Status:
ACTIVE_NOT_RECRUITING
Immunogenicity of the 9vHPV Vaccination 2-dose Regimen Among Children 4 to 8 Years Old
Lead Sponsor:
Boston Medical Center
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Human Papilloma Virus
Eligibility:
All Genders
4-8 years
Phase:
EARLY_PHASE1
Brief Summary
This study is an open-label nonrandomized exploratory proof of concept and descriptive 4-year immunogenicity study to assess immunogenicity after administration of a 2-dose regimen of 9-valent human p...
Detailed Description
Study participants will include 150 boys and girls aged 4-8 years (total, 75 boys and 75 girls) to receive 2 doses of the 9vHPV vaccine at 0 and 12 months. Patients will be recruited by age-group to a...
Eligibility Criteria
Inclusion
- Children aged 4-8 years old
- Receives care at the Boston Medical Center or one of the affiliated Community heath centers
- Naïve to HPV Vaccine
Exclusion
- A history of severe allergic reaction, including known allergy to any vaccine component, specially severe allergic reaction to yeast
- Immunocompromised/previous immunosuppressive therapy
- Thrombocytopenia or other coagulation disorder
Key Trial Info
Start Date :
September 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2028
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT05329961
Start Date
September 26 2022
End Date
December 1 2028
Last Update
July 2 2025
Active Locations (1)
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1
Boston Medical Center
Boston, Massachusetts, United States, 02118