants
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 3.
|
Base Study: 9- to 15-Year-Old Males (Lot 1)
n=669 Participants
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
|
Base Study: 16- to 26-Year-Old Females (Lot 1)
n=470 Participants
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
|
Total
n=3074 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
9 to 12 years
|
440 Participants
n=5 Participants
|
432 Participants
n=7 Participants
|
432 Participants
n=5 Participants
|
450 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1754 Participants
n=8 Participants
|
|
Age, Customized
13 to 15 years
|
208 Participants
n=5 Participants
|
211 Participants
n=7 Participants
|
212 Participants
n=5 Participants
|
219 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
850 Participants
n=8 Participants
|
|
Age, Customized
16 to 26 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
470 Participants
n=21 Participants
|
470 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
648 Participants
n=5 Participants
|
643 Participants
n=7 Participants
|
644 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
470 Participants
n=21 Participants
|
2405 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
669 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
669 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 4 weeks post-vaccination 3 (Month 7)Population: 9-15-year-old females and 16-26-year-old females who received 3 vaccinations from Lot 1 and met following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range.
Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using a competitive luminex immunoassay (cLIA). Titers were reported in milli Merck Units/mL.
Outcome measures
| Measure |
Base Study: 9- to 15-Year-Old Females (Lot 1)
n=535 Participants
9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
|
Base Study: 9- to 15-Year-Old Males (Lot 1)
n=378 Participants
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
|
Base Study: 9- to 15-Year-Old Females (Lot 3)
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 3.
|
|---|---|---|---|
|
Base Study: Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] and 16- to 26-Year-Old Females [Lot 1])
Anti-HPV 6
|
1715.4 milli Merck Units/mL
Interval 1595.1 to 1844.7
|
900.8 milli Merck Units/mL
Interval 822.3 to 986.9
|
—
|
|
Base Study: Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] and 16- to 26-Year-Old Females [Lot 1])
Anti-HPV 11
|
1295.1 milli Merck Units/mL
Interval 1204.1 to 1393.0
|
706.6 milli Merck Units/mL
Interval 645.2 to 773.8
|
—
|
|
Base Study: Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] and 16- to 26-Year-Old Females [Lot 1])
Anti-HPV 16
|
6979.8 milli Merck Units/mL
Interval 6508.1 to 7485.8
|
3522.6 milli Merck Units/mL
Interval 3223.5 to 3849.5
|
—
|
|
Base Study: Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] and 16- to 26-Year-Old Females [Lot 1])
Anti-HPV 18
|
2153.7 milli Merck Units/mL
Interval 1980.4 to 2342.1
|
882.7 milli Merck Units/mL
Interval 795.4 to 979.5
|
—
|
|
Base Study: Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] and 16- to 26-Year-Old Females [Lot 1])
Anti-HPV 31
|
1891.6 milli Merck Units/mL
Interval 1745.7 to 2049.7
|
753.9 milli Merck Units/mL
Interval 682.5 to 832.7
|
—
|
|
Base Study: Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] and 16- to 26-Year-Old Females [Lot 1])
Anti-HPV 33
|
980.4 milli Merck Units/mL
Interval 911.7 to 1054.3
|
466.8 milli Merck Units/mL
Interval 426.9 to 510.3
|
—
|
|
Base Study: Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] and 16- to 26-Year-Old Females [Lot 1])
Anti-HPV 45
|
714.4 milli Merck Units/mL
Interval 651.9 to 782.8
|
272.2 milli Merck Units/mL
Interval 243.8 to 303.9
|
—
|
|
Base Study: Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] and 16- to 26-Year-Old Females [Lot 1])
Anti-HPV 52
|
932.9 milli Merck Units/mL
Interval 864.8 to 1006.4
|
419.6 milli Merck Units/mL
Interval 381.4 to 461.5
|
—
|
|
Base Study: Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] and 16- to 26-Year-Old Females [Lot 1])
Anti-HPV 58
|
1286.7 milli Merck Units/mL
Interval 1195.7 to 1384.6
|
590.5 milli Merck Units/mL
Interval 538.2 to 647.9
|
—
|
PRIMARY outcome
Timeframe: 4 weeks post-vaccination 3 (Month 7)Population: 9-15-year-old males and 16-26-year-old females who received 3 vaccinations from Lot 1 and met following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range.
Serum antibody titers for HPV VLPs, Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using a competitive luminex immunoassay (cLIA). Titers were reported in milli Merck Units/mL.
Outcome measures
| Measure |
Base Study: 9- to 15-Year-Old Females (Lot 1)
n=570 Participants
9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
|
Base Study: 9- to 15-Year-Old Males (Lot 1)
n=378 Participants
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
|
Base Study: 9- to 15-Year-Old Females (Lot 3)
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 3.
|
|---|---|---|---|
|
Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Males [Lot 1] and 16- to 26-Year-Old Females [Lot 1])
Anti-HPV 6
|
2084.7 milli Merck Units/mL
Interval 1944.0 to 2235.7
|
900.8 milli Merck Units/mL
Interval 822.3 to 986.9
|
—
|
|
Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Males [Lot 1] and 16- to 26-Year-Old Females [Lot 1])
Anti-HPV 11
|
1487.1 milli Merck Units/mL
Interval 1386.5 to 1595.0
|
706.6 milli Merck Units/mL
Interval 645.2 to 773.8
|
—
|
|
Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Males [Lot 1] and 16- to 26-Year-Old Females [Lot 1])
Anti-HPV 16
|
8628.9 milli Merck Units/mL
Interval 8065.9 to 9231.3
|
3522.6 milli Merck Units/mL
Interval 3223.5 to 3849.5
|
—
|
|
Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Males [Lot 1] and 16- to 26-Year-Old Females [Lot 1])
Anti-HPV 18
|
2822.8 milli Merck Units/mL
Interval 2602.8 to 3061.5
|
882.7 milli Merck Units/mL
Interval 795.4 to 979.5
|
—
|
|
Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Males [Lot 1] and 16- to 26-Year-Old Females [Lot 1])
Anti-HPV 31
|
2221.2 milli Merck Units/mL
Interval 2056.1 to 2399.5
|
753.9 milli Merck Units/mL
Interval 682.5 to 832.7
|
—
|
|
Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Males [Lot 1] and 16- to 26-Year-Old Females [Lot 1])
Anti-HPV 33
|
1198.7 milli Merck Units/mL
Interval 1117.1 to 1286.2
|
466.8 milli Merck Units/mL
Interval 426.9 to 510.3
|
—
|
|
Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Males [Lot 1] and 16- to 26-Year-Old Females [Lot 1])
Anti-HPV 45
|
907.0 milli Merck Units/mL
Interval 830.2 to 991.0
|
272.2 milli Merck Units/mL
Interval 243.8 to 303.9
|
—
|
|
Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Males [Lot 1] and 16- to 26-Year-Old Females [Lot 1])
Anti-HPV 52
|
1037.8 milli Merck Units/mL
Interval 964.4 to 1116.9
|
419.6 milli Merck Units/mL
Interval 381.4 to 461.5
|
—
|
|
Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Males [Lot 1] and 16- to 26-Year-Old Females [Lot 1])
Anti-HPV 58
|
1567.7 milli Merck Units/mL
Interval 1460.2 to 1683.1
|
590.5 milli Merck Units/mL
Interval 538.2 to 647.9
|
—
|
PRIMARY outcome
Timeframe: 4 weeks post-vaccination 3 (Month 7)Population: 9-15-year-old females who received 3 vaccinations from Lots 1, 2, or 3 and met following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range.
Serum antibody titers for HPV VLPs, Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using cLIA. Titers were reported in milli Merck Units/mL.
Outcome measures
| Measure |
Base Study: 9- to 15-Year-Old Females (Lot 1)
n=535 Participants
9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
|
Base Study: 9- to 15-Year-Old Males (Lot 1)
n=549 Participants
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
|
Base Study: 9- to 15-Year-Old Females (Lot 3)
n=565 Participants
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 3.
|
|---|---|---|---|
|
Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study)
Anti-HPV 6
|
1715.4 milli Merck Units/mL
Interval 1588.7 to 1852.2
|
1763.3 milli Merck Units/mL
Interval 1635.4 to 1901.3
|
1659.9 milli Merck Units/mL
Interval 1540.3 to 1788.7
|
|
Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study)
Anti-HPV 11
|
1295.1 milli Merck Units/mL
Interval 1197.8 to 1400.3
|
1311.7 milli Merck Units/mL
Interval 1214.9 to 1416.3
|
1232.0 milli Merck Units/mL
Interval 1141.7 to 1329.5
|
|
Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study)
Anti-HPV 16
|
6979.8 milli Merck Units/mL
Interval 6476.1 to 7522.8
|
7292.9 milli Merck Units/mL
Interval 6772.7 to 7853.1
|
6948.2 milli Merck Units/mL
Interval 6458.7 to 7474.9
|
|
Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study)
Anti-HPV 18
|
2153.7 milli Merck Units/mL
Interval 1970.9 to 2353.5
|
2134.1 milli Merck Units/mL
Interval 1955.6 to 2329.0
|
1966.6 milli Merck Units/mL
Interval 1804.3 to 2143.5
|
|
Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study)
Anti-HPV 31
|
1891.6 milli Merck Units/mL
Interval 1738.5 to 2058.2
|
1867.8 milli Merck Units/mL
Interval 1719.3 to 2029.1
|
1879.0 milli Merck Units/mL
Interval 1731.0 to 2039.6
|
|
Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study)
Anti-HPV 33
|
980.4 milli Merck Units/mL
Interval 909.2 to 1057.2
|
922.7 milli Merck Units/mL
Interval 856.2 to 994.4
|
931.1 milli Merck Units/mL
Interval 865.0 to 1002.3
|
|
Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study)
Anti-HPV 45
|
714.4 milli Merck Units/mL
Interval 650.1 to 785.0
|
827.7 milli Merck Units/mL
Interval 754.1 to 908.5
|
678.4 milli Merck Units/mL
Interval 619.0 to 743.6
|
|
Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study)
Anti-HPV 52
|
932.9 milli Merck Units/mL
Interval 860.8 to 1011.0
|
1007.9 milli Merck Units/mL
Interval 931.0 to 1091.2
|
971.2 milli Merck Units/mL
Interval 898.1 to 1050.3
|
|
Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study)
Anti-HPV 58
|
1286.7 milli Merck Units/mL
Interval 1190.0 to 1391.3
|
1344.9 milli Merck Units/mL
Interval 1244.6 to 1453.3
|
1208.1 milli Merck Units/mL
Interval 1119.6 to 1303.6
|
PRIMARY outcome
Timeframe: Up to 5 days after any vaccinationPopulation: All participants who received at least one dose of 9vHPV vaccine and had available follow-up data. Per protocol, this outcome measure included data from 9- to 15-year-old females regardless of lot administered.
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine was also an AE. AEs such as redness, swelling, and pain/tenderness/soreness at the injection site were recorded.
Outcome measures
| Measure |
Base Study: 9- to 15-Year-Old Females (Lot 1)
n=1923 Participants
9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
|
Base Study: 9- to 15-Year-Old Males (Lot 1)
n=662 Participants
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
|
Base Study: 9- to 15-Year-Old Females (Lot 3)
n=466 Participants
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 3.
|
|---|---|---|---|
|
Base Study: Percentage of Participants With Injection Site Adverse Experiences (AEs)
|
81.9 Percentage of Participants
|
72.8 Percentage of Participants
|
85.4 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to 15 days after any vaccinationPopulation: All participants who received at least one dose of 9vHPV vaccine and had available follow-up data. Per protocol, this outcome measure included data from 9- to 15-year-old females regardless of lot administered.
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine was also an AE. Systemic AEs were those not categorized as injection-site AEs.
Outcome measures
| Measure |
Base Study: 9- to 15-Year-Old Females (Lot 1)
n=1923 Participants
9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
|
Base Study: 9- to 15-Year-Old Males (Lot 1)
n=662 Participants
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
|
Base Study: 9- to 15-Year-Old Females (Lot 3)
n=466 Participants
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 3.
|
|---|---|---|---|
|
Base Study: Percentage of Participants With Systemic AEs
|
45.0 Percentage of Participants
|
41.8 Percentage of Participants
|
57.1 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to 5 days after any vaccinationPopulation: All participants who received at least one dose of 9vHPV vaccine and had available follow-up data. Per protocol, this outcome measure included data from 9- to 15-year-old females regardless of lot administered.
Participants collected their oral body temperature in the evening of their vaccination day and at the same time each day thereafter for 4 days. The maximum body temperature obtained within 5 days of any of the 3 vaccinations was recorded. The percentage of participants who had at least 1 oral body temperature reading that was ≥100.0°F (≥37.8ºC) was summarized.
Outcome measures
| Measure |
Base Study: 9- to 15-Year-Old Females (Lot 1)
n=1908 Participants
9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
|
Base Study: 9- to 15-Year-Old Males (Lot 1)
n=660 Participants
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
|
Base Study: 9- to 15-Year-Old Females (Lot 3)
n=463 Participants
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 3.
|
|---|---|---|---|
|
Base Study: Percentage of Participants With Body Temperature ≥100.0°F (≥37.8ºC)
|
8.4 Percentage of Participants
|
10.0 Percentage of Participants
|
8.4 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to ~Month 126Population: All participants who met the following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range.
Serum antibody titers (milli Merck Units/mL) measured by cLIA to each of the 9vHPV types were assessed. Per protocol, the extension study included data from 9- to 15-year-old females regardless of lot administered.
Outcome measures
| Measure |
Base Study: 9- to 15-Year-Old Females (Lot 1)
n=971 Participants
9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
|
Base Study: 9- to 15-Year-Old Males (Lot 1)
n=301 Participants
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
|
Base Study: 9- to 15-Year-Old Females (Lot 3)
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 3.
|
|---|---|---|---|
|
Extension Study: GMTs For Each of the HPV Types Contained in the Vaccine
Anti-HPV 6
|
122.3 milli Merck Units/mL
Interval 111.1 to 134.7
|
129.5 milli Merck Units/mL
Interval 112.5 to 149.1
|
—
|
|
Extension Study: GMTs For Each of the HPV Types Contained in the Vaccine
Anti-HPV 11
|
80.2 milli Merck Units/mL
Interval 72.5 to 88.8
|
91.0 milli Merck Units/mL
Interval 78.4 to 105.6
|
—
|
|
Extension Study: GMTs For Each of the HPV Types Contained in the Vaccine
Anti-HPV 16
|
403.0 milli Merck Units/mL
Interval 357.3 to 454.5
|
414.3 milli Merck Units/mL
Interval 353.8 to 485.3
|
—
|
|
Extension Study: GMTs For Each of the HPV Types Contained in the Vaccine
Anti-HPV 18
|
128.1 milli Merck Units/mL
Interval 116.7 to 140.7
|
148.4 milli Merck Units/mL
Interval 130.2 to 169.2
|
—
|
|
Extension Study: GMTs For Each of the HPV Types Contained in the Vaccine
Anti-HPV 31
|
108.9 milli Merck Units/mL
Interval 97.6 to 121.6
|
128.6 milli Merck Units/mL
Interval 111.2 to 148.8
|
—
|
|
Extension Study: GMTs For Each of the HPV Types Contained in the Vaccine
Anti-HPV 33
|
59.2 milli Merck Units/mL
Interval 53.7 to 65.2
|
69.6 milli Merck Units/mL
Interval 60.7 to 79.7
|
—
|
|
Extension Study: GMTs For Each of the HPV Types Contained in the Vaccine
Anti-HPV 45
|
42.1 milli Merck Units/mL
Interval 37.7 to 47.1
|
49.8 milli Merck Units/mL
Interval 43.0 to 57.8
|
—
|
|
Extension Study: GMTs For Each of the HPV Types Contained in the Vaccine
Anti-HPV 52
|
55.3 milli Merck Units/mL
Interval 50.5 to 60.6
|
59.6 milli Merck Units/mL
Interval 52.0 to 68.4
|
—
|
|
Extension Study: GMTs For Each of the HPV Types Contained in the Vaccine
Anti-HPV 58
|
76.5 milli Merck Units/mL
Interval 69.2 to 84.6
|
90.5 milli Merck Units/mL
Interval 78.4 to 104.6
|
—
|
PRIMARY outcome
Timeframe: Up to ~Month 126Population: All participants who met the following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range.
Serum antibody titers for HPV VLPs Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 was determined and reported in milli Merck Units/mL. The percentage of participants seropositive to each HPV type was reported. Per protocol, the extension study included data from 9- to 15-year-old females regardless of lot administered.
Outcome measures
| Measure |
Base Study: 9- to 15-Year-Old Females (Lot 1)
n=971 Participants
9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
|
Base Study: 9- to 15-Year-Old Males (Lot 1)
n=301 Participants
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
|
Base Study: 9- to 15-Year-Old Females (Lot 3)
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 3.
|
|---|---|---|---|
|
Extension Study: Percentage of Participants Who Are Seropositive to Each of the HPV Types Contained in the Vaccine
Anti-HPV 6
|
82.7 Percentage of Participants
Interval 78.3 to 86.6
|
84.1 Percentage of Participants
Interval 77.8 to 89.2
|
—
|
|
Extension Study: Percentage of Participants Who Are Seropositive to Each of the HPV Types Contained in the Vaccine
Anti-HPV 11
|
85.2 Percentage of Participants
Interval 81.0 to 88.9
|
87.0 Percentage of Participants
Interval 81.0 to 91.7
|
—
|
|
Extension Study: Percentage of Participants Who Are Seropositive to Each of the HPV Types Contained in the Vaccine
Anti-HPV 16
|
97.3 Percentage of Participants
Interval 95.0 to 98.8
|
98.3 Percentage of Participants
Interval 95.0 to 99.6
|
—
|
|
Extension Study: Percentage of Participants Who Are Seropositive to Each of the HPV Types Contained in the Vaccine
Anti-HPV 18
|
80.1 Percentage of Participants
Interval 75.5 to 84.2
|
83.7 Percentage of Participants
Interval 77.4 to 88.8
|
—
|
|
Extension Study: Percentage of Participants Who Are Seropositive to Each of the HPV Types Contained in the Vaccine
Anti-HPV 31
|
90.1 Percentage of Participants
Interval 86.4 to 93.0
|
92.7 Percentage of Participants
Interval 87.8 to 96.0
|
—
|
|
Extension Study: Percentage of Participants Who Are Seropositive to Each of the HPV Types Contained in the Vaccine
Anti-HPV 33
|
85.2 Percentage of Participants
Interval 81.0 to 88.8
|
89.3 Percentage of Participants
Interval 83.8 to 93.4
|
—
|
|
Extension Study: Percentage of Participants Who Are Seropositive to Each of the HPV Types Contained in the Vaccine
Anti-HPV 45
|
81.8 Percentage of Participants
Interval 77.2 to 85.9
|
92.3 Percentage of Participants
Interval 87.2 to 95.8
|
—
|
|
Extension Study: Percentage of Participants Who Are Seropositive to Each of the HPV Types Contained in the Vaccine
Anti-HPV 52
|
88.2 Percentage of Participants
Interval 84.4 to 91.4
|
89.2 Percentage of Participants
Interval 83.7 to 93.4
|
—
|
|
Extension Study: Percentage of Participants Who Are Seropositive to Each of the HPV Types Contained in the Vaccine
Anti-HPV 58
|
96.5 Percentage of Participants
Interval 94.0 to 98.2
|
97.1 Percentage of Participants
Interval 93.5 to 99.1
|
—
|
SECONDARY outcome
Timeframe: 4 weeks post-vaccination 3 (Month 7)Population: 9-15-year-old females and 16-26-year-old females who received 3 vaccinations from Lot 1 and met following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range.
Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using cLIA. The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30, HPV Type 11: ≥16; HPV Type 16: ≥20, HPV Type 18: ≥24, HPV Type 31: ≥10, HPV Type 33: ≥8, HPV Type 45: ≥8, HPV Type 52: ≥8, and HPV Type 58: ≥8.
Outcome measures
| Measure |
Base Study: 9- to 15-Year-Old Females (Lot 1)
n=535 Participants
9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
|
Base Study: 9- to 15-Year-Old Males (Lot 1)
n=378 Participants
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
|
Base Study: 9- to 15-Year-Old Females (Lot 3)
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 3.
|
|---|---|---|---|
|
Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] and 16- to 26-Year-Old Females [Lot 1])
Anti-HPV 6 cLIA ≥30 mMU/mL
|
99.8 Percentage of Participants
Interval 98.9 to 100.0
|
99.7 Percentage of Participants
Interval 98.3 to 100.0
|
—
|
|
Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] and 16- to 26-Year-Old Females [Lot 1])
Anti-HPV 11 cLIA ≥16 mMU/mL
|
100 Percentage of Participants
Interval 99.3 to 100.0
|
100 Percentage of Participants
Interval 98.9 to 100.0
|
—
|
|
Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] and 16- to 26-Year-Old Females [Lot 1])
Anti-HPV 16 cLIA ≥20 mMU/mL
|
100 Percentage of Participants
Interval 99.3 to 100.0
|
100 Percentage of Participants
Interval 98.9 to 100.0
|
—
|
|
Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] and 16- to 26-Year-Old Females [Lot 1])
Anti-HPV 18 cLIA ≥24 mMU/mL
|
99.8 Percentage of Participants
Interval 99.0 to 100.0
|
99.7 Percentage of Participants
Interval 98.4 to 100.0
|
—
|
|
Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] and 16- to 26-Year-Old Females [Lot 1])
Anti-HPV 31 cLIA ≥10 mMU/mL
|
100.0 Percentage of Participants
Interval 99.3 to 100.0
|
99.7 Percentage of Participants
Interval 98.4 to 100.0
|
—
|
|
Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] and 16- to 26-Year-Old Females [Lot 1])
Anti-HPV 33 cLIA ≥8 mMU/mL
|
100.0 Percentage of Participants
Interval 99.3 to 100.0
|
99.7 Percentage of Participants
Interval 98.4 to 100.0
|
—
|
|
Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] and 16- to 26-Year-Old Females [Lot 1])
Anti-HPV 45 cLIA ≥8 mMU/mL
|
99.8 Percentage of Participants
Interval 99.0 to 100.0
|
99.5 Percentage of Participants
Interval 98.1 to 99.9
|
—
|
|
Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] and 16- to 26-Year-Old Females [Lot 1])
Anti-HPV 52 cLIA ≥8 mMU/mL
|
100.0 Percentage of Participants
Interval 99.3 to 100.0
|
99.7 Percentage of Participants
Interval 98.4 to 100.0
|
—
|
|
Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] and 16- to 26-Year-Old Females [Lot 1])
Anti-HPV 58 cLIA ≥8 mMU/mL
|
100.0 Percentage of Participants
Interval 99.3 to 100.0
|
100.0 Percentage of Participants
Interval 98.9 to 100.0
|
—
|
SECONDARY outcome
Timeframe: 4 weeks post-vaccination 3 (Month 7)Population: 9-15-year-old males and 16-26-year-old females who received 3 vaccinations from Lot 1 and met following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range
Serum antibody titers for HPV VLPs, Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using cLIA. The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30, HPV Type 11: ≥16; HPV Type 16: ≥20, HPV Type 18: ≥24, HPV Type 31: ≥10, HPV Type 33: ≥8, HPV Type 45: ≥8, HPV Type 52: ≥8, and HPV Type 58: ≥8.
Outcome measures
| Measure |
Base Study: 9- to 15-Year-Old Females (Lot 1)
n=570 Participants
9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
|
Base Study: 9- to 15-Year-Old Males (Lot 1)
n=378 Participants
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
|
Base Study: 9- to 15-Year-Old Females (Lot 3)
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 3.
|
|---|---|---|---|
|
Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Males [Lot 1] Versus 16- to 26-Year-Old Females [Lot 1])
Anti-HPV 6 cLIA ≥30 mMU/mL
|
99.8 Percentage of Participants
Interval 99.0 to 100.0
|
99.7 Percentage of Participants
Interval 98.3 to 100.0
|
—
|
|
Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Males [Lot 1] Versus 16- to 26-Year-Old Females [Lot 1])
Anti-HPV 11 cLIA ≥16 mMU/mL
|
100.0 Percentage of Participants
Interval 99.3 to 100.0
|
100.0 Percentage of Participants
Interval 98.9 to 100.0
|
—
|
|
Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Males [Lot 1] Versus 16- to 26-Year-Old Females [Lot 1])
Anti-HPV 16 cLIA ≥20 mMU/mL
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
100.0 Percentage of Participants
Interval 98.9 to 100.0
|
—
|
|
Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Males [Lot 1] Versus 16- to 26-Year-Old Females [Lot 1])
Anti-HPV 18 cLIA ≥24 mMU/mL
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
99.7 Percentage of Participants
Interval 98.4 to 100.0
|
—
|
|
Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Males [Lot 1] Versus 16- to 26-Year-Old Females [Lot 1])
Anti-HPV 31 cLIA ≥10 mMU/mL
|
100.0 Percentage of Participants
Interval 99.3 to 100.0
|
99.7 Percentage of Participants
Interval 98.4 to 100.0
|
—
|
|
Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Males [Lot 1] Versus 16- to 26-Year-Old Females [Lot 1])
Anti-HPV 33 cLIA ≥8 mMU/mL
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
99.7 Percentage of Participants
Interval 98.4 to 100.0
|
—
|
|
Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Males [Lot 1] Versus 16- to 26-Year-Old Females [Lot 1])
Anti-HPV 45 cLIA ≥8 mMU/mL
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
99.5 Percentage of Participants
Interval 98.1 to 99.9
|
—
|
|
Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Males [Lot 1] Versus 16- to 26-Year-Old Females [Lot 1])
Anti-HPV 52 cLIA ≥8 mMU/mL
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
99.7 Percentage of Participants
Interval 98.4 to 100.0
|
—
|
|
Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Males [Lot 1] Versus 16- to 26-Year-Old Females [Lot 1])
Anti-HPV 58 cLIA ≥8 mMU/mL
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
100.0 Percentage of Participants
Interval 98.9 to 100.0
|
—
|
SECONDARY outcome
Timeframe: 4 weeks post-vaccination 3 (Month 7)Population: 9- to 15-year-old females who received 3 vaccinations from Lots 1, 2, and 3 and met following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range
Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post- vaccination 3 using cLIA. The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30, HPV Type 11: ≥16; HPV Type 16: ≥20, HPV Type 18: ≥24, HPV Type 31: ≥10, HPV Type 33: ≥8, HPV Type 45: ≥8, HPV Type 52: ≥8, and HPV Type 58: ≥8.
Outcome measures
| Measure |
Base Study: 9- to 15-Year-Old Females (Lot 1)
n=535 Participants
9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
|
Base Study: 9- to 15-Year-Old Males (Lot 1)
n=549 Participants
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
|
Base Study: 9- to 15-Year-Old Females (Lot 3)
n=565 Participants
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 3.
|
|---|---|---|---|
|
Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (Lot Consistency Study)
HPV 6 cLIA ≥30 mMU/mL
|
99.8 Percentage of Participants
Interval 98.9 to 100.0
|
99.8 Percentage of Participants
Interval 99.0 to 100.0
|
99.3 Percentage of Participants
Interval 98.1 to 99.8
|
|
Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (Lot Consistency Study)
HPV 11 cLIA ≥16 mMU/mL
|
100.0 Percentage of Participants
Interval 99.3 to 100.0
|
100.0 Percentage of Participants
Interval 99.3 to 100.0
|
99.6 Percentage of Participants
Interval 98.7 to 100.0
|
|
Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (Lot Consistency Study)
HPV 16 cLIA ≥20 mMU/mL
|
100.0 Percentage of Participants
Interval 99.3 to 100.0
|
100.0 Percentage of Participants
Interval 99.3 to 100.0
|
99.6 Percentage of Participants
Interval 98.7 to 100.0
|
|
Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (Lot Consistency Study)
HPV 18 cLIA ≥24 mMU/mL
|
99.8 Percentage of Participants
Interval 99.0 to 100.0
|
100.0 Percentage of Participants
Interval 99.3 to 100.0
|
99.6 Percentage of Participants
Interval 98.7 to 100.0
|
|
Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (Lot Consistency Study)
HPV 31 cLIA ≥10 mMU/mL
|
100.0 Percentage of Participants
Interval 99.3 to 100.0
|
100.0 Percentage of Participants
Interval 99.3 to 100.0
|
99.8 Percentage of Participants
Interval 99.0 to 100.0
|
|
Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (Lot Consistency Study)
HPV 33 cLIA ≥8 mMU/mL
|
100.0 Percentage of Participants
Interval 99.3 to 100.0
|
100.0 Percentage of Participants
Interval 99.3 to 100.0
|
99.6 Percentage of Participants
Interval 98.7 to 100.0
|
|
Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (Lot Consistency Study)
HPV 45 cLIA ≥8 mMU/mL
|
99.8 Percentage of Participants
Interval 99.0 to 100.0
|
100.0 Percentage of Participants
Interval 99.3 to 100.0
|
99.6 Percentage of Participants
Interval 98.7 to 100.0
|
|
Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (Lot Consistency Study)
HPV 52 cLIA ≥8 mMU/mL
|
100.0 Percentage of Participants
Interval 99.3 to 100.0
|
100.0 Percentage of Participants
Interval 99.3 to 100.0
|
99.6 Percentage of Participants
Interval 98.7 to 100.0
|
|
Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (Lot Consistency Study)
HPV 58 cLIA ≥8 mMU/mL
|
100.0 Percentage of Participants
Interval 99.3 to 100.0
|
100.0 Percentage of Participants
Interval 99.3 to 100.0
|
99.6 Percentage of Participants
Interval 98.7 to 100.0
|
SECONDARY outcome
Timeframe: Up to ~Month 126Population: The per-protocol effectiveness population, which included participants who were seronegative (by cLIA) to the relevant HPV type(s) at Day 1 (seronegative to both HPV 6 and 11 for analysis of HPV 6 and 11 HPV11-related endpoints), received all 3 doses of 9vHPV vaccine with the correct dose of the clinical material within 1 year, and had no other protocol violation that could interfere with evaluation of vaccine effectiveness.
Persistent infection is when a participant is positive by polymerase chain reaction (PCR) for the same HPV type in cervicovaginal/external genital swabs or tissue specimens collected at consecutive visits at least 6 months (+/-1 month visit window) apart. Incidence was estimated as cases per 10,000 person-years. Person-years follow-up was from beginning of long-term follow-up or when a study participant reached 16 years of age, whichever came later. Per protocol, the extension study included 9- to 15-year-old females regardless of lot administered.
Outcome measures
| Measure |
Base Study: 9- to 15-Year-Old Females (Lot 1)
n=872 Participants
9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
|
Base Study: 9- to 15-Year-Old Males (Lot 1)
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
|
Base Study: 9- to 15-Year-Old Females (Lot 3)
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 3.
|
|---|---|---|---|
|
Extension Study: Combined Incidence of HPV 6/11/16/18/31/33/45/52/58-Related Persistent Infection in Females
|
52.4 Cases per 10,000 person-years
95% Confidence Interval 33.6 • Interval 33.6 to 78.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to ~Month 126Population: The per-protocol effectiveness population, which included participants who were seronegative (by cLIA) to the relevant HPV type(s) at Day 1 (seronegative to both HPV 6 and 11 for analysis of HPV 6 and 11-related endpoints), received all 3 doses of 9vHPV vaccine with the correct dose of the clinical material within 1 year, and had no other protocol violation that could interfere with evaluation of vaccine effectiveness.
Persistent infection is when a participant is positive by PCR for the same HPV type in external genital swabs or tissue specimens collected at consecutive visits at least 6 months (+/-1 month visit window) apart. Incidence was estimated as cases per 10,000 person-years. Person-years follow-up was from beginning of long-term follow-up or when a study participant reached 16 years of age, whichever came later.
Outcome measures
| Measure |
Base Study: 9- to 15-Year-Old Females (Lot 1)
n=261 Participants
9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
|
Base Study: 9- to 15-Year-Old Males (Lot 1)
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
|
Base Study: 9- to 15-Year-Old Females (Lot 3)
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 3.
|
|---|---|---|---|
|
Extension Study: Combined Incidence of HPV 6/11/16/18/31/33/45/52/58-Related Persistent Infection in Males
|
54.6 Cases per 10,000 person-years
95% Confidence Interval 21.9 • Interval 21.9 to 112.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to ~Month 126Population: The per-protocol effectiveness population, which included participants who were seronegative (by cLIA) to the relevant HPV type(s) at Day 1 (seronegative to both HPV 6 and 11 for analysis of HPV 6 and 11-related endpoints), received all 3 doses of 9vHPV vaccine with the correct dose of the clinical material within 1 year, and had no other protocol violation that could interfere with evaluation of vaccine effectiveness.
The combined incidence of cervical intraepithelial neoplasia, vulvar intraepithelial neoplasia, vaginal intraepithelial neoplasia, genital warts, and cervical/vulvar/vaginal cancers, related to HPV 6/11/16/18/31/33/45/52/58 was assessed. This outcome measure was determined by clinical/pathologic criteria and positive PCR assay for HPV type. Incidence was estimated as cases per 10,000 person-years. Person-years follow-up was calculated starting from the beginning of the long-term follow-up study or the date when the study participant reached 16 years of age, whichever came later. Per protocol, the extension study included data from 9- to 15-year-old females regardless of lot administered.
Outcome measures
| Measure |
Base Study: 9- to 15-Year-Old Females (Lot 1)
n=866 Participants
9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
|
Base Study: 9- to 15-Year-Old Males (Lot 1)
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
|
Base Study: 9- to 15-Year-Old Females (Lot 3)
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 3.
|
|---|---|---|---|
|
Extension Study: Combined Incidence of Cervical Intraepithelial Neoplasia, Vulvar Intraepithelial Neoplasia, Vaginal Intraepithelial Neoplasia, Genital Warts, and Cervical/Vulvar/Vaginal Cancers Related to HPV 6/11/16/18/31/33/45/52/58 in Females
|
2.2 Cases per 10,000 person-years
95% Confidence Interval 0.1 • Interval 0.1 to 12.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to ~Month 126Population: The per-protocol effectiveness population, which included participants who were seronegative (by cLIA) to the relevant HPV type(s) at Day 1 (seronegative to both HPV 6 and 11 for analysis of HPV 6 and 11-related endpoints), received all 3 doses of 9vHPV vaccine with the correct dose of the clinical material within 1 year, and had no other protocol violation that could interfere with evaluation of vaccine effectiveness.
The combined incidence of penile intraepithelial neoplasia, penile/perineal/perianal cancers, and genital warts related to HPV6/11/16/18/31/33/45/52/58 was assessed. This outcome measure was determined by clinical/pathologic criteria and positive PCR assay for HPV type. Incidence was estimated as cases per 10,000 person-years. For each study participant, person-years follow up was calculated starting from the beginning of the long-term follow-up study or the date when the study participant reached 16 years of age, whichever came later.
Outcome measures
| Measure |
Base Study: 9- to 15-Year-Old Females (Lot 1)
n=261 Participants
9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
|
Base Study: 9- to 15-Year-Old Males (Lot 1)
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
|
Base Study: 9- to 15-Year-Old Females (Lot 3)
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 3.
|
|---|---|---|---|
|
Extension Study: Combined Incidence of Penile Intraepithelial Neoplasia, Penile/Perineal/Perianal Cancers and Genital Warts Related to HPV 6/11/16/18/31/33/45/52/58 in Males
|
0.0 Cases per 10,000 person-years
95% Confidence Interval 0.0 • Interval 0.0 to 28.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to ~Month 126Population: All participants who received at least 1 study vaccination in the base study and had follow-up data.
A serious adverse event (SAE) included a death which resulted in the participant discontinuing the study, a serious adverse experience that was considered by an investigator who was a qualified physician to be possibly, probably, or definitely vaccine related or study procedure related. Per protocol, the extension study included data from 9- to 15-year-old females regardless of lot administered.
Outcome measures
| Measure |
Base Study: 9- to 15-Year-Old Females (Lot 1)
n=971 Participants
9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
|
Base Study: 9- to 15-Year-Old Males (Lot 1)
n=301 Participants
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
|
Base Study: 9- to 15-Year-Old Females (Lot 3)
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 3.
|
|---|---|---|---|
|
Extension Study: Percentage of Participants With Vaccine-Related or Procedure-Related Serious Adverse Events
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
—
|
Adverse Events
Base Study: 9- to 15-Year-Old Females (Lot 1)
Serious events: 6 serious events
Other events: 538 other events
Deaths: 0 deaths
Base Study: 9- to 15-Year-Old Females (Lot 2)
Serious events: 2 serious events
Other events: 537 other events
Deaths: 0 deaths
Base Study: 9- to 15-Year-Old Females (Lot 3)
Serious events: 8 serious events
Other events: 554 other events
Deaths: 0 deaths
Base Study: 9- to 15-Year-Old Males (Lot 1)
Serious events: 11 serious events
Other events: 505 other events
Deaths: 0 deaths
Base Study: 16- to 26-Year-Old Females (Lot 1)
Serious events: 15 serious events
Other events: 404 other events
Deaths: 0 deaths
EXT1: 9- to 15-Year-Old Females
Serious events: 2 serious events
Other events: 0 other events
Deaths: 1 deaths
EXT1: 9- to 15-Year-Old Males
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
EXT2: 9- to 15-Year-Old Females
Serious events: 3 serious events
Other events: 0 other events
Deaths: 1 deaths
EXT2: 9- to 15-Year-Old Males
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Base Study: 9- to 15-Year-Old Females (Lot 1)
n=643 participants at risk
9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
|
Base Study: 9- to 15-Year-Old Females (Lot 2)
n=639 participants at risk
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 2.
|
Base Study: 9- to 15-Year-Old Females (Lot 3)
n=641 participants at risk
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 3.
|
Base Study: 9- to 15-Year-Old Males (Lot 1)
n=662 participants at risk
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
|
Base Study: 16- to 26-Year-Old Females (Lot 1)
n=466 participants at risk
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
|
EXT1: 9- to 15-Year-Old Females
n=1604 participants at risk
In the base study, participants received the 9vHPV L1 VLP vaccine (0.5 mL intramuscular injection) at Day 1, Month 2, and Month 6 and were evaluated through Month 12. In the extension study, the participants were followed up for safety and immunogenicity up to Month 36 (EXT1).
|
EXT1: 9- to 15-Year-Old Males
n=568 participants at risk
In the base study, participants received the 9vHPV L1 VLP vaccine (0.5 mL intramuscular injection) at Day 1, Month 2, and Month 6 and were evaluated through Month 12. In the extension study, the participants were followed up for safety and immunogenicity up to Month 36 (EXT1).
|
EXT2: 9- to 15-Year-Old Females
n=971 participants at risk
In the base study, participants received the 9vHPV L1 VLP vaccine (0.5 mL intramuscular injection) at Day 1, Month 2, and Month 6 and were evaluated through Month 12. In the extension study, the participants were followed up for immunogenicity, effectiveness, and safety up to Month 126 (EXT2).
|
EXT2: 9- to 15-Year-Old Males
n=301 participants at risk
In the base study, participants received the 9vHPV L1 VLP vaccine (0.5 mL intramuscular injection) at Day 1, Month 2, and Month 6 and were evaluated through Month 12. In the extension study, the participants were followed up for immunogenicity, effectiveness, and safety up to Month 126 (EXT2).
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/643 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/639 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/641 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/662 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.21%
1/466 • Number of events 3 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/1604 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/568 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/971 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/301 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/643 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/639 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.16%
1/641 • Number of events 1 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/662 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/466 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/1604 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/568 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/971 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/301 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.16%
1/643 • Number of events 1 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/639 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/641 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/662 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/466 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/1604 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/568 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/971 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/301 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/643 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/639 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.16%
1/641 • Number of events 1 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/662 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/466 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/1604 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/568 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/971 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/301 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
|
General disorders
Pyrexia
|
0.00%
0/643 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/639 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.16%
1/641 • Number of events 1 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/662 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/466 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/1604 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/568 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/971 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/301 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/643 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/639 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/641 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/662 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.21%
1/466 • Number of events 1 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/1604 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/568 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/971 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/301 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
|
Infections and infestations
Appendicitis
|
0.16%
1/643 • Number of events 1 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.16%
1/639 • Number of events 1 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/641 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.45%
3/662 • Number of events 3 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/466 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/1604 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/568 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/971 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/301 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
|
Infections and infestations
Disseminated tuberculosis
|
0.00%
0/643 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/639 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/641 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/662 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/466 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/1604 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/568 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.10%
1/971 • Number of events 1 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/301 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/643 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/639 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/641 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.15%
1/662 • Number of events 1 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/466 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/1604 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/568 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/971 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/301 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/643 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/639 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.16%
1/641 • Number of events 1 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/662 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/466 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/1604 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/568 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/971 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/301 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/643 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/639 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.16%
1/641 • Number of events 1 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/662 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/466 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/1604 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/568 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/971 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/301 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
|
Infections and infestations
Paronychia
|
0.00%
0/643 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/639 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.16%
1/641 • Number of events 1 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/662 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/466 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/1604 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/568 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/971 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/301 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/643 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/639 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/641 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.15%
1/662 • Number of events 1 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/466 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/1604 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/568 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/971 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/301 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
|
Infections and infestations
Pneumonia
|
0.16%
1/643 • Number of events 1 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/639 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/641 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/662 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/466 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/1604 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/568 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/971 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/301 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
|
Infections and infestations
Sepsis
|
0.00%
0/643 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/639 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/641 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/662 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/466 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.06%
1/1604 • Number of events 1 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/568 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/971 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/301 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/643 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/639 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.16%
1/641 • Number of events 1 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/662 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/466 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/1604 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/568 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/971 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/301 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.16%
1/643 • Number of events 1 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/639 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/641 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/662 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/466 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/1604 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/568 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/971 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/301 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/643 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/639 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/641 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/662 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.21%
1/466 • Number of events 1 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/1604 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/568 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/971 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/301 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/643 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/639 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/641 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.15%
1/662 • Number of events 1 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/466 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/1604 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/568 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/971 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/301 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/643 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/639 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.16%
1/641 • Number of events 1 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/662 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.21%
1/466 • Number of events 1 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/1604 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/568 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/971 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/301 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/643 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/639 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/641 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/662 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.21%
1/466 • Number of events 1 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/1604 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/568 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/971 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/301 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.00%
0/643 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/639 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/641 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/662 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.21%
1/466 • Number of events 1 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/1604 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/568 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/971 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/301 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/643 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/639 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/641 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.15%
1/662 • Number of events 1 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/466 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/1604 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/568 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/971 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/301 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/643 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/639 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/641 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.15%
1/662 • Number of events 1 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/466 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/1604 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/568 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/971 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/301 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
|
Injury, poisoning and procedural complications
Tongue injury
|
0.00%
0/643 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/639 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.16%
1/641 • Number of events 1 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/662 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/466 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/1604 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/568 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/971 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/301 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
|
Nervous system disorders
Brain injury
|
0.00%
0/643 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/639 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/641 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.15%
1/662 • Number of events 1 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/466 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/1604 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/568 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/971 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/301 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
|
Nervous system disorders
Headache
|
0.00%
0/643 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/639 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/641 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/662 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.21%
1/466 • Number of events 1 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/1604 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/568 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/971 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/301 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/643 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/639 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/641 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/662 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.21%
1/466 • Number of events 1 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/1604 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/568 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/971 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/301 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
|
Pregnancy, puerperium and perinatal conditions
Abortion threatened
|
0.00%
0/643 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/639 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/641 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/662 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/466 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/1604 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/568 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.10%
1/971 • Number of events 1 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/301 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
|
Pregnancy, puerperium and perinatal conditions
Cervical incompetence
|
0.00%
0/643 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/639 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/641 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/662 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.21%
1/466 • Number of events 1 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/1604 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/568 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/971 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/301 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/643 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/639 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/641 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/662 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.21%
1/466 • Number of events 1 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/1604 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/568 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/971 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/301 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
|
Pregnancy, puerperium and perinatal conditions
Foetal distress syndrome
|
0.00%
0/643 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/639 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/641 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/662 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.21%
1/466 • Number of events 1 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/1604 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/568 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/971 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/301 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
|
Pregnancy, puerperium and perinatal conditions
Premature baby
|
0.00%
0/643 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/639 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/641 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/662 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/466 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.06%
1/1604 • Number of events 1 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/568 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.10%
1/971 • Number of events 1 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/301 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
|
Psychiatric disorders
Acute psychosis
|
0.00%
0/643 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/639 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.16%
1/641 • Number of events 1 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/662 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/466 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/1604 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/568 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/971 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/301 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/643 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/639 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/641 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.15%
1/662 • Number of events 1 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/466 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/1604 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/568 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/971 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/301 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/643 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/639 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/641 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/662 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.21%
1/466 • Number of events 1 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/1604 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/568 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/971 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/301 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.16%
1/643 • Number of events 1 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/639 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/641 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/662 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/466 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/1604 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/568 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/971 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/301 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis
|
0.00%
0/643 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/639 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/641 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.15%
1/662 • Number of events 1 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/466 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/1604 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/568 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/971 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/301 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.16%
1/643 • Number of events 1 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/639 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/641 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/662 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/466 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/1604 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/568 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/971 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/301 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
|
Surgical and medical procedures
Abortion induced
|
0.00%
0/643 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.16%
1/639 • Number of events 1 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/641 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/662 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
1.1%
5/466 • Number of events 5 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/1604 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/568 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/971 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/301 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
Other adverse events
| Measure |
Base Study: 9- to 15-Year-Old Females (Lot 1)
n=643 participants at risk
9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
|
Base Study: 9- to 15-Year-Old Females (Lot 2)
n=639 participants at risk
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 2.
|
Base Study: 9- to 15-Year-Old Females (Lot 3)
n=641 participants at risk
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 3.
|
Base Study: 9- to 15-Year-Old Males (Lot 1)
n=662 participants at risk
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
|
Base Study: 16- to 26-Year-Old Females (Lot 1)
n=466 participants at risk
9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
|
EXT1: 9- to 15-Year-Old Females
n=1604 participants at risk
In the base study, participants received the 9vHPV L1 VLP vaccine (0.5 mL intramuscular injection) at Day 1, Month 2, and Month 6 and were evaluated through Month 12. In the extension study, the participants were followed up for safety and immunogenicity up to Month 36 (EXT1).
|
EXT1: 9- to 15-Year-Old Males
n=568 participants at risk
In the base study, participants received the 9vHPV L1 VLP vaccine (0.5 mL intramuscular injection) at Day 1, Month 2, and Month 6 and were evaluated through Month 12. In the extension study, the participants were followed up for safety and immunogenicity up to Month 36 (EXT1).
|
EXT2: 9- to 15-Year-Old Females
n=971 participants at risk
In the base study, participants received the 9vHPV L1 VLP vaccine (0.5 mL intramuscular injection) at Day 1, Month 2, and Month 6 and were evaluated through Month 12. In the extension study, the participants were followed up for immunogenicity, effectiveness, and safety up to Month 126 (EXT2).
|
EXT2: 9- to 15-Year-Old Males
n=301 participants at risk
In the base study, participants received the 9vHPV L1 VLP vaccine (0.5 mL intramuscular injection) at Day 1, Month 2, and Month 6 and were evaluated through Month 12. In the extension study, the participants were followed up for immunogenicity, effectiveness, and safety up to Month 126 (EXT2).
|
|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Injection site erythema
|
28.6%
184/643 • Number of events 264 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
30.0%
192/639 • Number of events 287 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
30.4%
195/641 • Number of events 281 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
24.0%
159/662 • Number of events 219 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
28.3%
132/466 • Number of events 220 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/1604 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/568 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/971 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/301 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
|
General disorders
Injection site pain
|
78.7%
506/643 • Number of events 1166 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
80.3%
513/639 • Number of events 1183 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
82.5%
529/641 • Number of events 1215 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
70.2%
465/662 • Number of events 919 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
84.3%
393/466 • Number of events 970 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/1604 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/568 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/971 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/301 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
|
General disorders
Injection site swelling
|
32.2%
207/643 • Number of events 317 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
37.1%
237/639 • Number of events 372 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
35.3%
226/641 • Number of events 380 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
26.1%
173/662 • Number of events 249 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
32.2%
150/466 • Number of events 261 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/1604 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/568 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/971 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/301 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
|
General disorders
Pyrexia
|
11.8%
76/643 • Number of events 91 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
8.9%
57/639 • Number of events 67 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
10.0%
64/641 • Number of events 74 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
12.7%
84/662 • Number of events 94 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
9.2%
43/466 • Number of events 53 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/1604 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/568 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/971 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/301 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
|
Nervous system disorders
Headache
|
18.7%
120/643 • Number of events 182 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
19.1%
122/639 • Number of events 170 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
17.6%
113/641 • Number of events 156 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
14.8%
98/662 • Number of events 143 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
22.7%
106/466 • Number of events 166 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/1604 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/568 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/971 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
0.00%
0/301 • Base Study: Up to ~12 months; Extension Study: Up to ~126 months
Base Study and Extension Study: ACM was analyzed in all randomized participants. Safety was analyzed in all participants who received at least one dose of 9vHPV and had available follow-up data, per protocol. ACM and safety were reported separately for base study, first extension (EXT1) and second extension (EXT2).
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication guidelines.
- Publication restrictions are in place
Restriction type: OTHER