Cervarix TM
BiologicalIntramuscular administration into the deltoid region of the non-dominant arm according to a 0, 1, 12-month schedule.
Other names: HPV vaccine (GSK580299)
NCT Number: NCT00552279
Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. The current phase 3b study is designed to assess the immunogenicity and safety of GlaxoSmithKline Biologicals' HPV vaccine GSK580299 administered according to an alternative dosing schedule as compared to the standard dosing schedule in young female subjects aged 15 - 25 years. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Looking for future studies?
Notify Me15 year–25 year
Female
Interventional
Phase 3
GSK Investigational Site, Brescia, Lombardy, Italy
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intramuscular administration into the deltoid region of the non-dominant arm according to a 0, 1, 12-month schedule.
Other names: HPV vaccine (GSK580299)
Time frame: One month after the third vaccine dose
Seroconversion is defined as the appearance of anti-HPV-16 and/or anti- HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination.
Cut-off values were 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti- HPV-18 antibodies.
Time frame: One month after the third vaccine dose
Titer given as geometric mean titer (GMT).
Time frame: One month after the second vaccine dose
Seroconversion is defined as the appearance of anti-HPV-16 and/or anti- HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination.
Cut-off values were 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti- HPV-18 antibodies.
Time frame: One month after the second vaccine dose
Titer given as GMT.
Time frame: During the 7-day (Days 0-6) period following each vaccination
Solicited local symptoms assessed include pain, redness and swelling at the injection site.
Time frame: During the 7-day (Days 0-6) period following each vaccination
Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash, and urticaria.
Time frame: During the 30-day (Days 0-29) period following each vaccination
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time frame: During the entire study period (up to Month 18 or up to Month 12)
Entire study period = up to Month 18 Cervarix-12 & Month 12 Cervarix-6.
NOCDs assessed include eg. autoimmune disorders (NOADs), asthma, type I diabetes. MSCs assessed include AEs prompting emergency room visits and physician office visits not related to common illnesses.
An SAE is any untoward medical occurrence that: results in death, is lifethreatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Time frame: During the entire study period (up to Month 18 or Month 12)
Entire study period = up to Month 18 Cervarix-12 & Month 12 Cervarix-6
Number of pregnancies and pregnancy outcomes.
Time frame: After the third vaccine dose
GlaxoSmithKline
Industry
Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' HPV Vaccine GSK580299 Administered According to an Alternative Dosing Schedule as Compared to the Standard Dosing Schedule in Young Female Subjects Aged 15-25 Years
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT00947115
Communicable Diseases, DNA Virus Infections
Munich, Bavaria, Germany
View Trial DetailsNCT01031069
Communicable Diseases, DNA Virus Infections
Porto Alegre, Rio Grande do Sul, Brazil
View Trial DetailsNCT01381575
Communicable Diseases, DNA Virus Infections
Coquitlam, British Columbia, Canada
View Trial DetailsNCT00877877
Communicable Diseases, DNA Virus Infections
Bogotá, Colombia
View Trial Details