Papillomavirus Infections
Conditions
Keywords
Human Papilloma Virus
Brief summary
This is an immunogenicity and safety study of Gardasil (V501) in females 9 to 23 years of age in Korea.
Interventions
BIOLOGICALGardasil™
Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)
BIOLOGICALPlacebo
Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
9 Years to 23 Years
Healthy volunteers
Yes
Inclusion criteria
* Girls ages 9 to 15 years (must not yet have had coitarche) * Healthy females ages 16 to 23 years (individuals with a lifetime history of 0 to 3 male or female sexual partners)
Exclusion criteria
All Subjects: * History of known prior vaccination with an HPV vaccine. Women Ages 16 to 23 Only: * Individuals with any prior history of genital warts or treatment for genital warts. * Individuals with \> 3 lifetime male or female sexual partners.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Seroconvert to HPV 6. | Week 4 Postdose 3 | 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. |
| Number of Participants Who Seroconvert to HPV 11. | Week 4 Postdose 3 | 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. |
| Number of Participants Who Seroconvert to HPV 16. | Week 4 Postdose 3 | 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. |
| Number of Participants Who Seroconvert to HPV 18. | Week 4 Postdose 3 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Experiences | Overall study including 14 calendar days after the last vaccination visit. | Number of participants who reported 1 or more adverse experience. |
Participant flow
Recruitment details
Patients were recruited at 10 medical sites in Korea. First Patient Treated: 20-Oct-2005 Last Patient Treated: 24-Jun-2006
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Gardasil™ Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6) | 117 |
| Placebo Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6) | 59 |
| Total | 176 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
Baseline characteristics
| Characteristic | Gardasil™ | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 16.7 years STANDARD_DEVIATION 4.9 | 16.5 years STANDARD_DEVIATION 5.2 | 16.6 years STANDARD_DEVIATION 5 |
| Race/Ethnicity, Customized | 117 participants | 59 participants | 176 participants |
| Sex: Female, Male Female | 117 Participants | 59 Participants | 176 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 88 / 117 | 41 / 59 |
| serious Total, serious adverse events | 1 / 117 | 1 / 59 |
Outcome results
Primary
Number of Participants Who Seroconvert to HPV 11.
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gardasil™ | Number of Participants Who Seroconvert to HPV 11. | 112 Participants |
| Placebo | Number of Participants Who Seroconvert to HPV 11. | 1 Participants |
95% CI: [96.8, 100]
Primary
Number of Participants Who Seroconvert to HPV 16.
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gardasil™ | Number of Participants Who Seroconvert to HPV 16. | 112 Participants |
| Placebo | Number of Participants Who Seroconvert to HPV 16. | 0 Participants |
95% CI: [95.2, 100]
Primary
Number of Participants Who Seroconvert to HPV 18.
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gardasil™ | Number of Participants Who Seroconvert to HPV 18. | 109 Participants |
| Placebo | Number of Participants Who Seroconvert to HPV 18. | 0 Participants |
95% CI: [95, 100]
Primary
Number of Participants Who Seroconvert to HPV 6.
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gardasil™ | Number of Participants Who Seroconvert to HPV 6. | 109 Participants |
| Placebo | Number of Participants Who Seroconvert to HPV 6. | 0 Participants |
95% CI: [93.6, 99.8]
Secondary
Number of Participants With Adverse Experiences
Number of participants who reported 1 or more adverse experience.
Time frame: Overall study including 14 calendar days after the last vaccination visit.
Population: All participants who received at least 1 dose of injection.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gardasil™ | Number of Participants With Adverse Experiences | Discontinued due to an Serious AE | 0 Participants |
| Gardasil™ | Number of Participants With Adverse Experiences | Discontinued due to an Adverse Experience (AE) | 0 Participants |
| Gardasil™ | Number of Participants With Adverse Experiences | Discontinued due to serious vaccine-related AE | 0 Participants |
| Gardasil™ | Number of Participants With Adverse Experiences | Discontinued due to vaccine related AE | 0 Participants |
| Placebo | Number of Participants With Adverse Experiences | Discontinued due to serious vaccine-related AE | 0 Participants |
| Placebo | Number of Participants With Adverse Experiences | Discontinued due to an Serious AE | 0 Participants |
| Placebo | Number of Participants With Adverse Experiences | Discontinued due to vaccine related AE | 0 Participants |
| Placebo | Number of Participants With Adverse Experiences | Discontinued due to an Adverse Experience (AE) | 0 Participants |