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

Active Not RecruitingEARLY_Phase 1

Sponsor: Boston Medical Center

Conditions: Human Papilloma Virus

Interventions: Gardasil9

Countries: United States

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).

Eligibility overview

Sex: ALL

Age: 4 Years to 8 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Children aged 4-8 years old
2. Receives care at the Boston Medical Center or one of the affiliated Community heath centers
3. Naïve to HPV Vaccine

Exclusion Criteria:

1. A history of severe allergic reaction, including known allergy to any vaccine component, specially severe allergic reaction to yeast
2. Immunocompromised/previous immunosuppressive therapy
3. Thrombocytopenia or other coagulation disorder

Locations (1)

Boston, Massachusetts, United States