HPV Vaccine Regimens for Human Papillomavirus

Recruiting in Palo Alto (17 mi)

+29 other locations

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Merck Sharp & Dohme Corp.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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).

Eligibility Criteria

This trial is for boys and girls aged 9-14, and young women aged 16-26 with a history of limited sexual partners. Participants should not be sexually active during the study or plan to become so. Women must have normal Pap tests. Those previously vaccinated with one dose of HPV vaccine can join, but those who are pregnant, immunocompromised, or have severe allergies cannot.

Inclusion Criteria

I received one HPV vaccine dose over a year ago and no others.

I received one dose of the 9vHPV vaccine over a year ago and no other HPV vaccines since.

I am a woman aged 16-26, never had or only had normal Pap tests, and have had up to 4 sexual partners.

Exclusion Criteria

History of severe allergic reaction that required medical intervention

Known allergy to any vaccine component

Currently immunocompromised, or been diagnosed with immunodeficiency

Participant Groups

The study is testing extended two-dose regimens (0,12; 0,24; 0,36; and 0,60 months) of the 9vHPV vaccine in younger participants against the standard three-dose regimen given to young women at intervals of 0,2,and6 months. The aim is to compare safety and immune response over a period of up to eight years.

Group I: Cohort 4: 2 Doses of 9vHPV Vaccine Given 60 Months Apart Experimental Treatment 1 Intervention

9 to 10 year old girls and boys receive a 2-dose regimen of 9vHPV vaccine at Day 1 and Month 60.

Group II: Cohort 3: 2 Doses of 9vHPV Vaccine Given 36 Months Apart Experimental Treatment 1 Intervention

9 to 12 year old girls and boys receive a 2-dose regimen of 9vHPV vaccine at Day 1 and Month 36.

Group III: Cohort 2: 2 Doses of 9vHPV Vaccine Given 24 Months Apart Experimental Treatment 1 Intervention

9 to 13 year old girls and boys receive a 2-dose regimen of 9vHPV vaccine at Day 1 and Months 24.

Group IV: Cohort 1: 2 Doses of 9vHPV Vaccine Given 12 Months Apart Experimental Treatment 1 Intervention

9 to 14 year old girls and boys receive a 2-dose regimen of 9vHPV vaccine at Day 1 and Month 12.

Group V: Cohort 0: 1 Dose of 9vHPV Vaccine (previous 1-dose recipients) Experimental Treatment 1 Intervention

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.

Group VI: Cohort 5: 3 Doses of 9vHPV Vaccine Given Over a 6-Month Period Active Control 1 Intervention

16 to 26 year old young women receive 3 dose regimen of 9vHPV vaccine at Day 1, Month 2 and Month 6.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Kaiser Permanente San Jose ( Site 0046) San Jose, CA

Encompass Clinical Research ( Site 0022) Spring Valley, CA

Coastal Carolina Research Center ( Site 0032) North Charleston, SC

University of Texas Medical Branch-Sealy Institute for Vaccine Sciences Clinical Trials Program ( Si Galveston, TX

More Trial Locations

Who Is Running the Clinical Trial?

Merck Sharp & Dohme Corp. Lead Sponsor

Merck Sharp & Dohme LLC Lead Sponsor

References