Trial Outcomes & Findings for A Study to Evaluate the Immunogenicity, Safety and Tolerability of Quadrivalent Human Papillomavirus Vaccine (V501) in Chinese Girls Aged 9-19 Years and Young Women Aged 20-26 Years (V501-213) (NCT NCT03493542)
NCT ID: NCT03493542
Last Updated: 2024-12-31
Results Overview
The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using IgG LIA.
COMPLETED
PHASE3
766 participants
Month 60 post-vaccination 1
2024-12-31
Participant Flow
Participant milestones
| Measure |
Base Study: Chinese Girls Aged 9 to 19 Years
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
Base Study: Chinese Young Women Aged 20 to 26 Years
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
Extension Study: Chinese Girls Aged 9 to 19 Years
In base study, participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 and followed up to Month 7. In the extension studies after Month 7, the participants were followed up for safety and immunogenicity up to Month 60 (EXT)
|
|---|---|---|---|
|
Base Study
STARTED
|
383
|
383
|
0
|
|
Base Study
Vaccination 1
|
383
|
383
|
0
|
|
Base Study
Vaccination 2
|
379
|
378
|
0
|
|
Base Study
Vaccination 3
|
378
|
377
|
0
|
|
Base Study
COMPLETED
|
383
|
379
|
0
|
|
Base Study
NOT COMPLETED
|
0
|
4
|
0
|
|
Extension Study
STARTED
|
0
|
0
|
365
|
|
Extension Study
COMPLETED
|
0
|
0
|
338
|
|
Extension Study
NOT COMPLETED
|
0
|
0
|
27
|
Reasons for withdrawal
| Measure |
Base Study: Chinese Girls Aged 9 to 19 Years
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
Base Study: Chinese Young Women Aged 20 to 26 Years
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
Extension Study: Chinese Girls Aged 9 to 19 Years
In base study, participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 and followed up to Month 7. In the extension studies after Month 7, the participants were followed up for safety and immunogenicity up to Month 60 (EXT)
|
|---|---|---|---|
|
Base Study
Withdrawal by Subject
|
0
|
4
|
0
|
|
Extension Study
Consent withdrawal by parent/guardian
|
0
|
0
|
2
|
|
Extension Study
Withdrawal by Subject
|
0
|
0
|
25
|
Baseline Characteristics
A Study to Evaluate the Immunogenicity, Safety and Tolerability of Quadrivalent Human Papillomavirus Vaccine (V501) in Chinese Girls Aged 9-19 Years and Young Women Aged 20-26 Years (V501-213)
Baseline characteristics by cohort
| Measure |
Base Study: Chinese Girls Aged 9 to 19 Years
n=383 Participants
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
Base Study: Chinese Young Women Aged 20 to 26 Years
n=383 Participants
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
Total
n=766 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
14.3 years
STANDARD_DEVIATION 3.3 • n=5 Participants
|
23.4 years
STANDARD_DEVIATION 1.8 • n=7 Participants
|
18.8 years
STANDARD_DEVIATION 5.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
383 Participants
n=5 Participants
|
383 Participants
n=7 Participants
|
766 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
383 Participants
n=5 Participants
|
383 Participants
n=7 Participants
|
766 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
383 Participants
n=5 Participants
|
383 Participants
n=7 Participants
|
766 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 7 (1 month postdose 3)Population: Per protocol, the analysis population included the participants with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine.
Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using a Competitive Luminex Immunoassay (cLIA). Antibody titers were expressed as milli Merck Units/milliliter (mMU/mL).
Outcome measures
| Measure |
Chinese Girls Aged 9 to 19 Years
n=383 Participants
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
Base Study: Chinese Young Women Aged 20 to 26 Years
n=383 Participants
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
|---|---|---|
|
Base Stage: Geometric Mean Titers for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18: Competitive Luminex Immunoassay (cLIA)
Anti-HPV 6
|
975.2 mMU/mL
Interval 905.6 to 1050.2
|
686.6 mMU/mL
Interval 635.5 to 741.7
|
|
Base Stage: Geometric Mean Titers for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18: Competitive Luminex Immunoassay (cLIA)
Anti-HPV 11
|
807.4 mMU/mL
Interval 749.8 to 869.4
|
580.2 mMU/mL
Interval 537.0 to 626.8
|
|
Base Stage: Geometric Mean Titers for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18: Competitive Luminex Immunoassay (cLIA)
Anti-HPV 16
|
4573.7 mMU/mL
Interval 4244.5 to 4928.3
|
2989.2 mMU/mL
Interval 2766.7 to 3229.6
|
|
Base Stage: Geometric Mean Titers for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18: Competitive Luminex Immunoassay (cLIA)
Anti-HPV 18
|
1176.5 mMU/mL
Interval 1069.0 to 1294.8
|
708.6 mMU/mL
Interval 642.4 to 781.6
|
PRIMARY outcome
Timeframe: Month 12 post-vaccination 1Population: Per protocol, the analysis population included participants with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine.
Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using a Competitive Luminex Immunoassay (cLIA). Antibody titers were expressed as (mMU/mL).
Outcome measures
| Measure |
Chinese Girls Aged 9 to 19 Years
n=365 Participants
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
Base Study: Chinese Young Women Aged 20 to 26 Years
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
|---|---|---|
|
Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 12 Assessed by cLIA
Anti-HPV 6
|
259.1 mMU/mL
Interval 237.6 to 282.4
|
—
|
|
Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 12 Assessed by cLIA
Anti-HPV 11
|
206.7 mMU/mL
Interval 190.5 to 224.3
|
—
|
|
Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 12 Assessed by cLIA
Anti-HPV 16
|
1149.8 mMU/mL
Interval 1054.6 to 1253.7
|
—
|
|
Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 12 Assessed by cLIA
Anti-HPV 18
|
284.2 mMU/mL
Interval 257.3 to 313.8
|
—
|
PRIMARY outcome
Timeframe: Month 24 post-vaccination 1Population: Per protocol, the analysis population included participants with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine.
Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using a Competitive Luminex Immunoassay (cLIA). Antibody titers were expressed as (mMU/mL).
Outcome measures
| Measure |
Chinese Girls Aged 9 to 19 Years
n=365 Participants
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
Base Study: Chinese Young Women Aged 20 to 26 Years
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
|---|---|---|
|
Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 24 Assessed by cLIA
Anti-HPV 6
|
137.9 mMU/mL
Interval 125.5 to 151.4
|
—
|
|
Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 24 Assessed by cLIA
Anti-HPV 11
|
110.3 mMU/mL
Interval 101.0 to 120.6
|
—
|
|
Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 24 Assessed by cLIA
Anti-HPV 16
|
522.6 mMU/mL
Interval 472.1 to 578.5
|
—
|
|
Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 24 Assessed by cLIA
Anti-HPV 18
|
157.2 mMU/mL
Interval 142.7 to 173.3
|
—
|
PRIMARY outcome
Timeframe: Month 36 post-vaccination 1Population: Per protocol, the analysis population included participants with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine.
Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using a Competitive Luminex Immunoassay (cLIA). Antibody titers were expressed as (mMU/mL).
Outcome measures
| Measure |
Chinese Girls Aged 9 to 19 Years
n=365 Participants
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
Base Study: Chinese Young Women Aged 20 to 26 Years
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
|---|---|---|
|
Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 36 Assessed by cLIA
Anti-HPV 18
|
131.9 mMU/mL
Interval 120.2 to 144.8
|
—
|
|
Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 36 Assessed by cLIA
Anti-HPV 6
|
110.6 mMU/mL
Interval 101.3 to 120.7
|
—
|
|
Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 36 Assessed by cLIA
Anti-HPV 11
|
87.0 mMU/mL
Interval 79.6 to 95.2
|
—
|
|
Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 36 Assessed by cLIA
Anti-HPV 16
|
400.8 mMU/mL
Interval 359.5 to 446.8
|
—
|
PRIMARY outcome
Timeframe: Month 48 post-vaccination 1Population: Per protocol, the analysis population included participants with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine.
Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using a Competitive Luminex Immunoassay (cLIA). Antibody titers were expressed as (mMU/mL).
Outcome measures
| Measure |
Chinese Girls Aged 9 to 19 Years
n=365 Participants
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
Base Study: Chinese Young Women Aged 20 to 26 Years
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
|---|---|---|
|
Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 48 Assessed by cLIA
Anti-HPV 11
|
81.8 mMU/mL
Interval 74.8 to 89.3
|
—
|
|
Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 48 Assessed by cLIA
Anti-HPV 6
|
103.0 mMU/mL
Interval 94.4 to 112.4
|
—
|
|
Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 48 Assessed by cLIA
Anti-HPV 16
|
347.5 mMU/mL
Interval 310.0 to 389.6
|
—
|
|
Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 48 Assessed by cLIA
Anti-HPV 18
|
130.3 mMU/mL
Interval 118.9 to 142.7
|
—
|
PRIMARY outcome
Timeframe: Month 60 post-vaccination 1Population: Per protocol, the analysis population included participants with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine.
Serum antibody titers (Geometric mean titers) for HPV virus-like particles (VLPs) Types 6, 11, 16, and 18 were measured. Antibodies were measured using a Competitive Luminex Immunoassay (cLIA). Antibody titers were expressed as (mMU/mL).
Outcome measures
| Measure |
Chinese Girls Aged 9 to 19 Years
n=365 Participants
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
Base Study: Chinese Young Women Aged 20 to 26 Years
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
|---|---|---|
|
Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 60 Assessed by cLIA
Anti-HPV 11
|
67.3 mMU/mL
Interval 61.6 to 73.5
|
—
|
|
Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 60 Assessed by cLIA
Anti-HPV 18
|
113.6 mMU/mL
Interval 103.7 to 124.5
|
—
|
|
Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 60 Assessed by cLIA
Anti-HPV 6
|
87.6 mMU/mL
Interval 80.4 to 95.4
|
—
|
|
Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 60 Assessed by cLIA
Anti-HPV 16
|
283.2 mMU/mL
Interval 250.8 to 319.8
|
—
|
PRIMARY outcome
Timeframe: Month 12 post-vaccination 1Population: Per protocol, the analysis population included participants with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine.
The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using cLIA.
Outcome measures
| Measure |
Chinese Girls Aged 9 to 19 Years
n=365 Participants
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
Base Study: Chinese Young Women Aged 20 to 26 Years
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
|---|---|---|
|
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 12 Assessed by cLIA
Anti-HPV 16
|
100.0 Percentage of Participants
Interval 98.9 to 100.0
|
—
|
|
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 12 Assessed by cLIA
Anti-HPV 6
|
99.1 Percentage of Participants
Interval 97.4 to 99.8
|
—
|
|
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 12 Assessed by cLIA
Anti-HPV 11
|
99.7 Percentage of Participants
Interval 98.3 to 100.0
|
—
|
|
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 12 Assessed by cLIA
Anti-HPV 18
|
96.9 Percentage of Participants
Interval 94.3 to 98.5
|
—
|
PRIMARY outcome
Timeframe: Month 24 post-vaccination 1Population: Per protocol, the analysis population included participants with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine.
The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using cLIA.
Outcome measures
| Measure |
Chinese Girls Aged 9 to 19 Years
n=365 Participants
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
Base Study: Chinese Young Women Aged 20 to 26 Years
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
|---|---|---|
|
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 24 Assessed by cLIA
Anti-HPV 18
|
87.7 Percentage of Participants
Interval 83.5 to 91.1
|
—
|
|
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 24 Assessed by cLIA
Anti-HPV 6
|
88.8 Percentage of Participants
Interval 84.9 to 92.0
|
—
|
|
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 24 Assessed by cLIA
Anti-HPV 11
|
95.3 Percentage of Participants
Interval 92.4 to 97.4
|
—
|
|
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 24 Assessed by cLIA
Anti-HPV 16
|
99.7 Percentage of Participants
Interval 98.3 to 100.0
|
—
|
PRIMARY outcome
Timeframe: Month 36 post-vaccination 1Population: Per protocol, the analysis population included participants with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine.
The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using cLIA.
Outcome measures
| Measure |
Chinese Girls Aged 9 to 19 Years
n=365 Participants
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
Base Study: Chinese Young Women Aged 20 to 26 Years
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
|---|---|---|
|
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 36 Assessed by cLIA
Anti-HPV 6
|
83.6 Percentage of Participants
Interval 79.1 to 87.5
|
—
|
|
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 36 Assessed by cLIA
Anti-HPV 11
|
92.1 Percentage of Participants
Interval 88.6 to 94.8
|
—
|
|
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 36 Assessed by cLIA
Anti-HPV 16
|
98.8 Percentage of Participants
Interval 96.9 to 99.7
|
—
|
|
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 36 Assessed by cLIA
Anti-HPV 18
|
84.0 Percentage of Participants
Interval 79.4 to 87.9
|
—
|
PRIMARY outcome
Timeframe: Month 48 post-vaccination 1Population: Per protocol, the analysis population included participants with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine.
The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using cLIA.
Outcome measures
| Measure |
Chinese Girls Aged 9 to 19 Years
n=365 Participants
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
Base Study: Chinese Young Women Aged 20 to 26 Years
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
|---|---|---|
|
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 48 Assessed by cLIA
Anti-HPV 6
|
68.5 Percentage of Participants
Interval 63.0 to 73.6
|
—
|
|
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 48 Assessed by cLIA
Anti-HPV 11
|
85.2 Percentage of Participants
Interval 80.8 to 89.0
|
—
|
|
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 48 Assessed by cLIA
Anti-HPV 16
|
91.9 Percentage of Participants
Interval 88.4 to 94.6
|
—
|
|
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 48 Assessed by cLIA
Anti-HPV 18
|
64.6 Percentage of Participants
Interval 58.9 to 70.0
|
—
|
PRIMARY outcome
Timeframe: Month 60 post-vaccination 1Population: Per protocol, the analysis population included participants with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine.
The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using cLIA.
Outcome measures
| Measure |
Chinese Girls Aged 9 to 19 Years
n=365 Participants
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
Base Study: Chinese Young Women Aged 20 to 26 Years
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
|---|---|---|
|
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 60 Assessed by cLIA
Anti-HPV 6
|
61.9 Percentage of Participants
Interval 56.2 to 67.3
|
—
|
|
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 60 Assessed by cLIA
Anti-HPV 11
|
74.9 Percentage of Participants
Interval 69.7 to 79.7
|
—
|
|
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 60 Assessed by cLIA
Anti-HPV 16
|
87.1 Percentage of Participants
Interval 82.9 to 90.6
|
—
|
|
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 60 Assessed by cLIA
Anti-HPV 18
|
58.3 Percentage of Participants
Interval 52.5 to 63.9
|
—
|
PRIMARY outcome
Timeframe: Month 12 post-vaccination 1Population: Per protocol, the analysis population included participants with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine.
Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using IgG LIA. Antibody titers were expressed as (mMU/mL).
Outcome measures
| Measure |
Chinese Girls Aged 9 to 19 Years
n=365 Participants
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
Base Study: Chinese Young Women Aged 20 to 26 Years
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
|---|---|---|
|
Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 12 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)
Anti-HPV 6
|
217.0 mMU/mL
Interval 198.1 to 237.6
|
—
|
|
Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 12 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)
Anti-HPV 11
|
172.1 mMU/mL
Interval 158.3 to 187.1
|
—
|
|
Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 12 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)
Anti-HPV 16
|
1025.8 mMU/mL
Interval 945.5 to 1113.0
|
—
|
|
Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 12 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)
Anti-HPV 18
|
228.0 mMU/mL
Interval 204.4 to 254.4
|
—
|
PRIMARY outcome
Timeframe: Month 24 post-vaccination 1Population: Per protocol, the analysis population included participants with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine.
Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using IgG LIA. Antibody titers were expressed as (mMU/mL).
Outcome measures
| Measure |
Chinese Girls Aged 9 to 19 Years
n=365 Participants
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
Base Study: Chinese Young Women Aged 20 to 26 Years
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
|---|---|---|
|
Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 24 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)
Anti-HPV 16
|
394.9 mMU/mL
Interval 354.6 to 439.9
|
—
|
|
Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 24 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)
Anti-HPV 6
|
85.5 mMU/mL
Interval 76.4 to 95.6
|
—
|
|
Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 24 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)
Anti-HPV 11
|
68.6 mMU/mL
Interval 61.6 to 76.4
|
—
|
|
Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 24 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)
Anti-HPV 18
|
76.9 mMU/mL
Interval 67.0 to 88.3
|
—
|
PRIMARY outcome
Timeframe: Month 36 post-vaccination 1Population: Per protocol, the analysis population included participants with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine.
Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using IgG LIA. Antibody titers were expressed as (mMU/mL).
Outcome measures
| Measure |
Chinese Girls Aged 9 to 19 Years
n=365 Participants
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
Base Study: Chinese Young Women Aged 20 to 26 Years
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
|---|---|---|
|
Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 36 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)
Anti-HPV 6
|
66.5 mMU/mL
Interval 59.6 to 74.1
|
—
|
|
Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 36 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)
Anti-HPV 11
|
52.7 mMU/mL
Interval 47.2 to 58.8
|
—
|
|
Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 36 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)
Anti-HPV 16
|
304.0 mMU/mL
Interval 272.2 to 339.5
|
—
|
|
Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 36 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)
Anti-HPV 18
|
57.5 mMU/mL
Interval 50.0 to 66.1
|
—
|
PRIMARY outcome
Timeframe: Month 48 post-vaccination 1Population: Per protocol, the analysis population included participants with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine.
Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using IgG LIA.
Outcome measures
| Measure |
Chinese Girls Aged 9 to 19 Years
n=365 Participants
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
Base Study: Chinese Young Women Aged 20 to 26 Years
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
|---|---|---|
|
Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 48 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)
Anti-HPV 6
|
63.4 mMU/mL
Interval 56.8 to 70.8
|
—
|
|
Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 48 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)
Anti-HPV 11
|
51.1 mMU/mL
Interval 45.9 to 56.9
|
—
|
|
Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 48 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)
Anti-HPV 16
|
289.6 mMU/mL
Interval 258.7 to 324.2
|
—
|
|
Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 48 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)
Anti-HPV 18
|
55.3 mMU/mL
Interval 47.8 to 63.9
|
—
|
PRIMARY outcome
Timeframe: Month 60 post-vaccination 1Population: Per protocol, the analysis population included participants with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine.
Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using IgG LIA.
Outcome measures
| Measure |
Chinese Girls Aged 9 to 19 Years
n=365 Participants
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
Base Study: Chinese Young Women Aged 20 to 26 Years
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
|---|---|---|
|
Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 60 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)
Anti-HPV 6
|
58.6 mMU/mL
Interval 52.5 to 65.4
|
—
|
|
Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 60 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)
Anti-HPV 11
|
47.2 mMU/mL
Interval 42.4 to 52.5
|
—
|
|
Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 60 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)
Anti-HPV 16
|
264.3 mMU/mL
Interval 235.8 to 296.3
|
—
|
|
Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 60 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)
Anti-HPV 18
|
51.0 mMU/mL
Interval 44.0 to 59.1
|
—
|
PRIMARY outcome
Timeframe: Month 12 post-vaccination 1Population: Per protocol, the analysis population included participants with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine.
The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using IgG LIA.
Outcome measures
| Measure |
Chinese Girls Aged 9 to 19 Years
n=365 Participants
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
Base Study: Chinese Young Women Aged 20 to 26 Years
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
|---|---|---|
|
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 12 Assessed by IgG LIA
Anti-HPV 6
|
100.0 Percentage of Participants
Interval 98.9 to 100.0
|
—
|
|
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 12 Assessed by IgG LIA
Anti-HPV 11
|
100.0 Percentage of Participants
Interval 98.9 to 100.0
|
—
|
|
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 12 Assessed by IgG LIA
Anti-HPV 16
|
100.0 Percentage of Participants
Interval 98.9 to 100.0
|
—
|
|
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 12 Assessed by IgG LIA
Anti-HPV 18
|
100.0 Percentage of Participants
Interval 98.9 to 100.0
|
—
|
PRIMARY outcome
Timeframe: Month 24 post-vaccination 1Population: Per protocol, the analysis population included participants with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine.
The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using IgG LIA.
Outcome measures
| Measure |
Chinese Girls Aged 9 to 19 Years
n=365 Participants
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
Base Study: Chinese Young Women Aged 20 to 26 Years
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
|---|---|---|
|
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 24 Assessed by IgG LIA
Anti-HPV 16
|
100.0 Percentage of Participants
Interval 98.9 to 100.0
|
—
|
|
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 24 Assessed by IgG LIA
Anti-HPV 18
|
98.1 Percentage of Participants
Interval 95.9 to 99.3
|
—
|
|
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 24 Assessed by IgG LIA
Anti-HPV 6
|
98.4 Percentage of Participants
Interval 96.4 to 99.5
|
—
|
|
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 24 Assessed by IgG LIA
Anti-HPV 11
|
98.4 Percentage of Participants
Interval 96.4 to 99.5
|
—
|
PRIMARY outcome
Timeframe: Month 36 post-vaccination 1Population: Per protocol, the analysis population included participants with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine.
The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using IgG LIA.
Outcome measures
| Measure |
Chinese Girls Aged 9 to 19 Years
n=365 Participants
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
Base Study: Chinese Young Women Aged 20 to 26 Years
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
|---|---|---|
|
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 36 Assessed by IgG LIA
Anti-HPV 18
|
96.2 Percentage of Participants
Interval 93.4 to 98.0
|
—
|
|
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 36 Assessed by IgG LIA
Anti-HPV 6
|
98.1 Percentage of Participants
Interval 95.9 to 99.3
|
—
|
|
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 36 Assessed by IgG LIA
Anti-HPV 11
|
99.4 Percentage of Participants
Interval 97.7 to 99.9
|
—
|
|
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 36 Assessed by IgG LIA
Anti-HPV 16
|
100.0 Percentage of Participants
Interval 98.9 to 100.0
|
—
|
PRIMARY outcome
Timeframe: Month 48 post-vaccination 1Population: Per protocol, the analysis population included participants with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine.
The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using IgG LIA.
Outcome measures
| Measure |
Chinese Girls Aged 9 to 19 Years
n=365 Participants
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
Base Study: Chinese Young Women Aged 20 to 26 Years
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
|---|---|---|
|
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 48 Assessed by IgG LIA
Anti-HPV 6
|
97.4 Percentage of Participants
Interval 95.0 to 98.9
|
—
|
|
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 48 Assessed by IgG LIA
Anti-HPV 11
|
98.4 Percentage of Participants
Interval 96.3 to 99.5
|
—
|
|
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 48 Assessed by IgG LIA
Anti-HPV 16
|
100.0 Percentage of Participants
Interval 98.9 to 100.0
|
—
|
|
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 48 Assessed by IgG LIA
Anti-HPV 18
|
95.1 Percentage of Participants
Interval 92.0 to 97.2
|
—
|
PRIMARY outcome
Timeframe: Month 60 post-vaccination 1Population: Per protocol, the analysis population included participants with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine.
The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using IgG LIA.
Outcome measures
| Measure |
Chinese Girls Aged 9 to 19 Years
n=365 Participants
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
Base Study: Chinese Young Women Aged 20 to 26 Years
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
|---|---|---|
|
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 60 Assessed by IgG LIA
Anti-HPV 6
|
96.7 Percentage of Participants
Interval 94.1 to 98.4
|
—
|
|
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 60 Assessed by IgG LIA
Anti-HPV 11
|
98.4 Percentage of Participants
Interval 96.2 to 99.5
|
—
|
|
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 60 Assessed by IgG LIA
Anti-HPV 16
|
100.0 Percentage of Participants
Interval 98.8 to 100.0
|
—
|
|
Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 60 Assessed by IgG LIA
Anti-HPV 18
|
95.4 Percentage of Participants
Interval 92.3 to 97.4
|
—
|
SECONDARY outcome
Timeframe: Month 7 (1 month postdose 3)Population: Per protocol, the analysis population included the participants with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine.
Seroconversion is defined as changing serostatus from seronegative at Day 1 to seropositive at 1 month post dose 3. Antibodies were measured using a Competitive Luminex Immunoassay (cLIA). Antibody titers were expressed as milli Merck Units/milliliter (mMU/mL).
Outcome measures
| Measure |
Chinese Girls Aged 9 to 19 Years
n=383 Participants
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
Base Study: Chinese Young Women Aged 20 to 26 Years
n=383 Participants
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
|---|---|---|
|
Base Stage: Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18: cLIA
Anti-HPV 6
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
|
Base Stage: Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18: cLIA
Anti-HPV 11
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
|
Base Stage: Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18: cLIA
Anti-HPV 16
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
|
Base Stage: Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18: cLIA
Anti-HPV 18
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Month 7 (1 month postdose 3)Population: All participants who received the correct dose of all 3 study vaccinations within visit window; was seronegative at Day 1 for the human papilloma virus (HPV) type being analyzed; provided Month 7 serum sample within visit window; and did not meet any exclusion criteria at any time during base stage.
Antibodies to HPV Types 6, 11, 16, and 18 were measured using an IgG LIA. Antibody titers were expressed as milli Merck Units/milliliter (mMU/mL).
Outcome measures
| Measure |
Chinese Girls Aged 9 to 19 Years
n=383 Participants
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
Base Study: Chinese Young Women Aged 20 to 26 Years
n=383 Participants
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
|---|---|---|
|
Base Stage: Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18: IgG LIA
Anti-HPV 6
|
902.7 mMU/mL
Interval 831.2 to 980.3
|
604.5 mMU/mL
Interval 554.7 to 658.8
|
|
Base Stage: Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18: IgG LIA
Anti-HPV 11
|
756.2 mMU/mL
Interval 695.7 to 821.9
|
518.7 mMU/mL
Interval 475.5 to 565.9
|
|
Base Stage: Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18: IgG LIA
Anti-HPV 16
|
4170.0 mMU/mL
Interval 3849.3 to 4517.4
|
2659.3 mMU/mL
Interval 2447.8 to 2889.0
|
|
Base Stage: Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18: IgG LIA
Anti-HPV 18
|
1012.8 mMU/mL
Interval 918.7 to 1116.5
|
612.0 mMU/mL
Interval 553.9 to 676.1
|
SECONDARY outcome
Timeframe: Month 7 (1 month postdose 3)Population: All participants who received the correct dose of all 3 study vaccinations within visit window; was seronegative at Day 1 for the human papilloma virus (HPV) type being analyzed; provided Month 7 serum sample within visit window; and did not meet any exclusion criteria at any time during base stage.
The percentage of participants who seroconverted to each of HPV Types 6, 11, 16, and 18 was assessed. Antibodies were measured using IgG LIA.
Outcome measures
| Measure |
Chinese Girls Aged 9 to 19 Years
n=383 Participants
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
Base Study: Chinese Young Women Aged 20 to 26 Years
n=383 Participants
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
|---|---|---|
|
Base Stage: Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18: IgG LIA
Anti-HPV 6
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
|
Base Stage: Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18: IgG LIA
Anti-HPV 11
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
|
Base Stage: Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18: IgG LIA
Anti-HPV 16
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
|
Base Stage: Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18: IgG LIA
Anti-HPV 18
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to 15 days after any vaccinationPopulation: The analysis population concisted of participants who recieved at least one dose of study vaccination.
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs included injection-site redness, swelling, induration, pain, and pruritus.
Outcome measures
| Measure |
Chinese Girls Aged 9 to 19 Years
n=383 Participants
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
Base Study: Chinese Young Women Aged 20 to 26 Years
n=383 Participants
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
|---|---|---|
|
Base Stage: Percentage of Participants Who Experienced a Solicited Injection-site Adverse Event (AE)
|
36.6 Percentage of Participants
|
40.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to 15 days after any vaccinationPopulation: The analysis population concisted of participants who recieved at least one dose of study vaccination.
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs included hypersensitivity, headache, fatigue, vomiting, nausea, diarrhea, myalgia, pyrexia, and cough.
Outcome measures
| Measure |
Chinese Girls Aged 9 to 19 Years
n=383 Participants
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
Base Study: Chinese Young Women Aged 20 to 26 Years
n=383 Participants
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
|---|---|---|
|
Base Stage: Percentage of Participants Participants Who Experienced a Solicited Systemic AE
|
39.9 Percentage of Participants
|
42.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to Month 7 (1 month postdose 3)Population: The analysis population concisted of participants who recieved at least one dose of study vaccination.
An SAE is an AE that results in death, is life threatening, requires hospitalization or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, according to medical or scientific judgment, may jeopardize the participant or requires medical or surgical intervention to prevent one of the other outcomes listed in the above definition.
Outcome measures
| Measure |
Chinese Girls Aged 9 to 19 Years
n=383 Participants
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
Base Study: Chinese Young Women Aged 20 to 26 Years
n=383 Participants
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
|---|---|---|
|
Base Stage: Percentage of Participants Who Experienced a Serious Adverse Event (SAE)
|
1.6 Percentage of Participants
|
2.87 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to 31 days after any vaccinationPopulation: The analysis population concisted of participants who recieved at least one dose of study vaccination.
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment
Outcome measures
| Measure |
Chinese Girls Aged 9 to 19 Years
n=383 Participants
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
Base Study: Chinese Young Women Aged 20 to 26 Years
n=383 Participants
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
|---|---|---|
|
Base Stage: Percentage of Participants Who Experienced an AE
|
61.6 Percentage of Participants
|
68.9 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to 5 days after any vaccinationPopulation: The analysis population concisted of participants who recieved at least one dose of study vaccination.
In the global studies, fever is defined as an oral temperature of ≥37.8°C or 100.0°F, which is equivalent to axillary temperature of ≥37.2°C, while the definition of fever is axillary temperature of ≥37.1°C in Chinese criteria. To be compliant to Chinese criteria, axillary temperatures of ≥37.1°C was considered as a fever in this study. Body temperature readings assessed orally were converted to the axillary equivalent. The percentage of participants with a maximum axillary or converted axillary temperature was summarized by temperature range.
Outcome measures
| Measure |
Chinese Girls Aged 9 to 19 Years
n=383 Participants
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
Base Study: Chinese Young Women Aged 20 to 26 Years
n=383 Participants
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
|---|---|---|
|
Base Stage: Maximum Axillary Temperature: Merck Sharp & Dohme (MSD) Criteria
< 37.2 °C (99.0 °F)
|
87.2 Percentage of Participants
|
84.9 Percentage of Participants
|
|
Base Stage: Maximum Axillary Temperature: Merck Sharp & Dohme (MSD) Criteria
≥37.2 °C (99.0 °F) and < 38.3 °C (100.9 °F)
|
12.3 Percentage of Participants
|
14.9 Percentage of Participants
|
|
Base Stage: Maximum Axillary Temperature: Merck Sharp & Dohme (MSD) Criteria
≥ 38.3 °C (100.9 °F) and < 39.3 °C (102.7 °F)
|
0.3 Percentage of Participants
|
0.3 Percentage of Participants
|
|
Base Stage: Maximum Axillary Temperature: Merck Sharp & Dohme (MSD) Criteria
≥ 39.3 °C (102.7 °F) and < 40.3 °C (104.5 °F)
|
0.3 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Base Stage: Maximum Axillary Temperature: Merck Sharp & Dohme (MSD) Criteria
≥ 40.3 °C (104.5 °F)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Month 7 up to Month 60Population: The analysis population consisted of all participants who received at least 1 dose of study vaccination and had clinical follow-up for safety.
The percentage of participants with an SAE will be assessed. An SAE is an AE that results in death, is life threatening, requires hospitalization or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, according to medical or scientific judgment, may jeopardize the participant or requires medical or surgical intervention to prevent one of the other outcomes listed in the above definition.
Outcome measures
| Measure |
Chinese Girls Aged 9 to 19 Years
n=365 Participants
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
Base Study: Chinese Young Women Aged 20 to 26 Years
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
|---|---|---|
|
Extension Stage: Percentage of Participants Who Experienced an SAE
|
2.2 Percentage of Participants
|
—
|
Adverse Events
Base Study: Chinese Girls Aged 9 to 19 Years
Base Study: Chinese Young Women Aged 20 to 26 Years
Extension Study: Chinese Girls Aged 9 to 19 Years
Serious adverse events
| Measure |
Base Study: Chinese Girls Aged 9 to 19 Years
n=383 participants at risk
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
Base Study: Chinese Young Women Aged 20 to 26 Years
n=383 participants at risk
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
Extension Study: Chinese Girls Aged 9 to 19 Years
n=365 participants at risk
In base study, participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 and followed up to Month 7. In the extension studies after Month 7, the participants were followed up for safety and immunogenicity up to Month 60 (EXT).
|
|---|---|---|---|
|
Gastrointestinal disorders
Chronic gastritis
|
0.26%
1/383 • Number of events 1 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/383 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/365 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.26%
1/383 • Number of events 1 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/383 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/365 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/383 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.26%
1/383 • Number of events 2 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/365 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
|
Gastrointestinal disorders
Hypertrophic anal papilla
|
0.00%
0/383 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.26%
1/383 • Number of events 1 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/365 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
|
Infections and infestations
Bacterial vulvovaginitis
|
0.00%
0/383 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.26%
1/383 • Number of events 1 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/365 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
|
Infections and infestations
Complicated appendicitis
|
0.26%
1/383 • Number of events 1 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/383 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/365 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
|
Infections and infestations
Helicobacter infection
|
0.26%
1/383 • Number of events 1 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/383 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/365 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
|
Infections and infestations
Pelvic abscess
|
0.00%
0/383 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.26%
1/383 • Number of events 1 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/365 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
|
Infections and infestations
Skin infection
|
0.00%
0/383 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/383 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.27%
1/365 • Number of events 1 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/383 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.26%
1/383 • Number of events 1 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/365 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/383 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.26%
1/383 • Number of events 1 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/365 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.26%
1/383 • Number of events 1 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/383 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/365 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/383 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.26%
1/383 • Number of events 1 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/365 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/383 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.26%
1/383 • Number of events 1 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/365 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/383 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/383 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.27%
1/365 • Number of events 1 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/383 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.26%
1/383 • Number of events 1 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/365 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
|
Injury, poisoning and procedural complications
Peroneal nerve injury
|
0.00%
0/383 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.26%
1/383 • Number of events 1 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/365 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/383 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/383 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.27%
1/365 • Number of events 1 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/383 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.26%
1/383 • Number of events 1 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/365 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
|
Injury, poisoning and procedural complications
Sciatic nerve injury
|
0.00%
0/383 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.26%
1/383 • Number of events 1 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/365 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
|
Injury, poisoning and procedural complications
Skull fractured base
|
0.00%
0/383 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.26%
1/383 • Number of events 1 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/365 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/383 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.26%
1/383 • Number of events 1 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/365 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/383 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.26%
1/383 • Number of events 1 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/365 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/383 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/383 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.27%
1/365 • Number of events 1 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ependymoma
|
0.00%
0/383 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/383 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.27%
1/365 • Number of events 1 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian germ cell teratoma benign
|
0.00%
0/383 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.26%
1/383 • Number of events 1 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/365 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion missed
|
0.00%
0/383 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.26%
1/383 • Number of events 1 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/365 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/383 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.26%
1/383 • Number of events 1 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/365 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion threatened
|
0.00%
0/383 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/383 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.27%
1/365 • Number of events 1 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/383 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/383 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.27%
1/365 • Number of events 2 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
|
Pregnancy, puerperium and perinatal conditions
Foetal distress syndrome
|
0.00%
0/383 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/383 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.27%
1/365 • Number of events 1 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
|
Pregnancy, puerperium and perinatal conditions
Hyperemesis gravidarum
|
0.00%
0/383 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/383 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.55%
2/365 • Number of events 2 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
|
Pregnancy, puerperium and perinatal conditions
Oligohydramnios
|
0.00%
0/383 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.26%
1/383 • Number of events 1 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/365 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
|
Psychiatric disorders
Gastrointestinal somatic symptom disorder
|
0.26%
1/383 • Number of events 1 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/383 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/365 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
|
Renal and urinary disorders
Calculus urethral
|
0.26%
1/383 • Number of events 1 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/383 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/365 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
|
Reproductive system and breast disorders
Hydrosalpinx
|
0.00%
0/383 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.26%
1/383 • Number of events 1 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/365 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
|
Reproductive system and breast disorders
Mammary duct ectasia
|
0.00%
0/383 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.26%
1/383 • Number of events 1 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/365 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
|
Reproductive system and breast disorders
Pelvic adhesions
|
0.00%
0/383 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.26%
1/383 • Number of events 1 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/365 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
|
Reproductive system and breast disorders
Vulval eczema
|
0.00%
0/383 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.26%
1/383 • Number of events 1 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/365 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/383 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.26%
1/383 • Number of events 1 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/365 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/383 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/383 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.27%
1/365 • Number of events 1 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
|
Surgical and medical procedures
Abortion induced
|
0.26%
1/383 • Number of events 1 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/383 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/365 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
Other adverse events
| Measure |
Base Study: Chinese Girls Aged 9 to 19 Years
n=383 participants at risk
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
Base Study: Chinese Young Women Aged 20 to 26 Years
n=383 participants at risk
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
|
Extension Study: Chinese Girls Aged 9 to 19 Years
n=365 participants at risk
In base study, participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 and followed up to Month 7. In the extension studies after Month 7, the participants were followed up for safety and immunogenicity up to Month 60 (EXT).
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
3.9%
15/383 • Number of events 18 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
8.1%
31/383 • Number of events 33 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/365 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
|
General disorders
Fatigue
|
10.7%
41/383 • Number of events 59 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
11.0%
42/383 • Number of events 57 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/365 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
|
General disorders
Injection site pain
|
31.9%
122/383 • Number of events 189 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
39.7%
152/383 • Number of events 233 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/365 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
|
General disorders
Injection site pruritus
|
8.4%
32/383 • Number of events 33 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
4.2%
16/383 • Number of events 20 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/365 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
|
General disorders
Injection site swelling
|
5.7%
22/383 • Number of events 25 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
2.9%
11/383 • Number of events 14 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/365 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
|
General disorders
Pyrexia
|
27.2%
104/383 • Number of events 196 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
28.2%
108/383 • Number of events 194 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/365 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
|
Nervous system disorders
Headache
|
8.4%
32/383 • Number of events 47 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
11.0%
42/383 • Number of events 51 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/365 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.7%
37/383 • Number of events 40 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
10.7%
41/383 • Number of events 47 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/365 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.2%
16/383 • Number of events 16 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
7.6%
29/383 • Number of events 30 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
0.00%
0/365 • Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months
All participants who received at least 1 vaccination.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Results disclosure agreements
- Principal investigator is a sponsor employee If publication activity is not directed by the sponsor, 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. Authorship will be determined by mutual agreement and in line with International Committee of Medical Journal Editors authorship requirements.
- Publication restrictions are in place
Restriction type: OTHER