Safety and Immunogenicity of Extended 2-dose Regimens of 9vHPV Vaccine
- Conditions
- Prevention of persistent anogenital HPV infection and disease caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58Therapeutic area: Phenomena and Processes [G] - Immune system processes [G12]MedDRA version: 21.1Level: PTClassification code: 10071146Term: Human papilloma virus immunisation Class: 100000004865
- Registration Number
- CTIS2022-500256-37-00
- Lead Sponsor
- Merck Sharp & Dohme Corp.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 700
Boys and girls 9 to 15 years must not have had coitarche and do not plan on becoming sexually active during the vaccination period, Women 16 to 26 years who have never had a Papanicolaou (Pap) test or only have had normal Pap test results, Women 16 to 26 years with a lifetime history of 0 to 4 male and/or female sexual partners, Cohort 0 participants must have received 1 dose of 9vHPV vaccine at least 1 year prior to enrollment and did not receive a second dose of any HPV vaccine
Known allergy to any vaccine component, Received a marketed HPV vaccine or has participated in an HPV vaccine clinical trial (Cohorts 1-5), 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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method