A Phase IV, Randomised Study to Evaluate the Immune Responses of UK Adolescent Girls Receiving CervarixTM or GardasilTM Human Papillomavirus Vaccines
13 Years
15 Years
Female
HPV Infections
Trial Information
A Phase IV, Randomised Study to Evaluate the Immune Responses of UK Adolescent Girls Receiving CervarixTM or GardasilTM Human Papillomavirus Vaccines
This study looks at possible cross reactivity between different HPV serotypes and both
peripheral antibodies and mucosally-secreted antibodies.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Outcome Measure:
Measurable antibody mediated neutralisation of HPV serotype 6, 11, 16, 18 and genetically related serotypes, especially 45
Outcome Time Frame:
18 months from enrollment
Safety Issue:
No
Authority:
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study ID:
HPV CSP01
NCT ID:
NCT00956553
Start Date:
September 2009
Completion Date:
September 2013
Related Keywords:
- HPV Infections
- HPV
- Human Papilloma Virus
- Cervical cancer vaccine
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