Trial Outcomes & Findings for Immunogenicity and Safety of the 9-valent Human Papillomavirus (9vHPV) Vaccine in Japanese Boys and Girls (V503-066) (NCT NCT04772534)
NCT ID: NCT04772534
Last Updated: 2025-05-30
Results Overview
The percentage of seropositive participants is reported. Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined using competitive Luminex Immunoassay (cLIA). Seroconversion was defined as changing serostatus from seronegative at Day 1 to seropositive at 4 weeks post last vaccination.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
314 participants
Primary outcome timeframe
1 month after final dose (Month 7)
Results posted on
2025-05-30
Participant Flow
This study was conducted at 12 centers in Japan.
Participant milestones
| Measure |
3-Dose Regimen: 9 to 15 Year Old Boys
9 to 15 year old boys received a 3-dose regimen of 9-valent human papillomavirus (9vHPV) vaccine (Day 1, Month 2 and Month 6).
|
2-dose Regimen: 9 to 14 Year Old Boys
9 to 14 year old boys received a 2-dose regimen of 9vHPV vaccine (Day 1 and Month 6).
|
2-dose Regimen: 9 to 14 Year Old Girls
9 to 14 year old girls received a 2-dose regimen of 9vHPV vaccine (Day 1 and Month 6).
|
|---|---|---|---|
|
Overall Study
STARTED
|
105
|
104
|
105
|
|
Overall Study
COMPLETED
|
101
|
104
|
104
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
1
|
Reasons for withdrawal
| Measure |
3-Dose Regimen: 9 to 15 Year Old Boys
9 to 15 year old boys received a 3-dose regimen of 9-valent human papillomavirus (9vHPV) vaccine (Day 1, Month 2 and Month 6).
|
2-dose Regimen: 9 to 14 Year Old Boys
9 to 14 year old boys received a 2-dose regimen of 9vHPV vaccine (Day 1 and Month 6).
|
2-dose Regimen: 9 to 14 Year Old Girls
9 to 14 year old girls received a 2-dose regimen of 9vHPV vaccine (Day 1 and Month 6).
|
|---|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
1
|
Baseline Characteristics
Immunogenicity and Safety of the 9-valent Human Papillomavirus (9vHPV) Vaccine in Japanese Boys and Girls (V503-066)
Baseline characteristics by cohort
| Measure |
3-Dose Regimen: 9 to 15 Year Old Boys
n=105 Participants
9 to 15 year old boys received a 3-dose regimen of 9vHPV vaccine (Day 1, Month 2 and Month 6).
|
2-dose Regimen: 9 to 14 Year Old Boys
n=104 Participants
9 to 14 year old boys received a 2-dose regimen of 9vHPV vaccine (Day 1 and Month 6).
|
2-dose Regimen: 9 to 14 Year Old Girls
n=105 Participants
9 to 14 year old girls received a 2-dose regimen of 9vHPV vaccine (Day 1 and Month 6).
|
Total
n=314 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
11.8 Years
STANDARD_DEVIATION 2.0 • n=5 Participants
|
11.5 Years
STANDARD_DEVIATION 1.7 • n=7 Participants
|
11.4 Years
STANDARD_DEVIATION 1.6 • n=5 Participants
|
11.6 Years
STANDARD_DEVIATION 1.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
105 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
105 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
209 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
105 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
314 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
105 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
314 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 1 month after final dose (Month 7)Population: All participants who received all 9vHPV vaccinations at the correct dose and day range, have provided blood samples for serology within 21 to 49 days of the last dose, are seronegative to the appropriate HPV type(s) at Day 1, and had no protocol violations that could interfere with immune response, are included.
The percentage of seropositive participants is reported. Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined using competitive Luminex Immunoassay (cLIA). Seroconversion was defined as changing serostatus from seronegative at Day 1 to seropositive at 4 weeks post last vaccination.
Outcome measures
| Measure |
3-Dose Regimen: 9 to 15 Year Old Boys
n=103 Participants
9 to 15 year old boys received a 3-dose regimen of 9vHPV vaccine (Day 1, Month 2 and Month 6).
|
2-dose Regimen: 9 to 14 Year Old Boys
n=104 Participants
9 to 14 year old boys received a 2-dose regimen of 9vHPV vaccine (Day 1 and Month 6).
|
2-dose Regimen: 9 to 14 Year Old Girls
n=104 Participants
9 to 14 year old girls received a 2-dose regimen of 9vHPV vaccine (Day 1 and Month 6).
|
|---|---|---|---|
|
Seroconversion Percentages for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Anti-HPV 6
|
100.0 Percentage of Participants
Interval 96.0 to 100.0
|
100.0 Percentage of Participants
Interval 96.0 to 100.0
|
100.0 Percentage of Participants
Interval 96.1 to 100.0
|
|
Seroconversion Percentages for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Anti-HPV 11
|
100.0 Percentage of Participants
Interval 96.0 to 100.0
|
100.0 Percentage of Participants
Interval 96.0 to 100.0
|
100.0 Percentage of Participants
Interval 96.1 to 100.0
|
|
Seroconversion Percentages for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Anti-HPV 16
|
100.0 Percentage of Participants
Interval 96.3 to 100.0
|
100.0 Percentage of Participants
Interval 96.3 to 100.0
|
100.0 Percentage of Participants
Interval 96.3 to 100.0
|
|
Seroconversion Percentages for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Anti-HPV 18
|
100.0 Percentage of Participants
Interval 96.2 to 100.0
|
100.0 Percentage of Participants
Interval 96.1 to 100.0
|
100.0 Percentage of Participants
Interval 95.7 to 100.0
|
|
Seroconversion Percentages for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Anti-HPV 31
|
100.0 Percentage of Participants
Interval 96.0 to 100.0
|
100.0 Percentage of Participants
Interval 96.1 to 100.0
|
100.0 Percentage of Participants
Interval 96.0 to 100.0
|
|
Seroconversion Percentages for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Anti-HPV 33
|
100.0 Percentage of Participants
Interval 95.8 to 100.0
|
100.0 Percentage of Participants
Interval 96.0 to 100.0
|
100.0 Percentage of Participants
Interval 96.2 to 100.0
|
|
Seroconversion Percentages for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Anti-HPV 45
|
100.0 Percentage of Participants
Interval 96.2 to 100.0
|
100.0 Percentage of Participants
Interval 96.2 to 100.0
|
100.0 Percentage of Participants
Interval 96.3 to 100.0
|
|
Seroconversion Percentages for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Anti-HPV 52
|
100.0 Percentage of Participants
Interval 96.3 to 100.0
|
100.0 Percentage of Participants
Interval 96.2 to 100.0
|
100.0 Percentage of Participants
Interval 96.3 to 100.0
|
|
Seroconversion Percentages for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Anti-HPV 58
|
100.0 Percentage of Participants
Interval 96.4 to 100.0
|
100.0 Percentage of Participants
Interval 96.4 to 100.0
|
100.0 Percentage of Participants
Interval 96.3 to 100.0
|
PRIMARY outcome
Timeframe: Up to 5 days after each vaccination (up to ~6 months)Population: All treated participants are included.
The number of participants with injection-site AEs (erythema/redness, pain and swelling) is reported. An AE any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Outcome measures
| Measure |
3-Dose Regimen: 9 to 15 Year Old Boys
n=103 Participants
9 to 15 year old boys received a 3-dose regimen of 9vHPV vaccine (Day 1, Month 2 and Month 6).
|
2-dose Regimen: 9 to 14 Year Old Boys
n=104 Participants
9 to 14 year old boys received a 2-dose regimen of 9vHPV vaccine (Day 1 and Month 6).
|
2-dose Regimen: 9 to 14 Year Old Girls
n=104 Participants
9 to 14 year old girls received a 2-dose regimen of 9vHPV vaccine (Day 1 and Month 6).
|
|---|---|---|---|
|
Number of Participants With at Least 1 Injection-site Adverse Event (AE)
|
87 Participants
|
85 Participants
|
92 Participants
|
PRIMARY outcome
Timeframe: Up to 15 days after each vaccination (up to ~6.5 months)Population: All treated participants are included.
The number of participants with a systemic AE is reported. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Outcome measures
| Measure |
3-Dose Regimen: 9 to 15 Year Old Boys
n=103 Participants
9 to 15 year old boys received a 3-dose regimen of 9vHPV vaccine (Day 1, Month 2 and Month 6).
|
2-dose Regimen: 9 to 14 Year Old Boys
n=104 Participants
9 to 14 year old boys received a 2-dose regimen of 9vHPV vaccine (Day 1 and Month 6).
|
2-dose Regimen: 9 to 14 Year Old Girls
n=104 Participants
9 to 14 year old girls received a 2-dose regimen of 9vHPV vaccine (Day 1 and Month 6).
|
|---|---|---|---|
|
Number of Participants With at Least 1 Systemic Adverse Event
|
55 Participants
|
41 Participants
|
33 Participants
|
PRIMARY outcome
Timeframe: Up to ~Month 30Population: All treated participants are included.
The number of participants with an SAE is reported. An SAE is defined as one that results in death, is life threatening, or requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or other important medical event that may require medical intervention.
Outcome measures
| Measure |
3-Dose Regimen: 9 to 15 Year Old Boys
n=103 Participants
9 to 15 year old boys received a 3-dose regimen of 9vHPV vaccine (Day 1, Month 2 and Month 6).
|
2-dose Regimen: 9 to 14 Year Old Boys
n=104 Participants
9 to 14 year old boys received a 2-dose regimen of 9vHPV vaccine (Day 1 and Month 6).
|
2-dose Regimen: 9 to 14 Year Old Girls
n=104 Participants
9 to 14 year old girls received a 2-dose regimen of 9vHPV vaccine (Day 1 and Month 6).
|
|---|---|---|---|
|
Number of Participants With at Least 1 Serious Adverse Event (SAE)
|
0 Participants
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 1 month after final dose (Month 7)Population: All participants who received all 9vHPV vaccinations at the correct dose and day range, have provided blood samples for serology within 21 to 49 days of the last dose, are seronegative to the appropriate HPV type(s) at Day 1, and had no protocol violations that could interfere with immune response, are included.
The GMT for each HPV serotype is presented. Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined using competitive Luminex Immunoassay (cLIA).
Outcome measures
| Measure |
3-Dose Regimen: 9 to 15 Year Old Boys
n=103 Participants
9 to 15 year old boys received a 3-dose regimen of 9vHPV vaccine (Day 1, Month 2 and Month 6).
|
2-dose Regimen: 9 to 14 Year Old Boys
n=104 Participants
9 to 14 year old boys received a 2-dose regimen of 9vHPV vaccine (Day 1 and Month 6).
|
2-dose Regimen: 9 to 14 Year Old Girls
n=104 Participants
9 to 14 year old girls received a 2-dose regimen of 9vHPV vaccine (Day 1 and Month 6).
|
|---|---|---|---|
|
Geometric Mean Titers (GMTs) for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Anti-HPV 31
|
2095.0 GMT (mMU/mL)
Interval 1717.2 to 2555.9
|
1908.5 GMT (mMU/mL)
Interval 1619.3 to 2249.4
|
1838.7 GMT (mMU/mL)
Interval 1571.8 to 2151.0
|
|
Geometric Mean Titers (GMTs) for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Anti-HPV 33
|
894.9 GMT (mMU/mL)
Interval 753.1 to 1063.4
|
1272.1 GMT (mMU/mL)
Interval 1085.2 to 1491.2
|
1283.1 GMT (mMU/mL)
Interval 1132.4 to 1453.8
|
|
Geometric Mean Titers (GMTs) for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Anti-HPV 45
|
848.9 GMT (mMU/mL)
Interval 701.1 to 1027.8
|
508.4 GMT (mMU/mL)
Interval 431.7 to 598.8
|
599.6 GMT (mMU/mL)
Interval 520.6 to 690.4
|
|
Geometric Mean Titers (GMTs) for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Anti-HPV 6
|
1759.8 GMT (mMU/mL)
Interval 1481.2 to 2090.8
|
2417.0 GMT (mMU/mL)
Interval 2057.3 to 2839.6
|
2343.2 GMT (mMU/mL)
Interval 2036.1 to 2695.5
|
|
Geometric Mean Titers (GMTs) for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Anti-HPV 11
|
1341.8 GMT (mMU/mL)
Interval 1136.1 to 1584.9
|
1510.1 GMT (mMU/mL)
Interval 1310.3 to 1740.4
|
1508.5 GMT (mMU/mL)
Interval 1340.8 to 1697.0
|
|
Geometric Mean Titers (GMTs) for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Anti-HPV 16
|
7020.8 GMT (mMU/mL)
Interval 5955.3 to 8277.1
|
9808.5 GMT (mMU/mL)
Interval 8437.7 to 11402.0
|
9800.0 GMT (mMU/mL)
Interval 8440.1 to 11379.1
|
|
Geometric Mean Titers (GMTs) for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Anti-HPV 18
|
2629.6 GMT (mMU/mL)
Interval 2154.7 to 3209.1
|
2464.6 GMT (mMU/mL)
Interval 2095.6 to 2898.5
|
2999.8 GMT (mMU/mL)
Interval 2509.3 to 3586.3
|
|
Geometric Mean Titers (GMTs) for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Anti-HPV 52
|
925.3 GMT (mMU/mL)
Interval 774.9 to 1105.0
|
587.4 GMT (mMU/mL)
Interval 503.3 to 685.5
|
582.7 GMT (mMU/mL)
Interval 517.3 to 656.4
|
|
Geometric Mean Titers (GMTs) for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Anti-HPV 58
|
1401.7 GMT (mMU/mL)
Interval 1177.4 to 1668.8
|
1350.6 GMT (mMU/mL)
Interval 1155.1 to 1579.1
|
1379.8 GMT (mMU/mL)
Interval 1216.4 to 1565.1
|
Adverse Events
3-Dose Regimen: 9 to 15 Year Old Boys
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
2-dose Regimen: 9 to 14 Year Old Boys
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
2-dose Regimen: 9 to 14 Year Old Girls
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
3-Dose Regimen: 9 to 15 Year Old Boys
n=103 participants at risk
9 to 15 year old boys received a 3-dose regimen of 9vHPV vaccine (Day 1, Month 2 and Month 6).
|
2-dose Regimen: 9 to 14 Year Old Boys
n=104 participants at risk
9 to 14 year old boys received a 2-dose regimen of 9vHPV vaccine (Day 1 and Month 6).
|
2-dose Regimen: 9 to 14 Year Old Girls
n=104 participants at risk
9 to 14 year old girls received a 2-dose regimen of 9vHPV vaccine (Day 1 and Month 6).
|
|---|---|---|---|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/103 • Up to ~Month 30
All treated participants are included.
|
0.96%
1/104 • Up to ~Month 30
All treated participants are included.
|
0.96%
1/104 • Up to ~Month 30
All treated participants are included.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/103 • Up to ~Month 30
All treated participants are included.
|
0.00%
0/104 • Up to ~Month 30
All treated participants are included.
|
0.96%
1/104 • Up to ~Month 30
All treated participants are included.
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.00%
0/103 • Up to ~Month 30
All treated participants are included.
|
0.96%
1/104 • Up to ~Month 30
All treated participants are included.
|
0.00%
0/104 • Up to ~Month 30
All treated participants are included.
|
|
Eye disorders
Strabismus
|
0.00%
0/103 • Up to ~Month 30
All treated participants are included.
|
0.00%
0/104 • Up to ~Month 30
All treated participants are included.
|
0.96%
1/104 • Up to ~Month 30
All treated participants are included.
|
Other adverse events
| Measure |
3-Dose Regimen: 9 to 15 Year Old Boys
n=103 participants at risk
9 to 15 year old boys received a 3-dose regimen of 9vHPV vaccine (Day 1, Month 2 and Month 6).
|
2-dose Regimen: 9 to 14 Year Old Boys
n=104 participants at risk
9 to 14 year old boys received a 2-dose regimen of 9vHPV vaccine (Day 1 and Month 6).
|
2-dose Regimen: 9 to 14 Year Old Girls
n=104 participants at risk
9 to 14 year old girls received a 2-dose regimen of 9vHPV vaccine (Day 1 and Month 6).
|
|---|---|---|---|
|
General disorders
Pyrexia
|
17.5%
18/103 • Up to ~Month 30
All treated participants are included.
|
11.5%
12/104 • Up to ~Month 30
All treated participants are included.
|
7.7%
8/104 • Up to ~Month 30
All treated participants are included.
|
|
Nervous system disorders
Headache
|
9.7%
10/103 • Up to ~Month 30
All treated participants are included.
|
8.7%
9/104 • Up to ~Month 30
All treated participants are included.
|
5.8%
6/104 • Up to ~Month 30
All treated participants are included.
|
|
Infections and infestations
Nasopharyngitis
|
5.8%
6/103 • Up to ~Month 30
All treated participants are included.
|
2.9%
3/104 • Up to ~Month 30
All treated participants are included.
|
3.8%
4/104 • Up to ~Month 30
All treated participants are included.
|
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 If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission.
- Publication restrictions are in place
Restriction type: OTHER