Infections

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Uterine Cervical Neoplasms

Communicable Diseases

All Drugs and Chemicals

Vaccines

Immunologic Factors

Women received 3 doses of Cervarix TM (human papillomavirus (HPV) vaccine) administered according to a 0, 1, 12-month schedule

Women received 3 doses of Cervarix TM (HPV vaccine) administered according to a 0, 1, 6-month schedule.

Intramuscular administration into the deltoid region of the non-dominant arm according to a 0, 1, 12-month schedule.

Cervarix TM

Intramuscular administration into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.

GSK Clinical Trials

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.

Immunogenicity and Safety of GlaxoSmithKline Biologicals' Huma Papillomavirus (HPV) Vaccine 580299 in Healthy Females 15 - 25 Years of Age

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

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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.

Titer given as geometric mean titer (GMT).

Solicited local symptoms assessed include pain, redness and swelling at the injection site.

Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash, and urticaria.

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.

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.

Entire study period = up to Month 18 Cervarix-12 \& Month 12 Cervarix-6

Number of pregnancies and pregnancy outcomes.

GlaxoSmithKline

Analysis for other adverse events were performed on the Total vaccinated cohort, on subjects with available data.

Women received 3 doses of Cervarix™ (human papillomavirus \[HPV\] vaccine) administered according to a 0, 1, 12-month schedule.

Cervarix-12 Group

Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.

Cervarix-6 Group

Total

Age, Continuous

Sex: Female, Male

GSK Response Center

Anti-HPV-16

Anti-HPV-18

Analysis was performed on initially seronegative subjects from the According-to-Protocol (ATP) cohort for analysis of immunogenicity

Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies

Analysis was performed on initially seronegative subjects from the ATP cohort for analysis of immunogenicity

Titer of Anti-HPV-16 and Anti-HPV-18 Antibodies

Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies

Pain

Redness

Swelling

Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.

Number of Subjects Reporting Solicited Local Symptoms

Arthralgia

Fatigue

Temperature ≥ 37.5°C

Gastro-intestinal symptoms

Headache

Myalgia

Rash

Urticaria

Number of Subjects Reporting Solicited General Symptoms

Number of Subjects Reporting Unsolicited Adverse Events (AE)

MSCs

NOCDs

NOADs

SAEs

Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs), New Onset Autoimmune Diseases (NOADs), Serious Adverse Events (SAEs), and Medically Significant Conditions (MSCs)

Spots Global Cancer Trial Database for Immunogenicity and Safety of GlaxoSmithKline Biologicals' Huma Papillomavirus (HPV) Vaccine 580299 in Healthy Females 15 - 25 Years of Age

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial