Human Papillomavirus Vaccines
Conditions
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.
Interventions
BIOLOGICALGardasil and Gardasil-9
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.
Sponsors
Centers for Disease Control and Prevention
Laval University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Single group exploratory study
Eligibility
Sex/Gender
FEMALE
Age
12 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
Have received a single dose of Gardasil 3-8 years before recruitement. \-
Exclusion criteria
Immunossupressed or blood coagulation problems \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anti-HPV seropositivity | One month post vaccine administration. | Seropositivity to 9 HPV types included in Gardasil-9 vaccine will be assessed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Canada
Outcome results
None listed