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

Laval University

Status and phase: Completed; Phase 3

Conditions: Human Papillomavirus Vaccines

Treatments: Biological: Gardasil and Gardasil-9

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03431246

CÉ: 2017-3036-21

Details and patient eligibility

About

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

Full description

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.

Enrollment: 32 patients

Sex: Female

Ages: 12 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Have received a single dose of Gardasil 3-8 years before recruitement.

Exclusion Criteria: Immunossupressed or blood coagulation problems

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Gardasil and Gardasil-9

Experimental group

Treatment:

Biological: Gardasil and Gardasil-9