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Clinical Trials/EUCTR2008-006773-32-GB
EUCTR2008-006773-32-GB
Active, not recruiting
Phase 1

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

Health Protection Agency0 sites84 target enrollmentApril 16, 2009

Overview

Phase
Phase 1
Intervention
Not specified
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.
Sponsor
Health Protection Agency
Enrollment
84
Status
Active, not recruiting
Last Updated
7 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 16, 2009
End Date
November 30, 2011
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Eligibility Criteria

Inclusion Criteria

  • Aged between 13 and 15 years at the time of the first immunisation
  • 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

Outcomes

Primary Outcomes

Not specified

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