A phase IV, randomized, open-label, controlled, post-licensure study to evaluate the safety of GlaxoSmithKline Biologicals’ HPV-16/18 L1 VLP AS04 vaccine (Cervarix®) when administered intramuscularly according to a 0, 1, 6-month schedule in females aged 18-25 years. - EPI-HPV-111103

GlaxoSmithKline Biologicals0 sites100,000 target enrollmentJanuary 20, 2009

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: o medical condition will be investigated in this study. The study will follow vaccinated females and collect safety data focussing on autoimmune diseases, pregnancy outcomes and SAEs considered to be related to the vaccine.
Sponsor: GlaxoSmithKline Biologicals
Enrollment: 100000
Status: Active, not recruiting
Last Updated: 6 years ago

No summary available.

Registry

who.int

Start Date

January 20, 2009

End Date

November 27, 2012

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•Female subjects who the GP or other healthcare professional believes that they can and will comply with the requirements of the protocol (e.g. willing to receive full vaccination course, available for a 24 month follow\-up period) should be enrolled in the study.
•A female between, and including, 18\-25 years of age at the time of the first vaccination (i.e. ineligible on the subject’s 26th birthday).
•Female subjects who are registered with a GP practice in Scotland.
•Written informed consent obtained from the female subject.
•Willing to give permission for their paper record, electronic medical records and prescribing data to be accessed and abstracted by study investigators.
•Willing to be contacted and interviewed by study investigators, should the need arise for assessment of all events of interest to the study.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range

•Previous vaccination against HPV or HAV.
•Hypersensitivity to the active substances or to any of the excipients of the vaccines.
•Suffering from an acute severe febrile illness. However, the presence of a minor infection, such as a cold, is not a contraindication for immunization.
•Pregnant or lactating female (self\-reported). Subjects of childbearing potential must not be pregnant. Absence of pregnancy should be verified (e.g. urine pregnancy test) as per the investigator's clinical judgement.
•Female planning to become pregnant or planning to discontinue contraceptive precautions from first dose of vaccine up to 2 months after the last dose of vaccine.
•Females with confirmed diagnosis of AIDs. Females with a suspected diagnosis of an AID can be enrolled in the study if before the end of the recruitment period it is firmly established that the disease in question is not an AID.
•Use of any investigational or non\-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.