Status:
COMPLETED
Immunogenicity and Safety Study of GSK Biologicals' Human Papillomavirus 580299 Vaccine in Healthy Female Subjects
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Papillomavirus
Eligibility:
FEMALE
9-17 years
Phase:
PHASE3
Brief Summary
This study is designed to evaluate the immunogenicity and safety of GlaxoSmithKline Biologicals' human papillomavirus (HPV) vaccine in pre-teen and adolescent female subjects aged 9 - 17 years. One gr...
Eligibility Criteria
Inclusion
- Subjects who the investigator believes that they or their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
- Healthy Chinese females between and including 9 and 17 years of age at the time of the first vaccination.
- Written informed consent obtained from the parent(s)/LAR(s) of the subject and informed assent obtained from the subject, if appropriate, prior to enrolment.
- Healthy subjects as established by medical history and history-directed clinical examination before entering into the study.
- Subjects must not be pregnant. Absence of pregnancy will be verified with a urine pregnancy test before each vaccination.
- Subjects must be either of non-childbearing potential, or if of childbearing potential, they must be abstinent or have practiced adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and agree to continue such precautions for 2 months after completion of the vaccination series.
Exclusion
- Use of any investigational or non-registered product other than the study vaccines 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 (i.e., Days 0-29) the first dose of vaccine.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
- A subject planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the study period and up to two months after the last vaccine dose.
- Pregnant or breastfeeding. Subjects must be at least three months post-pregnancy and not breastfeeding to enter the study.
- Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the protocol during the study period.
- Previous administration of components of the study vaccine.
- History of chronic condition(s) requiring treatment such as cancer or autoimmune disease.
- History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the vaccine.
- Hypersensitivity to latex.
- 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 :
October 24 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 8 2010
Estimated Enrollment :
750 Patients enrolled
Trial Details
Trial ID
NCT00996125
Start Date
October 24 2009
End Date
December 8 2010
Last Update
August 17 2018
Active Locations (1)
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1
GSK Investigational Site
Taizhou, Jiangsu, China, 225300