This study will investigate vaccines that prevent premalignant cervical lesions and cervical cancer causally related to Human Papillomavirus (HPV) types 16 and 18. This study will investigate whether immunisation against infection with HPV 16 and 18 may impact on other oncogenic HPV types, through cross-protection. MedDRA version: 9.1 Level: LLT Classification code 10058580 Term: Human papilloma virus serology test
Conditions
Interventions
Trade Name: Cervarix
Product Name: Cervarix
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Human Papillomavirus type 16 L1 protein
Sponsors
Health Protection Agency
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Pregnant or become pregnant during the course of the trial (no contraindications to vaccination for those taking the contraceptive pill). • Allergic to vaccine components
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: ;Primary end point(s): This is an immunogenicity study and does not have disease endpoints. For all participants, serology will be conducted on samples collected up to one year after the first dose of HPV vaccine.; Main Objective: To undertake a comprehensive comparative evaluation of the HPV-specific immune responses against oncogenic HPV types induced when adolescent female subjects are vaccinated with either Cervarix or Gardasil, by (i) examining the levels of antibody-mediated cross-neutralisation elicited to oncogenic HPV types following vaccination with either Cervarix or Gardasil (ii) comparing the levels and patterns of cross-neutralisation induced by each vaccine to highlight potential differences in immunogenicity between the vaccines (iii) assessing whether there are differences in the specificity of mucosal antibodies or cell-mediated immune responses elicited by each vaccine | — |
Countries
United Kingdom
Outcome results
None listed