Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Infections

Symptoms and General Pathology

Uterine Cervical Neoplasms

Communicable Diseases

All Drugs and Chemicals

Vaccines

Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).

Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).

Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937).

Blood samples were collected at Years 5, 6, 7, 8, 9 and 10.

Blood sampling

CVS samples were collected at Years 5, 6, 7, 8, 9 and 10 in subjects who volunteered for this procedure.

Cervico-vaginal secretion (CVS) samples

GSK Clinical Trials

Infection with human papillomavirus (HPV) has been clearly established as the necessary cause of cervical cancer. This study is designed to evaluate the long-term immunogenicity and safety of the GSK Biologicals' 580299 HPV vaccine up to 10 years after administration of the first dose of HPV vaccine (Month 0) in primary study NCT00196937. This protocol posting deals with objectives \& outcome measures of the extension phase from Year 5 to Year 10. The objectives \& outcome measures of the primary phase and extension phase up to year 4 are presented in a separate protocol posting (NCT00196937).

Subjects were aged 15-55 years at the time of entry into the primary study (NCT00196937). No vaccine was administered in this extension study.

Results on outcome measures describing analyses on other studies are not reported in this record. Please refer to the records mentioned in the respective outcome measure titles.

Evaluation of Long-term Immunogenicity and Safety of a Human Papillomavirus (HPV) Vaccine in Healthy Female Subjects

Follow-up Study to Evaluate the Long-term Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV (580299) Vaccine in Healthy Female Subjects

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

Anti-HPV-16/18 antibody titers are presented as Geometric Mean Titers (GMTs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

The immune response of the HPV-16/18 vaccine (as determined by anti-HPV-16/18 antibodies assessed by ELISA) in the HPV-060 study population was compared with the immune response obtained in study HPV-001 and its long-term follow-up studies HPV-007/HPV-023 at equivalent timepoints and with the immune response obtained after natural infection in subjects from study HPV-008.

The immune response data for the efficacy studies HPV-001/HPV-007/HPV-023 can be found under the NCT record NCT00518336. The immune response data for the HPV-008 study can be found under the NCT record NCT00122681.

Anti-HPV-16/18 antibody titers are presented as Geometric Mean Titers (GMTs) and expressed in EL.U/mL.

The immune response of the HPV-16/18 vaccine (as determined by anti-HPV-16/18 antibodies assessed by ELISA) in the HPV-060 study population was compared with the immune response obtained in study HPV-001 and its long-term follow-up studies HPV-007/HPV-023 at equivalent timepoints and with the immune response obtained after natural infection in subjects from study HPV-008.

The immune response data for the efficacy studies HPV-001/HPV-007/HPV-023 can be found under the NCT number NCT00518336. The immune response data for the HPV-008 study can be found under the NCT number NCT00122681.

Seroconversion was defined as the appearance of anti-HPV-16 and anti- HPV-18 antibodies \[i.e. antibody titer greater than or equal to (≥) the cut-off value\] in the serum of subjects seronegative before vaccination in the primary study HPV-014 (NCT00196937). Cut-off values were 8 EL.U/mL for anti-HPV-16 antibody titers and 7 EL.U/mL for anti-HPV-18 antibody titers.

Seroconversion was defined as the appearance of anti-HPV-16 and anti-HPV-18 antibodies (i.e. antibody titer ≥ the cut-off value) in the serum of subjects seronegative before vaccination in the primary study HPV-014 (NCT00196937). Cut-off values were 19 EL.U/mL for anti-HPV-16 antibody titers and 18 EL.U/mL for anti-HPV-18 antibody titers.

Anti-HPV-16/18 titers in CVS samples are presented as GMTs and expressed in EL.U/mL.

IgG antibody titers in CVS samples are presented as GMTs and expressed in microgram per milliliter (µg/mL).

Total IgG antibody titers in CVS samples are presented as GMTs and expressed in microgram per milliliter (µg/mL).

Total IgG antibody titers are presented as GMTs and expressed in µg/mL.

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, or may have evolved into one of the outcomes listed above. Related SAE = SAE assessed by the investigator as causally related to the study vaccine administered in study HPV-014 (NCT00196937).

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. Related SAE = SAE assessed by the investigator as causally related to the study vaccine administered in study HPV-014 (NCT00196937).

GlaxoSmithKline

Other (non-serious) Adverse Events and solicited symptoms were not collected/assessed. This section displays the safety analysis on the subjects who participated in the primary study HPV-014 (NCT00196937), excluding those who were not selected or not consented for the present study HPV-060 (NCT00947115).

Cervarix 15-25 Years Group

Cervarix 26-45 Years Group

Cervarix 46-55 Years Group

Total

Age, Continuous

Sex: Female, Male

Black

White/Caucasian

Race/Ethnicity, Customized

GSK Response Center

Anti-HPV-16 [Year 5]

Anti-HPV-16 [Year 6]

Anti-HPV-16 [Year 7]

Anti-HPV-18 [Year 5]

Anti-HPV-18 [Year 6]

Anti-HPV-18 [Year 7]

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Years 5, 6 and 7, which included all evaluable subjects from the ATP cohort for immunogenicity of the primary study HPV-014 (NCT00196937), who were seronegative before vaccination and for whom immunogenicity data at Years 5, 6 and 7 were available.

Anti-Human Papillomavirus (Anti-HPV)-16/18 Antibody Titers in Serum at Years 5, 6 and 7

Anti-HPV-16 [Year 8]

Anti-HPV-16 [Year 9]

Anti-HPV-16 [Year 10]

Anti-HPV-18 [Year 8]

Anti-HPV-18 [Year 9]

Anti-HPV-18 [Year 10]

The analysis was performed on the ATP cohort for immunogenicity at Years 8, 9 and 10, which included all evaluable subjects from the ATP cohort for immunogenicity of the primary study HPV-014 (NCT00196937), who were seronegative before vaccination and for whom immunogenicity data at Years 8, 9 and 10 were available.

Anti-HPV-16/18 Antibody Titers in Serum at Years 8, 9 and 10

anti-HPV-16 [Year 5]

anti-HPV-16 [Year 6]

anti-HPV-16 [Year 7]

anti-HPV-18 [Year 5]

anti-HPV-18 [Year 6]

anti-HPV-18 [Year 7]

The analysis was performed on the ATP cohort for immunogenicity at Years 5, 6 and 7, which included all evaluable subjects from the ATP cohort for immunogenicity of the primary study HPV-014 (NCT00196937), who were seronegative before vaccination and for whom immunogenicity data at Years 5, 6 and 7 were available.

Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 5, 6 and 7

anti-HPV-16 [Year 8]

anti-HPV-16 [Year 9]

anti-HPV-16 [Year 10]

anti-HPV-18 [Year 8]

anti-HPV-18 [Year 9]

anti-HPV-18 [Year 10]

Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 8, 9 and 10

Analysis was performed on a subset of subjects from the Total Vaccinated Cohort (TVC), who volunteered for CVS sample collection at Years 5 and 6 and for whom the collected CVS sample contained less than 200 erythrocytes per microliter.

Anti-HPV-16/18 Secretion Antibody Titers in Cervico-vaginal Secretion (CVS) Samples at Years 5 and 6 in a Subset of Subjects

Analysis was performed on a subset of subjects from the TVC, who volunteered for CVS sample collection at Years 7, 8, 9 and 10 and for whom the collected CVS sample contained less than 200 erythrocytes per microliter.

Anti-HPV-16/18 Secretion Antibody Titers in CVS Samples at Years 7, 8, 9 and 10 in a Subset of Subjects

IgG secretion antibodies [Year 5]

IgG secretion antibodies [Year 6]

Analysis was performed on a subset of subjects from the TVC, who volunteered for CVS sample collection at Year 5 and Year 6 and for whom the collected CVS sample contained less than 200 erythrocytes per microliter.

Total Immunoglobulin G (IgG) Secretion Antibody Titers in CVS Samples at Years 5 and 6 in a Subset of Subjects

IgG secretion antibodies [Year 7]

IgG secretion antibodies [Year 8]

IgG secretion antibodies [Year 9]

IgG secretion antibodies [Year 10]

Analysis was performed on a subset of subjects from the TVC, who volunteered for CVS sample collection at Years 7, 8, 9, 10 and for whom the collected CVS sample contained less than 200 erythrocytes per microliter.

Total IgG Secretion Antibody Titers in CVS Samples at Years 7, 8, 9, and 10 in a Subset of Subjects

Total IgG serum antibodies [Year 5]

Total IgG serum antibodies [Year 6]

Total IgG serum antibodies [Year 7]

The analysis was performed on the ATP cohort for immunogenicity at Years 5, 6 and 7, which included all evaluable subjects from the ATP cohort for immunogenicity of the primary study HPV-014 (NCT00196937) and for whom immunogenicity data at Years 5, 6 and 7 were available.

Total IgG Antibody Titers in Serum at Years 5, 6 and 7 Based on the ATP Cohort for Immunogenicity

Total IgG serum antibodies [Year 8]

Total IgG serum antibodies [Year 9]

Total IgG serum antibodies [Year 10]

The analysis was performed on the ATP cohort for immunogenicity at Years 8, 9 and 10, which included all evaluable subjects from the ATP cohort for immunogenicity of the primary study HPV-014 (NCT00196937) and for whom immunogenicity data at Years 8, 9 and 10 were available.

Total IgG Antibody Titers in Serum at Years 8, 9 and 10 Based on the ATP Cohort for Immunogenicity

The analysis was performed on the TVC at Years 5, 6 and 7, which included all vaccinated subjects \[i.e. all subjects who received 3 doses of HPV vaccine in the primary study HPV-014 (NCT00196937)\] for whom data at Years 5, 6 and 7 were available.

Total IgG Antibody Titers in Serum at Years 5, 6 and 7 Based on the TVC

The analysis was performed on the Total Vaccinated Cohort at Years 8, 9 and 10, which included all vaccinated subjects \[i.e. all subjects who received 3 doses of HPV vaccine in the primary study HPV-014 (NCT00196937)\] for whom data at Years 8, 9 and 10 were available.

Total IgG Antibody Titers in Serum at Years 8, 9 and 10 Based on the TVC

Fatal SAE(s)

Related SAE(s)

The analysis was based on the TVC at Year 5, which included all vaccinated subjects \[i.e. all subjects who received 3 doses of HPV vaccine in the primary study HPV-014 (NCT00196937)\] for whom data were available at Year 5.

Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 4 in Primary Study HPV-014 (NCT00196937) to Year 5 in the Present Study

The analysis was based on the TVC at Year 6, which included all vaccinated subjects \[i.e. all subjects who received 3 doses of HPV vaccine in the primary study HPV-014 (NCT00196937)\] for whom data were available at Year 6.

Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 5 to Year 6

The analysis was based on the TVC at Year 7, which included all vaccinated subjects \[i.e. all subjects who received 3 doses of HPV vaccine in the primary study HPV-014 (NCT00196937)\] for whom data were available at Year 7.

Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 6 to Year 7

The analysis was based on the TVC at Year 8, which included all vaccinated subjects \[i.e. all subjects who received 3 doses of HPV vaccine in the primary study HPV-014 (NCT00196937)\] for whom data were available at Year 8.

Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 7 to Year 8

The analysis was based on the TVC at Year 9, which included all vaccinated subjects \[i.e. all subjects who received 3 doses of HPV vaccine in the primary study HPV-014 (NCT00196937)\] for whom data were available at Year 9.

Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 8 to Year 9

The analysis was based on the TVC at Year 10, which included all vaccinated subjects \[i.e. all subjects who received 3 doses of HPV vaccine in the primary study HPV-014 (NCT00196937)\] for whom data were available at Year 10.

Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 9 to Year 10

The analysis was performed on the TVC that included all vaccinated subjects \[i.e. all subjects who received 3 doses of HPV vaccine in the primary study HPV-014 (NCT00196937)\] for whom data were available throughout the study.

Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 0 to Year 10

Spots Global Cancer Trial Database for Evaluation of Long-term Immunogenicity and Safety of a Human Papillomavirus (HPV) Vaccine in Healthy Female Subjects

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