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

Female subjects who previously received the active control i.e. Hepatitis A vaccine in the primary study (NCT00122681) and who received the Cervarix vaccine in the current study. The Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1 and 6 months schedule.

All subjects will receive a 0.5 ml dose administered as an intramuscular injection, according to a 0, 1, 6-month schedule.

GSK Biological's HPV vaccine GSK580299 (Cervarix™)

GSK Clinical Trials

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 580299/008 and received the control vaccine (Hepatitis A vaccine).

Safety Study of GSK Biologicals' Human Papillomavirus Vaccine in 580299/008 Subjects From Canada or the US

Safety Study of GSK Biologicals' Human Papillomavirus Vaccine (GSK580299) in Female American and Canadian Subjects Who Had Received Control Vaccine in Study 580299/008

IPD for this study will be made available via the Clinical Study Data Request site.

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Any = Occurrence of any SAE regardless of intensity grade or relation to vaccination. Grade 3 = SAE which prevented normal, everyday activities. Related = SAE assessed by the investigator as related to the vaccination.

MSCs = Adverse events (AEs) prompting emergency room/physician visits not related to common diseases or routine visits for physical examination/vaccination, or SAEs not related to common diseases. Common diseases include: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury. Any = Occurrence of any MSC regardless of intensity grade or relation to vaccination. Grade 3 = MSC which prevented normal, everyday activities. Related = MSC assessed by the investigator as related to the vaccination.

GlaxoSmithKline

Cervarix Group

Age, Continuous

Sex: Female, Male

GSK Response Center

Any SAEs

Grade 3 SAEs

Related SAEs

The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of Cervarix vaccine in this study, for whom data were available.

Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)

Any MSCs

Grade 3 MSCs

Related MSCs

Number of Subjects With Any, Grade 3 and Related Medically Significant Conditions (MSCs)

Live infant NO apparent congenital anomaly

Elective termination NO apparent congenital anom.

Spontaneous abortion NO apparent congenital anom.

Lost to follow up

The analysis was based on pregnant subjects from the Total Vaccinated cohort, which included all subjects who received at least one dose of Cervarix vaccine in this study, for whom data were available.

Number of Subjects With Pregnancies and Pregnancy Outcomes.

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Safety Study of GSK Biologicals' Human Papillomavirus Vaccine in 580299/008 Subjects From Canada or the US	NCT00799825	Infections, Pap...	GSK Biological'...	18 Years -	GlaxoSmithKline
Safety Study of GSK Biologicals' Human Papillomavirus Vaccine in 580299/008 Subjects From Canada or the US	NCT00799825	Infections, Pap...	GSK Biological'...	18 Years -	GlaxoSmithKline

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