Immunogenicity of One Dose of Gardasil and One Dose of Gardasil-9
Phase 3
Completed
- Conditions
- Human Papillomavirus Vaccines
- Interventions
- Biological: Gardasil and Gardasil-9
- Registration Number
- NCT03431246
- Lead Sponsor
- Laval University
- Brief Summary
This study will assess the immunogenicity of one dose of Gardasil and one dose of Gardasil-9
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 32
Inclusion Criteria
Have received a single dose of Gardasil 3-8 years before recruitement.
Exclusion Criteria
Immunossupressed or blood coagulation problems
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Gardasil and Gardasil-9 Gardasil and Gardasil-9 -
- Primary Outcome Measures
Name Time Method Anti-HPV seropositivity One month post vaccine administration. Seropositivity to 9 HPV types included in Gardasil-9 vaccine will be assessed.
- Secondary Outcome Measures
Name Time Method HPV antibody titers One month post vaccine administration Geometrical mean titers of antibodies to 9 HPV types included in Gardasil-9 vaccine will be assessed
Trial Locations
- Locations (1)
Laval University Research Hospital Center
🇨🇦Quebec, Canada