Human Papillomavirus Vaccine Safety & Immunogenicity Trial in Healthy Young Adult Women With HPV Vaccine (GSK1674330A)

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 540

Inclusion Criteria

A woman whom the investigator believes can and will comply with the requirements of the protocol.
A woman between, and including, 18 and 25 years of age at the time of the first vaccination.
Written informed consent must be obtained from the subject prior to enrolment.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Subject must be of non-childbearing potential, or if of child bearing potential, she must have a negative pregnancy test and she must be using adequate contraceptive precautions for 30 days prior to the first vaccination and must agree to continue such precautions for two months after completion of the vaccination series.
Subject who has had no more than 6 lifetime sexual partners prior to enrolment.

Exclusion Criteria

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use up to six months after last dose of vaccine.
Concurrently participating in another clinical study, at any time during the study period (up to six months after last dose of vaccine), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose or planned during the study period up to one month after last dose of vaccine.
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 study vaccine. Planned administration/administration of routine vaccines up to 8 days before the first dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window.
Pregnant or breastfeeding. Women must be at least 3 months post-pregnancy and not breastfeeding to enter the study.
A woman planning to become pregnant or planning to discontinue contraceptive precautions during the study period, up to two months after the last vaccine dose.
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
Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccines.
Hypersensitivity to latex.
Known acute or chronic, clinically significant pulmonary, cardiovascular, 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, suspected allergy or reactions likely to be exacerbated by any component of the study vaccines.
History of having had colposcopy or has planned a colposcopy to evaluate an abnormal cervical cytology test.
Received immunoglobulins and/or blood product within 3 months preceding enrolment or planned administration during the study period up to one month after the last dose of vaccine. Enrolment will be deferred until the subject is outside of specified window.
Acute disease at the time of enrolment.
Heavy bleeding (menstruation or other) or heavy vaginal discharge in which a cervical sample cannot be collected. Enrolment will be deferred until condition is resolved according to investigators medical judgement.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C	GSK Biologicals' HPV vaccine (GSK1674330A)	-
Group E	GSK Biologicals' HPV vaccine (GSK1674330A)	-
Group A	GSK Biologicals' HPV vaccine (GSK1674330A)	-
Group B	GSK Biologicals' HPV vaccine (GSK1674330A)	-
Group D	GSK Biologicals' HPV vaccine (GSK1674330A)	-
Group F	Cervarix TM	-

Primary Outcome Measures

Name	Time	Method
Occurrence, intensity and relationship to vaccination of any solicited local or general symptoms	Within 7 days after each vaccine dose

Secondary Outcome Measures

Name	Time	Method
Occurrence of clinically relevant abnormalities in biochemical and hematological parameters	Assessed at Month 0, one month and six months after the last dose of vaccine
Occurrence of serious adverse events	Up to one month after the last dose of vaccine
Occurrence, intensity and relationship to vaccination of any unsolicited symptom	Within 30 days after each vaccine dose
Occurrence of serious adverse events during the extended safety follow-up	Up to six months after the last dose of vaccine
Occurrence of pregnancy and pregnancy outcomes, new onset chronic diseases or medically significant conditions, regardless of causal relationship to vaccination	Throughout the study period (Month 0 up to six months after the last dose of vaccine)
HPV-16 and HPV-18 seropositivity rates and GMTs before the second dose of vaccine	One month after the second dose of vaccine, and six months after the last dose of vaccine
Seropositivity rates to other defined HPV types and GMTs before the second dose of vaccine	One month after the second dose of vaccine and at one month and six months after the last dose of vaccine
HPV-16 and -18 seropositivity rates and GMTs	One month after the last dose of vaccine

Human Papillomavirus Vaccine Safety & Immunogenicity Trial in Healthy Young Adult Women With HPV Vaccine (GSK1674330A)

Recruitment & Eligibility

Study & Design

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