Safety and Immunogenicity of 9vHPV Vaccine Coadministered With mRNA-1273 SARS-CoV-2 Vaccine
- Conditions
- Papilloma viral infectionMedDRA version: 20.1Level: LLTClassification code 10063001Term: Human papilloma virus infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2021-003591-13-Outside-EU/EEA
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- Not specified
- Has not yet had coitarche and does not plan on becoming sexually active during the vaccination period
- Participant or participant's legally acceptable representative can read, understand, and complete the electronic vaccination report card (eVRC).
Are the trial subjects under 18? yes
Number of subjects for this age range: 160
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- Known allergy to any vaccine component
- History of severe allergic reaction that required medical intervention
- Thrombocytopenia or any coagulation disorder
- Has a history of myocarditis or pericarditis
- Has a history of a clinical or microbiological diagnosis of COVID-19 =90 days prior to Day 1 visit or history of multisystem inflammatory syndrome in children (MIS-C) at any time prior to Day 1 visit
- Females only: participant is pregnant
- 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
- Received a marketed HPV vaccine or has participated in an HPV vaccine clinical trial
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