Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Uterine Cervical Neoplasms

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

Vaccines

Healthy Chinese female subjects, above 26 years of age at study entry, who previously received HPV vaccine in HPV-039 study (NCT00779766), underwent cervical sample collection and didn't receive any vaccine in the current study.

Healthy Chinese female subjects, above 26 years of age at study entry, who previously received placebo (control group) in HPV-039 study (NCT00779766), were intended to receive HPV vaccine in the current study and were to provide cervical samples before HPV vaccination.

Three doses of Human Papillomavirus (Types 16, 18) Vaccine, Adsorbed administered intramuscularly in the deltoid region of the upper arm, according to a 0, 1, 6-month schedule.

HPV (Types 16, 18) Vaccine, Adsorbed

GSK Clinical Trials

This study was designed to enable all subjects who received placebo in the HPV-039 study (NCT00779766), to also receive GSK Biologicals' Human Papillomavirus (Types 16, 18) Vaccine, Adsorbed. Safety data in terms of serious adverse events (SAEs), any adverse events (AEs)/SAEs leading to premature discontinuation of the study, potential immune mediated diseases (pIMDs) and pregnancies (and their outcomes) were collected during the study period.

In addition, this study assessed the long term protective effect of the vaccine, in an exploratory manner, in terms of rates of HPV-related (vaccine type) incident cervical infection up to approximately 10 years after vaccination in subjects who participated in HPV-039 study (NCT00779766).

Treatment allocation depended on the randomization in the previous study i.e. only the subjects from the control group of HPV-039 study received HPV vaccination in the current study. Subjects who previously received the Human Papillomavirus (Types 16, 18) Vaccine, Adsorbed in HPV-039 study did not receive vaccination in this study.

Safety and Protective Effect Study of GSK Biologicals' Human Papillomavirus (Types 16, 18) Vaccine, Adsorbed (GSK580299) in Healthy Female Subjects From the HPV-039 Study

Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

SAEs assessed include any untoward medical occurrence that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Related SAEs are those SAEs assessed by the investigator as related to vaccination in the study.

pIMDS are a subset of adverse events (AEs) that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which might or might not have an autoimmune aetiology.

Pregnancy is the term used to describe the period in which a fetus develops inside a woman's womb or uterus. The subjects with confirmed pregnancies were followed up to determine the outcomes of the reported pregnancies. Outcomes of the reported pregnancies were: Live infant no apparent Congenital Anomaly (CA), Live infant CA, Elective termination no apparent CA, Elective termination CA, Spontaneous abortion no apparent CA, Spontaneous abortion CA, Stillbirth no apparent CA, Stillbirth CA, Ectopic pregnancy, Molar pregnancy, Lost to follow-up \& Pregnancy ongoing.

SAEs assessed include any untoward medical occurrence that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.

AEs assessed include any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. SAEs assessed include any untoward medical occurrence that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any is defined as the occurrence of any unsolicited AE/SAE regardless of intensity grade or relation to vaccination.

SAEs assessed include any untoward medical occurrence that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Related SAEs are those SAEs assessed by the investigator as activities related to study participation and not by study vaccine (e.g. SAEs due to invasive tests).

The incidence rate (n/T) of incident cervical infection with HPV-16 and/or HPV-18 (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group, over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100. Cervical infection caused by HPV Types 16 and 18 was assessed by detecting HPV DNA using Polymerase Chain Reaction (PCR). For single HPV type: Subjects DNA negative at Month 0 and seronegative at Month 0 for the corresponding HPV type in study HPV 039 (NCT00779766). For combined HPV types: Subjects DNA negative at Month 0 and seronegative at Month 0 for at least one HPV type (subjects were in the analysis of at least one single type) in study HPV 039 (NCT00779766).

The incidence rate (n/T) of incident cervical infection with HPV-16 and/or HPV-18 (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group, over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100. Cervical infection caused by HPV Types 16 and 18 was assessed by detecting HPV DNA using Polymerase Chain Reaction (PCR). For single HPV type: Subjects DNA negative at Month 0 for the corresponding HPV type in study HPV-039 (NCT00779766). For combined HPV types: Subjects DNA negative at Month 0 for at least one HPV type (subjects were in the analysis of at least one single type) in study HPV-039 (NCT00779766).

The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100. Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68. HRW-HPV = High-risk (oncogenic) HPV types without HPV-16 or HPV-18: HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. HR-HPV = High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. For single type: Subjects DNA negative at Month 0 for the corresponding HPV type in NCT00779766 study. For combined types: Subjects DNA negative at Month 0 for at least one HPV type (subjects were in the analysis of at least 1 single type) in NCT00779766 study.

GlaxoSmithKline

Other AEs were collected only on the vaccinated subjects in this study (Vacc-092 Group) while SAEs were collected on enrolled subjects of both groups in this study.

Vacc-039 Group

Vacc-092 Group

Total

Between 24 and 64 years

Age, Customized

Sex: Female, Male

Asian - Chinese Heritage

Race/Ethnicity, Customized

GSK Response Center

Analysis was performed on all subjects who received at least one dose of HPV vaccine (Vacc-092 Group) in the current study and for whom safety data were available.

Number of Subjects With Serious Adverse Events (SAEs) Related to Study Vaccine in Vacc-092 Group

Number of Subjects With Potential Immune Mediated Diseases (pIMDs) in Vacc-092 Group

Live infant no apparent CA

Live infant CA

Elective termination no apparent CA

Elective termination CA

Spontaneous abortion no apparent CA

Spontaneous abortion CA

Stillbirth no apparent CA

Stillbirth CA

Ectopic pregnancy

Molar pregnancy

Lost to follow-up

Pregnancy ongoing

Analysis was performed on pregnant subjects from the Vacc-092 Group in the current study and for whom pregnancy outcomes data were available.

Number of Pregnant Subjects Reported With Outcomes of Pregnancy in Vacc-092 Group

Number of Subjects With SAEs in Vacc-092 Group

Number of Subjects With Any Adverse Events or Serious Adverse Events (AE/SAE) Leading to Premature Discontinuation From the Study in Vacc-092 Group

Analysis was performed on the Total Enrolled Set, which included all subjects enrolled in the current study.

Number of Subjects With SAEs Related to Study Participation in All Study Groups

Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of HPV-16 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=1963). Those subjects were or were not enrolled in the current study, were HPV DNA negative and seronegative subjects at baseline and had cervical samples collected data.

Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of HPV-16 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=1917). Those subjects were or were not enrolled in the current study, were HPV DNA negative and seronegative subjects at baseline and had cervical samples collected data.

Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of HPV-18 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2356). Those subjects were or were not enrolled in the current study, were HPV DNA negative and seronegative subjects at baseline and had cervical samples collected data.

Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of HPV-18 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2357). Those subjects were or were not enrolled in the current study, were HPV DNA negative and seronegative subjects at baseline and had cervical samples collected data.

Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of HPV-16/18 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2534). Those subjects were or were not enrolled in the current study, were HPV DNA negative and seronegative subjects at baseline and had cervical samples collected data.

Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of HPV-16/18 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2547). Those subjects were or were not enrolled in the current study, were HPV DNA negative and seronegative subjects at baseline and had cervical samples collected data.

HPV-16

HPV-18

HPV-16/18

Analysis was performed on all subjects who participated in the current study, who were HPV DNA negative and seronegative at baseline \[at Month 0 in HPV-039 (NCT00779766) study\] and who had cervical samples collected data.

Incidence Rates of Incident Cervical Infection With HPV-16 and/or HPV-18 (by PCR) in HPV DNA Negative and Seronegative Subjects at Baseline in All Study Groups

Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of HPV-16/18 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2818). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.

Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of HPV-16/18 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2815). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.

Analysis was performed on all subjects who participated in the current study, who were HPV DNA negative at baseline \[at Month 0 in HPV-039 (NCT00779766) study\] regardless of initial serostatus and who had cervical samples collected data.

Incidence Rates of Incident Cervical Infection With HPV-16 and/or HPV-18 (by PCR) in HPV DNA Negative Subjects at Baseline, Regardless of Initial Serostatus in All Study Groups

Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-16 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2718). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.

Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-16 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2722). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.

Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-18 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2781). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.

Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-18 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2781). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.

Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-31 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2786). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.

Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-31 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2782). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.

Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-33 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2779). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.

Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-33 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2784). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.

Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-35 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2806). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.

Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-35 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2803). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.

Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-39 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2759). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.

Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-39 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2773). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.

Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-45 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2794). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.

Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-45 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2802). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.

Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-51 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2753). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.

Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-51 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2756). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.

Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-52 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2666). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.

Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-52 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2663). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.

Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-56 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2783). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.

Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-56 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2779). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.

Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-58 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2772). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.

Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-58 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2768). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.

Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-59 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2814). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.

Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-59 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2797). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.

Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-66 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2779). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.

Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-66 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2763). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.

Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-68 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2775). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.

Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-68 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2785). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.

Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-31/33/45 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2823). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.

Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-31/33/45 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2824). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.

Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-16/18/33/31/45 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2823). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.

Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-16/18/33/31/45 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2825). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.

Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HRW-HPV incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2823). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.

Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HRW-HPV incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2825). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.

Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HR-HPV incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2823). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.

Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HR-HPV incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2825). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.

HPV-31

HPV-33

HPV-35

HPV-39

HPV-45

HPV-51

HPV-52

HPV-56

HPV-58

HPV-59

HPV-66

HPV-68

HPV-31/33/45

HPV-16/18/33/31/45

HRW-HPV

HR-HPV

Incidence Rates of Incident Cervical Infection With Any Oncogenic HPV Type or Combination of Oncogenic HPV Types in HPV DNA Negative Subjects at Baseline, Regardless of Initial Serostatus in All Study Groups

Spots Global Cancer Trial Database for Safety and Protective Effect Study of GSK Biologicals' Human Papillomavirus (Types 16, 18) Vaccine, Adsorbed (GSK580299) in Healthy Female Subjects From the HPV-039 Study

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