Trial Outcomes & Findings for A Study to Compare Immune Response of V503 to Gardasil in 16- to 26-year-old Men (V503-020) (NCT NCT02114385)

NCT ID: NCT02114385

Last Updated: 2018-11-01

Results Overview

Serum antibodies to HPV types 6, 11, 16, and 18 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 500 participants
• Primary outcome timeframe: 4 weeks postdose 3 (Month 7)
• Results posted on: 2018-11-01

Participant Flow

A total of 502 participants were screened and 500 were randomized

Participant milestones

Measure	V503 9-valent HPV \[Types 6, 11, 16, 18, 31, 33, 45, 52, and 58\] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6	GARDASIL Quadrivalent HPV \[Types 6, 11, 16, and 18\] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
Overall Study STARTED	249	251
Overall Study Vaccinated	249	251
Overall Study COMPLETED	246	243
Overall Study NOT COMPLETED	3	8

Reasons for withdrawal

Measure	V503 9-valent HPV \[Types 6, 11, 16, 18, 31, 33, 45, 52, and 58\] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6	GARDASIL Quadrivalent HPV \[Types 6, 11, 16, and 18\] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
Overall Study Withdrawal by Subject	3	2
Overall Study Lost to Follow-up	0	6

Baseline Characteristics

A Study to Compare Immune Response of V503 to Gardasil in 16- to 26-year-old Men (V503-020)

Baseline characteristics by cohort

Measure	V503 n=249 Participants 9-valent HPV \[Types 6, 11, 16, 18, 31, 33, 45, 52, and 58\] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6	GARDASIL n=251 Participants Quadrivalent HPV \[Types 6, 11, 16, and 18\] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6	Total n=500 Participants Total of all reporting groups
Age, Continuous	20.8 Years STANDARD_DEVIATION 2.7 • n=5 Participants	21.3 Years STANDARD_DEVIATION 3.0 • n=7 Participants	21.0 Years STANDARD_DEVIATION 2.8 • n=5 Participants
Age, Customized <18 years old	37 Participants n=5 Participants	38 Participants n=7 Participants	75 Participants n=5 Participants
Age, Customized >=18 years old	212 Participants n=5 Participants	213 Participants n=7 Participants	425 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	249 Participants n=5 Participants	251 Participants n=7 Participants	500 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks postdose 3 (Month 7)

Population: All randomized participants. The number contributing to each data point is participants who received all 3 vaccinations within acceptable day ranges, had Month 7 serology for the HPV type within acceptable day ranges, were seronegative at Day 1, and had no protocol violations that interfered with evaluation of immune response.

Serum antibodies to HPV types 6, 11, 16, and 18 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL.

Outcome measures

Measure	V503 n=249 Participants 9-valent HPV \[Types 6, 11, 16, 18, 31, 33, 45, 52, and 58\] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6	GARDASIL n=251 Participants Quadrivalent HPV \[Types 6, 11, 16, and 18\] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
Geometric Mean Titers (GMTs) to HPV Types 6/11/16/18 HPV Type 6	758.3 milli Merck U/mL Interval 665.9 to 863.4	618.4 milli Merck U/mL Interval 554.0 to 690.3
Geometric Mean Titers (GMTs) to HPV Types 6/11/16/18 HPV Type 11	681.7 milli Merck U/mL Interval 608.9 to 763.4	769.1 milli Merck U/mL Interval 683.5 to 865.3
Geometric Mean Titers (GMTs) to HPV Types 6/11/16/18 HPV Type 16	3924.1 milli Merck U/mL Interval 3513.8 to 4382.3	3787.9 milli Merck U/mL Interval 3378.4 to 4247.0
Geometric Mean Titers (GMTs) to HPV Types 6/11/16/18 HPV Type 18	884.3 milli Merck U/mL Interval 766.4 to 1020.4	790.9 milli Merck U/mL Interval 683.0 to 915.7

SECONDARY outcome

Timeframe: 4 weeks postdose 3 (Month 7)

Population: All randomized participants. The number contributing to each data point is participants who received all 3 vaccinations within acceptable day ranges, had Month 7 serology for the HPV type within acceptable day ranges, were seronegative at Day 1, and had no protocol violations that interfered with evaluation of immune response

Serum antibodies to HPV types 31, 33, 45, 52, and 58 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL.

Outcome measures

Measure	V503 n=249 Participants 9-valent HPV \[Types 6, 11, 16, 18, 31, 33, 45, 52, and 58\] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6	GARDASIL n=251 Participants Quadrivalent HPV \[Types 6, 11, 16, and 18\] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
GMTs to HPV Types 31/33/45/52/58 HPV Type 33	460.5 milli Merck U/mL Interval 410.6 to 516.4	3.4 milli Merck U/mL Interval 3.1 to 3.7
GMTs to HPV Types 31/33/45/52/58 HPV Type 45	262.9 milli Merck U/mL Interval 226.2 to 305.5	2.5 milli Merck U/mL Interval 2.3 to 2.8
GMTs to HPV Types 31/33/45/52/58 HPV Type 31	794.4 milli Merck U/mL Interval 694.2 to 909.2	14.8 milli Merck U/mL Interval 12.5 to 17.5
GMTs to HPV Types 31/33/45/52/58 HPV Type 52	430.7 milli Merck U/mL Interval 377.8 to 491.0	1.9 milli Merck U/mL Interval 1.8 to 2.1
GMTs to HPV Types 31/33/45/52/58 HPV Type 58	691.0 milli Merck U/mL Interval 614.9 to 776.5	5.7 milli Merck U/mL Interval 5.0 to 6.5

SECONDARY outcome

Timeframe: 4 weeks postdose 3 (Month 7)

Population: All randomized participants. The number contributing to each data point is participants who received all 3 vaccinations within acceptable day ranges, had Month 7 serology for the HPV type within acceptable day ranges, were seronegative at Day 1, and had no protocol violations that interfered with evaluation of immune response.

Serum antibodies to HPV types were measured with a Competitive Luminex Immunoassay. 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; HPV Type 58: ≥8.

Outcome measures

Measure	V503 n=249 Participants 9-valent HPV \[Types 6, 11, 16, 18, 31, 33, 45, 52, and 58\] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6	GARDASIL n=251 Participants Quadrivalent HPV \[Types 6, 11, 16, and 18\] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
Percentage of Participants Who Are Seropositive for HPV Types 6/11/16/18/31/33/45/52/58 HPV Type 33	100 Percentage of participants Interval 98.4 to 100.0	16.9 Percentage of participants Interval 12.4 to 22.4
Percentage of Participants Who Are Seropositive for HPV Types 6/11/16/18/31/33/45/52/58 HPV Type 45	100 Percentage of participants Interval 98.4 to 100.0	9.3 Percentage of participants Interval 5.9 to 13.8
Percentage of Participants Who Are Seropositive for HPV Types 6/11/16/18/31/33/45/52/58 HPV Type 52	100 Percentage of participants Interval 98.4 to 100.0	2.5 Percentage of participants Interval 0.9 to 5.5
Percentage of Participants Who Are Seropositive for HPV Types 6/11/16/18/31/33/45/52/58 HPV Type 58	100 Percentage of participants Interval 98.4 to 100.0	36.1 Percentage of participants Interval 29.9 to 42.6
Percentage of Participants Who Are Seropositive for HPV Types 6/11/16/18/31/33/45/52/58 HPV Type 6	98.2 Percentage of participants Interval 95.6 to 99.5	98.7 Percentage of participants Interval 96.2 to 99.7
Percentage of Participants Who Are Seropositive for HPV Types 6/11/16/18/31/33/45/52/58 HPV Type 11	100 Percentage of participants Interval 98.4 to 100.0	100 Percentage of participants Interval 98.4 to 100.0
Percentage of Participants Who Are Seropositive for HPV Types 6/11/16/18/31/33/45/52/58 HPV Type 16	100 Percentage of participants Interval 98.4 to 100.0	100 Percentage of participants Interval 98.5 to 100.0
Percentage of Participants Who Are Seropositive for HPV Types 6/11/16/18/31/33/45/52/58 HPV Type 18	99.6 Percentage of participants Interval 97.6 to 100.0	99.6 Percentage of participants Interval 97.7 to 100.0
Percentage of Participants Who Are Seropositive for HPV Types 6/11/16/18/31/33/45/52/58 HPV Type 31	100 Percentage of participants Interval 98.4 to 100.0	61.6 Percentage of participants Interval 55.1 to 67.8

SECONDARY outcome

Timeframe: Up to 15 days after any vaccination

Population: All participants who received at least one study vaccination and had safety follow-up data

The percentage of participants with one or more adverse events was assessed.

Outcome measures

Measure	V503 n=248 Participants 9-valent HPV \[Types 6, 11, 16, 18, 31, 33, 45, 52, and 58\] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6	GARDASIL n=248 Participants Quadrivalent HPV \[Types 6, 11, 16, and 18\] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
Percentage of Participants With One or More Adverse Events	82.3 Percentage of participants Interval 76.9 to 86.8	81.9 Percentage of participants Interval 76.5 to 86.4

SECONDARY outcome

Timeframe: Up to Month 7

Population: All participants who received at least one study vaccination and had safety follow-up data

The percentage of participants discontinued from the study due to an adverse event was assessed.

Outcome measures

Measure	V503 n=248 Participants 9-valent HPV \[Types 6, 11, 16, 18, 31, 33, 45, 52, and 58\] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6	GARDASIL n=248 Participants Quadrivalent HPV \[Types 6, 11, 16, and 18\] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
Percentage of Participants With Study Discontinuation Due to an Adverse Event	0 Percentage of participants Interval 0.0 to 1.5	0 Percentage of participants Interval 0.0 to 1.5

SECONDARY outcome

Timeframe: Up to 5 days after any vaccination

Population: All participants who received at least one study vaccination and had safety follow-up data

The percentage of participants with one or more injection-site adverse reactions (solicited or unsolicited) was assessed.

Outcome measures

Measure	V503 n=248 Participants 9-valent HPV \[Types 6, 11, 16, 18, 31, 33, 45, 52, and 58\] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6	GARDASIL n=248 Participants Quadrivalent HPV \[Types 6, 11, 16, and 18\] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
Percentage of Participants With One or More Injection-site Adverse Reactions	79.0 Percentage of participants Interval 73.4 to 83.9	72.2 Percentage of participants Interval 66.2 to 77.7

SECONDARY outcome

Timeframe: Up to 5 days after any vaccination

Population: All participants who received at least one study vaccination and had safety follow-up data

The percentage of participants with a maximum temperature ≥37.8 °C was assessed.

Outcome measures

Measure	V503 n=248 Participants 9-valent HPV \[Types 6, 11, 16, 18, 31, 33, 45, 52, and 58\] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6	GARDASIL n=248 Participants Quadrivalent HPV \[Types 6, 11, 16, and 18\] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
Percentage of Participants With Maximum Temperature ≥37.8 °C	2.8 Percentage of participants	2.4 Percentage of participants

SECONDARY outcome

Timeframe: Up to 15 days after any vaccination

Population: All participants who received at least one study vaccination and had safety follow-up data

The percentage of participants with one or more systemic adverse events was assessed.

Outcome measures

Measure	V503 n=248 Participants 9-valent HPV \[Types 6, 11, 16, 18, 31, 33, 45, 52, and 58\] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6	GARDASIL n=248 Participants Quadrivalent HPV \[Types 6, 11, 16, and 18\] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
Percentage of Participants With One or More Systemic Adverse Events	40.7 Percentage of participants Interval 34.6 to 47.1	40.3 Percentage of participants Interval 34.2 to 46.7

SECONDARY outcome

Timeframe: Up to 15 days after any vaccination

Population: All participants who received at least one study vaccination and had safety follow-up data

The percentage of participants with one or more serious adverse events was assessed.

Outcome measures

Measure	V503 n=248 Participants 9-valent HPV \[Types 6, 11, 16, 18, 31, 33, 45, 52, and 58\] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6	GARDASIL n=248 Participants Quadrivalent HPV \[Types 6, 11, 16, and 18\] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
Percentage of Participants With One or More Serious Adverse Events	0.0 Percentage of participants Interval 0.0 to 1.5	0.0 Percentage of participants Interval 0.0 to 1.5

Adverse Events

V503

Serious events: 0 serious events

Other events: 196 other events

Deaths: 0 deaths

GARDASIL

Serious events: 6 serious events

Other events: 189 other events

Deaths: 0 deaths

Serious adverse events

Measure	V503 n=248 participants at risk 9-valent HPV \[Types 6, 11, 16, 18, 31, 33, 45, 52, and 58\] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6	GARDASIL n=248 participants at risk Quadrivalent HPV \[Types 6, 11, 16, and 18\] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
Infections and infestations Cytomegalovirus infection	0.00% 0/248 • All adverse events: up to 15 days after each vaccination; serious adverse events: up to Month 7	0.40% 1/248 • Number of events 1 • All adverse events: up to 15 days after each vaccination; serious adverse events: up to Month 7
Injury, poisoning and procedural complications Concussion	0.00% 0/248 • All adverse events: up to 15 days after each vaccination; serious adverse events: up to Month 7	0.40% 1/248 • Number of events 1 • All adverse events: up to 15 days after each vaccination; serious adverse events: up to Month 7
Injury, poisoning and procedural complications Foot fracture	0.00% 0/248 • All adverse events: up to 15 days after each vaccination; serious adverse events: up to Month 7	0.40% 1/248 • Number of events 1 • All adverse events: up to 15 days after each vaccination; serious adverse events: up to Month 7
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/248 • All adverse events: up to 15 days after each vaccination; serious adverse events: up to Month 7	0.40% 1/248 • Number of events 1 • All adverse events: up to 15 days after each vaccination; serious adverse events: up to Month 7
Injury, poisoning and procedural complications Ligament injury	0.00% 0/248 • All adverse events: up to 15 days after each vaccination; serious adverse events: up to Month 7	0.40% 1/248 • Number of events 1 • All adverse events: up to 15 days after each vaccination; serious adverse events: up to Month 7
Injury, poisoning and procedural complications Ligament rupture	0.00% 0/248 • All adverse events: up to 15 days after each vaccination; serious adverse events: up to Month 7	0.40% 1/248 • Number of events 1 • All adverse events: up to 15 days after each vaccination; serious adverse events: up to Month 7

Other adverse events

Measure	V503 n=248 participants at risk 9-valent HPV \[Types 6, 11, 16, 18, 31, 33, 45, 52, and 58\] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6	GARDASIL n=248 participants at risk Quadrivalent HPV \[Types 6, 11, 16, and 18\] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
General disorders Injection-site erythema	15.3% 38/248 • Number of events 62 • All adverse events: up to 15 days after each vaccination; serious adverse events: up to Month 7	17.3% 43/248 • Number of events 64 • All adverse events: up to 15 days after each vaccination; serious adverse events: up to Month 7
General disorders Injection-site pain	77.8% 193/248 • Number of events 443 • All adverse events: up to 15 days after each vaccination; serious adverse events: up to Month 7	70.2% 174/248 • Number of events 350 • All adverse events: up to 15 days after each vaccination; serious adverse events: up to Month 7
General disorders Injection-site swelling	14.5% 36/248 • Number of events 47 • All adverse events: up to 15 days after each vaccination; serious adverse events: up to Month 7	9.3% 23/248 • Number of events 35 • All adverse events: up to 15 days after each vaccination; serious adverse events: up to Month 7
Infections and infestations Nasopharyngitis	4.4% 11/248 • Number of events 13 • All adverse events: up to 15 days after each vaccination; serious adverse events: up to Month 7	5.6% 14/248 • Number of events 16 • All adverse events: up to 15 days after each vaccination; serious adverse events: up to Month 7
Nervous system disorders Headache	11.7% 29/248 • Number of events 43 • All adverse events: up to 15 days after each vaccination; serious adverse events: up to Month 7	14.9% 37/248 • Number of events 51 • All adverse events: up to 15 days after each vaccination; serious adverse events: up to Month 7

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

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.
• Publication restrictions are in place

Restriction type: OTHER