Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Uterine Cervical Dysplasia

Precancerous Conditions

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Cervical Intraepithelial Neoplasia

All Drugs and Chemicals

Antibodies

Vaccines

Immunoglobulins

Immunologic Factors

Healthy Chinese female subjects, including and above 17 years of age at the time of enrollment, who received all three doses of the Cervarix vaccine in the HPV-058 (NCT00996125) primary study.

In order to assess the persistence of immune responses seven to eight years after the last vaccine dose against HPV-16/18, a blood sample (\~5 mL) will be taken from all the subjects, at Day 1.

Blood sampling for antibody determination

GSK Clinical Trials

The purpose of this study is to evaluate the persistence of immune response in subjects who received the HPV-16/18 vaccine, seven to eight years after the last dose of primary vaccination in the HPV-058 study. No new subjects will be enrolled in this extension study.

A Follow-up Extension Study to Evaluate the Persistence of Immune Response to GSK Biologicals' HPV Vaccine in Healthy Chinese Female Subjects Who Received Three Doses of the Vaccine in the HPV-058 Study

Persistence of Immune Response to GSK Biologicals' HPV Vaccine in Healthy Chinese Female Subjects From the HPV-058 Study

IPD for this study is available via the Clinical Study Data Request site.

A seropositive subject is defined as a subject whose antibody concentration is equal to or above the cut-off value of 19 Enzyme Linked Immunosorbent Assay units per milliliter (EL.U/mL).

A seropositive subject is defined as a subject whose antibody concentration is equal to or above the cut-off value of 18 EL.U/mL.

Anti-HPV-16 antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in EL.U/mL.

Anti-HPV-18 antibody concentrations are presented as GMCs, expressed in EL.U/mL.

A seropositive subject is defined as a subject whose antibody concentration is equal to or above the cut-off value of 19 EL.U/mL.

The number of seropositive subjects at Day 1 in the present study was compared with the number of seropositive subjects from the immunogenicity subset in HPV-039 (NCT00779766) study at Year 6.

Data corresponding to Day 1 time point of the present study can also be found in the primary outcome measure.

Data at Year 6 in subjects from the immunogenicity subset in HPV-039 study can be found in the respective NCT record NCT00779766 (please refer to Outcome measure 38, Row "≥19 EL.U/mL, sero-, \[Month 72\]" and Row "≥19 EL.U/mL, sero+, \[Month 72\]").

A seropositive subject is defined as a subject whose antibody concentration is equal to or above the cut-off value of 18 EL.U/mL.

The number of seropositive subjects at Day 1 in the present study was compared with the number of seropositive subjects from the immunogenicity subset in HPV-039 (NCT00779766) study at Year 6.

Data corresponding to Day 1 time point of the present study can also be found in the primary outcome measure.

Data at Year 6 in subjects from the immunogenicity subset in HPV-039 study can be found in the respective NCT record NCT00779766 (please refer to Outcome measure 39, Row "≥ 18 EL.U/mL, sero- \[Month 72\]" and Row "≥ 18 EL.U/mL, sero+ \[Month 72\]).

Anti-HPV-16 antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in EL.U/mL.

Anti-HPV-16 antibody concentrations at Day 1 in the present study were compared with the anti-HPV-16 antibody concentrations obtained as per the analysis performed on the immunogenicity subset in HPV-039 (NCT00779766) study at Year 6.

Data corresponding to Day 1 time point of the present study can also be found in the primary outcome measure.

Data at Year 6 in subjects from the immunogenicity subset in HPV-039 study can be found in the respective NCT record NCT00779766 (please refer to Outcome measure 40, Row "HPV-16, sero-, \[Month 72\]" and Row "HPV-16, sero+, \[Month 72\]").

Anti-HPV-18 antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in EL.U/mL.

Anti-HPV-18 antibody concentrations at Day 1 in the present study were compared with the anti-HPV-18 antibody concentrations obtained as per the analysis performed on the immunogenicity subset in HPV-039 (NCT00779766) study at Year 6.

Data corresponding to Day 1 time point of the present study can also be found in the primary outcome measure.

Data at Year 6 in subjects from the immunogenicity subset in HPV-039 study can be found in the respective NCT record NCT00779766 (please refer to Outcome measure 40, Row "HPV-18, sero-, \[Month 72\]" and Row "HPV-18, sero+, \[Month 72\]").

GlaxoSmithKline

There were no adverse events (AEs) data collected during the entire study period (i.e. at Day 1).

Only SAEs related to study procedures or concomitant GSK medications/vaccines and events with a fatal outcome were recorded and collected during the entire study period (i.e. at Day 1).

HPV Group

Age, Continuous

Sex: Female, Male

Asian - East Asian Heritage

Race/Ethnicity, Customized

GSK Response Center

The analysis was performed on the Per-Protocol Set (PPS) for analysis of immunogenicity, which included all evaluable subjects who were included in the according to protocol (ATP) immunogenicity analysis of the primary vaccination study HPV-058 (NCT00996125), and with serology results available at this blood sampling time point.

Number of Seropositive Subjects for Anti-HPV-16 Antibodies at Day 1 in HPV-093 (NCT03355820) Study

Number of Seropositive Subjects for Anti-HPV-18 Antibodies at Day 1 in HPV-093 (NCT03355820) Study

Anti-HPV-16 Antibody Concentrations at Day 1 in HPV-093 (NCT03355820) Study

Anti-HPV-18 Antibody Concentrations at Day 1 in HPV-093 (NCT03355820) Study

The analysis was performed on the PPS for analysis of immunogenicity in HPV-093 study and on the ATP cohort for analysis of immunogenicity which included all evaluable subjects in the immunogenicity subset of HPV-039 study. For Year 6 data in HPV-039 study, please refer to the Outcome measure 38 in NCT00779766 record.

Number of Seropositive Subjects for Anti-HPV-16 Antibodies at Day 1 in HPV-093 (NCT03355820) and at Year 6 in HPV-039 (NCT00779766) Studies

The analysis was performed on the PPS for analysis of immunogenicity in HPV-093 study and on the ATP cohort for analysis of immunogenicity which included all evaluable subjects in the immunogenicity subset of HPV-039 study. For Year 6 data in HPV-039 study, please refer to the Outcome measure 39 in NCT00779766 record.

Number of Seropositive Subjects for Anti-HPV-18 Antibodies at Day 1 in HPV-093 (NCT03355820) and at Year 6 in HPV-039 (NCT00779766) Studies

The analysis was performed on the PPS for analysis of immunogenicity in HPV-093 study and on the ATP cohort for analysis of immunogenicity which included all evaluable subjects in the immunogenicity subset of HPV-039 study. For Year 6 data in HPV-039 study, please refer to the Outcome measure 40 in NCT00779766 record.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Follow-up Extension Study to Evaluate the Persistence of Immune Response to GSK Biologicals' HPV Vaccine in Healthy Chinese Female Subjects Who Received Three Doses of the Vaccine in the HPV-058 Study	NCT03355820	Cervical Intrae...	Blood sampling ...	17 Years -	GlaxoSmithKline
A Follow-up Extension Study to Evaluate the Persistence of Immune Response to GSK Biologicals' HPV Vaccine in Healthy Chinese Female Subjects Who Received Three Doses of the Vaccine in the HPV-058 Study	NCT03355820	Cervical Intrae...	Blood sampling ...	17 Years -	GlaxoSmithKline

Spots Global Cancer Trial Database for blood sampling for antibody determination