HPV Infections
Conditions
Keywords
HPV, Human Papilloma Virus, Cervical cancer vaccine
Brief summary
This is a phase IV study to evaluate the body's immune response of participants to the Cervarix and Gardasil vaccines against the Human Papilloma Virus (HPV) types associated with increased risk of cervical cancer.
Detailed description
This study looks at possible cross reactivity between different HPV serotypes and both peripheral antibodies and mucosally-secreted antibodies.
Interventions
BIOLOGICALCervarix
Three doses of Cervarix at month 0, 1 and 6.
BIOLOGICALGardasil
Three doses of Gardasil at month 0, 1 and 6.
Sponsors
Public Health England
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
13 Years to 15 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged between 13 and 15 years at the time of the first immunisation * Female * No contraindications to vaccination as specified in the Green Book - Immunisation Against Infectious Disease, HMSO. * Written informed consent obtained from parent or guardian of subject
Exclusion criteria
* Pregnant or become pregnant during the course of the trial (no contraindications to vaccination for those taking the contraceptive pill). * Breast-feeding mothers * Allergic to vaccine components
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measurable antibody mediated neutralisation of HPV serotype 6, 11, 16, 18 and genetically related serotypes, especially 45 | 18 months from enrollment |
Secondary
| Measure | Time frame |
|---|---|
| Determine differences in vaccine formulation and their impact on cross protection. | 24 months from enrollment |
Countries
United Kingdom
Outcome results
None listed