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| ID | Type | Description | Link |
|---|---|---|---|
| 2005_066 |
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This is an immunogenicity and safety study of Gardasil (V501) in females 9 to 23 years of age in Korea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gardasil™ | Experimental | Gardasil™ 3 dose regimen |
|
| Placebo | Placebo Comparator | Gardasil™ matching placebo 3 dose regimen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gardasil™ | Biological | Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 4 Postdose 3 |
| 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. | Week 4 Postdose 3 |
| 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. | Week 4 Postdose 3 |
| 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. | Week 4 Postdose 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Experiences | Number of participants who reported 1 or more adverse experience. | Overall study including 14 calendar days after the last vaccination visit. |
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Inclusion Criteria:
Exclusion Criteria:
All Subjects:
Women Ages 16 to 23 Only:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17986242 | Background | Kang S, Kim KH, Kim YT, Kim YT, Kim JH, Song YS, Shin SH, Ryu HS, Han JW, Kang JH, Park SY. Safety and immunogenicity of a vaccine targeting human papillomavirus types 6, 11, 16 and 18: a randomized, placebo-controlled trial in 176 Korean subjects. Int J Gynecol Cancer. 2008 Sep-Oct;18(5):1013-9. doi: 10.1111/j.1525-1438.2007.01123.x. Epub 2007 Nov 6. | |
| 26930146 |
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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.
Patients were recruited at 10 medical sites in Korea.
First Patient Treated: 20-Oct-2005
Last Patient Treated: 24-Jun-2006
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| ID | Title | Description |
|---|---|---|
| FG000 | Gardasil™ | Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6) |
| FG001 | Placebo | Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Gardasil™ | Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6) |
| BG001 | Placebo | Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | Participants | Week 4 Postdose 3 |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gardasil™ | Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Traffic accident | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site erythema | General disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000068857 | Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 |
| ID | Term |
|---|---|
| D017778 | Vaccines, Combined |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Placebo | Biological | Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6) |
|
| Hurt L, Nsouli-Maktabi H, Rohrbeck P, Clark LL. Use of quadrivalent human papillomavirus vaccine and the prevalence of antibodies to vaccine-targeted strains among female service members before and after vaccination. MSMR. 2016 Feb;23(2):6-13. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
|
|
|
| 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. | 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. | Posted | Number | Participants | Week 4 Postdose 3 |
|
|
|
|
| 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. | 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. | Posted | Number | Participants | Week 4 Postdose 3 |
|
|
|
|
| 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. | 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. | Posted | Number | Participants | Week 4 Postdose 3 |
|
|
|
|
| Secondary | Number of Participants With Adverse Experiences | Number of participants who reported 1 or more adverse experience. | All participants who received at least 1 dose of injection. | Posted | Number | Participants | Overall study including 14 calendar days after the last vaccination visit. |
|
|
|
| 1 |
| 117 |
| 88 |
| 117 |
| EG001 | Placebo | Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6) | 1 | 59 | 41 | 59 |
| Acute pharyngitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| Injection site pain | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Injection site tenderness | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Fever | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Cold | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
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.
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D053918 |
| Papillomavirus Vaccines |
| D014765 | Viral Vaccines |
| Discontinued due to an Serious AE |
|
| Discontinued due to serious vaccine-related AE |
|