None listed
Conditions
Interventions
Group 1 Type of group
9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
Group name:Group 5 Type of group
9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Age
9 Years to 26 Years
Inclusion criteria
Inclusion criteria: • Subject is male or female, between the ages of 9 years and 0 days and 15 years and 364 days on the day of enrolment, or the subject is female between the ages of 16 years and 0 days and 26 years and 364 days on the day of enrollment. • Subjects age 9-15 must not yet have had first sexual intercourse and does not plan on becoming sexually active during the Day 1 through Month 7 period. • Subjects age 16-26 have a lifetime history of 0 to 4 male and/or female sexual partners at the time of enrollment. • Subject has never had Pap testing or has only had normal Pap test results. • Subject (or, for minor subjects, parent/legal guardian and subject) fully understands study procedures, alternative treatments available, the risks involved with the study, and voluntarily agrees to participate by giving written informed consent.
Exclusion criteria
Exclusion criteria: • Subject is pregnant (as determined by a serum pregnancy test or urine pregnancy test that is sensitive to 25 mIU/mL ß-hCG). • Subject has received a marketed HPV vaccine, or has participated in an HPV vaccine clinical trial and has received either active agent or placebo. • Subject is concurrently enrolled in clinical studies of investigational agents or studies involving collection of cervical specimens. • Subject has a known allergy to any vaccine component, including aluminum, yeast, or BENZONASE™ (nuclease, Nycomed [used to remove residual nucleic acids from this and other vaccines]). • Subject is currently immunocompromised or has been diagnosed as having a congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease, or other autoimmune condition. • Subject has a history of an abnormal cervical biopsy result (showing cervical intraepithelial neoplasia [CIN] or worse). • Subject has a history of or clinical evidence at the Day 1 pelvic examination of HPV-related external genital lesions (e.g., condyloma acuminata or vulvar intraepithelial neoplasia [VIN]) or external genital cancer, HPV-related vaginal lesions (e.g., condyloma acuminata or vaginal intraepithelial neoplasia [VaIN]) or vaginal cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name: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 a competitive luminex immunoassay (cLIA). Titers are reported in milli Merck Units/mL. Measure:Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] Versus 16- to 26-Year-Old Females [Lot 1]) Timepoints:4 weeks post-vaccination 3 (Month 7) ; Outcome name:Serum antibody titers for HPV VLPs, Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using a competitive luminex immunoassay (cLIA). Titers are reported in milli Merck Units/mL. Measure:GMTs for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Males [Lot 1] Versus 16- to 26-Year-Old Females [Lot 1]) Timepoints:4 weeks post-vaccination 3 (Month 7) ; Outcome name:Serum antibody titers for HPV 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. Measure:GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) Timepoints:4 weeks post-vaccination 3 (Month 7) ; Outcome name: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. Measure:Percentage of Participants With Injection Site Adverse Experiences (AEs) Timepoints:up to 5 days after any vaccination ; Outcome name: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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name: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. 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. Measure:Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] Versus 16- to 26-Year-Old Females [Lot 1]) Timepoints:4 weeks post-vaccination 3 (Month 7) ; Outcome name:Serum antibody titers for HPV VLPs, Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using 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. Measure:Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Males [Lot 1] Versus 16- to 26-Year-Old Females [Lot 1]) Timepoints:4 weeks post-vaccination 3 (Month 7) ; Outcome name: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. 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. Measure:Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) Timepoints:4 weeks post-va | — |
Countries
Austria, Belgium, Brazil, Chile, Colombia, Costa Rica, Finland, India, Korea South, Peru, Poland, South Africa, Spain, Sweden, Taiwan, Thailand, United States
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed