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Vaccines

Healthy female subjects aged 26 years and above, who received control vaccine in the primary study NCT00294047, were administrated 3 intramuscular injections of Cervarix vaccine into the deltoid of the non-dominant arm, according to a 0, 1, 6-month schedule in the current study.

3-dose schedule intramuscularly vaccination

GSK580299 (Cervarix)

GSK Clinical Trials

This extension study is designed to assess the safety of GSK Biological's HPV vaccine GSK580299 in female subjects who took part in the primary study NCT00294047 and received the control vaccine in countries for which the licensed GSK HPV vaccine is not indicated for the subject's age group (26 years and older). This study is thus conducted to enable all women who received the control placebo in the primary NCT00294047 study to receive the GSK580299 vaccine.

This Protocol Posting has been updated following Protocol Amendment 1, December 2010, leading to the update of 1 of the primary outcome measures and following Protocol Amendment 2, January 2011, leading to the removal of one of the exclusion criteria.

The Safety Evaluation of the GSK-580299 Vaccine in Women From the Control Group in the Primary NCT00294047 Study

Safety Study of GSK Biologicals' Human Papillomavirus Vaccine (GSK-580299) in Healthy Female Control Subjects From the Primary NCT00294047 Study

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

Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as the occurrence of any SAE regardless of intensity grade or relation to vaccination. Grade 3 SAE = SAE which prevented normal, everyday activities (in adults/adolescents, such an SAE, for example, prevented attendance at work/school and necessitated the administration of corrective therapy). Related SAE = SAE assessed by the investigator as causally related to the study vaccination.

Medically significant conditions (MSCs) are defined as:

AEs prompting emergency room or physician visits that were not related to common diseases, or not related to routine visits for physical examination or vaccination; SAEs that were 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.

Potential immune-mediated diseases (pIMDs) are a subset of medically significant conditions that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.

Any was defined as the occurrence of any MSC or pIMD regardless of intensity grade or relation to vaccination. Grade 3 MSC or pIMD = a MSC or pIMD which prevented normal, everyday activities. Related MSC or pIMD = a MSC or pIMD assessed by the investigator as related to the vaccination.

Live infant NO apparent congenital anomaly; Live infant congenital anomaly; Premature live infant NO apparent congenital anomaly; Premature live infant congenital anomaly; Elective termination NO apparent congenital anomaly; Elective termination congenital anomaly; Therapeutic abortion; Ectopic pregnancy; Spontaneous abortion NO apparent congenital anomaly; Spontaneous abortion congenital anomaly; Stillbirth NO apparent congenital anomaly; Stillbirth congenital anomaly; Molar pregnancy; Pregnancy ongoing; Lost to follow up.

GlaxoSmithKline

Non-serious solicited adverse events were not collected in this study. Non-serious unsolicited events collected in this study did not exceed the threshold of 5%.

HPV Vaccine

Age, Continuous

Sex: Female, Male

Geographic ancestry

Race/Ethnicity, Customized

GSK Response Center

Any SAE(s)

Grade 3 SAE(s)

Related SAE(s)

The analysis was based on the Total Vaccinated cohort, which included all subjects with the study vaccine administered.

Number of Subjects Reporting Serious Adverse Events

Any MSCs

Grade 3 MSCs

Related MSCs

Any pIMDs

Grade 3 pIMDs

Related pIMDs

Number of Subjects Reporting Medically Significant Conditions (MSCs) and Potential Immune-mediated Diseases (pIMDs)

Live infant NO apparent congenital anomaly

Live infant congenital anomaly

Premature live infant NO apparent congen. anomaly

Premature live infant congenital anomaly

Elective termination NO apparent congen. anomaly

Elective termination congenital anomaly

Therapeutic abortion

Ectopic pregnancy

Spontaneous abortion NO apparent congen. anomaly

Spontaneous abortion congenital anomaly

Stillbirth NO apparent congenital anomaly

Stillbirth congenital anomaly

Molar pregnancy

Pregnancy ongoing

Lost to follow up

The analysis was based on the Total Vaccinated cohort, which included all subjects with the study vaccine administered and who reported any pregnancies and outcomes of reported pregnancies.

Number of Subjects Reporting Pregnancies and Outcome of Reported Pregnancies

Overall Study

Healthy female subjects who received control vaccine in the primary study HPV-015 (NCT00294047), were administered three doses of Cervarix vaccine intramuscularly, according to a 0,1,6-month schedule.

This extension study is designed to assess the safety of GSK Biological's human papillomavirus (HPV) vaccine GSK580299 in female subjects who took part in the primary study NCT00294047 and received the control vaccine in countries for which the licensed GSK HPV vaccine is not indicated for the subject's age group (26 years and older). This study is thus conducted to enable all women who received the control placebo in the primary NCT00294047 study to receive the GSK580299 vaccine.

Safety Evaluation of the GSK-580299 Vaccine in Women From the Control Group in the Primary NCT00294047 Study

IPD is available via the Clinical Study Data Request site (click on the link provided below)

Assessed SAEs included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were congenital anomalies/birth defects in the offspring of a study subject. Any SAE = occurrence of the SAE regardless of intensity grade. Grade 3 SAE = an SAE which prevented normal, everyday activities. Related SAE = an SAE assessed by the investigator as causally related to the study vaccination.

Medically significant conditions were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases, or (2) not related to routine visits for physical examination or vaccination, or as SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury. Any MSC = occurrence of the MSC regardless of intensity grade. Grade 3 MSC = a MSC which prevented normal, everyday activities. Related MSC = MSC assessed by the investigator as related to the study vaccination.

pIMD(s) are a subset of medically significant conditions (MSCs) that included autoimmune diseases and other inflammatory and/or neurological disorders of interest which may or may not have had an autoimmune aetiology. Any pIMD = occurrence of the pIMD regardless of intensity grade. Grade 3 pIMD = a pIMD which prevented normal, everyday activities. Related pIMD = pIMD assessed by the investigator as related to the study vaccination.

Pregnancy is the term used to describe the period in which a fetus develops inside a woman's womb or uterus. In this study, the number of subjects with pregnancies was calculated. The subjects with confirmed pregnancies were followed up to determine the outcomes of the reported pregnancies.

Cervarix Group

Geographic Ancestry

The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.

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

Any MSC(s)

Grade 3 MSC(s)

Related MSC(s)

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

Any pIMD(s)

Grade 3 pIMD(s)

Related pIMD(s)

Number of Subjects Reporting Any, Grade 3 and Related Potentially Immune-Mediated Diseases (pIMDs)

Number of Subjects Reporting Pregnancies and Outcomes of the Reported Pregnancies

CervarixTM (GSK580299)

This phase IIIb study is designed to assess the safety of GlaxoSmithKline Biological's HPV vaccine GSK580299 in female subjects who took part in the HPV-023 (NCT00518336) study and received a placebo in the HPV-001 (NCT00689741) study.

Safety Evaluation of a Human Papillomavirus (HPV) Vaccine in Healthy Female Control Subjects From the GSK HPV 023 Study

Safety Study of GSK Biologicals' Human Papillomavirus Vaccine (GSK-580299) in Healthy Female Control Subjects From the GSK HPV-023 Study

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

MSCs include AEs 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 were based on reports from pregnant subjects in the study population. Pregnancy outcomes are pregnancies resulting in live births.

Non-serious solicited and unsolicited adverse events were not collected in this study.

Subjects received 3 intramuscular injections of Cervarix™ vaccine according to a 0, 1, 6-month schedule.

Any SAEs

Grade 3 SAEs

Related SAEs

The analysis was based on the Total Vaccinated cohort, which included all subjects with the study vaccine administered

Number of Subjects With Serious Adverse Events (SAEs)

Number of Subjects With Potential Immune-mediated Disease (pIMDs)

Vaccine-related MSCs

Number of Subjects With Medically Significant Conditions (MSCs)

The analysis was performed on the number of pregnant subjects participating in the study.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Safety Evaluation of the GSK-580299 Vaccine in Women From the Control Group in the Primary NCT00294047 Study	NCT01249365	Infections, Pap...	GSK580299 (Cerv...	26 Years -	GlaxoSmithKline
Safety Evaluation of the GSK-580299 Vaccine in Women From the Control Group in the Primary NCT00294047 Study	NCT01190189	Infections, Pap...	GSK580299 (Cerv...	26 Years -	GlaxoSmithKline
Safety Evaluation of a Human Papillomavirus (HPV) Vaccine in Healthy Female Control Subjects From the GSK HPV 023 Study	NCT01418937	Infections, Pap...	CervarixTM (GSK...	26 Years -	GlaxoSmithKline
Safety Evaluation of the GSK-580299 Vaccine in Women From the Control Group in the Primary NCT00294047 Study	NCT01190189	Infections, Pap...	GSK580299 (Cerv...	26 Years -	GlaxoSmithKline

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