Safety Study of GSK Biologicals' Human Papillomavirus Vaccine in 580299/008 Subjects From Brazil, Taiwan or Thailand

Infections, Papillomavirus Clinical Trial

Official title:

Safety Study of GSK Biologicals' Human Papillomavirus Vaccine (GSK580299) in Female Brazilian, Taiwanese and Thai Subjects Who Had Received Control Vaccine in Study 580299/008

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00849381
• Other study ID #: 111758
• Status: Completed
• Phase: Phase 3
• First received: February 19, 2009
• Last updated: September 4, 2014
• Start date: April 2009
• Est. completion date: December 2012

Study information

• Verified date: August 2014
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of HealthBrazil: ANVISAThailand: Royal Thai Army Medical Department
• Study type: Interventional

Clinical Trial Summary

This phase 3b study is designed to assess the safety of GlaxoSmithKline Biological's HPV vaccine GSK580299 in female subjects who took part in study 008/580299 and received the control vaccine (Hepatitis A vaccine).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1239
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 26 Years and older

Eligibility

Inclusion Criteria:

• Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study

• A subject previously enrolled in the primary study (NCT00122681), who received the active control hepatitis A vaccine, and who cannot receive commercially available HPV-16/18 L1 VLP AS04 vaccine because the vaccine has not yet been granted licensure in the subject's country or because the subject is above the age for which the vaccine is licensed.

• Written informed consent must be obtained from the subject prior to enrolment.

• A woman aged 26 years or older at the time of the first vaccination in this study.

• Healthy subjects as established by medical history and clinical examination before entering into the study.

• Subjects must not be pregnant. Absence of pregnancy should be verified with a urine pregnancy test.

• Subject 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 Criteria:

• Pregnant or lactating female. Enrolment should be deferred until three months after pregnancy has been completed or after lactating has ceased.

• A woman planning to become pregnant or likely to become pregnant or planning to discontinue contraceptive prevention during the study period and up to two months after the last vaccine dose.

• 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 during the study period and the extended safety follow-up period.

• 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 non-investigational product (pharmaceutical product or device).

• Previous vaccination against HPV or planned administration of another HPV vaccine during the study other than that foreseen by protocol.

• Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days (i.e. Day 0-29) of each dose of vaccine. 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 is allowed. Enrolment will be deferred until the subject is outside of specified window.

• Previous administration of components of the investigational vaccine.

• History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccine.

• Hypersensitivity to latex.

• Acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, haematological, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests, which in the opinion of the investigator precludes administration of the study vaccine.

• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.

• Cancer or autoimmune disease under treatment.

• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.

• Acute disease at the time of enrolment.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infections, Papillomavirus

Intervention

Biological:
• GSK580299, GSK Biological's HPV vaccine
All subjects will receive 3 doses administered as an intramuscular injection, according to a 0, 1, 6-month schedule.

Locations

Country	Name	City	State
Brazil	GSK Investigational Site	Campinas
Brazil	GSK Investigational Site	Curitiba
Brazil	GSK Investigational Site	Porto Alegre	Rio Grande Do Sul
Taiwan	GSK Investigational Site	Taipei
Taiwan	GSK Investigational Site	Taipei
Taiwan	GSK Investigational Site	Taipei
Thailand	GSK Investigational Site	Bangkok
Thailand	GSK Investigational Site	Bangkok
Thailand	GSK Investigational Site	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Brazil,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)	SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.; Note: Results from one center where compliance issues were discovered are presented also separately.	During the entire study period (up to Month 12)	No
Primary	Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs)	MSCs include adverse events prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.	During the entire study period (up to Month 12)	No
Primary	Number of Subjects With Pregnancies and Pregnancy Outcomes	The pregnancy outcomes reported included elective termination, live birth and spontaneous abortion, all of which occurred with no apparent congenital (congenit.) anomalies (anom.) Note: Results from one non-compliant center (NCC) are also presented separately.	During the entire study period (up to Month 12)	No