Safety and Immunogenicity of Extended 2-dose Regimens of 9-valent Human Papillomavirus (9vHPV) Vaccine (V503-069)

Merck Sharp & Dohme (MSD)

Status and phase: Active, not recruiting; Phase 3

Conditions: Papillomavirus Infections

Treatments: Biological: 9vHPV vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT04708041

V503-069 (Other Identifier)

U1111-1274-2496 (Registry Identifier)

2022-500253-37 (Registry Identifier)

2020-003736-24 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 700 estimated patients

Sex: All

Ages: 9 to 26 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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700 participants in 6 patient groups

Cohort 0: 1 Dose of 9vHPV Vaccine (previous 1-dose recipients)

Experimental group

Description:

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.

Treatment:

Biological: 9vHPV vaccine

Cohort 1: 2 Doses of 9vHPV Vaccine Given 12 Months Apart

Experimental group

Description:

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

Treatment:

Biological: 9vHPV vaccine

Cohort 2: 2 Doses of 9vHPV Vaccine Given 24 Months Apart

Experimental group

Description:

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

Treatment:

Biological: 9vHPV vaccine

Cohort 3: 2 Doses of 9vHPV Vaccine Given 36 Months Apart

Experimental group

Description:

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

Treatment:

Biological: 9vHPV vaccine

Cohort 4: 2 Doses of 9vHPV Vaccine Given 60 Months Apart

Experimental group

Description:

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

Treatment:

Biological: 9vHPV vaccine

Cohort 5: 3 Doses of 9vHPV Vaccine Given Over a 6-Month Period

Active Comparator group

Description:

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

Treatment:

Biological: 9vHPV vaccine