Clinical trial NCT01418937: Safety Evaluation of a Human Papillomavirus (HPV) Vaccine in Healthy Female Control Subjects From the GSK HPV 023 Study
Official title: Safety Study of GSK Biologicals' Human Papillomavirus Vaccine (GSK-580299) in Healthy Female Control Subjects From the GSK HPV-023 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections, Papillomavirus
Keywords: HPV vaccine
serious adverse events (SAEs)
medically significant conditions
cervical neoplasia
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-08-17
Enrollment: 164
Sex: FEMALE
Minimum age (years): 26
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This phase IIIb study is designed to assess the safety of GlaxoSmithKline Biological's HPV vaccine GSK580299 in female subjects who took part in the HPV-023 (NCT00518336) study and received a placebo in the HPV-001 (NCT00689741) study.


Eligibility criteria: Inclusion Criteria:

* Subjects who the investigator believes can and will comply with the requirements of the protocol.
* A subject previously enrolled in Study HPV-023 (NCT00518336), who received placebo in Study HPV-001 (NCT00689741), and who is 26 years of age or older.
* Written informed consent must be obtained from the subject prior to enrollment.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.
* Female subjects of non-childbearing potential may be enrolled in the study.
* Female subjects of childbearing potential may be enrolled in the study, if the subject has practiced adequate contraception for 30 days prior to vaccination, and has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion Criteria:

* Pregnant or breastfeeding: enrollment should be deferred to at least three months after delivery and after breastfeeding is ceased.
* A woman planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the vaccination phase of the study, and up to two months after the last vaccine dose.
* Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Previous vaccination against HPV or planned administration of another HPV vaccine during the study other than that foreseen in the protocol.
* 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 of each dose of the vaccine, with the exception of administration of routine meningococcal, hepatitis B, hepatitis A, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccine up to 8 days before each dose of study vaccine. Enrollment will be deferred until the subject is outside of specified window.
* 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.
* Previous administration of vaccine components.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* Cancer or autoimmune disease under treatment.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
* History of any neurological disorders or seizures.
* Acute disease and/or fever at the time of enrollment. Enrollment will be deferred until condition is resolved.
* Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests, which in the opinion of the investigator precludes administration of the study vaccine.

Primary outcomes:
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: Throughout the study period (from Month 0 up to Month 12)
measure: Number of Subjects With Potential Immune-mediated Disease (pIMDs)
timeFrame: Throughout the study period (from Month 0 up to Month 12)
measure: Number of Subjects With Medically Significant Conditions (MSCs)
timeFrame: Throughout the study period (from Month 0 up to Month 12)
measure: Number of Pregnant Subjects Reporting Pregnancy Outcomes
timeFrame: Throughout the study period (from Month 0 up to Month 12)
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: GSK Investigational Site
state: Rio Grande Do Sul
city: Campinas
country: Brazil
facility: GSK Investigational Site
city: Curitiba
country: Brazil
facility: GSK Investigational Site
city: Fortaleza
country: Brazil
facility: GSK Investigational Site
city: São Paulo
country: Brazil
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: