Status:
COMPLETED
Immunogenicity and Safety of a Commercially Available Vaccine Co-administered With GSK HPV Vaccine (580299)
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Papillomavirus
Papillomavirus Vaccines
Eligibility:
FEMALE
20-25 years
Phase:
PHASE3
Brief Summary
Infection with human papillomavirus (HPV) has been clearly established as the necessary cause of cervical cancer. The current Phase 3b study is designed to assess the immunogenicity and safety of a co...
Eligibility Criteria
Inclusion
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
- A female between, and including, 20 and 25 years of age at the time of the first vaccination.
- Written informed consent obtained from the subject.
- Healthy subjects as established by medical history and history directed clinical examination before entering into the study.
- Subjects must not be pregnant.
- Subjects must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
Exclusion
- 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.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after each dose of vaccine. Administration of routine vaccines such as meningococcal, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccines up to 8 days before the first dose of study vaccine is allowed.
- Concurrently participating in another clinical study, at any time during the study period (up to Month 13), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- A subject planning to become pregnant, likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the study period and up to two months after the last vaccine dose.
- Pregnant or breastfeeding women.
- Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period
- Previous administration of components of the investigational vaccine.
- Previous vaccination against hepatitis B or planned administration of any hepatitis B vaccine other than that foreseen by the study protocol during the study period.
- History of hepatitis B infection.
- Known exposure to hepatitis B within the previous 6 weeks.
- Known acute or chronic, clinically significant neurologic, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests.
- Cancer or autoimmune disease under treatment.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
Key Trial Info
Start Date :
March 11 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 18 2009
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT00637195
Start Date
March 11 2008
End Date
June 18 2009
Last Update
January 3 2020
Active Locations (2)
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1
GSK Investigational Site
Ghent, Belgium, 9000
2
GSK Investigational Site
La Louvière, Belgium, 7100