Trial Outcomes & Findings for Immunobridging Study of 9- Valent Human Papillomavirus (9vHPV) Vaccine (V503) in Chinese Females 9 to 45 Years of Age (V503-024) (NCT NCT03903562)
NCT ID: NCT03903562
Last Updated: 2026-04-06
Results Overview
Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined using cLIA. The HPV-9 cLIA assay was used to quantify the antibodies. This assay evaluated the serological response before and after 9vHPV vaccination and measured HPV infection-induced antibodies. The GMT for each HPV type was expressed as milli Merck units/mL (mMU/mL).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1990 participants
Primary outcome timeframe
1 month post vaccination 3 (Month 7)
Results posted on
2026-04-06
Participant Flow
Participant milestones
| Measure |
9 to 19 Years of Age
Chinese females 9 to 19 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6. Participants in the 9 to 19 years of age group who completed 3 doses of V503 were eligible for Stage II and followed up to Month 60.
|
20 to 26 Years of Age
Chinese females 20 to 26 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
27 to 45 Years of Age
Chinese females 27 to 45 years of received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
|---|---|---|---|
|
Stage I
STARTED
|
690
|
650
|
650
|
|
Stage I
Vaccination 1
|
688
|
650
|
650
|
|
Stage I
Vaccination 2
|
683
|
647
|
644
|
|
Stage I
Vaccination 3
|
682
|
635
|
641
|
|
Stage I
9 to 15 Years of Age Who Received at Least 1 Vaccination
|
458
|
0
|
0
|
|
Stage I
COMPLETED
|
682
|
635
|
641
|
|
Stage I
NOT COMPLETED
|
8
|
15
|
9
|
|
Stage II
STARTED
|
682
|
0
|
0
|
|
Stage II
COMPLETED
|
645
|
0
|
0
|
|
Stage II
NOT COMPLETED
|
37
|
0
|
0
|
Reasons for withdrawal
| Measure |
9 to 19 Years of Age
Chinese females 9 to 19 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6. Participants in the 9 to 19 years of age group who completed 3 doses of V503 were eligible for Stage II and followed up to Month 60.
|
20 to 26 Years of Age
Chinese females 20 to 26 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
27 to 45 Years of Age
Chinese females 27 to 45 years of received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
|---|---|---|---|
|
Stage I
withdrawal by parent/guardian
|
3
|
0
|
0
|
|
Stage I
Withdrawal by Subject
|
5
|
15
|
9
|
|
Stage II
Withdrawal by Subject
|
25
|
0
|
0
|
|
Stage II
Lost to Follow-up
|
12
|
0
|
0
|
Baseline Characteristics
Immunobridging Study of 9- Valent Human Papillomavirus (9vHPV) Vaccine (V503) in Chinese Females 9 to 45 Years of Age (V503-024)
Baseline characteristics by cohort
| Measure |
9 to 19 Years of Age
n=690 Participants
Chinese females 9 to 19 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6. Participants in the 9 to 19 years of age group who completed 3 doses of V503 were eligible for Stage II and followed up to Month 60.
|
20 to 26 Years of Age
n=650 Participants
Chinese females 20 to 26 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
27 to 45 Years of Age
n=650 Participants
Chinese females 27 to 45 years of received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
Total
n=1990 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
690 Participants
n=5 Participants
|
650 Participants
n=5 Participants
|
650 Participants
n=10 Participants
|
1990 Participants
n=5 Participants
|
|
Age, Continuous
|
14.0 years
STANDARD_DEVIATION 3.0 • n=5 Participants
|
23.1 years
STANDARD_DEVIATION 1.7 • n=5 Participants
|
35.5 years
STANDARD_DEVIATION 5.1 • n=10 Participants
|
24.0 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
690 Participants
n=5 Participants
|
650 Participants
n=5 Participants
|
650 Participants
n=10 Participants
|
1990 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
690 Participants
n=5 Participants
|
650 Participants
n=5 Participants
|
650 Participants
n=10 Participants
|
1990 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 month post vaccination 3 (Month 7)Population: Per protocol, included participants 9-19 and 20-26 years old who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type and in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine.
Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined using cLIA. The HPV-9 cLIA assay was used to quantify the antibodies. This assay evaluated the serological response before and after 9vHPV vaccination and measured HPV infection-induced antibodies. The GMT for each HPV type was expressed as milli Merck units/mL (mMU/mL).
Outcome measures
| Measure |
9 to 19 Years of Age
n=688 Participants
Chinese females 9 to 19 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6. Participants in the 9 to 19 years of age group who completed 3 doses of V503 were eligible for Stage II and followed up to Month 60.
|
20 to 26 Years of Age
n=650 Participants
Chinese females 20 to 26 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
27 to 45 Years of Age
Chinese females 27 to 45 years of received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
|---|---|---|---|
|
Stage I: Competitive Luminex Immunoassay (cLIA) Geometric Mean Titers (GMTs) for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age and 20 to 26 Years of Age: Month 7
Anti-HPV 6
|
1129.7 mMU/mL
Interval 1069.8 to 1193.0
|
861.7 mMU/mL
Interval 817.5 to 908.4
|
—
|
|
Stage I: Competitive Luminex Immunoassay (cLIA) Geometric Mean Titers (GMTs) for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age and 20 to 26 Years of Age: Month 7
Anti-HPV 11
|
926.7 mMU/mL
Interval 876.4 to 979.8
|
702.6 mMU/mL
Interval 662.7 to 744.9
|
—
|
|
Stage I: Competitive Luminex Immunoassay (cLIA) Geometric Mean Titers (GMTs) for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age and 20 to 26 Years of Age: Month 7
Anti-HPV 16
|
4972.3 mMU/mL
Interval 4696.9 to 5263.9
|
3723.7 mMU/mL
Interval 3513.0 to 3946.9
|
—
|
|
Stage I: Competitive Luminex Immunoassay (cLIA) Geometric Mean Titers (GMTs) for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age and 20 to 26 Years of Age: Month 7
Anti-HPV 18
|
1438.4 mMU/mL
Interval 1349.0 to 1533.6
|
1031.6 mMU/mL
Interval 964.4 to 1103.6
|
—
|
|
Stage I: Competitive Luminex Immunoassay (cLIA) Geometric Mean Titers (GMTs) for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age and 20 to 26 Years of Age: Month 7
Anti-HPV 31
|
1161.5 mMU/mL
Interval 1093.2 to 1234.2
|
821.9 mMU/mL
Interval 770.5 to 876.7
|
—
|
|
Stage I: Competitive Luminex Immunoassay (cLIA) Geometric Mean Titers (GMTs) for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age and 20 to 26 Years of Age: Month 7
Anti-HPV 33
|
664.3 mMU/mL
Interval 626.3 to 704.7
|
497.5 mMU/mL
Interval 468.1 to 528.8
|
—
|
|
Stage I: Competitive Luminex Immunoassay (cLIA) Geometric Mean Titers (GMTs) for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age and 20 to 26 Years of Age: Month 7
Anti-HPV 45
|
442.9 mMU/mL
Interval 415.0 to 472.7
|
299.1 mMU/mL
Interval 279.8 to 319.9
|
—
|
|
Stage I: Competitive Luminex Immunoassay (cLIA) Geometric Mean Titers (GMTs) for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age and 20 to 26 Years of Age: Month 7
Anti-HPV 52
|
505.9 mMU/mL
Interval 478.4 to 535.0
|
397.8 mMU/mL
Interval 374.4 to 422.8
|
—
|
|
Stage I: Competitive Luminex Immunoassay (cLIA) Geometric Mean Titers (GMTs) for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age and 20 to 26 Years of Age: Month 7
Anti-HPV 58
|
725.3 mMU/mL
Interval 685.6 to 767.4
|
535.9 mMU/mL
Interval 503.2 to 570.8
|
—
|
PRIMARY outcome
Timeframe: 1 month post vaccination 3 (Month 7)Population: Per protocol, included participants 27-45 and 20-26 years old who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type and in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine.
The percentage of participants who are seropositive for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 was determined using cLIA. Seroconversion was defined as changing serostatus from seronegative at baseline (Day 1) to seropositive at 1 month after last dose. Cutoff values for HPV seropositivity are ≥50, 29, 41, 59, 29, 22, 15, 20, and 15 mMU/mL for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, respectively.
Outcome measures
| Measure |
9 to 19 Years of Age
n=650 Participants
Chinese females 9 to 19 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6. Participants in the 9 to 19 years of age group who completed 3 doses of V503 were eligible for Stage II and followed up to Month 60.
|
20 to 26 Years of Age
n=650 Participants
Chinese females 20 to 26 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
27 to 45 Years of Age
Chinese females 27 to 45 years of received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
|---|---|---|---|
|
Stage I: Percentage of Participants 27 to 45 Years of Age and 20 to 26 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 7
Anti-HPV 6 ≥50 mMU/mL
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
100.0 Percentage of Participants
Interval 99.3 to 100.0
|
—
|
|
Stage I: Percentage of Participants 27 to 45 Years of Age and 20 to 26 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 7
Anti-HPV 11 ≥29 mMU/mL
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
100.0 Percentage of Participants
Interval 99.3 to 100.0
|
—
|
|
Stage I: Percentage of Participants 27 to 45 Years of Age and 20 to 26 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 7
Anti-HPV 16 ≥41 mMU/mL
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
—
|
|
Stage I: Percentage of Participants 27 to 45 Years of Age and 20 to 26 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 7
Anti-HPV 18 ≥59 mMU/mL
|
99.8 Percentage of Participants
Interval 99.0 to 100.0
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
—
|
|
Stage I: Percentage of Participants 27 to 45 Years of Age and 20 to 26 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 7
Anti-HPV 31 ≥29 mMU/mL
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
—
|
|
Stage I: Percentage of Participants 27 to 45 Years of Age and 20 to 26 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 7
Anti-HPV 33 ≥22 mMU/mL
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
—
|
|
Stage I: Percentage of Participants 27 to 45 Years of Age and 20 to 26 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 7
Anti-HPV 45 ≥15 mMU/mL
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
—
|
|
Stage I: Percentage of Participants 27 to 45 Years of Age and 20 to 26 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 7
Anti-HPV 52 ≥20 mMU/mL
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
—
|
|
Stage I: Percentage of Participants 27 to 45 Years of Age and 20 to 26 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 7
Anti-HPV 58 ≥15 mMU/mL
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
100.0 Percentage of Participants
Interval 99.3 to 100.0
|
—
|
PRIMARY outcome
Timeframe: Month 12Population: Per protocol, included participants 9 to 19 years of age who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type and in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine.
Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined using cLIA. The HPV-9 cLIA assay was used to quantify the antibodies. This assay evaluated the serological response before and after 9vHPV vaccination and measured HPV infection-induced antibodies. The GMT for each HPV type was expressed as mMU/mL.
Outcome measures
| Measure |
9 to 19 Years of Age
n=682 Participants
Chinese females 9 to 19 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6. Participants in the 9 to 19 years of age group who completed 3 doses of V503 were eligible for Stage II and followed up to Month 60.
|
20 to 26 Years of Age
Chinese females 20 to 26 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
27 to 45 Years of Age
Chinese females 27 to 45 years of received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
|---|---|---|---|
|
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 12
Anti-HPV 6
|
420.3 mMU/mL
Interval 393.3 to 449.1
|
—
|
—
|
|
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 12
Anti-HPV 11
|
341.9 mMU/mL
Interval 320.1 to 365.3
|
—
|
—
|
|
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 12
Anti-HPV 16
|
1748.7 mMU/mL
Interval 1636.7 to 1868.3
|
—
|
—
|
|
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 12
Anti-HPV 18
|
472.2 mMU/mL
Interval 440.6 to 506.1
|
—
|
—
|
|
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 12
Anti-HPV 31
|
403.5 mMU/mL
Interval 375.6 to 433.5
|
—
|
—
|
|
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 12
Anti-HPV 33
|
237.7 mMU/mL
Interval 221.8 to 254.8
|
—
|
—
|
|
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 12
Anti-HPV 45
|
144.0 mMU/mL
Interval 133.4 to 155.3
|
—
|
—
|
|
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 12
Anti-HPV 52
|
187.6 mMU/mL
Interval 175.8 to 200.2
|
—
|
—
|
|
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 12
Anti-HPV 58
|
272.5 mMU/mL
Interval 255.5 to 290.7
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 24Population: Per protocol, included participants 9 to 19 years of age who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type and in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine.
Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined using cLIA. The HPV-9 cLIA assay was used to quantify the antibodies. This assay evaluated the serological response before and after 9vHPV vaccination and measured HPV infection-induced antibodies. The GMT for each HPV type was expressed as mMU/mL.
Outcome measures
| Measure |
9 to 19 Years of Age
n=682 Participants
Chinese females 9 to 19 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6. Participants in the 9 to 19 years of age group who completed 3 doses of V503 were eligible for Stage II and followed up to Month 60.
|
20 to 26 Years of Age
Chinese females 20 to 26 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
27 to 45 Years of Age
Chinese females 27 to 45 years of received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
|---|---|---|---|
|
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 24
Anti-HPV 6
|
210.2 mMU/mL
Interval 196.4 to 225.0
|
—
|
—
|
|
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 24
Anti-HPV 11
|
172.2 mMU/mL
Interval 160.7 to 184.5
|
—
|
—
|
|
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 24
Anti-HPV 16
|
774.8 mMU/mL
Interval 717.2 to 837.1
|
—
|
—
|
|
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 24
Anti-HPV 18
|
226.9 mMU/mL
Interval 211.8 to 243.0
|
—
|
—
|
|
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 24
Anti-HPV 31
|
205.3 mMU/mL
Interval 190.4 to 221.4
|
—
|
—
|
|
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 24
Anti-HPV 33
|
120.4 mMU/mL
Interval 112.2 to 129.2
|
—
|
—
|
|
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 24
Anti-HPV 45
|
72.1 mMU/mL
Interval 66.8 to 77.8
|
—
|
—
|
|
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 24
Anti-HPV 52
|
97.5 mMU/mL
Interval 91.3 to 104.2
|
—
|
—
|
|
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 24
Anti-HPV 58
|
125.8 mMU/mL
Interval 117.0 to 135.3
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 36Population: Per protocol, included participants 9 to 19 years of age who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type and in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine.
Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined using cLIA. The HPV-9 cLIA assay was used to quantify the antibodies. This assay evaluated the serological response before and after 9vHPV vaccination and measured HPV infection-induced antibodies. The GMT for each HPV type was expressed as mMU/mL.
Outcome measures
| Measure |
9 to 19 Years of Age
n=682 Participants
Chinese females 9 to 19 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6. Participants in the 9 to 19 years of age group who completed 3 doses of V503 were eligible for Stage II and followed up to Month 60.
|
20 to 26 Years of Age
Chinese females 20 to 26 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
27 to 45 Years of Age
Chinese females 27 to 45 years of received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
|---|---|---|---|
|
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 36
Anti-HPV 6
|
172.6 mMU/mL
Interval 161.6 to 184.4
|
—
|
—
|
|
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 36
Anti-HPV 11
|
136.5 mMU/mL
Interval 127.6 to 146.0
|
—
|
—
|
|
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 36
Anti-HPV 16
|
600.5 mMU/mL
Interval 554.3 to 650.6
|
—
|
—
|
|
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 36
Anti-HPV 18
|
178.0 mMU/mL
Interval 166.3 to 190.5
|
—
|
—
|
|
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 36
Anti-HPV 31
|
166.9 mMU/mL
Interval 154.7 to 180.0
|
—
|
—
|
|
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 36
Anti-HPV 33
|
95.1 mMU/mL
Interval 88.6 to 102.1
|
—
|
—
|
|
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 36
Anti-HPV 45
|
56.9 mMU/mL
Interval 52.8 to 61.4
|
—
|
—
|
|
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 36
Anti-HPV 52
|
78.1 mMU/mL
Interval 73.2 to 83.4
|
—
|
—
|
|
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 36
Anti-HPV 58
|
100.9 mMU/mL
Interval 93.9 to 108.5
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 48Population: Per protocol, included participants 9 to 19 years of age who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type and in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine.
Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined using cLIA. The HPV-9 cLIA assay was used to quantify the antibodies. This assay evaluated the serological response before and after 9vHPV vaccination and measured HPV infection-induced antibodies. The GMT for each HPV type was expressed as mMU/mL.
Outcome measures
| Measure |
9 to 19 Years of Age
n=682 Participants
Chinese females 9 to 19 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6. Participants in the 9 to 19 years of age group who completed 3 doses of V503 were eligible for Stage II and followed up to Month 60.
|
20 to 26 Years of Age
Chinese females 20 to 26 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
27 to 45 Years of Age
Chinese females 27 to 45 years of received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
|---|---|---|---|
|
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 48
Anti-HPV 6
|
170.3 mMU/mL
Interval 158.9 to 182.6
|
—
|
—
|
|
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 48
Anti-HPV 11
|
123.4 mMU/mL
Interval 115.0 to 132.3
|
—
|
—
|
|
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 48
Anti-HPV 16
|
612.6 mMU/mL
Interval 568.8 to 659.8
|
—
|
—
|
|
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 48
Anti-HPV 18
|
151.9 mMU/mL
Interval 140.1 to 164.8
|
—
|
—
|
|
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 48
Anti-HPV 31
|
165.6 mMU/mL
Interval 153.2 to 178.9
|
—
|
—
|
|
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 48
Anti-HPV 33
|
87.9 mMU/mL
Interval 81.4 to 94.9
|
—
|
—
|
|
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 48
Anti-HPV 45
|
53.5 mMU/mL
Interval 49.4 to 57.9
|
—
|
—
|
|
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 48
Anti-HPV 52
|
75.3 mMU/mL
Interval 70.5 to 80.4
|
—
|
—
|
|
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 48
Anti-HPV 58
|
97.1 mMU/mL
Interval 90.5 to 104.2
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 60Population: Per protocol, included participants 9 to 19 years of age who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type and in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine.
Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined using cLIA. The HPV-9 cLIA assay was used to quantify the antibodies. This assay evaluated the serological response before and after 9vHPV vaccination and measured HPV infection-induced antibodies. The GMT for each HPV type was expressed as mMU/mL.
Outcome measures
| Measure |
9 to 19 Years of Age
n=682 Participants
Chinese females 9 to 19 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6. Participants in the 9 to 19 years of age group who completed 3 doses of V503 were eligible for Stage II and followed up to Month 60.
|
20 to 26 Years of Age
Chinese females 20 to 26 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
27 to 45 Years of Age
Chinese females 27 to 45 years of received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
|---|---|---|---|
|
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 60
Anti-HPV 58
|
86.8 mMU/mL
Interval 80.6 to 93.4
|
—
|
—
|
|
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 60
Anti-HPV 16
|
541.7 mMU/mL
Interval 502.0 to 584.5
|
—
|
—
|
|
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 60
Anti-HPV 18
|
132.9 mMU/mL
Interval 122.5 to 144.1
|
—
|
—
|
|
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 60
Anti-HPV 6
|
154.2 mMU/mL
Interval 143.5 to 165.6
|
—
|
—
|
|
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 60
Anti-HPV 11
|
111.3 mMU/mL
Interval 103.5 to 119.6
|
—
|
—
|
|
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 60
Anti-HPV 31
|
147.1 mMU/mL
Interval 135.9 to 159.2
|
—
|
—
|
|
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 60
Anti-HPV 33
|
79.0 mMU/mL
Interval 73.1 to 85.3
|
—
|
—
|
|
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 60
Anti-HPV 45
|
48.3 mMU/mL
Interval 44.5 to 52.4
|
—
|
—
|
|
Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 60
Anti-HPV 52
|
68.6 mMU/mL
Interval 64.1 to 73.3
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 12Population: Per protocol, included participants 9 to 19 years of age who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type and in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine.
The percentage of participants who are seropositive for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 was determined using cLIA. Seroconversion was defined as changing serostatus from seronegative at baseline (Day 1) to seropositive at 1 month after last dose. Cutoff values for HPV seropositivity are ≥50, 29, 41, 59, 29, 22, 15, 20, and 15 mMU/mL for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, respectively.
Outcome measures
| Measure |
9 to 19 Years of Age
n=682 Participants
Chinese females 9 to 19 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6. Participants in the 9 to 19 years of age group who completed 3 doses of V503 were eligible for Stage II and followed up to Month 60.
|
20 to 26 Years of Age
Chinese females 20 to 26 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
27 to 45 Years of Age
Chinese females 27 to 45 years of received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
|---|---|---|---|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 12
Anti-HPV 6 ≥50 mMU/mL
|
99.5 Percentage of Participants
Interval 98.6 to 99.9
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 12
Anti-HPV 11 ≥29 mMU/mL
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 12
Anti-HPV 16 ≥41 mMU/mL
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 12
Anti-HPV 18 ≥59 mMU/mL
|
99.0 Percentage of Participants
Interval 97.9 to 99.6
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 12
Anti-HPV 31 ≥29 mMU/mL
|
99.4 Percentage of Participants
Interval 98.4 to 99.8
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 12
Anti-HPV 33 ≥22 mMU/mL
|
99.5 Percentage of Participants
Interval 98.6 to 99.9
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 12
Anti-HPV 45 ≥15 mMU/mL
|
98.9 Percentage of Participants
Interval 97.8 to 99.6
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 12
Anti-HPV 52 ≥20 mMU/mL
|
99.7 Percentage of Participants
Interval 98.9 to 100.0
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 12
Anti-HPV 58 ≥15 mMU/mL
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 24Population: Per protocol, included participants 9 to 19 years of age who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type and in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine.
The percentage of participants who are seropositive for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 was determined using cLIA. Seroconversion was defined as changing serostatus from seronegative at baseline (Day 1) to seropositive at 1 month after last dose. Cutoff values for HPV seropositivity are ≥50, 29, 41, 59, 29, 22, 15, 20, and 15 mMU/mL for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, respectively.
Outcome measures
| Measure |
9 to 19 Years of Age
n=682 Participants
Chinese females 9 to 19 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6. Participants in the 9 to 19 years of age group who completed 3 doses of V503 were eligible for Stage II and followed up to Month 60.
|
20 to 26 Years of Age
Chinese females 20 to 26 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
27 to 45 Years of Age
Chinese females 27 to 45 years of received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
|---|---|---|---|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 24
Anti-HPV 6 ≥50 mMU/mL
|
96.4 Percentage of Participants
Interval 94.6 to 97.7
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 24
Anti-HPV 11 ≥29 mMU/mL
|
98.3 Percentage of Participants
Interval 96.9 to 99.1
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 24
Anti-HPV 16 ≥41 mMU/mL
|
99.1 Percentage of Participants
Interval 98.0 to 99.7
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 24
Anti-HPV 18 ≥59 mMU/mL
|
95.7 Percentage of Participants
Interval 93.8 to 97.1
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 24
Anti-HPV 31 ≥29 mMU/mL
|
98.0 Percentage of Participants
Interval 96.6 to 98.9
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 24
Anti-HPV 33 ≥22 mMU/mL
|
98.0 Percentage of Participants
Interval 96.5 to 98.9
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 24
Anti-HPV 45 ≥15 mMU/mL
|
96.8 Percentage of Participants
Interval 95.1 to 98.0
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 24
Anti-HPV 52 ≥20 mMU/mL
|
96.9 Percentage of Participants
Interval 95.3 to 98.1
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 24
Anti-HPV 58 ≥15 mMU/mL
|
98.0 Percentage of Participants
Interval 96.6 to 98.9
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 36Population: Per protocol, included participants 9 to 19 years of age who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type and in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine.
The percentage of participants who are seropositive for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 was determined using cLIA. Seroconversion was defined as changing serostatus from seronegative at baseline (Day 1) to seropositive at 1 month after last dose. Cutoff values for HPV seropositivity are ≥65, 37, 79, 85, 46, 26, 21, 30 and 31 mMU/mL for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, respectively.
Outcome measures
| Measure |
9 to 19 Years of Age
n=682 Participants
Chinese females 9 to 19 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6. Participants in the 9 to 19 years of age group who completed 3 doses of V503 were eligible for Stage II and followed up to Month 60.
|
20 to 26 Years of Age
Chinese females 20 to 26 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
27 to 45 Years of Age
Chinese females 27 to 45 years of received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
|---|---|---|---|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 36
Anti-HPV 6 ≥65 mMU/mL
|
87.3 Percentage of Participants
Interval 84.5 to 89.9
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 36
Anti-HPV 11 ≥37 mMU/mL
|
94.5 Percentage of Participants
Interval 92.4 to 96.1
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 36
Anti-HPV 16 ≥79 mMU/mL
|
97.0 Percentage of Participants
Interval 95.4 to 98.2
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 36
Anti-HPV 18 ≥85 mMU/mL
|
80.5 Percentage of Participants
Interval 77.1 to 83.5
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 36
Anti-HPV 31 ≥46 mMU/mL
|
90.5 Percentage of Participants
Interval 88.0 to 92.7
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 36
Anti-HPV 33 ≥26 mMU/mL
|
94.8 Percentage of Participants
Interval 92.8 to 96.4
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 36
Anti-HPV 45 ≥21 mMU/mL
|
84.9 Percentage of Participants
Interval 81.9 to 87.6
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 36
Anti-HPV 52 ≥30 mMU/mL
|
86.9 Percentage of Participants
Interval 84.0 to 89.4
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 36
Anti-HPV 58 ≥31 mMU/mL
|
90.2 Percentage of Participants
Interval 87.5 to 92.4
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 48Population: Per protocol, included participants 9 to 19 years of age who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type and in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine.
The percentage of participants who are seropositive for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 was determined using cLIA. Seroconversion was defined as changing serostatus from seronegative at baseline (Day 1) to seropositive at 1 month after last dose. Cutoff values for HPV seropositivity are ≥34, 25, 32, 26, 15, 10, 10, 14 and 10 mMU/mL for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, respectively.
Outcome measures
| Measure |
9 to 19 Years of Age
n=682 Participants
Chinese females 9 to 19 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6. Participants in the 9 to 19 years of age group who completed 3 doses of V503 were eligible for Stage II and followed up to Month 60.
|
20 to 26 Years of Age
Chinese females 20 to 26 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
27 to 45 Years of Age
Chinese females 27 to 45 years of received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
|---|---|---|---|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 48
Anti-HPV 6 ≥34 mMU/mL
|
94.2 Percentage of Participants
Interval 92.0 to 95.9
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 48
Anti-HPV 11 ≥25 mMU/mL
|
95.9 Percentage of Participants
Interval 94.1 to 97.4
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 48
Anti-HPV 16 ≥32 mMU/mL
|
99.1 Percentage of Participants
Interval 98.0 to 99.7
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 48
Anti-HPV 18 ≥26 mMU/mL
|
92.3 Percentage of Participants
Interval 89.8 to 94.3
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 48
Anti-HPV 31 ≥15 mMU/mL
|
98.3 Percentage of Participants
Interval 96.9 to 99.1
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 48
Anti-HPV 33 ≥10 mMU/mL
|
97.4 Percentage of Participants
Interval 95.8 to 98.5
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 48
Anti-HPV 45 ≥10 mMU/mL
|
92.7 Percentage of Participants
Interval 90.4 to 94.6
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 48
Anti-HPV 52 ≥14 mMU/mL
|
96.8 Percentage of Participants
Interval 95.1 to 98.0
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 48
Anti-HPV 58 ≥10 mMU/mL
|
98.5 Percentage of Participants
Interval 97.3 to 99.3
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 60Population: Per protocol, included participants 9 to 19 years of age who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type and in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine.
The percentage of participants who are seropositive for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 was determined using cLIA. Seroconversion was defined as changing serostatus from seronegative at baseline (Day 1) to seropositive at 1 month after last dose. Cutoff values for HPV seropositivity are ≥34, 25, 32, 26, 15, 10, 10, 14 and 10 mMU/mL for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, respectively.
Outcome measures
| Measure |
9 to 19 Years of Age
n=682 Participants
Chinese females 9 to 19 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6. Participants in the 9 to 19 years of age group who completed 3 doses of V503 were eligible for Stage II and followed up to Month 60.
|
20 to 26 Years of Age
Chinese females 20 to 26 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
27 to 45 Years of Age
Chinese females 27 to 45 years of received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
|---|---|---|---|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 60
Anti-HPV 6 ≥34 mMU/mL
|
92.5 Percentage of Participants
Interval 90.2 to 94.5
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 60
Anti-HPV 11 ≥25 mMU/mL
|
93.5 Percentage of Participants
Interval 91.3 to 95.4
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 60
Anti-HPV 16 ≥32 mMU/mL
|
98.9 Percentage of Participants
Interval 97.7 to 99.5
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 60
Anti-HPV 18 ≥26 mMU/mL
|
90.3 Percentage of Participants
Interval 87.6 to 92.5
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 60
Anti-HPV 31 ≥15 mMU/mL
|
97.6 Percentage of Participants
Interval 96.0 to 98.6
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 60
Anti-HPV 33 ≥10 mMU/mL
|
96.2 Percentage of Participants
Interval 94.4 to 97.6
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 60
Anti-HPV 45 ≥10 mMU/mL
|
89.7 Percentage of Participants
Interval 87.0 to 91.9
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 60
Anti-HPV 52 ≥14 mMU/mL
|
95.3 Percentage of Participants
Interval 93.3 to 96.8
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 60
Anti-HPV 58 ≥10 mMU/mL
|
97.9 Percentage of Participants
Interval 96.4 to 98.9
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 12Population: Per protocol, included participants 9 to 19 years of age who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type and in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine.
Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined using IgG LIA. The HPV-9 IgG LIA assay was used to quantify the antibodies. This assay evaluated the serological response before and after 9vHPV vaccination and measured HPV infection-induced antibodies. The GMT for each HPV type was expressed as mMU/mL. Although the same name (mMU/mL) is used for the unit of measurement in both cLIA and IgG LIA, the 'cLIA mMU/mL' and the 'IgG LIA mMU/mL' are actually different units of measurement and cannot be directly compared.
Outcome measures
| Measure |
9 to 19 Years of Age
n=682 Participants
Chinese females 9 to 19 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6. Participants in the 9 to 19 years of age group who completed 3 doses of V503 were eligible for Stage II and followed up to Month 60.
|
20 to 26 Years of Age
Chinese females 20 to 26 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
27 to 45 Years of Age
Chinese females 27 to 45 years of received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
|---|---|---|---|
|
Stage II: Immunoglobulin G Luminex Immunoassay (IgG LIA) GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 12
Anti-HPV 6
|
355.1 mMU/mL
Interval 329.4 to 382.7
|
—
|
—
|
|
Stage II: Immunoglobulin G Luminex Immunoassay (IgG LIA) GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 12
Anti-HPV 11
|
290.5 mMU/mL
Interval 270.1 to 312.4
|
—
|
—
|
|
Stage II: Immunoglobulin G Luminex Immunoassay (IgG LIA) GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 12
Anti-HPV 16
|
1505.2 mMU/mL
Interval 1405.6 to 1611.9
|
—
|
—
|
|
Stage II: Immunoglobulin G Luminex Immunoassay (IgG LIA) GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 12
Anti-HPV 18
|
340.1 mMU/mL
Interval 314.5 to 367.8
|
—
|
—
|
|
Stage II: Immunoglobulin G Luminex Immunoassay (IgG LIA) GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 12
Anti-HPV 31
|
331.7 mMU/mL
Interval 307.2 to 358.2
|
—
|
—
|
|
Stage II: Immunoglobulin G Luminex Immunoassay (IgG LIA) GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 12
Anti-HPV 33
|
194.7 mMU/mL
Interval 180.6 to 210.0
|
—
|
—
|
|
Stage II: Immunoglobulin G Luminex Immunoassay (IgG LIA) GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 12
Anti-HPV 45
|
112.1 mMU/mL
Interval 103.3 to 121.7
|
—
|
—
|
|
Stage II: Immunoglobulin G Luminex Immunoassay (IgG LIA) GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 12
Anti-HPV 52
|
153.3 mMU/mL
Interval 142.7 to 164.8
|
—
|
—
|
|
Stage II: Immunoglobulin G Luminex Immunoassay (IgG LIA) GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 12
Anti-HPV 58
|
230.0 mMU/mL
Interval 214.6 to 246.4
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 24Population: Per protocol, included participants 9 to 19 years of age who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type and in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine.
Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined using IgG LIA. The HPV-9 IgG LIA assay was used to quantify the antibodies. This assay evaluated the serological response before and after 9vHPV vaccination and measured HPV infection-induced antibodies. The GMT for each HPV type was expressed as mMU/mL.
Outcome measures
| Measure |
9 to 19 Years of Age
n=682 Participants
Chinese females 9 to 19 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6. Participants in the 9 to 19 years of age group who completed 3 doses of V503 were eligible for Stage II and followed up to Month 60.
|
20 to 26 Years of Age
Chinese females 20 to 26 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
27 to 45 Years of Age
Chinese females 27 to 45 years of received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
|---|---|---|---|
|
Stage II: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 24
Anti-HPV 45
|
58.4 mMU/mL
Interval 53.5 to 63.9
|
—
|
—
|
|
Stage II: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 24
Anti-HPV 52
|
82.6 mMU/mL
Interval 76.7 to 89.1
|
—
|
—
|
|
Stage II: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 24
Anti-HPV 58
|
115.2 mMU/mL
Interval 106.8 to 124.4
|
—
|
—
|
|
Stage II: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 24
Anti-HPV 6
|
186.3 mMU/mL
Interval 172.2 to 201.5
|
—
|
—
|
|
Stage II: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 24
Anti-HPV 11
|
159.0 mMU/mL
Interval 147.3 to 171.7
|
—
|
—
|
|
Stage II: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 24
Anti-HPV 16
|
750.8 mMU/mL
Interval 695.2 to 810.8
|
—
|
—
|
|
Stage II: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 24
Anti-HPV 18
|
153.6 mMU/mL
Interval 140.4 to 168.0
|
—
|
—
|
|
Stage II: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 24
Anti-HPV 31
|
174.8 mMU/mL
Interval 161.1 to 189.6
|
—
|
—
|
|
Stage II: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 24
Anti-HPV 33
|
99.1 mMU/mL
Interval 91.3 to 107.5
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 36Population: Per protocol, included participants 9 to 19 years of age who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type and in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine.
Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined using IgG LIA. The HPV-9 IgG LIA assay was used to quantify the antibodies. This assay evaluated the serological response before and after 9vHPV vaccination and measured HPV infection-induced antibodies. The GMT for each HPV type was expressed as mMU/mL.
Outcome measures
| Measure |
9 to 19 Years of Age
n=682 Participants
Chinese females 9 to 19 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6. Participants in the 9 to 19 years of age group who completed 3 doses of V503 were eligible for Stage II and followed up to Month 60.
|
20 to 26 Years of Age
Chinese females 20 to 26 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
27 to 45 Years of Age
Chinese females 27 to 45 years of received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
|---|---|---|---|
|
Stage II: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 36
Anti-HPV 6
|
143.2 mMU/mL
Interval 132.0 to 155.5
|
—
|
—
|
|
Stage II: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 36
Anti-HPV 11
|
121.9 mMU/mL
Interval 112.5 to 132.2
|
—
|
—
|
|
Stage II: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 36
Anti-HPV 16
|
566.1 mMU/mL
Interval 521.8 to 614.2
|
—
|
—
|
|
Stage II: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 36
Anti-HPV 18
|
112.3 mMU/mL
Interval 102.1 to 123.4
|
—
|
—
|
|
Stage II: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 36
Anti-HPV 31
|
137.3 mMU/mL
Interval 126.1 to 149.5
|
—
|
—
|
|
Stage II: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 36
Anti-HPV 33
|
75.4 mMU/mL
Interval 69.2 to 82.1
|
—
|
—
|
|
Stage II: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 36
Anti-HPV 45
|
44.2 mMU/mL
Interval 40.3 to 48.4
|
—
|
—
|
|
Stage II: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 36
Anti-HPV 52
|
65.0 mMU/mL
Interval 60.2 to 70.3
|
—
|
—
|
|
Stage II: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 36
Anti-HPV 58
|
90.0 mMU/mL
Interval 83.1 to 97.6
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 48Population: Per protocol, included participants 9 to 19 years of age who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type and in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine.
Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined using IgG LIA. The HPV-9 IgG LIA assay was used to quantify the antibodies. This assay evaluated the serological response before and after 9vHPV vaccination and measured HPV infection-induced antibodies. The GMT for each HPV type was expressed as mMU/mL.
Outcome measures
| Measure |
9 to 19 Years of Age
n=682 Participants
Chinese females 9 to 19 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6. Participants in the 9 to 19 years of age group who completed 3 doses of V503 were eligible for Stage II and followed up to Month 60.
|
20 to 26 Years of Age
Chinese females 20 to 26 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
27 to 45 Years of Age
Chinese females 27 to 45 years of received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
|---|---|---|---|
|
Stage II: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 48
Anti-HPV 6
|
121.4 mMU/mL
Interval 111.9 to 131.8
|
—
|
—
|
|
Stage II: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 48
Anti-HPV 11
|
104.4 mMU/mL
Interval 96.3 to 113.2
|
—
|
—
|
|
Stage II: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 48
Anti-HPV 16
|
491.4 mMU/mL
Interval 452.7 to 533.4
|
—
|
—
|
|
Stage II: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 48
Anti-HPV 18
|
96.0 mMU/mL
Interval 87.2 to 105.7
|
—
|
—
|
|
Stage II: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 48
Anti-HPV 31
|
122.0 mMU/mL
Interval 112.0 to 133.0
|
—
|
—
|
|
Stage II: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 48
Anti-HPV 33
|
65.8 mMU/mL
Interval 60.4 to 71.8
|
—
|
—
|
|
Stage II: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 48
Anti-HPV 45
|
38.7 mMU/mL
Interval 35.4 to 42.4
|
—
|
—
|
|
Stage II: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 48
Anti-HPV 52
|
56.6 mMU/mL
Interval 52.3 to 61.3
|
—
|
—
|
|
Stage II: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 48
Anti-HPV 58
|
79.7 mMU/mL
Interval 73.5 to 86.5
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 60Population: Per protocol, included participants 9 to 19 years of age who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type and in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine.
Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined using IgG LIA. The HPV-9 IgG LIA assay was used to quantify the antibodies. This assay evaluated the serological response before and after 9vHPV vaccination and measured HPV infection-induced antibodies. The GMT for each HPV type was expressed as mMU/mL.
Outcome measures
| Measure |
9 to 19 Years of Age
n=682 Participants
Chinese females 9 to 19 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6. Participants in the 9 to 19 years of age group who completed 3 doses of V503 were eligible for Stage II and followed up to Month 60.
|
20 to 26 Years of Age
Chinese females 20 to 26 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
27 to 45 Years of Age
Chinese females 27 to 45 years of received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
|---|---|---|---|
|
Stage II: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 60
Anti-HPV 6
|
106.8 mMU/mL
Interval 98.1 to 116.3
|
—
|
—
|
|
Stage II: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 60
Anti-HPV 11
|
91.3 mMU/mL
Interval 83.9 to 99.2
|
—
|
—
|
|
Stage II: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 60
Anti-HPV 16
|
433.6 mMU/mL
Interval 398.2 to 472.2
|
—
|
—
|
|
Stage II: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 60
Anti-HPV 18
|
81.9 mMU/mL
Interval 74.2 to 90.3
|
—
|
—
|
|
Stage II: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 60
Anti-HPV 31
|
106.1 mMU/mL
Interval 97.1 to 115.9
|
—
|
—
|
|
Stage II: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 60
Anti-HPV 33
|
58.3 mMU/mL
Interval 53.4 to 63.6
|
—
|
—
|
|
Stage II: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 60
Anti-HPV 45
|
33.6 mMU/mL
Interval 30.6 to 36.9
|
—
|
—
|
|
Stage II: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 60
Anti-HPV 52
|
49.6 mMU/mL
Interval 45.7 to 54.0
|
—
|
—
|
|
Stage II: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 60
Anti-HPV 58
|
70.8 mMU/mL
Interval 65.0 to 77.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 12Population: Per protocol, included participants 9 to 19 years of age who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type and in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine.
The percentage of participants who are seropositive for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 was determined using IgG LIA. Seroconversion was defined as changing serostatus from seronegative at baseline (Day 1) to seropositive at 1 month after last dose. Cutoff values for HPV seropositivity are ≥9, 6, 5, 5, 3, 4, 3, 5 and 5 mMU/mL for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, respectively.
Outcome measures
| Measure |
9 to 19 Years of Age
n=682 Participants
Chinese females 9 to 19 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6. Participants in the 9 to 19 years of age group who completed 3 doses of V503 were eligible for Stage II and followed up to Month 60.
|
20 to 26 Years of Age
Chinese females 20 to 26 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
27 to 45 Years of Age
Chinese females 27 to 45 years of received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
|---|---|---|---|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 12
Anti-HPV 33 ≥4 mMU/mL
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 12
Anti-HPV 45 ≥3 mMU/mL
|
99.8 Percentage of Participants
Interval 99.1 to 100.0
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 12
Anti-HPV 6 ≥9 mMU/mL
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 12
Anti-HPV 11 ≥6 mMU/mL
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 12
Anti-HPV 16 ≥5 mMU/mL
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 12
Anti-HPV 18 ≥5 mMU/mL
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 12
Anti-HPV 31 ≥3 mMU/mL
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 12
Anti-HPV 52 ≥5 mMU/mL
|
99.8 Percentage of Participants
Interval 99.1 to 100.0
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 12
Anti-HPV 58 ≥5 mMU/mL
|
99.8 Percentage of Participants
Interval 99.1 to 100.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 24Population: Per protocol, included participants 9 to 19 years of age who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type and in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine.
The percentage of participants who are seropositive for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 was determined using IgG LIA. Seroconversion was defined as changing serostatus from seronegative at baseline (Day 1) to seropositive at 1 month after last dose. Cutoff values for HPV seropositivity are ≥9, 6, 5, 5, 3, 4, 3, 5 and 5 mMU/mL for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, respectively.
Outcome measures
| Measure |
9 to 19 Years of Age
n=682 Participants
Chinese females 9 to 19 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6. Participants in the 9 to 19 years of age group who completed 3 doses of V503 were eligible for Stage II and followed up to Month 60.
|
20 to 26 Years of Age
Chinese females 20 to 26 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
27 to 45 Years of Age
Chinese females 27 to 45 years of received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
|---|---|---|---|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 24
Anti-HPV 6 ≥9 mMU/mL
|
99.8 Percentage of Participants
Interval 99.1 to 100.0
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 24
Anti-HPV 11 ≥6 mMU/mL
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 24
Anti-HPV 16 ≥5 mMU/mL
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 24
Anti-HPV 18 ≥5 mMU/mL
|
99.4 Percentage of Participants
Interval 98.4 to 99.8
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 24
Anti-HPV 31 ≥3 mMU/mL
|
99.8 Percentage of Participants
Interval 99.1 to 100.0
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 24
Anti-HPV 33 ≥4 mMU/mL
|
99.8 Percentage of Participants
Interval 99.1 to 100.0
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 24
Anti-HPV 45 ≥3 mMU/mL
|
99.1 Percentage of Participants
Interval 98.0 to 99.7
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 24
Anti-HPV 52 ≥5 mMU/mL
|
99.8 Percentage of Participants
Interval 99.1 to 100.0
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 24
Anti-HPV 58 ≥5 mMU/mL
|
99.5 Percentage of Participants
Interval 98.6 to 99.9
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 36Population: Per protocol, included participants 9 to 19 years of age who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type and in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine.
The percentage of participants who are seropositive for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 was determined using IgG LIA. Seroconversion was defined as changing serostatus from seronegative at baseline (Day 1) to seropositive at 1 month after last dose. Cutoff values for HPV seropositivity are ≥9, 6, 5, 5, 3, 4, 3, 5 and 5 mMU/mL for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, respectively.
Outcome measures
| Measure |
9 to 19 Years of Age
n=682 Participants
Chinese females 9 to 19 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6. Participants in the 9 to 19 years of age group who completed 3 doses of V503 were eligible for Stage II and followed up to Month 60.
|
20 to 26 Years of Age
Chinese females 20 to 26 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
27 to 45 Years of Age
Chinese females 27 to 45 years of received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
|---|---|---|---|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 36
Anti-HPV 6 ≥9 mMU/mL
|
99.7 Percentage of Participants
Interval 98.8 to 100.0
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 36
Anti-HPV 11 ≥6 mMU/mL
|
99.7 Percentage of Participants
Interval 98.8 to 100.0
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 36
Anti-HPV 16 ≥5 mMU/mL
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 36
Anti-HPV 18 ≥5 mMU/mL
|
98.7 Percentage of Participants
Interval 97.4 to 99.4
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 36
Anti-HPV 31 ≥3 mMU/mL
|
99.8 Percentage of Participants
Interval 99.1 to 100.0
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 36
Anti-HPV 33 ≥4 mMU/mL
|
99.4 Percentage of Participants
Interval 98.4 to 99.8
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 36
Anti-HPV 45 ≥3 mMU/mL
|
98.4 Percentage of Participants
Interval 97.1 to 99.2
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 36
Anti-HPV 52 ≥5 mMU/mL
|
99.2 Percentage of Participants
Interval 98.1 to 99.7
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 36
Anti-HPV 58 ≥5 mMU/mL
|
99.0 Percentage of Participants
Interval 97.9 to 99.6
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 48Population: Per protocol, included participants 9 to 19 years of age who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type and in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine.
The percentage of participants who are seropositive for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 was determined using IgG LIA. Seroconversion was defined as changing serostatus from seronegative at baseline (Day 1) to seropositive at 1 month after last dose. Cutoff values for HPV seropositivity are ≥9, 6, 5, 5, 3, 4, 3, 5 and 5 mMU/mL for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, respectively.
Outcome measures
| Measure |
9 to 19 Years of Age
n=682 Participants
Chinese females 9 to 19 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6. Participants in the 9 to 19 years of age group who completed 3 doses of V503 were eligible for Stage II and followed up to Month 60.
|
20 to 26 Years of Age
Chinese females 20 to 26 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
27 to 45 Years of Age
Chinese females 27 to 45 years of received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
|---|---|---|---|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 48
Anti-HPV 6 ≥9 mMU/mL
|
99.2 Percentage of Participants
Interval 98.1 to 99.7
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 48
Anti-HPV 11 ≥6 mMU/mL
|
99.2 Percentage of Participants
Interval 98.1 to 99.7
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 48
Anti-HPV 16 ≥5 mMU/mL
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 48
Anti-HPV 18 ≥5 mMU/mL
|
98.5 Percentage of Participants
Interval 97.2 to 99.3
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 48
Anti-HPV 31 ≥3 mMU/mL
|
99.5 Percentage of Participants
Interval 98.6 to 99.9
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 48
Anti-HPV 33 ≥4 mMU/mL
|
98.5 Percentage of Participants
Interval 97.2 to 99.3
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 48
Anti-HPV 45 ≥3 mMU/mL
|
98.6 Percentage of Participants
Interval 97.3 to 99.3
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 48
Anti-HPV 52 ≥5 mMU/mL
|
98.7 Percentage of Participants
Interval 97.5 to 99.4
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 48
Anti-HPV 58 ≥5 mMU/mL
|
99.0 Percentage of Participants
Interval 97.9 to 99.6
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 60Population: Per protocol, included participants 9 to 19 years of age who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type and in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine.
The percentage of participants who are seropositive for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 was determined using IgG LIA. Seroconversion was defined as changing serostatus from seronegative at baseline (Day 1) to seropositive at 1 month after last dose. Cutoff values for HPV seropositivity are ≥9, 6, 5, 5, 3, 4, 3, 5 and 5 mMU/mL for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, respectively.
Outcome measures
| Measure |
9 to 19 Years of Age
n=682 Participants
Chinese females 9 to 19 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6. Participants in the 9 to 19 years of age group who completed 3 doses of V503 were eligible for Stage II and followed up to Month 60.
|
20 to 26 Years of Age
Chinese females 20 to 26 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
27 to 45 Years of Age
Chinese females 27 to 45 years of received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
|---|---|---|---|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 60
Anti-HPV 6 ≥9 mMU/mL
|
99.0 Percentage of Participants
Interval 97.9 to 99.6
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 60
Anti-HPV 11 ≥6 mMU/mL
|
99.0 Percentage of Participants
Interval 97.9 to 99.6
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 60
Anti-HPV 16 ≥5 mMU/mL
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 60
Anti-HPV 18 ≥5 mMU/mL
|
97.5 Percentage of Participants
Interval 95.9 to 98.6
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 60
Anti-HPV 31 ≥3 mMU/mL
|
99.7 Percentage of Participants
Interval 98.8 to 100.0
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 60
Anti-HPV 33 ≥4 mMU/mL
|
98.2 Percentage of Participants
Interval 96.8 to 99.1
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 60
Anti-HPV 45 ≥3 mMU/mL
|
97.9 Percentage of Participants
Interval 96.4 to 98.9
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 60
Anti-HPV 52 ≥5 mMU/mL
|
98.2 Percentage of Participants
Interval 96.8 to 99.1
|
—
|
—
|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 60
Anti-HPV 58 ≥5 mMU/mL
|
98.7 Percentage of Participants
Interval 97.4 to 99.4
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month post vaccination 3 (Month 7)Population: Per protocol, included participants 9-19 and 20-26 years old who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type and in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine.
The percentage of participants who are seropositive for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 was determined using cLIA. Seroconversion was defined as changing serostatus from seronegative at baseline (Day 1) to seropositive at 1 month after last dose. Cutoff values for HPV seropositivity are ≥50, 29, 41, 59, 29, 22, 15, 20, and 15 mMU/mL for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, respectively.
Outcome measures
| Measure |
9 to 19 Years of Age
n=688 Participants
Chinese females 9 to 19 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6. Participants in the 9 to 19 years of age group who completed 3 doses of V503 were eligible for Stage II and followed up to Month 60.
|
20 to 26 Years of Age
n=650 Participants
Chinese females 20 to 26 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
27 to 45 Years of Age
Chinese females 27 to 45 years of received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
|---|---|---|---|
|
Stage I: Percentage of Participants 9 to 19 Years of Age and 20 to 26 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 7
Anti-HPV 58 ≥15 mMU/mL
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
—
|
|
Stage I: Percentage of Participants 9 to 19 Years of Age and 20 to 26 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 7
Anti-HPV 6 ≥50 mMU/mL
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
—
|
|
Stage I: Percentage of Participants 9 to 19 Years of Age and 20 to 26 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 7
Anti-HPV 11 ≥29 mMU/mL
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
—
|
|
Stage I: Percentage of Participants 9 to 19 Years of Age and 20 to 26 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 7
Anti-HPV 16 ≥41 mMU/mL
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
—
|
|
Stage I: Percentage of Participants 9 to 19 Years of Age and 20 to 26 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 7
Anti-HPV 18 ≥59 mMU/mL
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
99.8 Percentage of Participants
Interval 99.0 to 100.0
|
—
|
|
Stage I: Percentage of Participants 9 to 19 Years of Age and 20 to 26 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 7
Anti-HPV 31 ≥29 mMU/mL
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
—
|
|
Stage I: Percentage of Participants 9 to 19 Years of Age and 20 to 26 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 7
Anti-HPV 33 ≥22 mMU/mL
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
—
|
|
Stage I: Percentage of Participants 9 to 19 Years of Age and 20 to 26 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 7
Anti-HPV 45 ≥15 mMU/mL
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
—
|
|
Stage I: Percentage of Participants 9 to 19 Years of Age and 20 to 26 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 7
Anti-HPV 52 ≥20 mMU/mL
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
—
|
SECONDARY outcome
Timeframe: 1 month post vaccination 3 (Month 7)Population: Per protocol, included participants 9-15 and 20-26 years old who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type and in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine.
Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined using cLIA. The HPV-9 cLIA assay was used to quantify the antibodies. This assay evaluated the serological response before and after 9vHPV vaccination and measured HPV infection-induced antibodies. The GMT for each HPV type were expressed as mMU/mL. As pre-specified per protocol, participants 20 to 26 years of age and a subset of participants 9 to 15 years of age were included in the analysis.
Outcome measures
| Measure |
9 to 19 Years of Age
n=650 Participants
Chinese females 9 to 19 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6. Participants in the 9 to 19 years of age group who completed 3 doses of V503 were eligible for Stage II and followed up to Month 60.
|
20 to 26 Years of Age
n=458 Participants
Chinese females 20 to 26 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
27 to 45 Years of Age
Chinese females 27 to 45 years of received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
|---|---|---|---|
|
Stage I: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 15 Years of Age and 20 to 26 Years of Age: Month 7
Anti-HPV 16
|
3723.7 mMU/mL
Interval 3513.0 to 3946.9
|
5279.6 mMU/mL
Interval 4943.8 to 5638.3
|
—
|
|
Stage I: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 15 Years of Age and 20 to 26 Years of Age: Month 7
Anti-HPV 18
|
1031.6 mMU/mL
Interval 964.4 to 1103.6
|
1582.4 mMU/mL
Interval 1469.4 to 1704.1
|
—
|
|
Stage I: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 15 Years of Age and 20 to 26 Years of Age: Month 7
Anti-HPV 31
|
821.9 mMU/mL
Interval 770.5 to 876.7
|
1253.1 mMU/mL
Interval 1167.7 to 1344.9
|
—
|
|
Stage I: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 15 Years of Age and 20 to 26 Years of Age: Month 7
Anti-HPV 33
|
497.5 mMU/mL
Interval 468.1 to 528.8
|
699.6 mMU/mL
Interval 653.5 to 748.9
|
—
|
|
Stage I: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 15 Years of Age and 20 to 26 Years of Age: Month 7
Anti-HPV 45
|
299.1 mMU/mL
Interval 279.8 to 319.9
|
490.5 mMU/mL
Interval 454.3 to 529.6
|
—
|
|
Stage I: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 15 Years of Age and 20 to 26 Years of Age: Month 7
Anti-HPV 52
|
397.8 mMU/mL
Interval 374.4 to 422.8
|
535.1 mMU/mL
Interval 501.4 to 571.1
|
—
|
|
Stage I: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 15 Years of Age and 20 to 26 Years of Age: Month 7
Anti-HPV 58
|
535.9 mMU/mL
Interval 503.2 to 570.8
|
771.5 mMU/mL
Interval 721.8 to 824.6
|
—
|
|
Stage I: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 15 Years of Age and 20 to 26 Years of Age: Month 7
Anti-HPV 6
|
861.7 mMU/mL
Interval 817.5 to 908.4
|
1201.1 mMU/mL
Interval 1123.6 to 1284.0
|
—
|
|
Stage I: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 15 Years of Age and 20 to 26 Years of Age: Month 7
Anti-HPV 11
|
702.6 mMU/mL
Interval 662.7 to 744.9
|
981.6 mMU/mL
Interval 917.5 to 1050.2
|
—
|
SECONDARY outcome
Timeframe: 1 month post vaccination 3 (Month 7)Population: Per protocol, included participants 9 to 15 years of age who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type and in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine.
The percentage of participants who are seropositive for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 was determined using cLIA. Seroconversion was defined as changing serostatus from seronegative at baseline (Day 1) to seropositive at 1 month after last dose. Cutoff values for HPV seropositivity are ≥50, 29, 41, 59, 29, 22, 15, 20, and 15 mMU/mL for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, respectively. As pre-specified per protocol, a subset of participants 9 to 15 years of age were included in the analysis.
Outcome measures
| Measure |
9 to 19 Years of Age
n=458 Participants
Chinese females 9 to 19 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6. Participants in the 9 to 19 years of age group who completed 3 doses of V503 were eligible for Stage II and followed up to Month 60.
|
20 to 26 Years of Age
Chinese females 20 to 26 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
27 to 45 Years of Age
Chinese females 27 to 45 years of received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
|---|---|---|---|
|
Stage I: Percentage of Participants 9 to 15 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 7
Anti-HPV 6 ≥50 mMU/mL
|
100.0 Percentage of Participants
Interval 99.1 to 100.0
|
—
|
—
|
|
Stage I: Percentage of Participants 9 to 15 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 7
Anti-HPV 11 ≥29 mMU/mL
|
100.0 Percentage of Participants
Interval 99.1 to 100.0
|
—
|
—
|
|
Stage I: Percentage of Participants 9 to 15 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 7
Anti-HPV 16 ≥41 mMU/mL
|
100.0 Percentage of Participants
Interval 99.2 to 100.0
|
—
|
—
|
|
Stage I: Percentage of Participants 9 to 15 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 7
Anti-HPV 18 ≥59 mMU/mL
|
100.0 Percentage of Participants
Interval 99.1 to 100.0
|
—
|
—
|
|
Stage I: Percentage of Participants 9 to 15 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 7
Anti-HPV 31 ≥29 mMU/mL
|
100.0 Percentage of Participants
Interval 99.2 to 100.0
|
—
|
—
|
|
Stage I: Percentage of Participants 9 to 15 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 7
Anti-HPV 33 ≥22 mMU/mL
|
100.0 Percentage of Participants
Interval 99.1 to 100.0
|
—
|
—
|
|
Stage I: Percentage of Participants 9 to 15 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 7
Anti-HPV 45 ≥15 mMU/mL
|
100.0 Percentage of Participants
Interval 99.2 to 100.0
|
—
|
—
|
|
Stage I: Percentage of Participants 9 to 15 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 7
Anti-HPV 52 ≥20 mMU/mL
|
100.0 Percentage of Participants
Interval 99.1 to 100.0
|
—
|
—
|
|
Stage I: Percentage of Participants 9 to 15 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 7
Anti-HPV 58 ≥15 mMU/mL
|
100.0 Percentage of Participants
Interval 99.1 to 100.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month post vaccination 3 (Month 7)Population: Per protocol, included participants 27 to 45 years of age who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type and in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine.
Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined using cLIA. The HPV-9 cLIA assay was used to quantify the antibodies. This assay evaluated the serological response before and after 9vHPV vaccination and measured HPV infection-induced antibodies. The GMT for each HPV type were expressed as mMU/mL.
Outcome measures
| Measure |
9 to 19 Years of Age
n=650 Participants
Chinese females 9 to 19 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6. Participants in the 9 to 19 years of age group who completed 3 doses of V503 were eligible for Stage II and followed up to Month 60.
|
20 to 26 Years of Age
Chinese females 20 to 26 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
27 to 45 Years of Age
Chinese females 27 to 45 years of received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
|---|---|---|---|
|
Stage I: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 27 to 45 Years of Age: Month 7
Anti-HPV 6
|
784.1 mMU/mL
Interval 738.9 to 832.1
|
—
|
—
|
|
Stage I: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 27 to 45 Years of Age: Month 7
Anti-HPV 11
|
634.7 mMU/mL
Interval 596.1 to 675.8
|
—
|
—
|
|
Stage I: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 27 to 45 Years of Age: Month 7
Anti-HPV 16
|
3175.0 mMU/mL
Interval 2983.0 to 3379.5
|
—
|
—
|
|
Stage I: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 27 to 45 Years of Age: Month 7
Anti-HPV 18
|
838.9 mMU/mL
Interval 783.8 to 897.8
|
—
|
—
|
|
Stage I: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 27 to 45 Years of Age: Month 7
Anti-HPV 31
|
699.9 mMU/mL
Interval 658.3 to 744.1
|
—
|
—
|
|
Stage I: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 27 to 45 Years of Age: Month 7
Anti-HPV 33
|
422.7 mMU/mL
Interval 396.9 to 450.1
|
—
|
—
|
|
Stage I: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 27 to 45 Years of Age: Month 7
Anti-HPV 45
|
245.1 mMU/mL
Interval 229.8 to 261.5
|
—
|
—
|
|
Stage I: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 27 to 45 Years of Age: Month 7
Anti-HPV 52
|
342.1 mMU/mL
Interval 322.2 to 363.2
|
—
|
—
|
|
Stage I: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 27 to 45 Years of Age: Month 7
Anti-HPV 58
|
435.2 mMU/mL
Interval 408.1 to 464.2
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month post vaccination 3 (Month 7)Population: Participants who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type and in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine were analyzed.
Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined using IgG LIA. The HPV-9 IgG LIA assay was used to quantify the antibodies. This assay evaluated the serological response before and after 9vHPV vaccination and measured HPV infection-induced antibodies. The GMT for each HPV type was expressed as mMU/mL.
Outcome measures
| Measure |
9 to 19 Years of Age
n=688 Participants
Chinese females 9 to 19 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6. Participants in the 9 to 19 years of age group who completed 3 doses of V503 were eligible for Stage II and followed up to Month 60.
|
20 to 26 Years of Age
n=650 Participants
Chinese females 20 to 26 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
27 to 45 Years of Age
n=650 Participants
Chinese females 27 to 45 years of received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
|---|---|---|---|
|
Stage I: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age, 20 to 26 Years of Age, and 27 to 45 Years of Age: Month 7
Anti-HPV 11
|
939.9 mMU/mL
Interval 884.2 to 999.1
|
670.6 mMU/mL
Interval 628.8 to 715.2
|
566.1 mMU/mL
Interval 526.0 to 609.1
|
|
Stage I: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age, 20 to 26 Years of Age, and 27 to 45 Years of Age: Month 7
Anti-HPV 6
|
1177.1 mMU/mL
Interval 1105.1 to 1253.7
|
835.9 mMU/mL
Interval 785.7 to 889.3
|
717.2 mMU/mL
Interval 668.3 to 769.8
|
|
Stage I: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age, 20 to 26 Years of Age, and 27 to 45 Years of Age: Month 7
Anti-HPV 16
|
4746.8 mMU/mL
Interval 4473.9 to 5036.4
|
3435.0 mMU/mL
Interval 3232.2 to 3650.5
|
2867.6 mMU/mL
Interval 2685.8 to 3061.7
|
|
Stage I: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age, 20 to 26 Years of Age, and 27 to 45 Years of Age: Month 7
Anti-HPV 18
|
1303.8 mMU/mL
Interval 1219.5 to 1393.8
|
910.3 mMU/mL
Interval 848.6 to 976.5
|
741.7 mMU/mL
Interval 690.6 to 796.5
|
|
Stage I: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age, 20 to 26 Years of Age, and 27 to 45 Years of Age: Month 7
Anti-HPV 31
|
1082.5 mMU/mL
Interval 1016.4 to 1152.9
|
744.2 mMU/mL
Interval 695.5 to 796.2
|
630.2 mMU/mL
Interval 589.5 to 673.6
|
|
Stage I: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age, 20 to 26 Years of Age, and 27 to 45 Years of Age: Month 7
Anti-HPV 33
|
647.1 mMU/mL
Interval 607.3 to 689.5
|
461.7 mMU/mL
Interval 433.0 to 492.4
|
384.5 mMU/mL
Interval 359.0 to 411.9
|
|
Stage I: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age, 20 to 26 Years of Age, and 27 to 45 Years of Age: Month 7
Anti-HPV 45
|
397.9 mMU/mL
Interval 371.7 to 425.9
|
260.7 mMU/mL
Interval 243.0 to 279.6
|
213.7 mMU/mL
Interval 199.6 to 228.8
|
|
Stage I: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age, 20 to 26 Years of Age, and 27 to 45 Years of Age: Month 7
Anti-HPV 52
|
478.8 mMU/mL
Interval 450.7 to 508.8
|
354.7 mMU/mL
Interval 332.0 to 379.0
|
278.3 mMU/mL
Interval 259.2 to 298.8
|
|
Stage I: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age, 20 to 26 Years of Age, and 27 to 45 Years of Age: Month 7
Anti-HPV 58
|
698.8 mMU/mL
Interval 659.0 to 741.1
|
501.0 mMU/mL
Interval 469.4 to 534.8
|
399.3 mMU/mL
Interval 373.2 to 427.2
|
SECONDARY outcome
Timeframe: 1 month post vaccination 3 (Month 7)Population: Participants who 1) received all vaccinations in the planned regimen, 2) were seronegative at Day 1 for the relevant HPV type in the analysis of HPV types 6 and 11, the participant must be seronegative to both HPV 6 and 11, 3) had a serum sample collected 1 month after last dose within an acceptable day range, and 4) had no other protocol violations that could interfere with the evaluation of participant's immune response to the study vaccine were analyzed.
The percentage of participants who are seropositive for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 was determined using IgG LIA. Seroconversion was defined as changing serostatus from seronegative at baseline (Day 1) to seropositive at 1 month after last dose. Cutoff values for HPV seropositivity are ≥9, 6, 5, 5, 3, 4, 3, 5 and 5 mMU/mL for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, respectively.
Outcome measures
| Measure |
9 to 19 Years of Age
n=688 Participants
Chinese females 9 to 19 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6. Participants in the 9 to 19 years of age group who completed 3 doses of V503 were eligible for Stage II and followed up to Month 60.
|
20 to 26 Years of Age
n=650 Participants
Chinese females 20 to 26 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
27 to 45 Years of Age
n=650 Participants
Chinese females 27 to 45 years of received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
|---|---|---|---|
|
Stage I: Percentage of Participants 9 to 19 Years of Age, 20 to 26 Years of Age, and 27 to 45 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 7
Anti-HPV 31 ≥3 mMU/mL
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
|
Stage I: Percentage of Participants 9 to 19 Years of Age, 20 to 26 Years of Age, and 27 to 45 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 7
Anti-HPV 58 ≥5 mMU/mL
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
100.0 Percentage of Participants
Interval 99.3 to 100.0
|
|
Stage I: Percentage of Participants 9 to 19 Years of Age, 20 to 26 Years of Age, and 27 to 45 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 7
Anti-HPV 6 ≥9 mMU/mL
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
100.0 Percentage of Participants
Interval 99.3 to 100.0
|
|
Stage I: Percentage of Participants 9 to 19 Years of Age, 20 to 26 Years of Age, and 27 to 45 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 7
Anti-HPV 11 ≥6 mMU/mL
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
100.0 Percentage of Participants
Interval 99.3 to 100.0
|
|
Stage I: Percentage of Participants 9 to 19 Years of Age, 20 to 26 Years of Age, and 27 to 45 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 7
Anti-HPV 16 ≥5 mMU/mL
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
|
Stage I: Percentage of Participants 9 to 19 Years of Age, 20 to 26 Years of Age, and 27 to 45 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 7
Anti-HPV 18 ≥5 mMU/mL
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
|
Stage I: Percentage of Participants 9 to 19 Years of Age, 20 to 26 Years of Age, and 27 to 45 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 7
Anti-HPV 33 ≥4 mMU/mL
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
|
Stage I: Percentage of Participants 9 to 19 Years of Age, 20 to 26 Years of Age, and 27 to 45 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 7
Anti-HPV 45 ≥3 mMU/mL
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
|
Stage I: Percentage of Participants 9 to 19 Years of Age, 20 to 26 Years of Age, and 27 to 45 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 7
Anti-HPV 52 ≥5 mMU/mL
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
100.0 Percentage of Participants
Interval 99.4 to 100.0
|
SECONDARY outcome
Timeframe: Up to 8 days post any vaccination (up to ~Day 192)Population: The analysis population consisted of all participants who received at least 1 dose of study vaccination.
An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study vaccine or protocol-specified procedure is also an AE. The participant or the parent/guardian of the participant was to record the presence of any vaccination report card (VRC)-prompted injection-site AEs that occurred in the 8 days after any vaccination. The percentage of participants with an injection-site AE prompted on the VRC (erythema, pain, swelling and induration) is reported.
Outcome measures
| Measure |
9 to 19 Years of Age
n=688 Participants
Chinese females 9 to 19 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6. Participants in the 9 to 19 years of age group who completed 3 doses of V503 were eligible for Stage II and followed up to Month 60.
|
20 to 26 Years of Age
n=650 Participants
Chinese females 20 to 26 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
27 to 45 Years of Age
n=650 Participants
Chinese females 27 to 45 years of received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
|---|---|---|---|
|
Stage I: Percentage of Participants Who Experience at Least 1 Solicited Injection-site Adverse Event (AE)
Injection site pain
|
39.1 Percentage of Participants
95% Confidence Interval 35.4 • Interval 35.4 to 42.9
|
44.5 Percentage of Participants
95% Confidence Interval 40.6 • Interval 40.6 to 48.4
|
39.1 Percentage of Participants
95% Confidence Interval 35.3 • Interval 35.3 to 42.9
|
|
Stage I: Percentage of Participants Who Experience at Least 1 Solicited Injection-site Adverse Event (AE)
Injection site swelling
|
8.1 Percentage of Participants
95% Confidence Interval 6.2 • Interval 6.2 to 10.4
|
8.9 Percentage of Participants
95% Confidence Interval 6.8 • Interval 6.8 to 11.4
|
5.4 Percentage of Participants
95% Confidence Interval 3.8 • Interval 3.8 to 7.4
|
|
Stage I: Percentage of Participants Who Experience at Least 1 Solicited Injection-site Adverse Event (AE)
Injection site erythema
|
9.3 Percentage of Participants
95% Confidence Interval 7.2 • Interval 7.2 to 11.7
|
11.1 Percentage of Participants
95% Confidence Interval 8.8 • Interval 8.8 to 13.7
|
7.4 Percentage of Participants
95% Confidence Interval 5.5 • Interval 5.5 to 9.7
|
|
Stage I: Percentage of Participants Who Experience at Least 1 Solicited Injection-site Adverse Event (AE)
Injection site induration
|
6.3 Percentage of Participants
95% Confidence Interval 4.6 • Interval 4.6 to 8.3
|
8.0 Percentage of Participants
95% Confidence Interval 6.0 • Interval 6.0 to 10.4
|
6.0 Percentage of Participants
95% Confidence Interval 4.3 • Interval 4.3 to 8.1
|
SECONDARY outcome
Timeframe: Up to 31 days post any vaccination (Up to ~Month 7)Population: The analysis population consisted of all participants who received at least 1 dose of study vaccination.
An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study vaccine or protocol-specified procedure is also an AE. The percentage of participants with a systemic AE is reported.
Outcome measures
| Measure |
9 to 19 Years of Age
n=688 Participants
Chinese females 9 to 19 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6. Participants in the 9 to 19 years of age group who completed 3 doses of V503 were eligible for Stage II and followed up to Month 60.
|
20 to 26 Years of Age
n=650 Participants
Chinese females 20 to 26 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
27 to 45 Years of Age
n=650 Participants
Chinese females 27 to 45 years of received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
|---|---|---|---|
|
Stage I: Percentage of Participants Who Experience at Least 1 Systemic AE
|
50.9 Percentage of Participants
95% Confidence Interval 47.1 • Interval 47.1 to 54.7
|
57.1 Percentage of Participants
95% Confidence Interval 53.2 • Interval 53.2 to 60.9
|
43.4 Percentage of Participants
95% Confidence Interval 39.5 • Interval 39.5 to 47.3
|
SECONDARY outcome
Timeframe: Day 1 to Month 7Population: The analysis population consisted of all participants who received at least 1 dose of study vaccination.
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the study vaccine. An SAE is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event. The percentage of participants that experienced 1 or more SAEs is reported.
Outcome measures
| Measure |
9 to 19 Years of Age
n=688 Participants
Chinese females 9 to 19 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6. Participants in the 9 to 19 years of age group who completed 3 doses of V503 were eligible for Stage II and followed up to Month 60.
|
20 to 26 Years of Age
n=650 Participants
Chinese females 20 to 26 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
27 to 45 Years of Age
n=650 Participants
Chinese females 27 to 45 years of received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
|---|---|---|---|
|
Stage I: Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE)
|
1.3 Percentage of Participants
Interval 0.6 to 2.5
|
2.6 Percentage of Participants
Interval 1.5 to 4.2
|
2.6 Percentage of Participants
Interval 1.5 to 4.2
|
SECONDARY outcome
Timeframe: Up to 8 days post any vaccination (Up to ~Day 192)Population: The analysis population consisted of all participants who received at least 1 dose of study vaccination.
Participant or participant's legally acceptable representative will be asked to record axillary temperature in the evening after each study vaccination and daily, at the same time of day whenever possible, for 8 days after each study vaccination in the VRC. The percentage of participant's who had an axillary temperature ≥37.1°C is reported.
Outcome measures
| Measure |
9 to 19 Years of Age
n=688 Participants
Chinese females 9 to 19 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6. Participants in the 9 to 19 years of age group who completed 3 doses of V503 were eligible for Stage II and followed up to Month 60.
|
20 to 26 Years of Age
n=650 Participants
Chinese females 20 to 26 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
27 to 45 Years of Age
n=650 Participants
Chinese females 27 to 45 years of received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
|---|---|---|---|
|
Stage I: Percentage of Participants With Elevated Axillary Temperature (≥37.1 C)
≥37.1°C (98.8°F) and <37.6°C (99.7°F)
|
20.8 Percentage of Participants
95% Confidence Interval 17.8 • Interval 17.8 to 24.0
|
23.8 Percentage of Participants
95% Confidence Interval 20.6 • Interval 20.6 to 27.3
|
11.7 Percentage of Participants
95% Confidence Interval 9.3 • Interval 9.3 to 14.4
|
|
Stage I: Percentage of Participants With Elevated Axillary Temperature (≥37.1 C)
≥37.6°C (99.7°F) and <39.1°C (102.4°F)
|
2.2 Percentage of Participants
95% Confidence Interval 1.2 • Interval 1.2 to 3.6
|
2.0 Percentage of Participants
95% Confidence Interval 1.1 • Interval 1.1 to 3.4
|
0.5 Percentage of Participants
95% Confidence Interval 0.1 • Interval 0.1 to 1.3
|
|
Stage I: Percentage of Participants With Elevated Axillary Temperature (≥37.1 C)
≥39.1°C (102.4°F)
|
0.3 Percentage of Participants
95% Confidence Interval 0.0 • Interval 0.0 to 1.0
|
0.2 Percentage of Participants
95% Confidence Interval 0.0 • Interval 0.0 to 0.9
|
0.0 Percentage of Participants
95% Confidence Interval 0.0 • Interval 0.0 to 0.6
|
SECONDARY outcome
Timeframe: Month 7 to Month 60Population: The analysis population consisted of all participants 9 to 19 years of age who received at least 1 dose of study vaccination.
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the study vaccine. An SAE is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event. The percentage of participants that experienced 1 or more SAEs is reported.
Outcome measures
| Measure |
9 to 19 Years of Age
n=682 Participants
Chinese females 9 to 19 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6. Participants in the 9 to 19 years of age group who completed 3 doses of V503 were eligible for Stage II and followed up to Month 60.
|
20 to 26 Years of Age
Chinese females 20 to 26 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
27 to 45 Years of Age
Chinese females 27 to 45 years of received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
|---|---|---|---|
|
Stage II: Percentage of Participants 9 to 19 Years of Age Who Experience at Least 1 Serious Adverse Event (SAE): Month 7 to Month 60
|
1.5 Percentage of Participants
|
—
|
—
|
Adverse Events
Stage I: 9 to 19 Years of Age
Serious events: 9 serious events
Other events: 411 other events
Deaths: 0 deaths
Stage I: 20 to 26 Years of Age
Serious events: 17 serious events
Other events: 424 other events
Deaths: 0 deaths
Stage I: 27 to 45 Years of Age
Serious events: 17 serious events
Other events: 346 other events
Deaths: 0 deaths
Stage II: 9 to 19 Years of Age
Serious events: 10 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Stage I: 9 to 19 Years of Age
n=688 participants at risk
Chinese females 9 to 19 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6. Participants in the 9 to 19 years of age group who completed 3 doses of V503 were eligible for Stage II and followed up to Month 60.
|
Stage I: 20 to 26 Years of Age
n=650 participants at risk
Chinese females 20 to 26 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
Stage I: 27 to 45 Years of Age
n=650 participants at risk
Chinese females 27 to 45 years of received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
Stage II: 9 to 19 Years of Age
n=682 participants at risk
Participants in the 9 to 19 years of age group who completed 3 doses of V503 were eligible for Stage II and followed up to Month 60.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
0.00%
0/688 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.15%
1/682 • Number of events 1 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/688 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.15%
1/650 • Number of events 1 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.15%
1/682 • Number of events 1 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/688 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.15%
1/650 • Number of events 1 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/682 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
|
Gastrointestinal disorders
Embedded tooth
|
0.15%
1/688 • Number of events 1 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/682 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
|
Gastrointestinal disorders
Enteritis
|
0.15%
1/688 • Number of events 1 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/682 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
|
Gastrointestinal disorders
Gastritis
|
0.15%
1/688 • Number of events 1 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/682 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
|
Gastrointestinal disorders
Haemoperitoneum
|
0.00%
0/688 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.15%
1/650 • Number of events 1 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/682 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
|
Gastrointestinal disorders
Inflammatory bowel disease
|
0.00%
0/688 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.15%
1/650 • Number of events 1 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/682 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/688 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.15%
1/682 • Number of events 1 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
|
Gastrointestinal disorders
Tooth impacted
|
0.00%
0/688 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.15%
1/650 • Number of events 1 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/682 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.15%
1/688 • Number of events 1 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/682 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/688 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.15%
1/650 • Number of events 1 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/682 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/688 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.15%
1/682 • Number of events 1 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/688 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.15%
1/650 • Number of events 1 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/682 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
|
Infections and infestations
Appendicitis perforated
|
0.15%
1/688 • Number of events 1 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/682 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/688 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.15%
1/650 • Number of events 1 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/682 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
|
Infections and infestations
Lymphadenitis bacterial
|
0.00%
0/688 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.15%
1/650 • Number of events 1 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/682 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/688 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.15%
1/650 • Number of events 1 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.15%
1/650 • Number of events 1 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.15%
1/682 • Number of events 1 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.15%
1/688 • Number of events 1 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/682 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
|
Infections and infestations
Tonsillitis bacterial
|
0.00%
0/688 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.15%
1/682 • Number of events 1 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
|
Injury, poisoning and procedural complications
Closed globe injury
|
0.00%
0/688 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.15%
1/650 • Number of events 1 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/682 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
|
Injury, poisoning and procedural complications
Craniofacial fracture
|
0.00%
0/688 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.15%
1/650 • Number of events 1 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/682 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/688 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.15%
1/650 • Number of events 1 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/682 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
|
Musculoskeletal and connective tissue disorders
Chondropathy
|
0.15%
1/688 • Number of events 1 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/682 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
|
Musculoskeletal and connective tissue disorders
Jaw cyst
|
0.00%
0/688 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.15%
1/650 • Number of events 1 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/682 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of breast
|
0.15%
1/688 • Number of events 1 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.46%
3/650 • Number of events 3 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/682 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/688 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.15%
1/682 • Number of events 1 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nipple neoplasm
|
0.00%
0/688 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.15%
1/650 • Number of events 1 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/682 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/688 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.15%
1/650 • Number of events 1 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/682 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion missed
|
0.00%
0/688 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.31%
2/650 • Number of events 2 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/682 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/688 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.15%
1/650 • Number of events 1 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/682 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
|
Pregnancy, puerperium and perinatal conditions
Biochemical pregnancy
|
0.00%
0/688 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.15%
1/650 • Number of events 1 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/682 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/688 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.15%
1/650 • Number of events 1 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/682 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/688 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.15%
1/650 • Number of events 1 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/682 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
|
Reproductive system and breast disorders
Abnormal uterine bleeding
|
0.00%
0/688 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.15%
1/682 • Number of events 1 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/688 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.31%
2/650 • Number of events 2 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/682 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/688 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.15%
1/650 • Number of events 1 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/682 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.00%
0/688 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.15%
1/650 • Number of events 1 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.15%
1/682 • Number of events 1 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
|
Reproductive system and breast disorders
Uterine adhesions
|
0.00%
0/688 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.15%
1/650 • Number of events 1 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/682 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
|
Reproductive system and breast disorders
Uterine diverticulum
|
0.00%
0/688 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.31%
2/650 • Number of events 2 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/682 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/688 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.15%
1/650 • Number of events 1 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.15%
1/650 • Number of events 1 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.15%
1/682 • Number of events 1 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/688 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.15%
1/650 • Number of events 1 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/682 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.15%
1/688 • Number of events 1 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/682 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
|
Skin and subcutaneous tissue disorders
Bromhidrosis
|
0.00%
0/688 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.15%
1/682 • Number of events 1 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
|
Surgical and medical procedures
Abortion induced
|
0.00%
0/688 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.15%
1/650 • Number of events 1 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/682 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
|
Vascular disorders
Hypertension
|
0.00%
0/688 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/650 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.15%
1/650 • Number of events 1 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/682 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
Other adverse events
| Measure |
Stage I: 9 to 19 Years of Age
n=688 participants at risk
Chinese females 9 to 19 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6. Participants in the 9 to 19 years of age group who completed 3 doses of V503 were eligible for Stage II and followed up to Month 60.
|
Stage I: 20 to 26 Years of Age
n=650 participants at risk
Chinese females 20 to 26 years of age received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
Stage I: 27 to 45 Years of Age
n=650 participants at risk
Chinese females 27 to 45 years of received a 0.5 mL per dose was administered as an intramuscular injection at Day 1, Month 2, and Month 6.
|
Stage II: 9 to 19 Years of Age
n=682 participants at risk
Participants in the 9 to 19 years of age group who completed 3 doses of V503 were eligible for Stage II and followed up to Month 60.
|
|---|---|---|---|---|
|
General disorders
Injection site swelling
|
8.7%
60/688 • Number of events 69 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
9.7%
63/650 • Number of events 72 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
5.8%
38/650 • Number of events 48 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/682 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
|
General disorders
Pyrexia
|
25.0%
172/688 • Number of events 256 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
26.9%
175/650 • Number of events 261 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
13.1%
85/650 • Number of events 117 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/682 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.4%
51/688 • Number of events 57 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
5.4%
35/650 • Number of events 36 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
4.2%
27/650 • Number of events 29 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/682 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
|
General disorders
Injection site induration
|
6.7%
46/688 • Number of events 52 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
8.9%
58/650 • Number of events 68 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
6.9%
45/650 • Number of events 51 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/682 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
|
General disorders
Injection site pain
|
39.2%
270/688 • Number of events 411 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
45.2%
294/650 • Number of events 492 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
39.8%
259/650 • Number of events 407 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/682 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
|
General disorders
Injection site erythema
|
9.3%
64/688 • Number of events 76 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
11.2%
73/650 • Number of events 93 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
7.4%
48/650 • Number of events 61 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/682 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.5%
45/688 • Number of events 53 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
6.8%
44/650 • Number of events 45 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
3.4%
22/650 • Number of events 24 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/682 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.1%
42/688 • Number of events 46 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
6.2%
40/650 • Number of events 44 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
2.9%
19/650 • Number of events 19 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
0.00%
0/682 • Stage I: Day 1 to Month 7; Stage II: Post Month 7 to Month 60
All-cause mortality included all enrolled participants. The analysis population for Serious and Other adverse events included all enrolled participants who received at least 1 dose of study vaccination.
|
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 investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
- Publication restrictions are in place
Restriction type: OTHER