Cervarix

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Background

Introduction

Cervarix is a vaccine intended to protect females against the diseases caused by infection with Human Papillomavirus (HPV) types 16 and 18. These diseases include: - cervical cancer(cancer of the cervix i.e. lower part of the uterus or womb), - precancerous cervical lesions(changes in cells of the cervix that have a risk of turning into cancer).

Cervarix will not protect against all types of Human Papillomavirus.HPV types 16 and 18 are responsible for approximately 70% ofcervical cancer cases. When a female is vaccinated with Cervarix, the immune system(the body’s natural defence system) will make antibodies against HPV types 16 and 18.

The Cervarix clinical trial programme

The pre-licensing programme for Cervarix comprised two major clinical trials (a ‘proof-ofconcept’ Phase IIb study and a larger Phase III trial) encompassing some 19,788 women aged

15–25 years. A further Phase III, community-based, randomised clinicaltrial is currently underway in Costa Rica, which is sponsored by the National Cancer Institute.


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