Status:
COMPLETED
Reactogenicity Study of Cervarix and Gardasil in UK Adolescent Girls
Lead Sponsor:
Public Health England
Conditions:
HPV Infections
Eligibility:
FEMALE
13-15 years
Phase:
PHASE4
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 ce...
Detailed Description
This study looks at possible cross reactivity between different HPV serotypes and both peripheral antibodies and mucosally-secreted antibodies.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00956553
Start Date
September 1 2009
End Date
September 1 2013
Last Update
October 1 2020
Active Locations (3)
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1
Public Health England
Stevenage, Hertfordshire, United Kingdom
2
Professor Elizabeth Miller
Gloucester, United Kingdom
3
Public Health England
London, United Kingdom, NW9 5HT