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
- 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.
- Registration Number
- EUCTR2007-006651-39-GB
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 100000
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 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.
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