A Phase IV, randomised study to evaluate the immune responses of UK adolescent girls receiving Cervarix(TM) or Gardasil(TM) Human Papillomavirus vaccines - RCT of immune response in UK adolescent girls to HPV vaccines
Phase 1
- Conditions
- 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
- Registration Number
- EUCTR2008-006773-32-GB
- Lead Sponsor
- Health Protection Agency
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 84
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
• Pregnant or become pregnant during the course of the trial (no contraindications to vaccination for those taking the contraceptive pill).
• Allergic to vaccine components
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method