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ACTIVE NOT RECRUITING
NCT05329961
EARLY_PHASE1

Immunogenicity of the 9vHPV Vaccination 2-dose Regimen Among Children 4 to 8 Years Old

Sponsor: Boston Medical Center

View on ClinicalTrials.gov

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 papillomavirus vaccine (9vHPV) vaccine separated by 12 months (months 0, 12).

Official title: An Open-Label Clinical Trial Evaluating the Immunogenicity of the 9vHPV Vaccination 2-dose Regimen Over a Four-year Follow up Among Children 4 to 8 Years Old, An Exploratory Immunogenicity Study

Key Details

Gender

All

Age Range

4 Years - 8 Years

Study Type

INTERVENTIONAL

Enrollment

155

Start Date

2022-09-26

Completion Date

2028-12

Last Updated

2025-07-02

Healthy Volunteers

Yes

Interventions

DRUG

Gardasil9

The Gardasil 9 vaccine is a recombinant L 1 VLP vaccine containing HPV types 6, 11,16,18, 31, 33, 45, 52 and 58 VLP. The vaccine is not currently licensed for children under 9 years of age but it is licensed in the USA for males and females ages 9 to 45 years old.

Locations (1)

Boston Medical Center

Boston, Massachusetts, United States