Human Papillomavirus Vaccine Immunogenicity and Safety Tr... | NCT00359619 | Trialant
NCT00359619
Sponsor
GlaxoSmithKline
Status
Completed
Last Update Posted
Jan 2, 2020Actual
Enrollment
383Actual
Phase
Phase 2
Conditions
Infections, Papillomavirus
Papillomavirus Vaccines
Interventions
CervarixTM
HPV investigational vaccine GSK568893A, different formulations
Countries
United States
Belgium
Protocol Section
Identification Module
NCT ID
NCT00359619
Obsolete or Duplicate NCT IDs
NCT00359502
NCT00359528
NCT00359827
Organization Study
108052 (FU month 18)
Secondary IDs
ID
Type
Description
Link
107919
Other Identifier
GSK
107921
Other Identifier
GSK
107918
Other Identifier
GSK
2004-003766-14
EudraCT Number
Brief Title
Human Papillomavirus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Biologicals Novel HPV Vaccine
Official Title
A Long-term, Follow-up of the Immunogenicity and Safety of GlaxoSmithKline Biologicals' Novel HPV Vaccine in Healthy Female Subjects Vaccinated in the Primary Study
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
Sep 12, 2006Actual
Primary Completion Date
Jan 30, 2007Actual
Completion Date
Jan 30, 2007Actual
First Submitted Date
Jul 18, 2006
First Submission Date that Met QC Criteria
Aug 1, 2006
First Posted Date
Aug 2, 2006Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 19, 2012
Results First Submitted that Met QC Criteria
Jan 8, 2015
Results First Posted Date
Feb 10, 2015Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Feb 4, 2011
Certification/Extension First Submitted that Passed QC Review
Feb 4, 2011
Certification/Extension First Posted Date
Feb 9, 2011Estimated
Last Update Submitted Date
Dec 27, 2019
Last Update Posted Date
Jan 2, 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 central cause of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the uterus or womb). This infection may go away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. GlaxoSmithKline Biological's has developed a HPV vaccine against the oncogenic types HPV-16 and HPV-18 formulated with the AS04 adjuvant (control vaccine) and is also evaluating novel HPV vaccines formulations. This study will evaluate the long-term immunogenicity and safety of a novel GSK Biological's vaccine in approximately 376 subjects who received the novel vaccine or the control vaccine administered in the primary study.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed Description
Not provided
Conditions Module
Conditions
Infections, Papillomavirus
Papillomavirus Vaccines
Keywords
HPV vaccine
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 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
383Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cervarix Group
Active Comparator
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Biological: CervarixTM
Cervarix 1 Group
Experimental
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Biological: HPV investigational vaccine GSK568893A, different formulations
Cervarix 2 Group
Experimental
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Biological: HPV investigational vaccine GSK568893A, different formulations
Cervarix 3 Group
Experimental
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Biological: HPV investigational vaccine GSK568893A, different formulations
Interventions
Name
Type
Description
Arm Group Labels
Other Names
CervarixTM
Biological
Subjects were administered three doses of HPV vaccine
Cervarix Group
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies.
Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 8 ELISA units per milliliter (EL.U/mL).
At Months 18, 24, 36 and 48.
Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies.
Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 8 EL.U/mL.
At Months 18, 24, 36 and 48.
Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies
Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 8 EL.U/mL.
At Months 18, 24, 36 and 48.
Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies.
Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 7 EL.U/mL.
At Months 18, 24, 36 and 48.
Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies.
Antibody titers were expressed as GMTs. The reference cut-off value was ≥ 7 EL.U/mL.
At Months 18, 24, 36 and 48.
Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies
Secondary Outcomes
Measure
Description
Time Frame
Number of Seroconverted Subjects Against Human Papillomavirus-31 (HPV-31) Antibodies.
Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 59 EL.U/mL.
At Months 18, 24, 36 and 48.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
A female who enrolled in the study 102115 and received three doses of vaccine.
Written informed consent obtained from the subject prior to enrolment.
Exclusion Criteria:
Use (or planned use during the study period) of any investigational or non-registered product or off-label use of licensed product (drug or vaccine).
Chronic administration of immunosuppressants or other immune-modifying drugs occurring less than three months prior to blood sampling.
Administration of immunoglobulins and/or any blood products within the three months preceding blood sampling.
Planned administration of any HPV vaccine, other than that foreseen by the study protocol, during the study period.
Accepts Healthy Volunteers
Yes
Sex
Female
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
25 Years
Standard Ages
Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
GSK Clinical Trials
GlaxoSmithKline
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
GSK Investigational Site
Denver
Colorado
80262
United States
GSK Investigational Site
References Module
Citations
Not provided
See Also Links
Label
URL
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
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.
A total number of 383 subjects were enrolled in the primary study. A total of 193, 216, 182 and 166 subjects attended Month 18, Month 24, Month 36 and Month 48 visits, respectively. No separate demography data was tabulated for these intermediate timepoints, as statistics were computed only after the last study visit at Month 48.
Recruitment Details
The study is a safety follow-up of the primary study NCT00231413, starting from Month 18 post-vaccination.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cervarix Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
FG001
Cervarix 1 Group
Periods
Title
Milestones
Reasons Not Completed
Overall Study
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
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel 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
Cervarix 4 Group
Experimental
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Biological: HPV investigational vaccine GSK568893A, different formulations
Cervarix 5 Group
Experimental
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Biological: HPV investigational vaccine GSK568893A, different formulations
Cervarix 6 Group
Experimental
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Biological: HPV investigational vaccine GSK568893A, different formulations
HPV investigational vaccine GSK568893A, different formulations
Biological
Subjects were administered three doses of HPV investigational vaccine
Cervarix 1 Group
Cervarix 2 Group
Cervarix 3 Group
Cervarix 4 Group
Cervarix 5 Group
Cervarix 6 Group
Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 7 EL.U/mL.
At Months 18, 24, 36 and 48.
Geometric Mean Titers (GMTs) for Human Papillomavirus-31 (HPV-31) Antibodies.
Antibody titers were expressed as GMTs. The reference cut-off value was ≥ 59 EL.U/mL.
At Months 18, 24, 36 and 48.
Number of Seroconverted Subjects Against Human Papillomavirus-45 (HPV-45) Antibodies.
Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 59 EL.U/mL.
At Months 18, 24, 36 and 48.
Geometric Mean Titers (GMTs) for Human Papillomavirus-45 (HPV-45) Antibodies.
Antibody titers were expressed as GMTs. The reference cut-off value was ≥ 59 EL.U/mL.
At Months 18, 24, 36 and 48.
Number of Subjects With at Least One New Onset of Chronic Disease (NOCDs)
NOCDs include conditions such as diabetes, autoimmune disease, asthma, allergies etc. At least one NOCD = At least one NOCD experienced (regardless of the Medical Dictionary for Regulatory Activities [MedDRA] Preferred Term)
From Month 0 to Months 18, 24, 36 and 48
Number of Subjects With at Least One Medically Significant Condition (MAEs).
MAEs were defined as adverse events (AEs) prompting emergency room or physician visits that were not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities, and injury. At least one MAE = At least one medically significant AE experienced (regardless of the MedDRA Preferred Term).
From Month 0 to Months 18, 24, 36 and 48
Number of Subjects With Any 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. Any = Occurrence of any symptom regardless of intensity grade.
From Month 0 to Months 18, 24, 36 and 48
Number of Subjects With Pregnancy Outcomes.
Pregnancy outcomes were healthy baby, spontaneous abortion and elective abortion.
From Month 0 to Month 18
Number of Subjects With Pregnancy Outcomes.
Pregnancy outcomes were healthy baby, spontaneous abortion, elective abortion and ongoing pregnancy.
From Month 0 to Month 24
Number of Subjects With Pregnancy Outcomes.
Pregnancy outcomes were healthy baby, abnormal infant/congenital anomaly, spontaneous abortion and elective abortion.
From Month 0 to Month 36
Number of Subjects With Pregnancy Outcomes.
Pregnancy outcomes were normal infant, abnormal infant/congenital anomaly, spontaneous abortion and elective termination.
From Month 0 to Month 48
Golden
Colorado
80401
United States
GSK Investigational Site
Salt Lake City
Utah
84109
United States
GSK Investigational Site
Salt Lake City
Utah
84121
United States
GSK Investigational Site
Brussels
1070
Belgium
GSK Investigational Site
Ghent
9000
Belgium
GSK Investigational Site
Leuven
3000
Belgium
GSK Investigational Site
Liège
4000
Belgium
GSK Investigational Site
Tienen
3300
Belgium
GSK Investigational Site
Wilrijk
2610
Belgium
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
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
FG002
Cervarix 2 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
FG003
Cervarix 3 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
FG004
Cervarix 4 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
FG005
Cervarix 5 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
FG006
Cervarix 6 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
FG00088 subjects
FG00150 subjects
FG00249 subjects
FG00348 subjects
FG00448 subjects
FG00550 subjects
FG00650 subjects
COMPLETED
FG00080 subjects
FG00145 subjects
FG00242 subjects
FG00345 subjects
FG00445 subjects
FG00545 subjects
FG00646 subjects
NOT COMPLETED
FG0008 subjects
FG0015 subjects
FG0027 subjects
FG0033 subjects
FG0043 subjects
FG0055 subjects
FG0064 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
Withdrawal by Subject
FG0003 subjects
FG0011 subjects
FG0024 subjects
FG0032 subjects
FG004
Other
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0004 subjects
FG0014 subjects
FG0022 subjects
FG0031 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cervarix Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
BG001
Cervarix 1 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
BG002
Cervarix 2 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
BG003
Cervarix 3 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
BG004
Cervarix 4 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
BG005
Cervarix 5 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
BG006
Cervarix 6 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00088
BG00150
BG00249
BG00348
BG00448
BG00550
BG00650
BG007383
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
Title
Measurements
BG00020.9± 2.03
BG00121.5± 2.18
BG00221.2± 2.07
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00088
BG00150
BG002
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 Against Human Papillomavirus-16 (HPV-16) Antibodies.
Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 8 ELISA units per milliliter (EL.U/mL).
The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Posted
Number
subjects
At Months 18, 24, 36 and 48.
ID
Title
Description
OG000
Cervarix Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG001
Cervarix 1 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG002
Cervarix 2 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG003
Cervarix 3 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG004
Cervarix 4 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG005
Cervarix 5 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG006
Cervarix 6 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00028
OG00112
OG00211
OG003
Title
Denominators
Categories
Anti-HPV-16, Month 18 (N=27,10,9,8,14,13,13)
Title
Measurements
OG00027
OG00110
OG0029
OG003
Primary
Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies.
Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 8 EL.U/mL.
The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Posted
Geometric Mean
95% Confidence Interval
EL.U/mL
At Months 18, 24, 36 and 48.
ID
Title
Description
OG000
Cervarix Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG001
Cervarix 1 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG002
Cervarix 2 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Primary
Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies
Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 8 EL.U/mL.
The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Posted
Geometric Mean
95% Confidence Interval
Titers
At Months 18, 24, 36 and 48.
ID
Title
Description
OG000
Cervarix Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG001
Cervarix 1 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG002
Cervarix 2 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Primary
Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies.
Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 7 EL.U/mL.
The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Posted
Number
subjects
At Months 18, 24, 36 and 48.
ID
Title
Description
OG000
Cervarix Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG001
Cervarix 1 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG002
Cervarix 2 Group
Primary
Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies.
Antibody titers were expressed as GMTs. The reference cut-off value was ≥ 7 EL.U/mL.
The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Posted
Geometric Mean
95% Confidence Interval
EL.U/mL
At Months 18, 24, 36 and 48.
ID
Title
Description
OG000
Cervarix Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG001
Cervarix 1 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG002
Cervarix 2 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Primary
Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies
Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 7 EL.U/mL.
The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Posted
Geometric Mean
95% Confidence Interval
Titers
At Months 18, 24, 36 and 48.
ID
Title
Description
OG000
Cervarix Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG001
Cervarix 1 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG002
Cervarix 2 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Secondary
Number of Seroconverted Subjects Against Human Papillomavirus-31 (HPV-31) Antibodies.
Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 59 EL.U/mL.
The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Posted
Number
subjects
At Months 18, 24, 36 and 48.
ID
Title
Description
OG000
Cervarix Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG001
Cervarix 1 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG002
Cervarix 2 Group
Secondary
Geometric Mean Titers (GMTs) for Human Papillomavirus-31 (HPV-31) Antibodies.
Antibody titers were expressed as GMTs. The reference cut-off value was ≥ 59 EL.U/mL.
The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Posted
Geometric Mean
95% Confidence Interval
EL.U/mL.
At Months 18, 24, 36 and 48.
ID
Title
Description
OG000
Cervarix Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG001
Cervarix 1 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG002
Cervarix 2 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Secondary
Number of Seroconverted Subjects Against Human Papillomavirus-45 (HPV-45) Antibodies.
Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 59 EL.U/mL.
The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Posted
Number
subjects
At Months 18, 24, 36 and 48.
ID
Title
Description
OG000
Cervarix Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG001
Cervarix 1 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG002
Cervarix 2 Group
Secondary
Geometric Mean Titers (GMTs) for Human Papillomavirus-45 (HPV-45) Antibodies.
Antibody titers were expressed as GMTs. The reference cut-off value was ≥ 59 EL.U/mL.
The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Posted
Geometric Mean
95% Confidence Interval
EL.U/mL
At Months 18, 24, 36 and 48.
ID
Title
Description
OG000
Cervarix Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG001
Cervarix 1 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG002
Cervarix 2 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Secondary
Number of Subjects With at Least One New Onset of Chronic Disease (NOCDs)
NOCDs include conditions such as diabetes, autoimmune disease, asthma, allergies etc. At least one NOCD = At least one NOCD experienced (regardless of the Medical Dictionary for Regulatory Activities [MedDRA] Preferred Term)
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Posted
Number
subjects
From Month 0 to Months 18, 24, 36 and 48
ID
Title
Description
OG000
Cervarix Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG001
Cervarix 1 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG002
Cervarix 2 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Secondary
Number of Subjects With at Least One Medically Significant Condition (MAEs).
MAEs were defined as adverse events (AEs) prompting emergency room or physician visits that were not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities, and injury. At least one MAE = At least one medically significant AE experienced (regardless of the MedDRA Preferred Term).
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Posted
Number
subjects
From Month 0 to Months 18, 24, 36 and 48
ID
Title
Description
OG000
Cervarix Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG001
Cervarix 1 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Secondary
Number of Subjects With Any 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. Any = Occurrence of any symptom regardless of intensity grade.
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Posted
Number
subjects
From Month 0 to Months 18, 24, 36 and 48
ID
Title
Description
OG000
Cervarix Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG001
Cervarix 1 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG002
Cervarix 2 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Secondary
Number of Subjects With Pregnancy Outcomes.
Pregnancy outcomes were healthy baby, spontaneous abortion and elective abortion.
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Posted
Number
subjects
From Month 0 to Month 18
ID
Title
Description
OG000
Cervarix Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG001
Cervarix 1 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG002
Cervarix 2 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Secondary
Number of Subjects With Pregnancy Outcomes.
Pregnancy outcomes were healthy baby, spontaneous abortion, elective abortion and ongoing pregnancy.
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Posted
Number
subjects
From Month 0 to Month 24
ID
Title
Description
OG000
Cervarix Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG001
Cervarix 1 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG002
Cervarix 2 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Secondary
Number of Subjects With Pregnancy Outcomes.
Pregnancy outcomes were healthy baby, abnormal infant/congenital anomaly, spontaneous abortion and elective abortion.
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Posted
Number
subjects
From Month 0 to Month 36
ID
Title
Description
OG000
Cervarix Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG001
Cervarix 1 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG002
Cervarix 2 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Secondary
Number of Subjects With Pregnancy Outcomes.
Pregnancy outcomes were normal infant, abnormal infant/congenital anomaly, spontaneous abortion and elective termination.
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Posted
Number
subjects
From Month 0 to Month 48
ID
Title
Description
OG000
Cervarix Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG001
Cervarix 1 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG002
Cervarix 2 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Time Frame
SAE(s): during the entire study period (i.e. Months 0-48); No Unsolicited AE(s) and solicited local/general symptoms data were collected during this study.
Description
Not provided
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
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
6
88
0
0
EG001
Cervarix 1 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
4
50
0
0
EG002
Cervarix 2 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
2
49
0
0
EG003
Cervarix 3 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
6
48
0
0
EG004
Cervarix 4 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
3
48
0
0
EG005
Cervarix 5 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1
50
0
0
EG006
Cervarix 6 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1
50
0
0
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Crohn's disease
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected88 at risk
EG0010 affected50 at risk
EG0020 affected49 at risk
EG0030 affected48 at risk
EG0040 affected48 at risk
EG0050 affected50 at risk
EG0061 affected50 at risk
Asthenia
General disorders
Non-systematic Assessment
EG0000 affected88 at risk
EG0011 affected50 at risk
EG0020 affected49 at risk
EG003
Appendicitis
Infections and infestations
Non-systematic Assessment
EG0001 affected88 at risk
EG0011 affected50 at risk
EG0021 affected49 at risk
EG003
Cellulitis
Infections and infestations
Non-systematic Assessment
EG0000 affected88 at risk
EG0010 affected50 at risk
EG0020 affected49 at risk
EG003
Clostridium difficile colitis
Infections and infestations
Non-systematic Assessment
EG0000 affected88 at risk
EG0010 affected50 at risk
EG0020 affected49 at risk
EG003
Gastroenteritis
Infections and infestations
Non-systematic Assessment
EG0000 affected88 at risk
EG0011 affected50 at risk
EG0020 affected49 at risk
EG003
Post procedural infection
Infections and infestations
Non-systematic Assessment
EG0001 affected88 at risk
EG0010 affected50 at risk
EG0020 affected49 at risk
EG003
Pyelonephritis
Infections and infestations
Non-systematic Assessment
EG0001 affected88 at risk
EG0010 affected50 at risk
EG0020 affected49 at risk
EG003
Tonsillitis streptococcal
Infections and infestations
Non-systematic Assessment
EG0000 affected88 at risk
EG0010 affected50 at risk
EG0020 affected49 at risk
EG003
Muscle rupture
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected88 at risk
EG0011 affected50 at risk
EG0020 affected49 at risk
EG003
Patellofemoral pain syndrome
Musculoskeletal and connective tissue disorders
Non-systematic Assessment
EG0000 affected88 at risk
EG0010 affected50 at risk
EG0020 affected49 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
Non-systematic Assessment
EG0000 affected88 at risk
EG0010 affected50 at risk
EG0020 affected49 at risk
EG003
Headache
Nervous system disorders
EG0001 affected88 at risk
EG0010 affected50 at risk
EG0020 affected49 at risk
EG003
Myelitis
Nervous system disorders
Non-systematic Assessment
EG0000 affected88 at risk
EG0010 affected50 at risk
EG0020 affected49 at risk
EG003
Abortion spontaneous
Pregnancy, puerperium and perinatal conditions
Non-systematic Assessment
EG0000 affected88 at risk
EG0010 affected50 at risk
EG0020 affected49 at risk
EG003
Abortion spontaneous complete
Pregnancy, puerperium and perinatal conditions
Non-systematic Assessment
EG0000 affected88 at risk
EG0010 affected50 at risk
EG0020 affected49 at risk
EG003
Foetal distress syndrome
Pregnancy, puerperium and perinatal conditions
Non-systematic Assessment
EG0001 affected88 at risk
EG0010 affected50 at risk
EG0020 affected49 at risk
EG003
Pre-eclampsia
Pregnancy, puerperium and perinatal conditions
Non-systematic Assessment
EG0000 affected88 at risk
EG0010 affected50 at risk
EG0021 affected49 at risk
EG003
Premature labour
Pregnancy, puerperium and perinatal conditions
Non-systematic Assessment
EG0000 affected88 at risk
EG0010 affected50 at risk
EG0021 affected49 at risk
EG003
Bulimia nervosa
Psychiatric disorders
Non-systematic Assessment
EG0000 affected88 at risk
EG0010 affected50 at risk
EG0020 affected49 at risk
EG003
Major depression
Psychiatric disorders
Non-systematic Assessment
EG0001 affected88 at risk
EG0010 affected50 at risk
EG0020 affected49 at risk
EG003
Post-traumatic stress disorder
Psychiatric disorders
Non-systematic Assessment
EG0001 affected88 at risk
EG0010 affected50 at risk
EG0020 affected49 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0000 affected88 at risk
EG0010 affected50 at risk
EG0020 affected49 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
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
Browse Leaves
Not provided
Browse Branches
Not provided
2 subjects
FG0050 subjects
FG0063 subjects
0 subjects
FG0050 subjects
FG0060 subjects
1 subjects
FG0055 subjects
FG0060 subjects
21.1
± 2.09
BG00421.4± 2.27
BG00521.2± 2.26
BG00620.7± 1.91
BG00721.1± 2.11
49
BG00348
BG00448
BG00550
BG00650
BG007383
Male
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
9
OG00416
OG00515
OG00615
8
OG00414
OG00513
OG00613
Anti-HPV-16, Month 24 (N=28,12,11,9,16,15,15)
Title
Measurements
OG00028
OG00112
OG00211
OG0039
OG00416
OG00515
OG00615
Anti-HPV-16, Month 36 (N=28,12,11,9,16,15,15)
Title
Measurements
OG00028
OG00112
OG00211
OG0039
OG00416
OG00515
OG00615
Anti-HPV-16, Month 48 (N=28,12,11,9,16,15,15)
Title
Measurements
OG00028
OG00112
OG00211
OG0039
OG00416
OG00515
OG00615
OG003
Cervarix 3 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG004
Cervarix 4 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG005
Cervarix 5 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG006
Cervarix 6 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00028
OG00112
OG00211
OG0039
OG00416
OG00515
OG00615
Title
Denominators
Categories
Anti-HPV-16 Month 18 (N=27,10,9,8,14,13,13)
Title
Measurements
OG0001933.9(1318.0 to 2837.5)
OG0011868.3(1263.0 to 2763.8)
OG0021902.3(603.5 to 5996.7)
OG0031996.4(1017.8 to 3915.8)
OG0041437.1(777.3 to 2657.0)
OG0052200.3(1284.4 to 3769.4)
OG0061769.8(914.9 to 3423.7)
Anti-HPV-16 Month 24 (N=28,12,11,9,16,15,15)
Title
Measurements
OG0001477.1(1039.3 to 2099.3)
OG0011381.6(942.1 to 2026.4)
OG0021339.9(553.1 to 3246.1)
OG003
Anti-HPV-16 Month 36 (N=28,12,11,9,16,15,15)
Title
Measurements
OG0001296.8(917.1 to 1833.6)
OG0011200.5(814.8 to 1768.9)
OG0021023.1(389.2 to 2689.8)
OG003
Anti-HPV-16 Month 48 (N=28,12,11,9,16,15,15)
Title
Measurements
OG0001300.9(952.3 to 1777.1)
OG0011115.4(780.3 to 1594.3)
OG0021007.5(361.3 to 2809.6)
OG003
OG003
Cervarix 3 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG004
Cervarix 4 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG005
Cervarix 5 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG006
Cervarix 6 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00033
OG00118
OG00216
OG00318
OG00418
OG00520
OG00619
Title
Denominators
Categories
Anti-HPV-16 Month 18 (N=32,15,13,16,16,17,17)
Title
Measurements
OG0001902.6(1309.3 to 2764.7)
OG0011558.5(1122.9 to 2163.2)
OG0021791.7(823.6 to 3897.7)
OG0031552.9(981.6 to 2456.5)
OG0041242.8(687.3 to 2247.4)
OG0051869.6(1161.1 to 3010.5)
OG0061764.4(1073.8 to 2899.2)
Anti-HPV-16 Month 24 (N=33,18,16,18,18,20,19)
Title
Measurements
OG0001472.8(1046.2 to 2073.3)
OG0011223.4(911.2 to 1642.6)
OG0021347.4(740.7 to 2451.1)
OG003
Anti-HPV-16 Month 36 (N=33,18,16,18,18,20,19)
Title
Measurements
OG0001291.7(928.4 to 1797.1)
OG0011031.2(764.2 to 1391.5)
OG0021032.9(538.9 to 1979.5)
OG003
Anti-HPV-16 Month 48 (N=33,18,16,18,18,20,19)
Title
Measurements
OG0001248.8(907.1 to 1719.1)
OG001955.5(722.7 to 1263.1)
OG0021104.9(556.9 to 2192.1)
OG003
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG003
Cervarix 3 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG004
Cervarix 4 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG005
Cervarix 5 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG006
Cervarix 6 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00026
OG00113
OG00214
OG00318
OG00412
OG00518
OG00617
Title
Denominators
Categories
Anti-HPV-18 Month 18 (N=26,10,12,16,11,15,15)
Title
Measurements
OG00026
OG00110
OG00212
OG00316
OG00411
OG00515
OG00615
Anti-HPV-18 Month 24 (N=26,13,14,18,12,18,17)
Title
Measurements
OG00026
OG00113
OG00214
OG003
Anti-HPV-18 Month 36 (N=26,13,14,18,12,18,17)
Title
Measurements
OG00026
OG00113
OG00214
OG003
Anti-HPV-18 Month 48 (N=26,13,14,18,12,18,17)
Title
Measurements
OG00026
OG00113
OG00214
OG003
OG003
Cervarix 3 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG004
Cervarix 4 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG005
Cervarix 5 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG006
Cervarix 6 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00026
OG00113
OG00214
OG00318
OG00412
OG00518
OG00617
Title
Denominators
Categories
Anti-HPV-18 Month 18 (N=26,10,12,16,11,15,15)
Title
Measurements
OG0001060.9(720.1 to 1562.9)
OG001469.3(247.6 to 889.4)
OG002532.5(211.2 to 1342.7)
OG003536.7(296.0 to 973.0)
OG004563.7(262.0 to 1212.5)
OG005637.9(394.8 to 1030.8)
OG006572.2(342.7 to 955.3)
Anti-HPV-18 Month 24 (N=26,13,14,18,12,18,17)
Title
Measurements
OG000781.7(538.5 to 1134.9)
OG001321.2(192.8 to 535.2)
OG002387.0(185.7 to 806.6)
OG003
Anti-HPV-18 Month 36 (N=26,13,14,18,12,18,17)
Title
Measurements
OG000733.6(487.2 to 1104.6)
OG001286.1(179.4 to 456.1)
OG002333.4(151.0 to 736.0)
OG003
Anti-HPV-18 Month 48 (N=26,13,14,18,12,18,17)
Title
Measurements
OG000729.3(516.0 to 1030.8)
OG001248.6(149.7 to 412.8)
OG002278.3(125.6 to 616.6)
OG003
OG003
Cervarix 3 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG004
Cervarix 4 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG005
Cervarix 5 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG006
Cervarix 6 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00033
OG00118
OG00216
OG00318
OG00418
OG00520
OG00619
Title
Denominators
Categories
Anti-HPV-16 Month 18 (N=32,15,13,16,16,17,17)
Title
Measurements
OG000994.4(699.5 to 1413.5)
OG001525.5(328.2 to 841.6)
OG002524.1(225.6 to 1217.5)
OG003536.7(296.0 to 973.0)
OG004551.1(312.4 to 972.2)
OG005574.9(355.3 to 930.2)
OG006570.5(365.6 to 890.4)
Anti-HPV-16 Month 24 (N=33,18,16,18,18,20,19)
Title
Measurements
OG000739.5(526.6 to 1038.3)
OG001355.2(236.2 to 534.3)
OG002410.5(217.0 to 776.6)
OG003
Anti-HPV-16 Month 36 (N=33,18,16,18,18,20,19)
Title
Measurements
OG000683.5(475.4 to 982.7)
OG001320.5(220.4 to 466.1)
OG002349.8(175.7 to 696.5)
OG003
Anti-HPV-16 Month 48 (N=33,18,16,18,18,20,19)
Title
Measurements
OG000666.3(477.9 to 929.2)
OG001284.6(190.8 to 424.7)
OG002297.7(148.9 to 595.3)
OG003
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG003
Cervarix 3 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG004
Cervarix 4 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG005
Cervarix 5 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG006
Cervarix 6 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00028
OG00116
OG00215
OG00315
OG00416
OG00518
OG00619
Title
Denominators
Categories
Anti-HPV-31 Month 18 (N=27,13,12,13,14,15,17)
Title
Measurements
OG00025
OG00113
OG00212
OG00313
OG00414
OG00515
OG00617
Anti-HPV-31 Month 24 (N=28,16,15,15,16,17,19)
Title
Measurements
OG00022
OG00116
OG00215
OG003
Anti-HPV-31 Month 36 (N=28,16,15,15,16,18,19)
Title
Measurements
OG00023
OG00116
OG00215
OG003
Anti-HPV-31 Month 48 (N=28,16,15,15,16,18,19)
Title
Measurements
OG00023
OG00116
OG00215
OG003
OG003
Cervarix 3 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG004
Cervarix 4 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG005
Cervarix 5 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG006
Cervarix 6 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00028
OG00116
OG00215
OG00315
OG00416
OG00518
OG00619
Title
Denominators
Categories
Anti-HPV-31 Month 18 (N=27,13,12,13,14,15,17)
Title
Measurements
OG000187.7(124.2 to 283.8)
OG0011776.8(1086.4 to 2906.1)
OG0022685.9(1157.8 to 6230.9)
OG0032388.8(1352.0 to 4220.8)
OG0042714.9(1312.1 to 5617.3)
OG0051952.4(1226.4 to 3108.2)
OG0063466.4(2077.8 to 5782.9)
Anti-HPV-31 Month 24 (N=28,16,15,15,16,17,19)
Title
Measurements
OG000125.3(80.6 to 194.8)
OG0011336.1(891.6 to 2002.2)
OG0022076.2(1168.0 to 3690.7)
OG003
Anti-HPV-31 Month 36 (N=28,16,15,15,16,18,19)
Title
Measurements
OG000164.6(107.7 to 251.7)
OG0011346.7(941.1 to 1927.0)
OG0021776.6(976.5 to 3232.1)
OG003
Anti-HPV-31 Month 48 (N=28,16,15,15,16,18,19)
Title
Measurements
OG000174.7(114.4 to 266.7)
OG0011284.5(878.4 to 1878.3)
OG0022105.3(1155.1 to 3837.3)
OG003
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG003
Cervarix 3 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG004
Cervarix 4 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG005
Cervarix 5 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG006
Cervarix 6 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00024
OG00117
OG00212
OG00313
OG00416
OG00518
OG00616
Title
Denominators
Categories
Anti-HPV-45 Month 18 (N=20,14,10,11,14,15,15)
Title
Measurements
OG00020
OG00114
OG00210
OG00311
OG00414
OG00515
OG00615
Anti-HPV-45 Month 24 (N=19,17,12,13,16,17,16)
Title
Measurements
OG00019
OG00117
OG00212
OG003
Anti-HPV-45 Month 36 (N=18,17,12,13,16,18,16)
Title
Measurements
OG00018
OG00117
OG00212
OG003
Anti-HPV-45 Month 48 (N=19,17,12,13,16,18,16)
Title
Measurements
OG00019
OG00117
OG00212
OG003
OG003
Cervarix 3 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG004
Cervarix 4 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG005
Cervarix 5 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG006
Cervarix 6 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00024
OG00117
OG00212
OG00313
OG00416
OG00518
OG00616
Title
Denominators
Categories
Anti-HPV-45 Month 18 (N=20,14,10,11,14,15,15)
Title
Measurements
OG000184.8(111.9 to 305.1)
OG001919.8(510.9 to 1655.9)
OG0021731.0(591.8 to 5063.3)
OG003959.1(557.9 to 1648.9)
OG0041086.6(528.7 to 2233.2)
OG0051235.8(757.9 to 2014.8)
OG0061094.9(613.1 to 1955.4)
Anti-HPV-45 Month 24 (N=19,17,12,13,16,17,16)
Title
Measurements
OG000138.3(86.4 to 221.4)
OG001713.0(440.6 to 1153.9)
OG0021274.5(590.1 to 2752.5)
OG003
Anti-HPV-45 Month 36 (N=18,17,12,13,16,18,16)
Title
Measurements
OG000165.4(97.9 to 279.4)
OG001707.8(451.9 to 1108.6)
OG0021103.9(521.0 to 2338.8)
OG003
Anti-HPV-45 Month 48 (N=19,17,12,13,16,18,16)
Title
Measurements
OG000190.7(115.8 to 314.1)
OG001659.0(415.4 to 1045.6)
OG0021036.2(477.2 to 2249.9)
OG003
OG003
Cervarix 3 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG004
Cervarix 4 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG005
Cervarix 5 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG006
Cervarix 6 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00088
OG00150
OG00249
OG00348
OG00448
OG00550
OG00650
Title
Denominators
Categories
NOCD(s) at Month 18
Title
Measurements
OG0006
OG0011
OG0026
OG0032
OG0043
OG0051
OG0062
NOCD(s) at Month 24
Title
Measurements
OG0006
OG0011
OG0026
OG003
NOCD(s) at Month 36
Title
Measurements
OG0007
OG0011
OG0026
OG003
NOCD(s) at Month 48
Title
Measurements
OG0007
OG0011
OG0027
OG003
OG002
Cervarix 2 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG003
Cervarix 3 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG004
Cervarix 4 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG005
Cervarix 5 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG006
Cervarix 6 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00088
OG00150
OG00249
OG00348
OG00448
OG00550
OG00650
Title
Denominators
Categories
MAE(s) at Month 18
Title
Measurements
OG0004
OG0013
OG0022
OG0034
OG0045
OG0051
OG0061
MAE(s) at Month 24
Title
Measurements
OG0006
OG0013
OG0023
OG003
MAE(s) at Month 36
Title
Measurements
OG0009
OG0014
OG0023
OG003
MAE(s) at Month 48
Title
Measurements
OG00014
OG0017
OG0025
OG003
OG003
Cervarix 3 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG004
Cervarix 4 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG005
Cervarix 5 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG006
Cervarix 6 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00088
OG00150
OG00249
OG00348
OG00448
OG00550
OG00650
Title
Denominators
Categories
Any SAE(s) at Month 18
Title
Measurements
OG0002
OG0013
OG0021
OG0033
OG0042
OG0050
OG0061
Any SAE(s) at Month 24
Title
Measurements
OG0002
OG0013
OG0021
OG003
Any SAE(s) at Month 36
Title
Measurements
OG0002
OG0013
OG0022
OG003
Any SAE(s) at Month 48
Title
Measurements
OG0006
OG0014
OG0022
OG003
OG003
Cervarix 3 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG004
Cervarix 4 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG005
Cervarix 5 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG006
Cervarix 6 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00088
OG00150
OG00249
OG00348
OG00448
OG00550
OG00650
Title
Denominators
Categories
Healthy baby
Title
Measurements
OG0003
OG0010
OG0022
OG0031
OG0040
OG0051
OG0063
Spontaneous abortion
Title
Measurements
OG0000
OG0010
OG0020
OG003
Elective abortion
Title
Measurements
OG0001
OG0010
OG0020
OG003
OG003
Cervarix 3 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG004
Cervarix 4 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG005
Cervarix 5 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG006
Cervarix 6 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00088
OG00150
OG00249
OG00348
OG00448
OG00550
OG00650
Title
Denominators
Categories
Healthy baby
Title
Measurements
OG0004
OG0011
OG0022
OG0032
OG0040
OG0051
OG0063
Spontaneous abortion
Title
Measurements
OG0000
OG0010
OG0020
OG003
Elective abortion
Title
Measurements
OG0001
OG0010
OG0020
OG003
Ongoing pregnancy
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG003
Cervarix 3 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG004
Cervarix 4 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG005
Cervarix 5 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG006
Cervarix 6 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Units
Counts
Participants
OG00088
OG00150
OG00249
OG00348
OG00448
OG00550
OG00650
Title
Denominators
Categories
Healthy baby
Title
Measurements
OG0004
OG0014
OG0023
OG0032
OG0040
OG0051
OG0063
Abnormal infant/congenital anomaly
Title
Measurements
OG0001
OG0010
OG0020
OG003
Spontaneous abortion
Title
Measurements
OG0000
OG0010
OG0020
OG003
Elective abortion
Title
Measurements
OG0001
OG0010
OG0020
OG003
OG003
Cervarix 3 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG004
Cervarix 4 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG005
Cervarix 5 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
OG006
Cervarix 6 Group
Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.