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

Subjects from one centre where compliance issues were discovered, who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study

Subjects from all study centres who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study.

All subjects will receive 3 doses administered as an intramuscular injection, according to a 0, 1, 6-month schedule.

GSK580299, GSK Biological's HPV vaccine

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

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

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

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.

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.

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.

GlaxoSmithKline

Other adverse events were not assessed in this study.

Subjects who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study.

Cervarix Group

Age, Continuous

Sex: Female, Male

Female

Male

Gender

GSK Response Center

Any SAEs all centers

Grade 3 SAEs all centers

Related SAEs all centers

Any SAEs non-compliant center (n=243)

Grade 3 SAEs non-compliant center (n=243)

Related SAEs non-compliant center (n=243)

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

Any MSCs all centers

Grade 3 MSCs all centers

Related MSCs all centers

Any MSCs non-compliant center (n=243)

Grade 3 MSCs non-compliant center (n=243)

Related MSCs non-compliant center (n=243)

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

Elective termination NO congenit. anom.

Live infant NO apparent congenit. anom.

Lost to follow up

Spontaneous abortion NO congenit. anom.

Pregnancy Ongoing

Elective termination NO congenit. anom.(NCC, n=25)

Live infant NO apparent congenit. anom.(NCC, n=25)

Lost to follow up (NCC, n=25)

Spontaneous abortion NO congenit. anom.(NCC, n=25)

Pregnancy Ongoing (NCC, n=25)

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

Number of Subjects With Pregnancies and Pregnancy Outcomes

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety Study of GSK Biologicals' Human Papillomavirus Vaccine in 580299/008 Subjects From Brazil, Taiwan or Thailand	NCT00849381	Infections, Pap...	GSK580299, GSK ...	26 Years -	GlaxoSmithKline
Safety Study of GSK Biologicals' Human Papillomavirus Vaccine in 580299/008 Subjects From Brazil, Taiwan or Thailand	NCT00849381	Infections, Pap...	GSK580299, GSK ...	26 Years -	GlaxoSmithKline
Safety Study of GSK Biologicals' Human Papillomavirus Vaccine in 580299/008 Subjects From Brazil, Taiwan or Thailand	NCT00849381	Infections, Pap...	GSK580299, GSK ...	26 Years -	GlaxoSmithKline
Safety Study of GSK Biologicals' Human Papillomavirus Vaccine in 580299/008 Subjects From Brazil, Taiwan or Thailand	NCT00849381	Infections, Pap...	GSK580299, GSK ...	26 Years -	GlaxoSmithKline

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