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Purpose

This is a 96-month safety and immunogenicity study conducted in boys and girls 9 to 14 years of age and in young women 16 to 26 years of age. From this study, the goal is to establish that the investigational extended 2-dose regimens (0, 12 months; 0, 24 months; 0, 36 months; and 0, 60 months) studied in boys and girls 9 to 14 years of age are generally safe and immunogenic, with an antibody response that is not inferior to that observed in young women 16 to 26 years of age who receive the standard 3-dose regimen of 9-valent human papillomavirus (9vHPV) vaccine at 0, 2, and 6 months (i.e., the population and dose regimen used to establish 9vHPV vaccine efficacy).

Condition

Eligibility

Eligible Ages
Between 9 Years and 26 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

Boys and Girls 9 to 15 Years: - Must not have had coitarche and does not plan on becoming sexually active during the vaccination period Women 16 to 26 Years: - Has never had a Papanicolaou (Pap) test or only had normal Pap test results - A lifetime history of 0 to 4 male and/or female sexual partners Cohort 0 Participants: - Received 1 dose of 9vHPV vaccine at least 1 year prior to enrollment and did not receive a second dose of any HPV vaccine

Exclusion Criteria

All Participants: - Known allergy to any vaccine component - History of severe allergic reaction that required medical intervention - Thrombocytopenia or any coagulation disorder - Females only: participant is pregnant or expecting to donate eggs during day 1 through month 7 - Currently immunocompromised, or been diagnosed with immunodeficiency - Had a splenectomy - Receiving or has received immunosuppressive therapies within the last year - Received any immunoglobulin product or blood-derived product within 3 months - Has received more than 1 dose of an HPV vaccine (Cohort 0) - Received a marketed HPV vaccine or has participated in an HPV vaccine clinical trial (Cohorts 1-5)

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort 0: 1 Dose of 9vHPV Vaccine (previous 1-dose recipients) 		10 to 15 year old girls and boys (who previously received 1 dose of 9vHPV vaccine) receive a second dose of 9vHPV vaccine at Day 1.
  • Biological: 9vHPV vaccine
    9-valent human papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection
Experimental
Cohort 1: 2 Doses of 9vHPV Vaccine Given 12 Months Apart 		9 to 14 year old girls and boys receive a 2-dose regimen of 9vHPV vaccine at Day 1 and Month 12.
  • Biological: 9vHPV vaccine
    9-valent human papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection
Experimental
Cohort 2: 2 Doses of 9vHPV Vaccine Given 24 Months Apart 		9 to 13 year old girls and boys receive a 2-dose regimen of 9vHPV vaccine at Day 1 and Months 24.
  • Biological: 9vHPV vaccine
    9-valent human papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection
Experimental
Cohort 3: 2 Doses of 9vHPV Vaccine Given 36 Months Apart 		9 to 12 year old girls and boys receive a 2-dose regimen of 9vHPV vaccine at Day 1 and Month 36.
  • Biological: 9vHPV vaccine
    9-valent human papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection
Experimental
Cohort 4: 2 Doses of 9vHPV Vaccine Given 60 Months Apart 		9 to 10 year old girls and boys receive a 2-dose regimen of 9vHPV vaccine at Day 1 and Month 60.
  • Biological: 9vHPV vaccine
    9-valent human papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection
Active Comparator
Cohort 5: 3 Doses of 9vHPV Vaccine Given Over a 6-Month Period 		16 to 26 year old young women receive 3 dose regimen of 9vHPV vaccine at Day 1, Month 2 and Month 6.
  • Biological: 9vHPV vaccine
    9-valent human papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection

More Details

Status
Active, not recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.