Cervical Intraepithelial Neoplasia
Conditions
Keywords
Adults, Human Papillomavirus (HPV), Cervical cancer, Safety
Brief summary
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).
Detailed description
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.
Interventions
BIOLOGICALHPV (Types 16, 18) Vaccine, Adsorbed
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.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
26 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * Written informed consent obtained from the subject prior to performing any study specific procedure. * Subjects previously enrolled in the HPV-039 study. * Subjects with negative pregnancy test at Visit 1. Additional inclusion criteria for subjects of HPV group undergoing vaccination ONLY: * Healthy subjects as established by medical history and clinical examination before entering into the study. * Female subjects of non-childbearing potential may be enrolled in the study. * Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause. * Female subjects of childbearing potential may be enrolled in the study, if the subject: * has practiced adequate contraception for 30 days prior to vaccination, and * has a negative pregnancy test on the day of vaccination, and * has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
Exclusion criteria
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device). * Previous vaccination against HPV outside of study HPV-039. Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Serious Adverse Events (SAEs) Related to Study Vaccine in Vacc-092 Group | During the entire study period (Day 1-Month 12) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Pregnant Subjects Reported With Outcomes of Pregnancy in Vacc-092 Group | During the entire study period (Day 1-Month 12) | 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. |
| Number of Subjects With SAEs in Vacc-092 Group | During the entire study period (Day 1-Month 12) | 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. |
| Number of Subjects With Any Adverse Events or Serious Adverse Events (AE/SAE) Leading to Premature Discontinuation From the Study in Vacc-092 Group | During the entire study period (Day 1-Month 12) | 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. |
| Number of Subjects With Potential Immune Mediated Diseases (pIMDs) in Vacc-092 Group | During the entire study period (Day 1-Month 12) | 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. |
| 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 | 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) | 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). |
| 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 | 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) | 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). |
| 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 | 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) | 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. |
| Number of Subjects With SAEs Related to Study Participation in All Study Groups | During the entire study period (Day 1-Month 12) | 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). |
Countries
China
Participant flow
Recruitment details
The study was conducted at 4 centers in China.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 1,671 |
| 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. | 1,866 |
| Total | 3,537 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Consent withdrawal, not due to an AE | 0 | 50 |
| Overall Study | Didn't meet inclusion/exclusion criteria | 0 | 28 |
| Overall Study | Migrated / moved from the study area | 0 | 55 |
| Overall Study | Refused vaccination step of the study | 0 | 44 |
| Overall Study | Study vaccine not administrated | 0 | 3 |
Baseline characteristics
| Characteristic | Vacc-039 Group | Vacc-092 Group | Total |
|---|---|---|---|
| Age, Customized Between 24 and 64 years | 1671 Participants | 1866 Participants | 3537 Participants |
| Race/Ethnicity, Customized Asian - Chinese Heritage | 1671 Participants | 1866 Participants | 3537 Participants |
| Sex: Female, Male Female | 1671 Participants | 1866 Participants | 3537 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1,671 | 0 / 1,866 |
| other Total, other adverse events | 0 / 0 | 1 / 1,791 |
| serious Total, serious adverse events | 0 / 1,671 | 1 / 1,866 |
Outcome results
Primary
Number of Subjects With Serious Adverse Events (SAEs) Related to Study Vaccine in Vacc-092 Group
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vacc-092 Group | Number of Subjects With Serious Adverse Events (SAEs) Related to Study Vaccine in Vacc-092 Group | 0 Participants |
Secondary
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
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vacc-092 Group | 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 |
| Vacc-092 Group | 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 |
| Vacc-092 Group | 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 |
| Vacc-092 Group | 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 |
| Vacc-092 Group | 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 |
| Vacc-092 Group | 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 |
| Vacc-092 Group | 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 |
| Vacc-092 Group | 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 |
| Vacc-092 Group | 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 |
| Vacc-092 Group | 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 |
| Vacc-092 Group | 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 |
| Vacc-092 Group | 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 |
| Vacc-092 Group | 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 |
| Vacc-092 Group | 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 |
| Vacc-092 Group | 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 |
| Vacc-092 Group | 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 |
| Vacc-092 Group | 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 |
| Vacc-092 Group | 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 |
| Vacc-092 Group | 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 | 0.78 events per 100 person-years |
| Vacc-092 Group | 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 | 0.61 events per 100 person-years |
| Vacc-092 Group | 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 | 0.32 events per 100 person-years |
| Vacc-092 Group | 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 | 0.63 events per 100 person-years |
| Vacc-092 Group | 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 | 0.55 events per 100 person-years |
| Vacc-092 Group | 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 | 0.93 events per 100 person-years |
| Vacc-092 Group | 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 | 1.91 events per 100 person-years |
| Vacc-092 Group | 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 | 5.56 events per 100 person-years |
| Vacc-092 Group | 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 | 0.79 events per 100 person-years |
| Vacc-092 Group | 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 | 0.45 events per 100 person-years |
| Vacc-092 Group | 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 | 0.46 events per 100 person-years |
| Vacc-092 Group | 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 | 0.39 events per 100 person-years |
| Vacc-092 Group | 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 | 0.32 events per 100 person-years |
| Vacc-092 Group | 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 | 0.22 events per 100 person-years |
| Vacc-092 Group | 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 | 0.93 events per 100 person-years |
| Vacc-092 Group | 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 |
| Vacc-092 Group | 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 | 0.52 events per 100 person-years |
| Vacc-092 Group | 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 | 5.13 events per 100 person-years |
Comparison: 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.95% CI: [0.11, 0.24]
Comparison: 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.95% CI: [0.72, 0.99]
Comparison: 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.95% CI: [0.06, 0.15]
Comparison: 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.95% CI: [0.38, 0.58]
Comparison: 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.95% CI: [0.15, 0.28]
Comparison: 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.95% CI: [0.39, 0.59]
Comparison: 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.95% CI: [0.18, 0.33]
Comparison: 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.95% CI: [0.33, 0.51]
Comparison: 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.95% CI: [0.23, 0.39]
Comparison: 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.95% CI: [0.28, 0.46]
Comparison: 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.95% CI: [0.75, 1.02]
Comparison: 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.95% CI: [0.67, 0.93]
Comparison: 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.95% CI: [0.07, 0.16]
Comparison: 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.95% CI: [0.15, 0.28]
Comparison: 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.95% CI: [0.88, 1.18]
Comparison: 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.95% CI: [1.03, 1.34]
Comparison: 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.95% CI: [1.48, 1.87]
Comparison: 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.95% CI: [1.61, 2]
Comparison: 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.95% CI: [0.5, 0.73]
Comparison: 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.95% CI: [0.53, 0.76]
Comparison: 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.95% CI: [0.42, 0.62]
Comparison: 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.95% CI: [0.55, 0.77]
Comparison: 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.95% CI: [0.24, 0.4]
Comparison: 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.95% CI: [0.28, 0.45]
Comparison: 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.95% CI: [0.51, 0.74]
Comparison: 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.95% CI: [0.54, 0.77]
Comparison: 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.95% CI: [0.46, 0.68]
Comparison: 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.95% CI: [0.49, 0.71]
Comparison: 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.95% CI: [0.41, 0.61]
Comparison: 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.95% CI: [0.84, 1.12]
Comparison: 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.95% CI: [0.63, 0.88]
Comparison: 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.95% CI: [1.91, 2.33]
Comparison: 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.95% CI: [4.79, 5.49]
Comparison: 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.95% CI: [5.36, 6.1]
Comparison: 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.95% CI: [4.94, 5.65]
Comparison: 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.95% CI: [5.91, 6.69]
Secondary
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
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).
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vacc-092 Group | 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 |
| Vacc-092 Group | 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 |
| Vacc-092 Group | 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 |
| Vacc-092 Group | 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 | 0.8 events per 100 person-years |
| Vacc-092 Group | 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 | 0.43 events per 100 person-years |
| Vacc-092 Group | 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 | 0.94 events per 100 person-years |
Comparison: 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.95% CI: [0.09, 0.23]
Comparison: 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.95% CI: [0.73, 1.05]
Comparison: 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.95% CI: [0.05, 0.15]
Comparison: 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.95% CI: [0.35, 0.56]
Comparison: 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.95% CI: [0.14, 0.27]
Comparison: 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.95% CI: [0.88, 1.18]
Secondary
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
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).
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vacc-092 Group | 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 |
| Vacc-092 Group | 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 | 1.1 events per 100 person-years |
Comparison: 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.95% CI: [0.19, 0.33]
Comparison: 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.95% CI: [1.06, 1.37]
Secondary
Number of Pregnant Subjects Reported With Outcomes of Pregnancy in Vacc-092 Group
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vacc-092 Group | Number of Pregnant Subjects Reported With Outcomes of Pregnancy in Vacc-092 Group | Elective termination CA | 0 Participants |
| Vacc-092 Group | Number of Pregnant Subjects Reported With Outcomes of Pregnancy in Vacc-092 Group | Spontaneous abortion no apparent CA | 0 Participants |
| Vacc-092 Group | Number of Pregnant Subjects Reported With Outcomes of Pregnancy in Vacc-092 Group | Spontaneous abortion CA | 0 Participants |
| Vacc-092 Group | Number of Pregnant Subjects Reported With Outcomes of Pregnancy in Vacc-092 Group | Stillbirth no apparent CA | 0 Participants |
| Vacc-092 Group | Number of Pregnant Subjects Reported With Outcomes of Pregnancy in Vacc-092 Group | Stillbirth CA | 0 Participants |
| Vacc-092 Group | Number of Pregnant Subjects Reported With Outcomes of Pregnancy in Vacc-092 Group | Ectopic pregnancy | 0 Participants |
| Vacc-092 Group | Number of Pregnant Subjects Reported With Outcomes of Pregnancy in Vacc-092 Group | Molar pregnancy | 0 Participants |
| Vacc-092 Group | Number of Pregnant Subjects Reported With Outcomes of Pregnancy in Vacc-092 Group | Lost to follow-up | 0 Participants |
| Vacc-092 Group | Number of Pregnant Subjects Reported With Outcomes of Pregnancy in Vacc-092 Group | Pregnancy ongoing | 0 Participants |
| Vacc-092 Group | Number of Pregnant Subjects Reported With Outcomes of Pregnancy in Vacc-092 Group | Live infant no apparent CA | 2 Participants |
| Vacc-092 Group | Number of Pregnant Subjects Reported With Outcomes of Pregnancy in Vacc-092 Group | Live infant CA | 0 Participants |
| Vacc-092 Group | Number of Pregnant Subjects Reported With Outcomes of Pregnancy in Vacc-092 Group | Elective termination no apparent CA | 8 Participants |
Secondary
Number of Subjects With Any Adverse Events or Serious Adverse Events (AE/SAE) Leading to Premature Discontinuation From the Study in Vacc-092 Group
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 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 | 0 Participants |
Secondary
Number of Subjects With Potential Immune Mediated Diseases (pIMDs) in Vacc-092 Group
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vacc-092 Group | Number of Subjects With Potential Immune Mediated Diseases (pIMDs) in Vacc-092 Group | 1 Participants |
Secondary
Number of Subjects With SAEs in Vacc-092 Group
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vacc-092 Group | Number of Subjects With SAEs in Vacc-092 Group | 1 Participants |
Secondary
Number of Subjects With SAEs Related to Study Participation in All Study Groups
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).
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vacc-092 Group | Number of Subjects With SAEs Related to Study Participation in All Study Groups | 0 Participants |
| Vacc-092 Group | Number of Subjects With SAEs Related to Study Participation in All Study Groups | 0 Participants |