Trial Outcomes & Findings for Human Papillomavirus (HPV) Registration Study (Gardasil)(V501-023)(COMPLETED) (NCT NCT00157950)

Results Overview

Vaccine-induced anti-HPV 6 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 6 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 20 mMU/mL.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

176 participants

Primary outcome timeframe

Week 4 Postdose 3

Results posted on

2016-02-04

Participant Flow

Patients were recruited at 10 medical sites in Korea. First Patient Treated: 20-Oct-2005 Last Patient Treated: 24-Jun-2006

A serum or urine pregnancy test was performed prior to each injection on all subjects. Results were available prior to vaccination. Any subject with a positive pregnancy test at Day 1 was not randomized or vaccinated, and was not eligible to continue in the study.

Participant milestones

Participant milestones
Measure	Gardasil™ Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)	Placebo Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
Overall Study STARTED	117	59
Overall Study Vaccinated at Dose 1	117	59
Overall Study Vaccinated at Dose 2	117	59
Overall Study Vaccinated at Dose 3	116	59
Overall Study COMPLETED	116	59
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Gardasil™ Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)	Placebo Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
Overall Study Death	1	0

Baseline Characteristics

Human Papillomavirus (HPV) Registration Study (Gardasil)(V501-023)(COMPLETED)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gardasil™ n=117 Participants Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)	Placebo n=59 Participants Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)	Total n=176 Participants Total of all reporting groups
Age, Continuous	16.7 years STANDARD_DEVIATION 4.9 • n=5 Participants	16.5 years STANDARD_DEVIATION 5.2 • n=7 Participants	16.6 years STANDARD_DEVIATION 5.0 • n=5 Participants
Sex: Female, Male Female	117 Participants n=5 Participants	59 Participants n=7 Participants	176 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized	117 participants n=5 Participants	59 participants n=7 Participants	176 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 4 Postdose 3

Population: Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.

Vaccine-induced anti-HPV 6 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 6 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 20 mMU/mL.

Outcome measures

Outcome measures
Measure	Gardasil™ n=111 Participants Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)	Placebo n=58 Participants Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
Number of Participants Who Seroconvert to HPV 6.	109 Participants	0 Participants

PRIMARY outcome

Timeframe: Week 4 Postdose 3

Population: Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.

Vaccine-induced anti-HPV 11 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 11 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 16 mMU/mL.

Outcome measures

Outcome measures
Measure	Gardasil™ n=112 Participants Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)	Placebo n=58 Participants Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
Number of Participants Who Seroconvert to HPV 11.	112 Participants	1 Participants

PRIMARY outcome

Timeframe: Week 4 Postdose 3

Population: Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.

Vaccine-induced anti-HPV 16 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 16 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 20 mMU/mL.

Outcome measures

Outcome measures
Measure	Gardasil™ n=113 Participants Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)	Placebo n=58 Participants Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
Number of Participants Who Seroconvert to HPV 16.	112 Participants	0 Participants

PRIMARY outcome

Timeframe: Week 4 Postdose 3

Population: Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.

Vaccine-induced anti-HPV 18 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 18 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 24 mMU/mL.

Outcome measures

Outcome measures
Measure	Gardasil™ n=110 Participants Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)	Placebo n=58 Participants Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
Number of Participants Who Seroconvert to HPV 18.	109 Participants	0 Participants

SECONDARY outcome

Timeframe: Overall study including 14 calendar days after the last vaccination visit.

Population: All participants who received at least 1 dose of injection.

Number of participants who reported 1 or more adverse experience.

Outcome measures

Outcome measures
Measure	Gardasil™ n=117 Participants Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)	Placebo n=59 Participants Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
Number of Participants With Adverse Experiences Discontinued due to an Adverse Experience (AE)	0 Participants	0 Participants
Number of Participants With Adverse Experiences Discontinued due to vaccine related AE	0 Participants	0 Participants
Number of Participants With Adverse Experiences Discontinued due to an Serious AE	0 Participants	0 Participants
Number of Participants With Adverse Experiences Discontinued due to serious vaccine-related AE	0 Participants	0 Participants

Adverse Events

Gardasil™

Serious events: 1 serious events

Other events: 88 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 41 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Gardasil™ n=117 participants at risk Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)	Placebo n=59 participants at risk Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
Injury, poisoning and procedural complications Traffic accident	0.85% 1/117 • During the double-blind period including 14 calendar days after the last vaccination visit. Although a participant may have had two or more adverse experiences the participant is counted only once in a category. The same participant may appear in different categories.	0.00% 0/59 • During the double-blind period including 14 calendar days after the last vaccination visit. Although a participant may have had two or more adverse experiences the participant is counted only once in a category. The same participant may appear in different categories.
Infections and infestations Acute pharyngitis	0.00% 0/117 • During the double-blind period including 14 calendar days after the last vaccination visit. Although a participant may have had two or more adverse experiences the participant is counted only once in a category. The same participant may appear in different categories.	1.7% 1/59 • During the double-blind period including 14 calendar days after the last vaccination visit. Although a participant may have had two or more adverse experiences the participant is counted only once in a category. The same participant may appear in different categories.

Other adverse events

Other adverse events
Measure	Gardasil™ n=117 participants at risk Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)	Placebo n=59 participants at risk Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
General disorders Injection site erythema	23.1% 27/117 • During the double-blind period including 14 calendar days after the last vaccination visit. Although a participant may have had two or more adverse experiences the participant is counted only once in a category. The same participant may appear in different categories.	6.8% 4/59 • During the double-blind period including 14 calendar days after the last vaccination visit. Although a participant may have had two or more adverse experiences the participant is counted only once in a category. The same participant may appear in different categories.
General disorders Injection site pain	72.6% 85/117 • During the double-blind period including 14 calendar days after the last vaccination visit. Although a participant may have had two or more adverse experiences the participant is counted only once in a category. The same participant may appear in different categories.	50.8% 30/59 • During the double-blind period including 14 calendar days after the last vaccination visit. Although a participant may have had two or more adverse experiences the participant is counted only once in a category. The same participant may appear in different categories.
General disorders Injection site swelling	28.2% 33/117 • During the double-blind period including 14 calendar days after the last vaccination visit. Although a participant may have had two or more adverse experiences the participant is counted only once in a category. The same participant may appear in different categories.	11.9% 7/59 • During the double-blind period including 14 calendar days after the last vaccination visit. Although a participant may have had two or more adverse experiences the participant is counted only once in a category. The same participant may appear in different categories.
General disorders Injection site tenderness	1.7% 2/117 • During the double-blind period including 14 calendar days after the last vaccination visit. Although a participant may have had two or more adverse experiences the participant is counted only once in a category. The same participant may appear in different categories.	5.1% 3/59 • During the double-blind period including 14 calendar days after the last vaccination visit. Although a participant may have had two or more adverse experiences the participant is counted only once in a category. The same participant may appear in different categories.
General disorders Fever	13.7% 16/117 • During the double-blind period including 14 calendar days after the last vaccination visit. Although a participant may have had two or more adverse experiences the participant is counted only once in a category. The same participant may appear in different categories.	16.9% 10/59 • During the double-blind period including 14 calendar days after the last vaccination visit. Although a participant may have had two or more adverse experiences the participant is counted only once in a category. The same participant may appear in different categories.
Infections and infestations Cold	8.5% 10/117 • During the double-blind period including 14 calendar days after the last vaccination visit. Although a participant may have had two or more adverse experiences the participant is counted only once in a category. The same participant may appear in different categories.	16.9% 10/59 • During the double-blind period including 14 calendar days after the last vaccination visit. Although a participant may have had two or more adverse experiences the participant is counted only once in a category. The same participant may appear in different categories.
Nervous system disorders Headache	4.3% 5/117 • During the double-blind period including 14 calendar days after the last vaccination visit. Although a participant may have had two or more adverse experiences the participant is counted only once in a category. The same participant may appear in different categories.	8.5% 5/59 • During the double-blind period including 14 calendar days after the last vaccination visit. Although a participant may have had two or more adverse experiences the participant is counted only once in a category. The same participant may appear in different categories.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER