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Safety and Immunogenicity of 9vHPV Vaccine Coadministered With mRNA-1273 SARS-CoV-2 Vaccine

Phase 1
Conditions
Papilloma viral infection
MedDRA version: 20.1Level: LLTClassification code 10063001Term: Human papilloma virus infectionSystem Organ Class: 10021881 - Infections and infestations
Therapeutic 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
Inclusion Criteria

- 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

Exclusion Criteria

- 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
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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