Evaluation of Safety and Immunogenicity of Co-administeri... | NCT00369824 | Trialant
NCT00369824
Sponsor
GlaxoSmithKline
Status
Completed
Last Update Posted
Jul 20, 2018Actual
Enrollment
1,330Actual
Phase
Phase 3
Conditions
Infections, Papillomavirus
Interventions
Different formulations of GSK Biologicals' HPV vaccine (580299)
Menactra TM
Boostrix TM
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00369824
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
107682
Secondary IDs
Not provided
Brief Title
Evaluation of Safety and Immunogenicity of Co-administering HPV Vaccine With Other Vaccines in Healthy Female Subjects
Official Title
A Randomized, Open Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline Biologicals' HPV Vaccine Co-administered Intramuscularly With Boostrix® and/or Menactra™ in Healthy Female Subjects Aged 11-18 Years
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Nov 2016
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 26, 2006
Primary Completion Date
Nov 22, 2007Actual
Completion Date
Feb 13, 2008Actual
First Submitted Date
Aug 28, 2006
First Submission Date that Met QC Criteria
Aug 28, 2006
First Posted Date
Aug 29, 2006Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 3, 2009
Results First Submitted that Met QC Criteria
Sep 3, 2009
Results First Posted Date
Oct 8, 2009Estimated
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
May 24, 2018
Last Update Posted Date
Jul 20, 2018Actual
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. Vaccination of pre-teens and adolescents, ideally before sexual debut and thus before exposure to oncogenic HPV, is a rational strategy for prevention of cervical cancer, and so HPV vaccination could complement the existing pre-adolescent/adolescents platform. Therefore, this Phase 3b study is designed to evaluate the safety and immunogenicity of co-administering Boostrix and/or Menactra with GSK Biologicals' HPV vaccine (580299) as compared to the administration of any of the vaccines alone.
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
Keywords
HPV
HPV, diptheria, pertussis, tetanus, meningitis
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
1,330Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cervarix + Boostrix/Menactra Group
Experimental
Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
Biological: Different formulations of GSK Biologicals' HPV vaccine (580299)
Biological: Menactra TM
Biological: Boostrix TM
Cervarix + Menactra/Boostrix Group
Experimental
Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
Biological: Different formulations of GSK Biologicals' HPV vaccine (580299)
Biological: Menactra TM
Biological: Boostrix TM
Cervarix + Boostrix + Menactra Group
Experimental
Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
Biological: Different formulations of GSK Biologicals' HPV vaccine (580299)
Biological: Menactra TM
Biological: Boostrix TM
Boostrix/Cervarix Group
Experimental
Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
Biological: Different formulations of GSK Biologicals' HPV vaccine (580299)
Biological: Menactra TM
Biological: Boostrix TM
Menactra/Cervarix Group
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Different formulations of GSK Biologicals' HPV vaccine (580299)
Biological
Three doses of vaccine administered intramuscularly, with the second and third dose given one month and six months after the first dose respectively
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 1.0 International Unit Per Milliliter (IU/mL)
Anti-D and anti-T antibodies cut-off values assessed include 1.0 international unit per milliliter (IU/mL)
Before and one month after vaccination with Boostrix
Concentration of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies
Concentrations given as Geometric Means Concentrations (GMCs)
Before and one month after vaccination with Boostrix
Titer of Meningococcal Serogroup A (Anti-A), Meningococcal Serogroup C (Anti-C), Meningococcal Serogroup Y (Anti-Y) and Meningococcal Serogroup W-135 (Anti-W135) Antibodies
Titers given as Geometric Mean Titers (GMTs)
Before and one month after vaccination with Menactra
Secondary Outcomes
Measure
Description
Time Frame
Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values
Cut-off values assessed include 8 enzyme-linked immunosorbent assay units Per Milliliter (EL.U/mL) for anti-HPV16 antibodies and 7 EL.U/mL for anti-HPV18 antibodies.
Before vaccination (PRE), one month post Dose 2 (Mth2) and one and six months post Dose 3 (Mth 7 and Mth 12)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Subjects who the investigator believes that they can, and will, comply with the requirements of the protocol should be enrolled in the study.
A female between, and including, 11 and 18 years of age at the time of the first vaccination.
Written informed consent obtained from parents/legally acceptable representative of the subject and written informed assent obtained from the subject if the subject is less than 18 years of age, or written informed consent obtained from the subject if the subject is 18 years of age.
Healthy subjects, as established by medical history and history-directed physical examination, before entering into the study.
Previously completed routine childhood vaccinations against diphtheria, tetanus and pertussis diseases, according to the recommended vaccination schedule at the time.
Subjects must have a negative urine pregnancy test.
Subjects of childbearing potential at the time of study entry are required to be abstinent or use adequate contraceptive precautions for 30 days prior to vaccination. Subjects also are required to agree to continue such precautions for two months after completion of the vaccination series. Female subjects who reach menarche (began menstruating) during the study and therefore become of child-bearing potential are required to agree to follow the same precautions.
Exclusion Criteria:
Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Concurrently participating in another clinical study, at any time during the study period (up to the Month 12/13 visit), in which the subject has been or will be exposed to an investigational or a non-investigational product.
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after each dose of vaccine. Administration of routine vaccines up to 8 days before the first dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window.
A woman planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the study period and up to two months after the last vaccine dose.
Pregnant or breastfeeding women.
Previous vaccination against HPV, or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period.
previous administration of components of the investigational vaccine
Administration of a pre-school booster of diphtheria, tetanus, pertussis vaccine within the previous five years.
Administration of a diphtheria-tetanus booster or tetanus-diphteria-acellular pertussis (Tdap) vaccine within the previous five years.
Previous vaccination against Neisseria meningitidis.
Hypersensitivity to latex.
Cancer or autoimmune disease under treatment.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine or following any other tetanus toxoid, diphtheria toxoid or pertussis-containing vaccine.
History of encephalopathy within seven days of administration of a previous dose of pertussis vaccine that is not attributable to another identifiable cause.
Progressive neurologic disorder, uncontrolled epilepsy or progressive encephalopathy.
Temperature of >= 105°F within 48 hours of receipt of a prior dose of diphteria- tetanu-pertussis (DTP) vaccine, not due to another identifiable cause.
Collapse or shock-like state within 48 hours of receipt of a prior dose of DTP vaccine.
Seizures with or without fever within three days of a prior dose of DTP vaccine.
Severe Arthus-type hypersensitivity reactions following a prior dose of tetanus toxoid within the previous 10 years.
Any confirmed or suspected immunosuppressive or immunodeficient condition
Acute disease at the time of enrolment. All vaccines can be administered to persons with a minor illness
Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
Wheeler CM, Harvey BM, Pichichero ME, Simon MW, Combs SP, Blatter MM, Marshall GS, Catteau G, Dobbelaere K, Descamps D, Dubin G, Schuind A. Immunogenicity and safety of human papillomavirus-16/18 AS04-adjuvanted vaccine coadministered with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine and/or meningococcal conjugate vaccine to healthy girls 11 to 18 years of age: results from a randomized open trial. Pediatr Infect Dis J. 2011 Dec;30(12):e225-34. doi: 10.1097/INF.0b013e31822d28df.
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.
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cervarix + Boostrix/Menactra Group
Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
FG001
Cervarix + Menactra/Boostrix 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
Experimental
Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
Biological: Different formulations of GSK Biologicals' HPV vaccine (580299)
Biological: Menactra TM
Cervarix Group
Experimental
Subjects received Cervarix at Months 0, 1 and 6.
Biological: Different formulations of GSK Biologicals' HPV vaccine (580299)
Boostrix/Cervarix Group
Cervarix + Boostrix + Menactra Group
Cervarix + Boostrix/Menactra Group
Cervarix + Menactra/Boostrix Group
Cervarix Group
Menactra/Cervarix Group
Menactra TM
Biological
One dose of vaccine administered intramuscularly
Boostrix/Cervarix Group
Cervarix + Boostrix + Menactra Group
Cervarix + Boostrix/Menactra Group
Cervarix + Menactra/Boostrix Group
Menactra/Cervarix Group
Boostrix TM
Biological
One dose of vaccine administered intramuscularly
Boostrix/Cervarix Group
Cervarix + Boostrix + Menactra Group
Cervarix + Boostrix/Menactra Group
Cervarix + Menactra/Boostrix Group
Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 0.1 International Unit Per Milliliter (IU/mL)
Anti-D and anti-T antibodies cut-off values assessed include 0.1 international unit per milliliter (IU/mL)
Before and one month after vaccination with Boostrix
Concentration of Anti-D and Anti-T Antibodies
Concentrations given as Geometric Mean Concentrations (GMCs)
Before and one month after vaccination with Boostrix
Number of Subjects With Booster Response for Anti-D and Anti-T
Booster responses for anti-D and anti-T defined as:
For initially seronegative subjects (pre-vaccination titer below cut-off: < 0.1 IU/mL): antibody titer at least 4 times the cut-off (post-vaccination titer ≥ 0.4 IU/mL)
For initially seropositive subjects (pre-vaccination titer above 0.1 IU/mL): an increase in antibody titer of at least 4 times the pre-vaccination titer
One month after vaccination with Boostrix
Number of Subjects With Booster Response for Anti-PT, Anti-FHA and Anti-PRN
Booster responses defined as:
For initially seronegative subjects (pre-vaccination titer below cut-off: < 5 EL.U/mL): antibody titers at least 4 times the cut-off,
For initially seropositive subjects with pre-vaccination titer above 5 EL.U/mL and < 20 EL.U/mL: an increase in antibody titers of at least 4 times the pre-vaccination titer,
For initially seropositive subjects with pre-vaccination titer ≥ 20 EL.U/mL: an increase in antibody titers of at least two times the pre-vaccination titer
One month after vaccination with Boostrix
Number of Subjects With Anti-A, Anti-C, Anti-Y and Anti-W135 Vaccine Response
Vaccine responses for anti-A, C, Y and W-135 defined as:
For initially seronegative subjects (pre-vaccination titer below cut-off of 8): antibody titers at least 4 times the cut-off (post vaccination titer ≥ 32)
For initially seropositive subjects (pre-vaccination titer above 8): antibody titers at least 4 times the pre-vaccination antibody titer
One month after vaccination with Menactra
Number of Subjects Reporting Solicited Local Symptoms
Solicited local symptoms assessed include pain, redness and swelling.
During the 7-day period following each vaccination
Number of Subjects Reporting Solicited General Symptoms
Solicited general symptoms assessed include Arthralgia, fatigue, fever, gastrointestinal, headache, myalgia, rash and urticaria
During the 7-day period following each vaccination
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Unsolicited adverse event = Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
During the 30-day period following each vaccination
Number of Subjects Reporting Serious Adverse Events
Serious adverse events assessed include medical occurrences that results in death, is 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.
During the active phase of the study (up to Month 7 or Month 8) and throughout the entire study (up to Month 12 or Month 13)
Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs)
NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes
During the active phase of the study (up to Month 7 or Month 8) and throughout the entire study period (up to Month 12 or Month 13)
Number of Subjects Reporting Medically Significant Adverse Events (AEs)
Medically significant AEs assessed include AEs prompting emergency room or physician visits that are not related to common diseases or SAEs that are not related to common diseases.
During the active phase (up to Month 7 or Month 8) and throughout the entire study (up to Month 12 or Month 13)
Chandler
Arizona
85224
United States
GSK Investigational Site
Mesa
Arizona
85203
United States
GSK Investigational Site
Jonesboro
Arkansas
72401
United States
GSK Investigational Site
Little Rock
Arkansas
72205
United States
GSK Investigational Site
Fountain Valley
California
92708
United States
GSK Investigational Site
Fresno
California
93720
United States
GSK Investigational Site
Long Beach
California
90806
United States
GSK Investigational Site
Madera
California
93637
United States
GSK Investigational Site
Rolling Hills Estates
California
90274
United States
GSK Investigational Site
Centennial
Colorado
80112
United States
GSK Investigational Site
Golden
Colorado
80401
United States
GSK Investigational Site
Thornton
Colorado
80233
United States
GSK Investigational Site
Cocoa Beach
Florida
32931
United States
GSK Investigational Site
West Palm Beach
Florida
33409
United States
GSK Investigational Site
Marietta
Georgia
30062
United States
GSK Investigational Site
Arkansas City
Kansas
67005
United States
GSK Investigational Site
Lenexa
Kansas
66219
United States
GSK Investigational Site
Wichita
Kansas
67207
United States
GSK Investigational Site
Bardstown
Kentucky
40004
United States
GSK Investigational Site
Lexington
Kentucky
40503
United States
GSK Investigational Site
Louisville
Kentucky
40202
United States
GSK Investigational Site
Bossier City
Louisiana
71111
United States
GSK Investigational Site
Milford
Massachusetts
01757
United States
GSK Investigational Site
Niles
Michigan
49120
United States
GSK Investigational Site
Stevensville
Michigan
49127
United States
GSK Investigational Site
Omaha
Nebraska
68134
United States
GSK Investigational Site
Edison
New Jersey
08817
United States
GSK Investigational Site
Whitehouse Station
New Jersey
08889
United States
GSK Investigational Site
Albuquerque
New Mexico
87131
United States
GSK Investigational Site
Rochester
New York
14620
United States
GSK Investigational Site
Cary
North Carolina
27518
United States
GSK Investigational Site
Laurinburg
North Carolina
28352
United States
GSK Investigational Site
Raleigh
North Carolina
27609
United States
GSK Investigational Site
Sylva
North Carolina
28779
United States
GSK Investigational Site
Akron
Ohio
44308
United States
GSK Investigational Site
Boardman
Ohio
44512
United States
GSK Investigational Site
Cleveland
Ohio
44118
United States
GSK Investigational Site
Portland
Oregon
97216
United States
GSK Investigational Site
Erie
Pennsylvania
16501
United States
GSK Investigational Site
Greenville
Pennsylvania
16125
United States
GSK Investigational Site
Philadelphia
Pennsylvania
19107
United States
GSK Investigational Site
Pittsburgh
Pennsylvania
15220
United States
GSK Investigational Site
Uniontown
Pennsylvania
15401
United States
GSK Investigational Site
Charleston
South Carolina
29401
United States
GSK Investigational Site
Charleston
South Carolina
29407
United States
GSK Investigational Site
Gray
Tennessee
37615
United States
GSK Investigational Site
San Angelo
Texas
76904
United States
GSK Investigational Site
Burke
Virginia
22015
United States
GSK Investigational Site
Vienna
Virginia
22180
United States
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
Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
FG002
Cervarix + Boostrix + Menactra Group
Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
FG003
Boostrix/Cervarix Group
Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
FG004
Menactra/Cervarix Group
Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
FG005
Cervarix Group
Subjects received Cervarix at Months 0, 1 and 6.
FG000212 subjects
FG001214 subjects
FG002214 subjects
FG003214 subjects
FG004214 subjects
FG005215 subjects
COMPLETED
FG000197 subjects
FG001195 subjects
FG002202 subjects
FG003199 subjects
FG004196 subjects
FG005204 subjects
NOT COMPLETED
FG00015 subjects
FG00119 subjects
FG00212 subjects
FG00315 subjects
FG00418 subjects
FG00511 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
Protocol Violation
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
Withdrawal by Subject
FG0009 subjects
FG0015 subjects
FG0025 subjects
FG0034 subjects
FG004
Lost to Follow-up
FG0006 subjects
FG00111 subjects
FG0027 subjects
FG0038 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cervarix + Boostrix/Menactra Group
Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
BG001
Cervarix + Menactra/Boostrix Group
Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
BG002
Cervarix + Boostrix + Menactra Group
Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
BG003
Boostrix/Cervarix Group
Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
BG004
Menactra/Cervarix Group
Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
BG005
Cervarix Group
Subjects received Cervarix at Months 0, 1 and 6.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000212
BG001214
BG002214
BG003214
BG004214
BG005215
BG0061283
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
BG00013.5± 2.27
BG00113.3± 2.28
BG00213.5± 2.26
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000212
BG001214
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 Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 1.0 International Unit Per Milliliter (IU/mL)
Anti-D and anti-T antibodies cut-off values assessed include 1.0 international unit per milliliter (IU/mL)
Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, Month 1 and only for Cervarix + Boostrix/Menactra, Cervarix + Boostrix + Menactra and Boostrix/Cervarix groups.
Posted
Count of Participants
Participants
Before and one month after vaccination with Boostrix
ID
Title
Description
OG000
Cervarix + Boostrix/Menactra Group
Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
OG001
Cervarix + Menactra/Boostrix Group
Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
OG002
Cervarix + Boostrix + Menactra Group
Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
OG003
Boostrix/Cervarix Group
Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
OG004
Menactra/Cervarix Group
Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
OG005
Cervarix Group
Subjects received Cervarix at Months 0, 1 and 6.
Units
Counts
Participants
OG000194
OG0010
OG002201
OG003
Title
Denominators
Categories
Anti-D (Before vaccination)
ParticipantsOG000193
ParticipantsOG0010
ParticipantsOG002199
ParticipantsOG003
Primary
Concentration of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies
Concentrations given as Geometric Means Concentrations (GMCs)
Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity Month 1, and only for Cervarix + Boostrix/Menactra, Cervarix + Boostrix + Menactra and Boostrix/Cervarix groups.
Posted
Geometric Mean
95% Confidence Interval
International Units per Milliliter
Before and one month after vaccination with Boostrix
ID
Title
Description
OG000
Cervarix + Boostrix/Menactra Group
Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
OG001
Cervarix + Menactra/Boostrix Group
Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
OG002
Cervarix + Boostrix + Menactra Group
Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
OG003
Boostrix/Cervarix Group
Primary
Titer of Meningococcal Serogroup A (Anti-A), Meningococcal Serogroup C (Anti-C), Meningococcal Serogroup Y (Anti-Y) and Meningococcal Serogroup W-135 (Anti-W135) Antibodies
Titers given as Geometric Mean Titers (GMTs)
Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity Month1 and only for Cervarix + Menactra/Boostrix, Cervarix + Boostrix + Menactra and Menactra/Cervarix groups.
Posted
Geometric Mean
95% Confidence Interval
Titer
Before and one month after vaccination with Menactra
ID
Title
Description
OG000
Cervarix + Boostrix/Menactra Group
Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
OG001
Cervarix + Menactra/Boostrix Group
Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
OG002
Cervarix + Boostrix + Menactra Group
Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
OG003
Boostrix/Cervarix Group
Secondary
Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values
Cut-off values assessed include 8 enzyme-linked immunosorbent assay units Per Milliliter (EL.U/mL) for anti-HPV16 antibodies and 7 EL.U/mL for anti-HPV18 antibodies.
Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity at Month 12/13
Posted
Count of Participants
Participants
Before vaccination (PRE), one month post Dose 2 (Mth2) and one and six months post Dose 3 (Mth 7 and Mth 12)
ID
Title
Description
OG000
Cervarix + Boostrix/Menactra Group
Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
OG001
Cervarix + Menactra/Boostrix Group
Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
OG002
Cervarix + Boostrix + Menactra Group
Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
OG003
Secondary
Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 0.1 International Unit Per Milliliter (IU/mL)
Anti-D and anti-T antibodies cut-off values assessed include 0.1 international unit per milliliter (IU/mL)
Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity Month 1, and only for Cervarix + Boostrix/Menactra, Cervarix + Boostrix + Menactra and Boostrix/Cervarix groups
Posted
Count of Participants
Participants
Before and one month after vaccination with Boostrix
ID
Title
Description
OG000
Cervarix + Boostrix/Menactra Group
Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
OG001
Cervarix + Menactra/Boostrix Group
Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
OG002
Cervarix + Boostrix + Menactra Group
Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
OG003
Secondary
Concentration of Anti-D and Anti-T Antibodies
Concentrations given as Geometric Mean Concentrations (GMCs)
Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity Month 1, and only for Cervarix + Boostrix/Menactra, Cervarix + Boostrix + Menactra and Boostrix/Cervarix groups.
Posted
Geometric Mean
95% Confidence Interval
International Unit per Milliliter
Before and one month after vaccination with Boostrix
ID
Title
Description
OG000
Cervarix + Boostrix/Menactra Group
Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
OG001
Cervarix + Menactra/Boostrix Group
Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
OG002
Cervarix + Boostrix + Menactra Group
Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
OG003
Boostrix/Cervarix Group
Secondary
Number of Subjects With Booster Response for Anti-D and Anti-T
Booster responses for anti-D and anti-T defined as:
For initially seronegative subjects (pre-vaccination titer below cut-off: < 0.1 IU/mL): antibody titer at least 4 times the cut-off (post-vaccination titer ≥ 0.4 IU/mL)
For initially seropositive subjects (pre-vaccination titer above 0.1 IU/mL): an increase in antibody titer of at least 4 times the pre-vaccination titer
Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity Month 1, and only for Cervarix + Boostrix/Menactra, Cervarix + Boostrix + Menactra and Boostrix/Cervarix groups.
Posted
Count of Participants
Participants
One month after vaccination with Boostrix
ID
Title
Description
OG000
Cervarix + Boostrix/Menactra Group
Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
OG001
Cervarix + Menactra/Boostrix Group
Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
OG002
Cervarix + Boostrix + Menactra Group
Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
Secondary
Number of Subjects With Booster Response for Anti-PT, Anti-FHA and Anti-PRN
Booster responses defined as:
For initially seronegative subjects (pre-vaccination titer below cut-off: < 5 EL.U/mL): antibody titers at least 4 times the cut-off,
For initially seropositive subjects with pre-vaccination titer above 5 EL.U/mL and < 20 EL.U/mL: an increase in antibody titers of at least 4 times the pre-vaccination titer,
For initially seropositive subjects with pre-vaccination titer ≥ 20 EL.U/mL: an increase in antibody titers of at least two times the pre-vaccination titer
Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity Month 1, and only for Cervarix + Boostrix/Menactra, Cervarix + Boostrix + Menactra and Boostrix + Cervarix groups.
Posted
Count of Participants
Participants
One month after vaccination with Boostrix
ID
Title
Description
OG000
Cervarix + Boostrix/Menactra Group
Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
OG001
Cervarix + Menactra/Boostrix Group
Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
OG002
Cervarix + Boostrix + Menactra Group
Secondary
Number of Subjects With Anti-A, Anti-C, Anti-Y and Anti-W135 Vaccine Response
Vaccine responses for anti-A, C, Y and W-135 defined as:
For initially seronegative subjects (pre-vaccination titer below cut-off of 8): antibody titers at least 4 times the cut-off (post vaccination titer ≥ 32)
For initially seropositive subjects (pre-vaccination titer above 8): antibody titers at least 4 times the pre-vaccination antibody titer
Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity Month 1, and only for Cervarix + Menactra/Boostrix, Cervarix + Boostrix + Menactra and Menactra/Cervarix groups
Posted
Count of Participants
Participants
One month after vaccination with Menactra
ID
Title
Description
OG000
Cervarix + Boostrix/Menactra Group
Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
OG001
Cervarix + Menactra/Boostrix Group
Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
OG002
Cervarix + Boostrix + Menactra Group
Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
Secondary
Number of Subjects Reporting Solicited Local Symptoms
Solicited local symptoms assessed include pain, redness and swelling.
Analysis was performed on the Total Vaccinated cohort including all vaccinated subjects receiving one dose at least
Posted
Count of Participants
Participants
During the 7-day period following each vaccination
ID
Title
Description
OG000
Cervarix + Boostrix/Menactra Group
Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
OG001
Cervarix + Menactra/Boostrix Group
Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
OG002
Cervarix + Boostrix + Menactra Group
Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
OG003
Boostrix/Cervarix Group
Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
Secondary
Number of Subjects Reporting Solicited General Symptoms
Solicited general symptoms assessed include Arthralgia, fatigue, fever, gastrointestinal, headache, myalgia, rash and urticaria
Analysis was performed on the Total Vaccinated cohort including all vaccinated subjects receiving one dose at least
Posted
Count of Participants
Participants
During the 7-day period following each vaccination
ID
Title
Description
OG000
Cervarix + Boostrix/Menactra Group
Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
OG001
Cervarix + Menactra/Boostrix Group
Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
OG002
Cervarix + Boostrix + Menactra Group
Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
OG003
Boostrix/Cervarix Group
Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
Secondary
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Unsolicited adverse event = Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
Posted
Count of Participants
Participants
During the 30-day period following each vaccination
ID
Title
Description
OG000
Cervarix + Boostrix/Menactra Group
Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
OG001
Cervarix + Menactra/Boostrix Group
Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
OG002
Cervarix + Boostrix + Menactra Group
Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
OG003
Boostrix/Cervarix Group
Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
Secondary
Number of Subjects Reporting Serious Adverse Events
Serious adverse events assessed include medical occurrences that results in death, is 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
Count of Participants
Participants
During the active phase of the study (up to Month 7 or Month 8) and throughout the entire study (up to Month 12 or Month 13)
ID
Title
Description
OG000
Cervarix + Boostrix/Menactra Group
Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
OG001
Cervarix + Menactra/Boostrix Group
Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
OG002
Cervarix + Boostrix + Menactra Group
Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
OG003
Boostrix/Cervarix Group
Secondary
Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs)
NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes
Posted
Count of Participants
Participants
During the active phase of the study (up to Month 7 or Month 8) and throughout the entire study period (up to Month 12 or Month 13)
ID
Title
Description
OG000
Cervarix + Boostrix/Menactra Group
Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
OG001
Cervarix + Menactra/Boostrix Group
Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
OG002
Cervarix + Boostrix + Menactra Group
Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
OG003
Boostrix/Cervarix Group
Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
Secondary
Number of Subjects Reporting Medically Significant Adverse Events (AEs)
Medically significant AEs assessed include AEs prompting emergency room or physician visits that are not related to common diseases or SAEs that are not related to common diseases.
Posted
Count of Participants
Participants
During the active phase (up to Month 7 or Month 8) and throughout the entire study (up to Month 12 or Month 13)
ID
Title
Description
OG000
Cervarix + Boostrix/Menactra Group
Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
OG001
Cervarix + Menactra/Boostrix Group
Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
OG002
Cervarix + Boostrix + Menactra Group
Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
OG003
Boostrix/Cervarix Group
Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
Time Frame
Not provided
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 + Boostrix/Menactra Group
Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
1
202
212
EG001
Cervarix + Menactra/Boostrix Group
Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
3
207
214
EG002
Cervarix + Boostrix + Menactra Group
Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
4
205
214
EG003
Boostrix/Cervarix Group
Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
0
208
214
EG004
Menactra/Cervarix Group
Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
7
202
214
EG005
Cervarix Group
Subjects received Cervarix at Months 0, 1 and 6.
4
203
215
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Appendicitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected212 at risk
EG0011 affected214 at risk
EG0020 affected214 at risk
EG0030 affected214 at risk
EG0042 affected214 at risk
EG0050 affected215 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected212 at risk
EG0010 affected214 at risk
EG0020 affected214 at risk
EG003
Abortion spontaneous complete
Pregnancy, puerperium and perinatal conditions
MedDRA
Non-systematic Assessment
EG0000 affected212 at risk
EG0010 affected214 at risk
EG0020 affected214 at risk
EG003
Adjustment disorder
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected212 at risk
EG0010 affected214 at risk
EG0020 affected214 at risk
EG003
Bipolar disorder
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected212 at risk
EG0010 affected214 at risk
EG0020 affected214 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected212 at risk
EG0010 affected214 at risk
EG0020 affected214 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA
Non-systematic Assessment
EG0000 affected212 at risk
EG0010 affected214 at risk
EG0020 affected214 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected212 at risk
EG0010 affected214 at risk
EG0020 affected214 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected212 at risk
EG0010 affected214 at risk
EG0020 affected214 at risk
EG003
Hyphaema
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected212 at risk
EG0010 affected214 at risk
EG0021 affected214 at risk
EG003
Ligament rupture
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected212 at risk
EG0010 affected214 at risk
EG0021 affected214 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA
Non-systematic Assessment
EG0000 affected212 at risk
EG0010 affected214 at risk
EG0020 affected214 at risk
EG003
Pyrexia
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected212 at risk
EG0010 affected214 at risk
EG0020 affected214 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected212 at risk
EG0010 affected214 at risk
EG0020 affected214 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected212 at risk
EG0010 affected214 at risk
EG0020 affected214 at risk
EG003
Stevens-johnson syndrome
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected212 at risk
EG0011 affected214 at risk
EG0020 affected214 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected212 at risk
EG0010 affected214 at risk
EG0020 affected214 at risk
EG003
Viral infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected212 at risk
EG0010 affected214 at risk
EG0021 affected214 at risk
EG003
Conversion disorder
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected212 at risk
EG0010 affected214 at risk
EG0021 affected214 at risk
EG003
Depression
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected212 at risk
EG0011 affected214 at risk
EG0020 affected214 at risk
EG003
Facial palsy
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0001 affected212 at risk
EG0010 affected214 at risk
EG0020 affected214 at risk
EG003
Proctitis
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected212 at risk
EG0010 affected214 at risk
EG0020 affected214 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected212 at risk
EG0011 affected214 at risk
EG0020 affected214 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Pain
General disorders
Systematic Assessment
EG000197 affected212 at risk
EG001204 affected214 at risk
EG002204 affected214 at risk
EG003203 affected214 at risk
EG004193 affected214 at risk
EG005201 affected215 at risk
Redness
General disorders
Systematic Assessment
EG00097 affected212 at risk
EG00193 affected214 at risk
EG002103 affected214 at risk
EG003
Swelling
General disorders
Systematic Assessment
EG00094 affected212 at risk
EG00190 affected214 at risk
EG002102 affected214 at risk
EG003
Arthralgia
General disorders
Systematic Assessment
EG00037 affected212 at risk
EG00142 affected214 at risk
EG00234 affected214 at risk
EG003
Fatigue
General disorders
Systematic Assessment
EG00094 affected212 at risk
EG001100 affected214 at risk
EG002111 affected214 at risk
EG003
Fever
General disorders
Systematic Assessment
EG00031 affected212 at risk
EG00132 affected214 at risk
EG00224 affected214 at risk
EG003
Gastrointestinal
General disorders
Systematic Assessment
EG00059 affected212 at risk
EG00162 affected214 at risk
EG00270 affected214 at risk
EG003
Headache
General disorders
Systematic Assessment
EG000107 affected212 at risk
EG001118 affected214 at risk
EG002124 affected214 at risk
EG003
Myalgia
General disorders
Systematic Assessment
EG00080 affected212 at risk
EG00189 affected214 at risk
EG002101 affected214 at risk
EG003
Rash
General disorders
Systematic Assessment
EG00011 affected212 at risk
EG00112 affected214 at risk
EG00219 affected214 at risk
EG003
Urticaria
General disorders
Systematic Assessment
EG0007 affected212 at risk
EG0015 affected214 at risk
EG00212 affected214 at risk
EG003
Injection site haematoma
General disorders
MedDRA
Non-systematic Assessment
EG00037 affected212 at risk
EG00135 affected214 at risk
EG00229 affected214 at risk
EG003
Headache
Nervous system disorders
MedDRA
Non-systematic Assessment
EG00013 affected212 at risk
EG00116 affected214 at risk
EG00213 affected214 at risk
EG003
Nasopharynigitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG00011 affected212 at risk
EG00113 affected214 at risk
EG00213 affected214 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0008 affected212 at risk
EG0018 affected214 at risk
EG0020 affected214 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected212 at risk
EG00110 affected214 at risk
EG00212 affected214 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA
Non-systematic Assessment
EG0009 affected212 at risk
EG0010 affected214 at risk
EG00213 affected214 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected212 at risk
EG0010 affected214 at risk
EG0020 affected214 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected212 at risk
EG0010 affected214 at risk
EG0020 affected214 at risk
EG003
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
D014917
Whooping Cough
D013742
Tetanus
D008581
Meningitis
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
D001885
Bordetella Infections
D016905
Gram-Negative Bacterial Infections
D001424
Bacterial Infections
D001423
Bacterial Infections and Mycoses
D012141
Respiratory Tract Infections
D012140
Respiratory Tract Diseases
D003015
Clostridium Infections
D016908
Gram-Positive Bacterial Infections
D000090862
Neuroinflammatory Diseases
D009422
Nervous System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
FG0050 subjects
6 subjects
FG0052 subjects
9 subjects
FG0056 subjects
1 subjects
FG0053 subjects
13.5
± 2.33
BG00413.3± 2.35
BG00513.4± 2.34
BG00613.4± 2.3
214
BG003214
BG004214
BG005215
BG0061283
Male
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
199
OG0040
OG0050
199
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00038
OG00233
OG00339
Anti-D (1 month after vaccination)
ParticipantsOG000194
ParticipantsOG0010
ParticipantsOG002201
ParticipantsOG003199
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG000193
OG002200
OG003190
Anti-T (Before vaccination)
ParticipantsOG000194
ParticipantsOG0010
ParticipantsOG002199
ParticipantsOG003199
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG00075
OG00275
OG00372
Anti-T (1 month after vaccination)
ParticipantsOG000194
ParticipantsOG0010
ParticipantsOG002201
ParticipantsOG003199
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG000194
OG002201
OG003198
Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
OG004
Menactra/Cervarix Group
Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
OG005
Cervarix Group
Subjects received Cervarix at Months 0, 1 and 6.
Units
Counts
Participants
OG000194
OG0010
OG002201
OG003199
OG0040
OG0050
Title
Denominators
Categories
Anti-PT (Before vaccination)
ParticipantsOG000194
ParticipantsOG0010
ParticipantsOG002196
ParticipantsOG003198
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG0009.515(8.078 to 11.207)
OG00210.356(8.733 to 12.280)
OG00311.164(9.319 to 13.375)
Anti-PT (1month after vaccination)
ParticipantsOG000194
ParticipantsOG0010
ParticipantsOG002201
ParticipantsOG003199
Anti-FHA (Before vaccination)
ParticipantsOG000192
ParticipantsOG0010
ParticipantsOG002195
ParticipantsOG003196
Anti-FHA (1month after vaccination)
ParticipantsOG000194
ParticipantsOG0010
ParticipantsOG002201
ParticipantsOG003199
Anti-PRN (Before vaccination)
ParticipantsOG000193
ParticipantsOG0010
ParticipantsOG002199
ParticipantsOG003199
Anti-PRN(1month after vaccination)
ParticipantsOG000194
ParticipantsOG0010
ParticipantsOG002199
ParticipantsOG003198
Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
OG004
Menactra/Cervarix Group
Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
OG005
Cervarix Group
Subjects received Cervarix at Months 0, 1 and 6.
Units
Counts
Participants
OG0000
OG001200
OG002200
OG0030
OG004203
OG0050
Title
Denominators
Categories
Anti-A (Before vaccination)
ParticipantsOG0000
ParticipantsOG001180
ParticipantsOG002179
ParticipantsOG0030
ParticipantsOG004184
ParticipantsOG0050
Title
Measurements
OG001898.650(780.476 to 1034.717)
OG002829.508(716.806 to 959.931)
OG004763.324(648.325 to 898.721)
Anti-A (1month after vaccination)
ParticipantsOG0000
ParticipantsOG001190
ParticipantsOG002181
ParticipantsOG0030
Anti-C (Before vaccination)
ParticipantsOG0000
ParticipantsOG001184
ParticipantsOG002190
ParticipantsOG0030
Anti-C (1month after vaccination)
ParticipantsOG0000
ParticipantsOG001200
ParticipantsOG002200
ParticipantsOG0030
Anti-Y (Before vaccination)
ParticipantsOG0000
ParticipantsOG001183
ParticipantsOG002189
ParticipantsOG0030
Anti-Y (1month after vaccination)
ParticipantsOG0000
ParticipantsOG001200
ParticipantsOG002200
ParticipantsOG0030
Anti-W135 (Before vaccination)
ParticipantsOG0000
ParticipantsOG001185
ParticipantsOG002188
ParticipantsOG0030
Anti-W135(1month after vaccination)
ParticipantsOG0000
ParticipantsOG001200
ParticipantsOG002200
ParticipantsOG0030
Boostrix/Cervarix Group
Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
OG004
Menactra/Cervarix Group
Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
OG005
Cervarix Group
Subjects received Cervarix at Months 0, 1 and 6.
Units
Counts
Participants
OG000163
OG001158
OG002165
OG003156
OG004147
OG005166
Title
Denominators
Categories
Anti-HPV16 PRE
ParticipantsOG000163
ParticipantsOG001158
ParticipantsOG002164
ParticipantsOG003156
ParticipantsOG004146
ParticipantsOG005166
Title
Measurements
OG00019
OG0018
OG0029
OG003
Anti-HPV16 Mth2
ParticipantsOG000163
ParticipantsOG001158
ParticipantsOG002163
ParticipantsOG003156
Anti-HPV16 Mth7
ParticipantsOG000161
ParticipantsOG001158
ParticipantsOG002164
ParticipantsOG003156
Anti-HPV16 Mth12
ParticipantsOG000163
ParticipantsOG001158
ParticipantsOG002164
ParticipantsOG003156
Anti-HPV18 PRE
ParticipantsOG000163
ParticipantsOG001157
ParticipantsOG002165
ParticipantsOG003152
Anti-HPV18 Mth2
ParticipantsOG000163
ParticipantsOG001157
ParticipantsOG002164
ParticipantsOG003152
Anti-HPV18 Mth7
ParticipantsOG000161
ParticipantsOG001157
ParticipantsOG002165
ParticipantsOG003152
Anti-HPV18 Mth12
ParticipantsOG000163
ParticipantsOG001157
ParticipantsOG002165
ParticipantsOG003152
Boostrix/Cervarix Group
Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
OG004
Menactra/Cervarix Group
Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
OG005
Cervarix Group
Subjects received Cervarix at Months 0, 1 and 6.
Units
Counts
Participants
OG000194
OG0010
OG002201
OG003199
OG0040
OG0050
Title
Denominators
Categories
Anti-D (Before vaccination)
ParticipantsOG000193
ParticipantsOG0010
ParticipantsOG002199
ParticipantsOG003199
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG000170
OG002181
OG003167
Anti-D (1month after vaccination)
ParticipantsOG000194
ParticipantsOG0010
ParticipantsOG002201
ParticipantsOG003199
Anti-T (Before vaccination)
ParticipantsOG000194
ParticipantsOG0010
ParticipantsOG002199
ParticipantsOG003199
Anti-T (1month after vaccination)
ParticipantsOG000194
ParticipantsOG0010
ParticipantsOG002201
ParticipantsOG003199
Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
OG004
Menactra/Cervarix Group
Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
OG005
Cervarix Group
Subjects received Cervarix at Months 0, 1 and 6.
Units
Counts
Participants
OG000194
OG0010
OG002201
OG003199
OG0040
OG0050
Title
Denominators
Categories
Anti-D (Before vaccination)
ParticipantsOG000193
ParticipantsOG0010
ParticipantsOG002199
ParticipantsOG003199
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG0000.362(0.305 to 0.431)
OG0020.368(0.315 to 0.430)
OG0030.331(0.280 to 0.390)
Anti-D (1month after vaccination)
ParticipantsOG000194
ParticipantsOG0010
ParticipantsOG002201
ParticipantsOG003199
Anti-T (Before vaccination)
ParticipantsOG000194
ParticipantsOG0010
ParticipantsOG002199
ParticipantsOG003199
Anti-T (1month after vaccination)
ParticipantsOG000194
ParticipantsOG0010
ParticipantsOG002201
ParticipantsOG003199
OG003
Boostrix/Cervarix Group
Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
OG004
Menactra/Cervarix Group
Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
OG005
Cervarix Group
Subjects received Cervarix at Months 0, 1 and 6.
Units
Counts
Participants
OG000194
OG0010
OG002199
OG003199
OG0040
OG0050
Title
Denominators
Categories
Anti-D
ParticipantsOG000193
ParticipantsOG0010
ParticipantsOG002199
ParticipantsOG003199
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG000175
OG002196
OG003182
Anti-T
ParticipantsOG000194
ParticipantsOG0010
ParticipantsOG002199
ParticipantsOG003199
Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
OG003
Boostrix/Cervarix Group
Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
OG004
Menactra/Cervarix Group
Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
OG005
Cervarix Group
Subjects received Cervarix at Months 0, 1 and 6.
Units
Counts
Participants
OG000194
OG0010
OG002197
OG003198
OG0040
OG0050
Title
Denominators
Categories
Anti-PT
ParticipantsOG000194
ParticipantsOG0010
ParticipantsOG002196
ParticipantsOG003198
ParticipantsOG0040
ParticipantsOG0050
Title
Measurements
OG000138
OG002116
OG003133
Anti-FHA
ParticipantsOG000192
ParticipantsOG0010
ParticipantsOG002195
ParticipantsOG003196
Anti-PRN
ParticipantsOG000193
ParticipantsOG0010
ParticipantsOG002197
ParticipantsOG003198
OG003
Boostrix/Cervarix Group
Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
OG004
Menactra/Cervarix Group
Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
OG005
Cervarix Group
Subjects received Cervarix at Months 0, 1 and 6.
Units
Counts
Participants
OG0000
OG001185
OG002189
OG0030
OG004192
OG0050
Title
Denominators
Categories
Anti-A
ParticipantsOG0000
ParticipantsOG001170
ParticipantsOG002160
ParticipantsOG0030
ParticipantsOG004167
ParticipantsOG0050
Title
Measurements
OG001127
OG002112
OG004139
Anti-C
ParticipantsOG0000
ParticipantsOG001184
ParticipantsOG002189
ParticipantsOG0030
Anti-Y
ParticipantsOG0000
ParticipantsOG001183
ParticipantsOG002188
ParticipantsOG0030
Anti-W135
ParticipantsOG0000
ParticipantsOG001185
ParticipantsOG002187
ParticipantsOG0030
OG004
Menactra/Cervarix Group
Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
OG005
Cervarix Group
Subjects received Cervarix at Months 0, 1 and 6.
Units
Counts
Participants
OG000209
OG001208
OG002209
OG003211
OG004209
OG005210
Title
Denominators
Categories
Pain
Title
Measurements
OG000197
OG001204
OG002204
OG003203
OG004193
OG005201
Redness
Title
Measurements
OG00097
OG00193
OG002103
OG003
Swelling
Title
Measurements
OG00094
OG00190
OG002102
OG003
OG004
Menactra/Cervarix Group
Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
OG005
Cervarix Group
Subjects received Cervarix at Months 0, 1 and 6.
Units
Counts
Participants
OG000209
OG001208
OG002210
OG003211
OG004209
OG005210
Title
Denominators
Categories
Arthralgia
Title
Measurements
OG00037
OG00142
OG00234
OG00348
OG00433
OG00547
Fatigue
Title
Measurements
OG00094
OG001100
OG002111
OG003
Fever
Title
Measurements
OG00031
OG00132
OG00224
OG003
Gastrointestinal
Title
Measurements
OG00059
OG00162
OG00270
OG003
Headache
Title
Measurements
OG000107
OG001118
OG002124
OG003
Myalgia
Title
Measurements
OG00080
OG00189
OG002101
OG003
Rash
Title
Measurements
OG00011
OG00112
OG00219
OG003
Urticaria
Title
Measurements
OG0007
OG0015
OG00212
OG003
OG004
Menactra/Cervarix Group
Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
OG005
Cervarix Group
Subjects received Cervarix at Months 0, 1 and 6.
Units
Counts
Participants
OG000212
OG001214
OG002214
OG003214
OG004214
OG005215
Title
Denominators
Categories
Title
Measurements
OG000108
OG001121
OG002119
OG003122
OG004127
OG005118
Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
OG004
Menactra/Cervarix Group
Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
OG005
Cervarix Group
Subjects received Cervarix at Months 0, 1 and 6.
Units
Counts
Participants
OG000212
OG001214
OG002214
OG003214
OG004214
OG005215
Title
Denominators
Categories
During the active phase
Title
Measurements
OG0000
OG0012
OG0023
OG0030
OG0045
OG0054
During the entire study
Title
Measurements
OG0001
OG0013
OG0024
OG003
OG004
Menactra/Cervarix Group
Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
OG005
Cervarix Group
Subjects received Cervarix at Months 0, 1 and 6.
Units
Counts
Participants
OG000212
OG001214
OG002214
OG003214
OG004214
OG005215
Title
Denominators
Categories
During the active phase
Title
Measurements
OG0003
OG0016
OG0026
OG0035
OG00411
OG0056
During the entire study
Title
Measurements
OG0003
OG0016
OG0026
OG003
OG004
Menactra/Cervarix Group
Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.