Trial Outcomes & Findings for A Study of the Safety, Tolerability, and Immunogenicity of a 9-valent Human Papillomavirus Vaccine ([9vHPV]; V503) Administered to 9- to 15-Year-Old Japanese Girls (V503-008). (NCT NCT01254643)
NCT ID: NCT01254643
Last Updated: 2018-11-28
Results Overview
Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using competitive luminex immunoassay (cLIA). The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30, HPV Type 11: ≥16; HPV Type 16: ≥20, HPV Type 18: ≥24, HPV Type 31: ≥10, HPV Type 33: ≥8, HPV Type 45: ≥8, HPV Type 52: ≥8, and HPV Type 58: ≥8.
COMPLETED
PHASE3
100 participants
4 weeks post-vaccination 3 (Month 7)
2018-11-28
Participant Flow
Participant milestones
| Measure |
All Enrolled
9-valent human papillomavirus (9vHPV) L1 VLP vaccine (V503), 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.
|
|---|---|
|
Overall Study
STARTED
|
100
|
|
Overall Study
Vaccination 1
|
100
|
|
Overall Study
Vaccination 2
|
99
|
|
Overall Study
Vaccination 3
|
99
|
|
Overall Study
COMPLETED
|
99
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
All Enrolled
9-valent human papillomavirus (9vHPV) L1 VLP vaccine (V503), 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
A Study of the Safety, Tolerability, and Immunogenicity of a 9-valent Human Papillomavirus Vaccine ([9vHPV]; V503) Administered to 9- to 15-Year-Old Japanese Girls (V503-008).
Baseline characteristics by cohort
| Measure |
All Enrolled
n=100 Participants
9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.
|
|---|---|
|
Age, Continuous
|
11.7 years
STANDARD_DEVIATION 1.7 • n=99 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 4 weeks post-vaccination 3 (Month 7)Population: Participants who received all 3 vaccinations and met criteria for Per Protocol Immunogenicity (PPI) Population (not a general protocol violator, received all vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range) for at least 1 of the 9 HPV types.
Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using competitive luminex immunoassay (cLIA). The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30, HPV Type 11: ≥16; HPV Type 16: ≥20, HPV Type 18: ≥24, HPV Type 31: ≥10, HPV Type 33: ≥8, HPV Type 45: ≥8, HPV Type 52: ≥8, and HPV Type 58: ≥8.
Outcome measures
| Measure |
All Enrolled
n=99 Participants
9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.
|
|---|---|
|
Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine
Anti-HPV 6 (n=97)
|
100 Percentage of Participants
Interval 96.3 to 100.0
|
|
Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine
Anti-HPV 11 (n=97)
|
100 Percentage of Participants
Interval 96.3 to 100.0
|
|
Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine
Anti-HPV 16 (n=99)
|
100 Percentage of Participants
Interval 96.3 to 100.0
|
|
Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine
Anti-HPV 18 (n=98)
|
100 Percentage of Participants
Interval 96.3 to 100.0
|
|
Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine
Anti-HPV 31 (n=97)
|
100 Percentage of Participants
Interval 96.3 to 100.0
|
|
Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine
Anti-HPV 33 (n=98)
|
100 Percentage of Participants
Interval 96.3 to 100.0
|
|
Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine
Anti-HPV 45 (n=99)
|
100 Percentage of Participants
Interval 96.3 to 100.0
|
|
Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine
Anti-HPV 52 (n=99)
|
100 Percentage of Participants
Interval 96.3 to 100.0
|
|
Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine
Anti-HPV 58 (n=95)
|
100 Percentage of Participants
Interval 96.2 to 100.0
|
PRIMARY outcome
Timeframe: up to 5 days after any vaccinationPopulation: Safety Population, which consisted of all participants who received at least one vaccination and had available follow-up data.
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. AEs such as redness, swelling, and pain/tenderness/soreness at the injection site were recorded.
Outcome measures
| Measure |
All Enrolled
n=100 Participants
9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.
|
|---|---|
|
Percentage of Participants With an Injection-site Adverse Event (AE)
|
95.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: up to 15 days after any vaccinationPopulation: Safety Population, which consisted of all participants who received at least one vaccination and had available follow-up data.
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Systemic AEs were those not categorized as injection-site AEs.
Outcome measures
| Measure |
All Enrolled
n=100 Participants
9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.
|
|---|---|
|
Percentage of Participants With a Non-Injection Site (Systemic) AE
|
35.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: up to 15 days after any vaccinationPopulation: Safety Population, which consists of all participants who received at least one vaccination and had available follow-up data.
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Adverse experience that is judged by the Investigator to be "definitely related," "probably related," or "possibly related" to the study drug is defined as a vaccine-related AE.
Outcome measures
| Measure |
All Enrolled
n=100 Participants
9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.
|
|---|---|
|
Percentage of Participants With a Vaccine-related AE
|
96.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: 4 weeks post-vaccination 3 (Month 7)Population: Participants who received all 3 vaccinations and met criteria for Per Protocol Immunogenicity (PPI) Population (not a general protocol violator, received all vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range) for at least 1 of the 9 HPV types.
Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using cLIA. Titers are reported in milli Merck Units/mL.
Outcome measures
| Measure |
All Enrolled
n=99 Participants
9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.
|
|---|---|
|
Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine
Anti-HPV 45 (n=99)
|
811.0 milli Merck units/mL
Interval 679.7 to 967.6
|
|
Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine
Anti-HPV 6 (n=97)
|
1836.5 milli Merck units/mL
Interval 1597.7 to 2111.0
|
|
Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine
Anti-HPV 11 (n=97)
|
1331.3 milli Merck units/mL
Interval 1135.0 to 1561.4
|
|
Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine
Anti-HPV 16 (n=99)
|
6823.6 milli Merck units/mL
Interval 5907.9 to 7881.2
|
|
Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine
Anti-HPV 18 (n=98)
|
2159.9 milli Merck units/mL
Interval 1803.8 to 2586.3
|
|
Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine
Anti-HPV 31 (n=97)
|
2052.5 milli Merck units/mL
Interval 1735.9 to 2426.8
|
|
Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine
Anti-HPV 33 (n=98)
|
994.8 milli Merck units/mL
Interval 857.2 to 1154.4
|
|
Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine
Anti-HPV 52 (n=99)
|
1069.1 milli Merck units/mL
Interval 908.4 to 1258.4
|
|
Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine
Anti-HPV 58 (n=95)
|
1488.2 milli Merck units/mL
Interval 1285.0 to 1723.4
|
Adverse Events
All Enrolled
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All Enrolled
n=100 participants at risk
9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.
|
|---|---|
|
General disorders
Injection site erythema
|
33.0%
33/100 • Number of events 57 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Serious AEs and Non-serious non-injection site AEs) and up to 30 months (Any death and serious drug-related AEs)
Safety Population, which consisted of all participants who received at least one vaccination and had available follow-up data.
|
|
General disorders
Injection site pain
|
93.0%
93/100 • Number of events 241 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Serious AEs and Non-serious non-injection site AEs) and up to 30 months (Any death and serious drug-related AEs)
Safety Population, which consisted of all participants who received at least one vaccination and had available follow-up data.
|
|
General disorders
Injection site swelling
|
42.0%
42/100 • Number of events 67 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Serious AEs and Non-serious non-injection site AEs) and up to 30 months (Any death and serious drug-related AEs)
Safety Population, which consisted of all participants who received at least one vaccination and had available follow-up data.
|
|
General disorders
Pyrexia
|
6.0%
6/100 • Number of events 6 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Serious AEs and Non-serious non-injection site AEs) and up to 30 months (Any death and serious drug-related AEs)
Safety Population, which consisted of all participants who received at least one vaccination and had available follow-up data.
|
|
Infections and infestations
Nasopharyngitis
|
9.0%
9/100 • Number of events 9 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Serious AEs and Non-serious non-injection site AEs) and up to 30 months (Any death and serious drug-related AEs)
Safety Population, which consisted of all participants who received at least one vaccination and had available follow-up data.
|
|
Nervous system disorders
Headache
|
8.0%
8/100 • Number of events 12 • Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Serious AEs and Non-serious non-injection site AEs) and up to 30 months (Any death and serious drug-related AEs)
Safety Population, which consisted of all participants who received at least one vaccination and had available follow-up data.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication timelines
- Publication restrictions are in place
Restriction type: OTHER