Immunogenicity of One Dose of Gardasil and One Dose of Gardasil-9

Laval University32 enrolled

Overview

This study will assess the immunogenicity of one dose of Gardasil and one dose of Gardasil-9

This is a one group exploratory study. The main objective of this study is to assess the persistance of anti-HPV after a single dose Gardasil and the effect of one dose of Gardasil-9 when administered 3-8 years later.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Human Papillomavirus Vaccines

Interventions

Gardasil and Gardasil-9BIOLOGICAL

All subjects will receive one dose of Gardasil-9. Blodd samples for serological testing will be collected just before and one month post Gardasil-9 administration.

Eligibility

Sex: FEMALEMin age: 12 YearsMax age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: Have received a single dose of Gardasil 3-8 years before recruitement. \- Exclusion Criteria: Immunossupressed or blood coagulation problems \-

Locations (1)

Laval University Research Hospital Center

Québec, Canada

Outcomes

Primary Outcomes

Anti-HPV seropositivity

Seropositivity to 9 HPV types included in Gardasil-9 vaccine will be assessed.

Time frame: One month post vaccine administration.

Secondary Outcomes

HPV antibody titers

Geometrical mean titers of antibodies to 9 HPV types included in Gardasil-9 vaccine will be assessed

Time frame: One month post vaccine administration

Data from ClinicalTrials.gov

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