Evaluation of Long-term Immunogenicity and Safety of a Hu... | NCT00877877 | Trialant
NCT00877877
Sponsor
GlaxoSmithKline
Status
Completed
Last Update Posted
Jan 18, 2020Actual
Enrollment
632Actual
Phase
Phase 3
Conditions
Infections, Papillomavirus
Papillomavirus Vaccines
Interventions
Blood sampling
Countries
Colombia
Germany
Honduras
Panama
Taiwan
Protocol Section
Identification Module
NCT ID
NCT00877877
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
111375
Secondary IDs
ID
Type
Description
Link
2008-000369-44
EudraCT Number
Brief Title
Evaluation of Long-term Immunogenicity and Safety of a Human Papillomavirus (HPV) Vaccine in Healthy Female Subjects.
Official Title
Follow-up Study to Evaluate the Long-term Immunogenicity and Safety of a HPV Vaccine (GSK 580299) in Healthy Female Subjects
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Dec 2019
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
May 7, 2009Actual
Primary Completion Date
Jan 6, 2015Actual
Completion Date
Jan 6, 2015Actual
First Submitted Date
Mar 26, 2009
First Submission Date that Met QC Criteria
Apr 7, 2009
First Posted Date
Apr 8, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 31, 2011
Results First Submitted that Met QC Criteria
Mar 31, 2011
Results First Posted Date
Apr 27, 2011Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Dec 31, 2019
Last Update Posted Date
Jan 18, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
Infection with human papillomavirus (HPV) has been clearly established as the necessary cause of cervical cancer. This study is designed to evaluate the long-term immunogenicity and safety of the 580299 HPV vaccine up to 10 years after administration of the first dose of HPV vaccine (Month 0) administered in the primary study 580299/013. This protocol posting deals with objectives & outcome measures of the extension phase from Month 60 to Month 120. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT00196924). The objectives & outcome measures of the extension phase up to Month 48 are presented in a separate protocol posting (NCT00316706).
Detailed Description
Subjects were aged 10-14 years at the time of entry into the primary study. No vaccine will be administered in this extension study.
Results on outcome measures describing analyses on other studies are not reported in this record. Please refer to the records mentioned in the respective outcome measure titles.
Conditions Module
Conditions
Infections, Papillomavirus
Papillomavirus Vaccines
Keywords
HPV vaccine
cervical cancer
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
632Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cervarix Group
Other
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarixâ„¢ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
Procedure: Blood sampling
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Blood sampling
Procedure
Blood samples were to be collected at Months 60, 72, 84, 96, 108 and 120
Cervarix Group
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL.
Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.
A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination.
A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination.
At Month 60
Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL.
Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.
A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination.
A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination.
At Month 72
Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL.
Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.
A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination.
A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination.
At Month 84
Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL.
Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.
A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination.
A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination.
Secondary Outcomes
Measure
Description
Time Frame
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
From Month 48 to Month 60
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Subjects who the investigator believes that they and/or their parents or legally acceptable representative (LAR) can and will comply with the requirements of the protocol should be enrolled in the study.
A female enrolled in the immunogenicity subset of study 580299-013, who received three doses of HPV vaccine and participated in the extension study of 580299-013.
Written informed assent obtained from the subject. For subjects below the legal age of consent, written informed consent must be obtained from a parent or legally acceptable representative of the subject.
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 product.
Use of any investigational or non-registered product (drug or vaccine) or planned use during the study period.
Administration or planned administration of any HPV vaccine, other than the vaccine administered in study 580299-013.
Chronic administration of immunosuppressants or other immune-modifying drugs occurring within the three months preceding study entry.
Administration of immunoglobulins and/or any blood products occurring within the three months preceding study entry.
Schwarz TF, Huang LM, Lin TY, Wittermann C, Panzer F, Valencia A, Suryakiran PV, Lin L, Descamps D. Long-term immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine in 10- to 14-year-old girls: open 6-year follow-up of an initial observer-blinded, randomized trial. Pediatr Infect Dis J. 2014 Dec;33(12):1255-61. doi: 10.1097/INF.0000000000000460.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Types
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Subjects enrolled in this study were primed with Cervarix vaccine as part of study NCT00196924. Subjects not returning for a specific visit were not withdrawn and could participate in the subsequent follow-up phases. Actual enrollment differed depending on the rate of return for the follow-up study, so not all subjects enrolled came to each visit.
Recruitment Details
Subjects who participated in the primary study (NCT00196924) and received 3 doses of Cervarix.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cervarix Group
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarixâ„¢ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
Periods
Title
Milestones
Reasons Not Completed
Year 5
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
At Month 96
Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).
At Month 60
Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).
At month 72
Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).
At Month 84
Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).
At Month 96
Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination. A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination.
At Month 108
Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).
At Month 108
Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination. A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination.
At Month 120
Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination. A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination.
At Month 120
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
From Month 60 to Month 72
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
From Month 72 to Month 84
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
From Month 84 to Month 96
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
From Month 96 to Month 108
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
From Month 108 to Month 120
Deggingen
Baden-Wurttemberg
73326
Germany
GSK Investigational Site
Ettenheim
Baden-Wurttemberg
77955
Germany
GSK Investigational Site
Kehl
Baden-Wurttemberg
77694
Germany
GSK Investigational Site
Mannheim
Baden-Wurttemberg
68161
Germany
GSK Investigational Site
Tauberbischofsheim
Baden-Wurttemberg
97941
Germany
GSK Investigational Site
Weilheim
Bavaria
82362
Germany
GSK Investigational Site
Würzburg
Bavaria
97070
Germany
GSK Investigational Site
Wolfenbüttel
Lower Saxony
38302
Germany
GSK Investigational Site
Bützow
Mecklenburg-Vorpommern
18246
Germany
GSK Investigational Site
Rostock
Mecklenburg-Vorpommern
18109
Germany
GSK Investigational Site
Bochum
North Rhine-Westphalia
44866
Germany
GSK Investigational Site
Willich
North Rhine-Westphalia
47877
Germany
GSK Investigational Site
Trier
Rhineland-Palatinate
54290
Germany
GSK Investigational Site
Flensburg
Schleswig-Holstein
24937
Germany
GSK Investigational Site
Harrislee
Schleswig-Holstein
24955
Germany
GSK Investigational Site
Niebüll
Schleswig-Holstein
25899
Germany
GSK Investigational Site
Weimar
Thuringia
99423
Germany
GSK Investigational Site
Berlin
10315
Germany
GSK Investigational Site
Berlin
10967
Germany
GSK Investigational Site
Hamburg
22307
Germany
GSK Investigational Site
Tegucigalpa
Francisco Morazán Department
11101
Honduras
GSK Investigational Site
Arraijan/Vista Alegre
Provincia de Panamá
Panama
GSK Investigational Site
La Chorrera
Panama
GSK Investigational Site
Taipei
10002
Taiwan
GSK Investigational Site
Taoyuan
333
Taiwan
Background
Schwarz TF, Huang LM, Valencia A, Panzer F, Chiu CH, Decreux A, Poncelet S, Karkada N, Folschweiller N, Lin L, Dubin G, Struyf F. A ten-year study of immunogenicity and safety of the AS04-HPV-16/18 vaccine in adolescent girls aged 10-14 years. Hum Vaccin Immunother. 2019;15(7-8):1970-1979. doi: 10.1080/21645515.2019.1625644. Epub 2019 Jul 17.
For additional information about this study please refer to the GSK Clinical Study Register
For additional information about this study please refer to the GSK Clinical Study Register
FG000397 subjects
COMPLETED
FG000397 subjects
NOT COMPLETED
FG0000 subjects
Year 6
Type
Comment
Milestone Data
STARTED
FG000529 subjects
COMPLETED
FG000529 subjects
NOT COMPLETED
FG0000 subjects
Year 7
Type
Comment
Milestone Data
STARTED
FG000523 subjects
COMPLETED
FG000523 subjects
NOT COMPLETED
FG0000 subjects
Year 8
Type
Comment
Milestone Data
STARTED
FG000522 subjects
COMPLETED
FG000522 subjects
NOT COMPLETED
FG0000 subjects
Year 9
Type
Comment
Milestone Data
STARTED
FG000507 subjects
COMPLETED
FG000507 subjects
NOT COMPLETED
FG0000 subjects
Year 10
Type
Comment
Milestone Data
STARTED
FG000495 subjects
COMPLETED
FG000495 subjects
NOT COMPLETED
FG0000 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cervarix Group
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarixâ„¢ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
Denominators
Units
Counts
Participants
BG000529
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Year 5
Title
Measurements
BG00017.1± 1.40
Year 6
Title
Measurements
BG00018.0± 1.40
Year 7
Sex/Gender, Customized
Year 5 cohort
Number
Participants
Title
Denominators
Categories
Female
Title
Measurements
BG000397
Male
Title
Measurements
BG000
Sex: Female, Male
Year 6 cohort
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000529
Male
BG000
Sex/Gender, Customized
Year 7 cohort
Number
Participants
Title
Denominators
Categories
Female
Title
Measurements
BG000523
Male
Title
Measurements
BG000
Sex/Gender, Customized
Year 8 cohort
Number
Participants
Title
Denominators
Categories
Female
Title
Measurements
BG000522
Male
Title
Measurements
BG000
Sex/Gender, Customized
Year 9 cohort
Number
Participants
Title
Denominators
Categories
Female
Title
Measurements
BG000507
Male
Title
Measurements
BG000
Sex/Gender, Customized
Year 10 cohort
Number
Participants
Title
Denominators
Categories
Female
Title
Measurements
BG000495
Male
Title
Measurements
BG000
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL.
Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.
A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination.
A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination.
Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 60 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 60 blood sampling timepoint.
Posted
Number
Subjects
At Month 60
ID
Title
Description
OG000
Cervarix Group
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarixâ„¢ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
Units
Counts
Participants
OG000358
Title
Denominators
Categories
anti-HPV-16 Month 60 [N=353]
Title
Measurements
OG000353
anti-HPV-18 Month 60 [N=358]
Title
Measurements
OG000358
Primary
Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL.
Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.
A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination.
A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination.
Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 72 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 72 blood sampling timepoint.
Posted
Number
Subjects
At Month 72
ID
Title
Description
OG000
Cervarix Group
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarixâ„¢ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
Units
Counts
Participants
Primary
Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL.
Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.
A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination.
A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination.
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 84 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 84 blood sampling timepoint.
Posted
Number
Subjects
At Month 84
ID
Title
Description
OG000
Cervarix Group
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarixâ„¢ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
Units
Counts
Participants
Primary
Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL.
Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.
A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination.
A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination.
Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 96 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 96 blood sampling timepoint.
Posted
Number
Subjects
At Month 96
ID
Title
Description
OG000
Cervarix Group
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarixâ„¢ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
Units
Counts
Participants
Primary
Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).
Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 60 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 60 blood sampling timepoint.
Posted
Geometric Mean
95% Confidence Interval
EL.U/mL
At Month 60
ID
Title
Description
OG000
Cervarix Group
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarixâ„¢ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
Units
Counts
Participants
OG000
Primary
Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).
Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 72 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 72 blood sampling timepoint.
Posted
Geometric Mean
95% Confidence Interval
EL.U/mL
At month 72
ID
Title
Description
OG000
Cervarix Group
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarixâ„¢ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
Units
Counts
Participants
OG000
Primary
Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 84 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 84 blood sampling timepoint.
Posted
Geometric Mean
95% Confidence Interval
EL.U/mL
At Month 84
ID
Title
Description
OG000
Cervarix Group
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarixâ„¢ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
Units
Counts
Participants
OG000
Primary
Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).
Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 96 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 96 blood sampling timepoint.
Posted
Geometric Mean
95% Confidence Interval
EL.U/mL
At Month 96
ID
Title
Description
OG000
Cervarix Group
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarixâ„¢ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
Units
Counts
Participants
OG000
Primary
Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination. A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination.
Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 108 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 108 blood sampling timepoint.
Posted
Number
Subjects
At Month 108
ID
Title
Description
OG000
Cervarix Group
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarixâ„¢ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
Units
Counts
Participants
Primary
Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 108 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 108 blood sampling timepoint.
Posted
Geometric Mean
95% Confidence Interval
EL.U/ML
At Month 108
ID
Title
Description
OG000
Cervarix Group
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarixâ„¢ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
Units
Counts
Participants
OG000
Primary
Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination. A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination.
Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 120 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 120 blood sampling timepoint.
Posted
Geometric Mean
95% Confidence Interval
EL.U/mL
At Month 120
ID
Title
Description
OG000
Cervarix Group
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarixâ„¢ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
Units
Counts
Participants
Primary
Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination. A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination.
Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 120 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 120 blood sampling timepoint.
Posted
Number
Subjects
At Month 120
ID
Title
Description
OG000
Cervarix Group
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarixâ„¢ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
Units
Counts
Participants
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
The analysis was performed on the Month 60 Total Vaccinated cohort, which included all vaccinated subjects (who had received 3 doses during the primary study (NCT00196924)) for whom data were available for the Month 60 time point.
Posted
Number
Subjects
From Month 48 to Month 60
ID
Title
Description
OG000
Cervarix Group
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarixâ„¢ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
Units
Counts
Participants
OG000
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Analysis was performed on the Month 72 Total Vaccinated cohort, which included all vaccinated subjects (who had received 3 doses during the primary study (NCT00196924)) for whom data were available for the Month 72 time point.
Posted
Number
Subjects
From Month 60 to Month 72
ID
Title
Description
OG000
Cervarix Group
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarixâ„¢ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
Units
Counts
Participants
OG000
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Analysis was performed on the Month 84 Total Vaccinated cohort, which included all vaccinated subjects (who had received 3 doses during the primary study (NCT00196924)) for whom data were available for the Month 84 time point.
Posted
Number
Subjects
From Month 72 to Month 84
ID
Title
Description
OG000
Cervarix Group
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarixâ„¢ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
Units
Counts
Participants
OG000
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Posted
Number
Subjects
From Month 84 to Month 96
ID
Title
Description
OG000
Cervarix Group
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarixâ„¢ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
Units
Counts
Participants
OG000
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Posted
Number
Subjects
From Month 96 to Month 108
ID
Title
Description
OG000
Cervarix Group
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarixâ„¢ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
Units
Counts
Participants
OG000
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Posted
Number
Subjects
From Month 108 to Month 120
ID
Title
Description
OG000
Cervarix Group
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarixâ„¢ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
Units
Counts
Participants
OG000
Time Frame
Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Description
Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Cervarix Group From Month 48 Until Month 60
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarixâ„¢ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule and for whom serious adverse events were collected from Month 48 until Month 60.
9
397
0
0
EG001
Cervarix Group From Month 60 Until Month 72
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarixâ„¢ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule and for whom serious adverse events were collected from Month 60 until Month 72.
20
529
0
0
EG002
Cervarix Group From Month 72 to Month 84
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarixâ„¢ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule and for whom serious adverse events were collected from Month 72 until Month 84.
20
523
0
0
EG003
Cervarix Group From Month 84 to Month 96
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarixâ„¢ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule and for whom serious adverse events were collected from Month 84 until Month 96.
8
522
0
0
EG004
Cervarix Group From Month 96 to Month 108
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarixâ„¢ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule and for whom serious adverse events were collected from Month 96 until Month 108.
15
507
0
0
EG005
Cervarix Group From Month 108 to Month 120
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarixâ„¢ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule and for whom serious adverse events were collected from Month 108 until Month 120.
6
495
0
0
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abortion spontaneous complete
Pregnancy, puerperium and perinatal conditions
MedDRA
Non-systematic Assessment
EG0001 affected397 at risk
EG0010 affected529 at risk
EG0020 affected523 at risk
EG0030 affected522 at risk
EG004
Abortion spontaneous incomplete
Pregnancy, puerperium and perinatal conditions
MedDRA
Non-systematic Assessment
EG0001 affected397 at risk
EG0013 affected529 at risk
EG0022 affected523 at risk
EG003
Abscess
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected397 at risk
EG0010 affected529 at risk
EG0020 affected523 at risk
EG003
Appendicitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected397 at risk
EG0011 affected529 at risk
EG0021 affected523 at risk
EG003
Cystitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected397 at risk
EG0010 affected529 at risk
EG0020 affected523 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected397 at risk
EG0010 affected529 at risk
EG0020 affected523 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected397 at risk
EG0010 affected529 at risk
EG0021 affected523 at risk
EG003
Ovarian cyst
Reproductive system and breast disorders
MedDRA
Non-systematic Assessment
EG0001 affected397 at risk
EG0010 affected529 at risk
EG0020 affected523 at risk
EG003
Skull malformation
Congenital, familial and genetic disorders
MedDRA
Non-systematic Assessment
EG0001 affected397 at risk
EG0010 affected529 at risk
EG0020 affected523 at risk
EG003
Threatened labour
Pregnancy, puerperium and perinatal conditions
MedDRA
Non-systematic Assessment
EG0001 affected397 at risk
EG0011 affected529 at risk
EG0020 affected523 at risk
EG003
Dengue fever
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected397 at risk
EG0012 affected529 at risk
EG0020 affected523 at risk
EG003
Pharyngeal abscess
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected397 at risk
EG0012 affected529 at risk
EG0020 affected523 at risk
EG003
Alcohol poisoning
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected397 at risk
EG0011 affected529 at risk
EG0020 affected523 at risk
EG003
Brain injury
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected397 at risk
EG0011 affected529 at risk
EG0020 affected523 at risk
EG003
Breast abscess
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected397 at risk
EG0011 affected529 at risk
EG0020 affected523 at risk
EG003
Burns third degree
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected397 at risk
EG0011 affected529 at risk
EG0020 affected523 at risk
EG003
Chronic sinusitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected397 at risk
EG0011 affected529 at risk
EG0020 affected523 at risk
EG003
Circulatory collapse
Vascular disorders
MedDRA
Non-systematic Assessment
EG0000 affected397 at risk
EG0011 affected529 at risk
EG0020 affected523 at risk
EG003
Endometritis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected397 at risk
EG0011 affected529 at risk
EG0020 affected523 at risk
EG003
Multiple injuries
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected397 at risk
EG0011 affected529 at risk
EG0022 affected523 at risk
EG003
Ovarian germ cell teratoma benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected397 at risk
EG0011 affected529 at risk
EG0020 affected523 at risk
EG003
Pain
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected397 at risk
EG0011 affected529 at risk
EG0020 affected523 at risk
EG003
Peritonitis
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected397 at risk
EG0011 affected529 at risk
EG0020 affected523 at risk
EG003
Pre-eclampsia
Pregnancy, puerperium and perinatal conditions
MedDRA
Non-systematic Assessment
EG0000 affected397 at risk
EG0011 affected529 at risk
EG0020 affected523 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected397 at risk
EG0011 affected529 at risk
EG0020 affected523 at risk
EG003
Type 1 diabetes mellitus
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected397 at risk
EG0011 affected529 at risk
EG0020 affected523 at risk
EG003
Olygohydramnios
Pregnancy, puerperium and perinatal conditions
MedDRA
Non-systematic Assessment
EG0000 affected397 at risk
EG0010 affected529 at risk
EG0022 affected523 at risk
EG003
Abortion induced
Surgical and medical procedures
MedDRA
Non-systematic Assessment
EG0000 affected397 at risk
EG0010 affected529 at risk
EG0021 affected523 at risk
EG003
Cerebral cyst
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected397 at risk
EG0010 affected529 at risk
EG0021 affected523 at risk
EG003
Congenital megaureter
Congenital, familial and genetic disorders
MedDRA
Non-systematic Assessment
EG0000 affected397 at risk
EG0010 affected529 at risk
EG0021 affected523 at risk
EG003
Crohn's disease
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected397 at risk
EG0010 affected529 at risk
EG0021 affected523 at risk
EG003
Depression
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected397 at risk
EG0010 affected529 at risk
EG0021 affected523 at risk
EG003
Diverticulum intestinal
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected397 at risk
EG0010 affected529 at risk
EG0021 affected523 at risk
EG003
Endometritis decidual
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected397 at risk
EG0010 affected529 at risk
EG0021 affected523 at risk
EG003
Fibroadenoma of breast
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected397 at risk
EG0010 affected529 at risk
EG0021 affected523 at risk
EG003
Foetal death
Pregnancy, puerperium and perinatal conditions
MedDRA
Non-systematic Assessment
EG0000 affected397 at risk
EG0010 affected529 at risk
EG0021 affected523 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected397 at risk
EG0010 affected529 at risk
EG0021 affected523 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected397 at risk
EG0010 affected529 at risk
EG0021 affected523 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected397 at risk
EG0010 affected529 at risk
EG0021 affected523 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected397 at risk
EG0010 affected529 at risk
EG0021 affected523 at risk
EG003
Stab wound
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected397 at risk
EG0010 affected529 at risk
EG0021 affected523 at risk
EG003
Talipes
Congenital, familial and genetic disorders
MedDRA
Non-systematic Assessment
EG0000 affected397 at risk
EG0010 affected529 at risk
EG0021 affected523 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected397 at risk
EG0010 affected529 at risk
EG0021 affected523 at risk
EG003
Urinary tract infection
Infections and infestations
Non-systematic Assessment
EG0000 affected397 at risk
EG0010 affected529 at risk
EG0020 affected523 at risk
EG003
Abdominal injury
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected397 at risk
EG0010 affected529 at risk
EG0020 affected523 at risk
EG003
Cervical incompetence
Pregnancy, puerperium and perinatal conditions
Non-systematic Assessment
EG0000 affected397 at risk
EG0010 affected529 at risk
EG0020 affected523 at risk
EG003
Drug abuse
Psychiatric disorders
Non-systematic Assessment
EG0000 affected397 at risk
EG0010 affected529 at risk
EG0020 affected523 at risk
EG003
Gestational diabetes
Pregnancy, puerperium and perinatal conditions
Non-systematic Assessment
EG0000 affected397 at risk
EG0010 affected529 at risk
EG0020 affected523 at risk
EG003
Hypertension
Vascular disorders
Non-systematic Assessment
EG0000 affected397 at risk
EG0010 affected529 at risk
EG0020 affected523 at risk
EG003
Ligament rupture
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected397 at risk
EG0010 affected529 at risk
EG0020 affected523 at risk
EG003
Peritonsillar abscess
Infections and infestations
Non-systematic Assessment
EG0000 affected397 at risk
EG0010 affected529 at risk
EG0020 affected523 at risk
EG003
Abortion spontaneous
Pregnancy, puerperium and perinatal conditions
EG0000 affected397 at risk
EG0010 affected529 at risk
EG0020 affected523 at risk
EG003
Coeliac disease
Gastrointestinal disorders
EG0000 affected397 at risk
EG0010 affected529 at risk
EG0020 affected523 at risk
EG003
Contusion
Injury, poisoning and procedural complications
EG0000 affected397 at risk
EG0010 affected529 at risk
EG0020 affected523 at risk
EG003
Ectopic pregnancy
Pregnancy, puerperium and perinatal conditions
EG0000 affected397 at risk
EG0010 affected529 at risk
EG0020 affected523 at risk
EG003
Endometritis
Infections and infestations
EG0000 affected397 at risk
EG0010 affected529 at risk
EG0020 affected523 at risk
EG003
Enteritis
Gastrointestinal disorders
EG0000 affected397 at risk
EG0010 affected529 at risk
EG0020 affected523 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
EG0000 affected397 at risk
EG0010 affected529 at risk
EG0020 affected523 at risk
EG003
Heart disease congenital
Congenital, familial and genetic disorders
EG0000 affected397 at risk
EG0010 affected529 at risk
EG0020 affected523 at risk
EG003
Hypovolaemic shock
Vascular disorders
EG0000 affected397 at risk
EG0010 affected529 at risk
EG0020 affected523 at risk
EG003
Neonatal asphyxia
Respiratory, thoracic and mediastinal disorders
EG0000 affected397 at risk
EG0010 affected529 at risk
EG0020 affected523 at risk
EG003
Neonatal respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
EG0000 affected397 at risk
EG0010 affected529 at risk
EG0020 affected523 at risk
EG003
Neonatal tachypnoea
Respiratory, thoracic and mediastinal disorders
EG0000 affected397 at risk
EG0010 affected529 at risk
EG0020 affected523 at risk
EG003
Ovarian cyst ruptured
Reproductive system and breast disorders
EG0000 affected397 at risk
EG0010 affected529 at risk
EG0020 affected523 at risk
EG003
Ovarian neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EG0000 affected397 at risk
EG0010 affected529 at risk
EG0020 affected523 at risk
EG003
Pilonidal cyst
Infections and infestations
EG0000 affected397 at risk
EG0010 affected529 at risk
EG0020 affected523 at risk
EG003
Postoperative wound infection
Infections and infestations
EG0000 affected397 at risk
EG0010 affected529 at risk
EG0020 affected523 at risk
EG003
Premature baby
Pregnancy, puerperium and perinatal conditions
EG0000 affected397 at risk
EG0010 affected529 at risk
EG0020 affected523 at risk
EG003
Pulmonary malformation
Congenital, familial and genetic disorders
EG0000 affected397 at risk
EG0010 affected529 at risk
EG0020 affected523 at risk
EG003
Stillbirth
Pregnancy, puerperium and perinatal conditions
EG0000 affected397 at risk
EG0010 affected529 at risk
EG0020 affected523 at risk
EG003
Syncope
Nervous system disorders
EG0000 affected397 at risk
EG0010 affected529 at risk
EG0020 affected523 at risk
EG003
Tension headache
Nervous system disorders
EG0000 affected397 at risk
EG0010 affected529 at risk
EG0020 affected523 at risk
EG003
Hodgkin's disease
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-systematic Assessment
EG0000 affected397 at risk
EG0010 affected529 at risk
EG0020 affected523 at risk
EG003
Inguinal hernia
Reproductive system and breast disorders
Non-systematic Assessment
EG0000 affected397 at risk
EG0010 affected529 at risk
EG0020 affected523 at risk
EG003
Irritable bowel syndrome
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected397 at risk
EG0010 affected529 at risk
EG0020 affected523 at risk
EG003
Pneumonia mycoplasmal
Infections and infestations
Non-systematic Assessment
EG0000 affected397 at risk
EG0010 affected529 at risk
EG0020 affected523 at risk
EG003
Other Adverse Events
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
Point of Contact
Title
Organization
Phone
Extension
Email
GSK Response Center
GlaxoSmithKline
866-435-7343
ID
Term
D030361
Papillomavirus Infections
D002583
Uterine Cervical Neoplasms
Ancestor Terms
ID
Term
D015229
Sexually Transmitted Diseases, Viral
D012749
Sexually Transmitted Diseases
D003141
Communicable Diseases
D007239
Infections
D004266
DNA Virus Infections
D014777
Virus Diseases
D014412
Tumor Virus Infections
D000091662
Genital Diseases
D000091642
Urogenital Diseases
D020969
Disease Attributes
D010335
Pathologic Processes
D013568
Pathological Conditions, Signs and Symptoms
D014594
Uterine Neoplasms
D005833
Genital Neoplasms, Female
D014565
Urogenital Neoplasms
D009371
Neoplasms by Site
D009369
Neoplasms
D002577
Uterine Cervical Diseases
D014591
Uterine Diseases
D005831
Genital Diseases, Female
D052776
Female Urogenital Diseases
D005261
Female Urogenital Diseases and Pregnancy Complications