Trial Outcomes & Findings 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 (NCT NCT03629886)
NCT ID: NCT03629886
Last Updated: 2024-03-15
Results Overview
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.
COMPLETED
PHASE4
6051 participants
During the entire study period (Day 1-Month 12)
2024-03-15
Participant Flow
The study was conducted at 4 centers in China.
Participant milestones
| Measure |
Vacc-039 Group
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.
|
Vacc-092 Group
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.
|
|---|---|---|
|
Overall Study
STARTED
|
1671
|
1866
|
|
Overall Study
COMPLETED
|
1671
|
1686
|
|
Overall Study
NOT COMPLETED
|
0
|
180
|
Reasons for withdrawal
| Measure |
Vacc-039 Group
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.
|
Vacc-092 Group
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.
|
|---|---|---|
|
Overall Study
Migrated / moved from the study area
|
0
|
55
|
|
Overall Study
Consent withdrawal, not due to an AE
|
0
|
50
|
|
Overall Study
Study vaccine not administrated
|
0
|
3
|
|
Overall Study
Didn't meet inclusion/exclusion criteria
|
0
|
28
|
|
Overall Study
Refused vaccination step of the study
|
0
|
44
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Vacc-039 Group
n=1671 Participants
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.
|
Vacc-092 Group
n=1866 Participants
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.
|
Total
n=3537 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Between 24 and 64 years
|
1671 Participants
n=5 Participants
|
1866 Participants
n=7 Participants
|
3537 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1671 Participants
n=5 Participants
|
1866 Participants
n=7 Participants
|
3537 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - Chinese Heritage
|
1671 Participants
n=5 Participants
|
1866 Participants
n=7 Participants
|
3537 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During the entire study period (Day 1-Month 12)Population: 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.
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.
Outcome measures
| Measure |
Vacc-092 Group
n=1791 Participants
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.
|
Vacc-092 Group
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.
|
|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs) Related to Study Vaccine in Vacc-092 Group
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: During the entire study period (Day 1-Month 12)Population: 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.
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.
Outcome measures
| Measure |
Vacc-092 Group
n=1791 Participants
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.
|
Vacc-092 Group
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.
|
|---|---|---|
|
Number of Subjects With Potential Immune Mediated Diseases (pIMDs) in Vacc-092 Group
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: During the entire study period (Day 1-Month 12)Population: Analysis was performed on pregnant subjects from the Vacc-092 Group in the current study and for whom pregnancy outcomes data were available.
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.
Outcome measures
| Measure |
Vacc-092 Group
n=10 Participants
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.
|
Vacc-092 Group
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.
|
|---|---|---|
|
Number of Pregnant Subjects Reported With Outcomes of Pregnancy in Vacc-092 Group
Live infant no apparent CA
|
2 Participants
|
—
|
|
Number of Pregnant Subjects Reported With Outcomes of Pregnancy in Vacc-092 Group
Live infant CA
|
0 Participants
|
—
|
|
Number of Pregnant Subjects Reported With Outcomes of Pregnancy in Vacc-092 Group
Elective termination no apparent CA
|
8 Participants
|
—
|
|
Number of Pregnant Subjects Reported With Outcomes of Pregnancy in Vacc-092 Group
Elective termination CA
|
0 Participants
|
—
|
|
Number of Pregnant Subjects Reported With Outcomes of Pregnancy in Vacc-092 Group
Spontaneous abortion no apparent CA
|
0 Participants
|
—
|
|
Number of Pregnant Subjects Reported With Outcomes of Pregnancy in Vacc-092 Group
Spontaneous abortion CA
|
0 Participants
|
—
|
|
Number of Pregnant Subjects Reported With Outcomes of Pregnancy in Vacc-092 Group
Stillbirth no apparent CA
|
0 Participants
|
—
|
|
Number of Pregnant Subjects Reported With Outcomes of Pregnancy in Vacc-092 Group
Stillbirth CA
|
0 Participants
|
—
|
|
Number of Pregnant Subjects Reported With Outcomes of Pregnancy in Vacc-092 Group
Ectopic pregnancy
|
0 Participants
|
—
|
|
Number of Pregnant Subjects Reported With Outcomes of Pregnancy in Vacc-092 Group
Molar pregnancy
|
0 Participants
|
—
|
|
Number of Pregnant Subjects Reported With Outcomes of Pregnancy in Vacc-092 Group
Lost to follow-up
|
0 Participants
|
—
|
|
Number of Pregnant Subjects Reported With Outcomes of Pregnancy in Vacc-092 Group
Pregnancy ongoing
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: During the entire study period (Day 1-Month 12)Population: 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.
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.
Outcome measures
| Measure |
Vacc-092 Group
n=1791 Participants
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.
|
Vacc-092 Group
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.
|
|---|---|---|
|
Number of Subjects With SAEs in Vacc-092 Group
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: During the entire study period (Day 1-Month 12)Population: 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.
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.
Outcome measures
| Measure |
Vacc-092 Group
n=1791 Participants
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.
|
Vacc-092 Group
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.
|
|---|---|---|
|
Number of Subjects With Any Adverse Events or Serious Adverse Events (AE/SAE) Leading to Premature Discontinuation From the Study in Vacc-092 Group
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: During the entire study period (Day 1-Month 12)Population: Analysis was performed on the Total Enrolled Set, which included all subjects enrolled in the current study.
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).
Outcome measures
| Measure |
Vacc-092 Group
n=1671 Participants
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.
|
Vacc-092 Group
n=1866 Participants
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.
|
|---|---|---|
|
Number of Subjects With SAEs Related to Study Participation in All Study Groups
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Month 0 in HPV-039 (NCT00779766) study [at the Day after Dose 1 (out of 3 doses administered in HPV-039)] until Month 120 (corresponding to Day 1 in the current study)Population: 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.
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).
Outcome measures
| Measure |
Vacc-092 Group
n=1486 Participants
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.
|
Vacc-092 Group
n=1678 Participants
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.
|
|---|---|---|
|
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
HPV-16
|
0.13 events per 100 person-years
Interval 0.07 to 0.21
|
0.8 events per 100 person-years
Interval 0.65 to 0.98
|
|
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
HPV-18
|
0.07 events per 100 person-years
Interval 0.03 to 0.13
|
0.43 events per 100 person-years
Interval 0.33 to 0.55
|
|
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
HPV-16/18
|
0.16 events per 100 person-years
Interval 0.1 to 0.24
|
0.94 events per 100 person-years
Interval 0.79 to 1.11
|
SECONDARY outcome
Timeframe: From Month 0 in HPV-039 (NCT00779766) study [at the Day after Dose 1 (out of 3 doses administered in HPV-039)] until Month 120 (corresponding to Day 1 in the current study)Population: 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.
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).
Outcome measures
| Measure |
Vacc-092 Group
n=1647 Participants
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.
|
Vacc-092 Group
n=1841 Participants
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.
|
|---|---|---|
|
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
|
0.22 events per 100 person-years
Interval 0.15 to 0.3
|
1.1 events per 100 person-years
Interval 0.95 to 1.27
|
SECONDARY outcome
Timeframe: From Month 0 in HPV-039 (NCT00779766) study [at the Day after Dose 1 (out of 3 doses administered in HPV-039)] until Month 120 (corresponding to Day 1 in the current study)Population: 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.
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.
Outcome measures
| Measure |
Vacc-092 Group
n=1650 Participants
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.
|
Vacc-092 Group
n=1842 Participants
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.
|
|---|---|---|
|
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
HPV-16
|
0.14 events per 100 person-years
Interval 0.09 to 0.22
|
0.79 events per 100 person-years
Interval 0.66 to 0.93
|
|
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
HPV-18
|
0.08 events per 100 person-years
Interval 0.04 to 0.13
|
0.45 events per 100 person-years
Interval 0.36 to 0.56
|
|
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
HPV-31
|
0.25 events per 100 person-years
Interval 0.17 to 0.34
|
0.46 events per 100 person-years
Interval 0.36 to 0.57
|
|
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
HPV-33
|
0.29 events per 100 person-years
Interval 0.21 to 0.39
|
0.39 events per 100 person-years
Interval 0.3 to 0.5
|
|
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
HPV-35
|
0.20 events per 100 person-years
Interval 0.14 to 0.29
|
0.32 events per 100 person-years
Interval 0.24 to 0.42
|
|
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
HPV-39
|
0.71 events per 100 person-years
Interval 0.58 to 0.86
|
0.78 events per 100 person-years
Interval 0.65 to 0.93
|
|
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
HPV-45
|
0.13 events per 100 person-years
Interval 0.08 to 0.2
|
0.22 events per 100 person-years
Interval 0.16 to 0.31
|
|
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
HPV-51
|
0.94 events per 100 person-years
Interval 0.79 to 1.11
|
0.93 events per 100 person-years
Interval 0.79 to 1.09
|
|
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
HPV-52
|
1.67 events per 100 person-years
Interval 1.47 to 1.9
|
1.67 events per 100 person-years
Interval 1.47 to 1.88
|
|
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
HPV-56
|
0.49 events per 100 person-years
Interval 0.39 to 0.62
|
0.52 events per 100 person-years
Interval 0.42 to 0.64
|
|
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
HPV-58
|
0.44 events per 100 person-years
Interval 0.34 to 0.56
|
0.61 events per 100 person-years
Interval 0.5 to 0.74
|
|
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
HPV-59
|
0.29 events per 100 person-years
Interval 0.21 to 0.38
|
0.32 events per 100 person-years
Interval 0.24 to 0.42
|
|
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
HPV-66
|
0.57 events per 100 person-years
Interval 0.46 to 0.7
|
0.63 events per 100 person-years
Interval 0.52 to 0.77
|
|
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
HPV-68
|
0.48 events per 100 person-years
Interval 0.37 to 0.6
|
0.55 events per 100 person-years
Interval 0.44 to 0.67
|
|
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
HPV-31/33/45
|
0.58 events per 100 person-years
Interval 0.47 to 0.71
|
0.93 events per 100 person-years
Interval 0.79 to 1.09
|
|
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
HPV-16/18/33/31/45
|
0.8 events per 100 person-years
Interval 0.66 to 0.96
|
1.91 events per 100 person-years
Interval 1.7 to 2.14
|
|
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
HRW-HPV
|
4.73 events per 100 person-years
Interval 4.35 to 5.13
|
5.13 events per 100 person-years
Interval 4.75 to 5.53
|
|
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
HR-HPV
|
4.85 events per 100 person-years
Interval 4.47 to 5.26
|
5.56 events per 100 person-years
Interval 5.16 to 5.98
|
Adverse Events
Vacc-039 Group
Vacc-092 Group
Serious adverse events
| Measure |
Vacc-039 Group
n=1671 participants at risk
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.
|
Vacc-092 Group
n=1791 participants at risk；n=1866 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/1671 • During the entire study period (Day 1-Month 12)
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.
|
0.05%
1/1866 • Number of events 1 • During the entire study period (Day 1-Month 12)
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.
|
Other adverse events
| Measure |
Vacc-039 Group
n=1671 participants at risk
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.
|
Vacc-092 Group
n=1791 participants at risk；n=1866 participants at risk
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.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
—
0/0 • During the entire study period (Day 1-Month 12)
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.
|
0.06%
1/1791 • Number of events 1 • During the entire study period (Day 1-Month 12)
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER