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Trial record 66 of 91 for:    cervarix

Evaluation of Long-term Immunogenicity and Safety of a Human Papillomavirus (HPV) Vaccine in Healthy Female Subjects.

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ClinicalTrials.gov Identifier: NCT00877877
Recruitment Status : Completed
First Posted : April 8, 2009
Results First Posted : April 27, 2011
Last Update Posted : September 23, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Infections, Papillomavirus
Intervention Procedure: Blood sampling
Enrollment 632
Recruitment Details Subjects who participated in the primary study (NCT00196924) and received 3 doses of Cervarix.
Pre-assignment Details Subjects enrolled in this study were primed with Cervarix vaccine as part of study NCT00196924. Subjects not returning for a specific visit were not withdrawn and could participate in the subsequent follow-up phases. Actual enrollment differed depending on the rate of return for the follow-up study, so not all subjects enrolled came to each visit.
Arm/Group Title Cervarix Group
Hide Arm/Group Description Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
Period Title: Year 5
Started 397
Completed 397
Not Completed 0
Period Title: Year 6
Started 529
Completed 529
Not Completed 0
Period Title: Year 7
Started 523
Completed 523
Not Completed 0
Period Title: Year 8
Started 522
Completed 522
Not Completed 0
Period Title: Year 9
Started 507
Completed 507
Not Completed 0
Period Title: Year 10
Started 495
Completed 495
Not Completed 0
Arm/Group Title Cervarix Group
Hide Arm/Group Description Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
Overall Number of Baseline Participants 529
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 529 participants
Year 5 17.1  (1.40)
Year 6 18.0  (1.40)
Year 7 19.0  (1.39)
Year 8 20.0  (1.40)
Year 9 21.1  (1.42)
Year 10 22.0  (1.40)
Gender   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 529 participants
Female 397
Male 0
[1]
Measure Description: Year 5 cohort
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 529 participants
Female
529
 100.0%
Male
0
   0.0%
[1]
Measure Description: Year 6 cohort
Gender   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 529 participants
Female 523
Male 0
[1]
Measure Description: Year 7 cohort
Gender   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 529 participants
Female 522
Male 0
[1]
Measure Description: Year 8 cohort
Gender   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 529 participants
Female 507
Male 0
[1]
Measure Description: Year 9 cohort
Gender   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 529 participants
Female 495
Male 0
[1]
Measure Description: Year 10 cohort
1.Primary Outcome
Title Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
Hide Description

Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL.

Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.

A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination.

A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination.

Time Frame At Month 60
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 60 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 60 blood sampling timepoint.
Arm/Group Title Cervarix Group
Hide Arm/Group Description:
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
Overall Number of Participants Analyzed 358
Measure Type: Number
Unit of Measure: Subjects
anti-HPV-16 Month 60 [N=353] 353
anti-HPV-18 Month 60 [N=358] 358
2.Primary Outcome
Title Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
Hide Description

Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL.

Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.

A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination.

A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination.

Time Frame At Month 72
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 72 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 72 blood sampling timepoint.
Arm/Group Title Cervarix Group
Hide Arm/Group Description:
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
Overall Number of Participants Analyzed 478
Measure Type: Number
Unit of Measure: Subjects
anti-HPV-16 Month 72 [N=475] 475
anti-HPV-18 Month 72 [N=478] 478
3.Primary Outcome
Title Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
Hide Description

Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL.

Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.

A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination.

A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination.

Time Frame At Month 84
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 84 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 84 blood sampling timepoint.
Arm/Group Title Cervarix Group
Hide Arm/Group Description:
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
Overall Number of Participants Analyzed 473
Measure Type: Number
Unit of Measure: Subjects
HPV-16 Month 84 [N=469] 469
HPV-18 Month 84 [N=473] 473
4.Primary Outcome
Title Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
Hide Description

Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL.

Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.

A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination.

A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination.

Time Frame At Month 96
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 96 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 96 blood sampling timepoint.
Arm/Group Title Cervarix Group
Hide Arm/Group Description:
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
Overall Number of Participants Analyzed 477
Measure Type: Number
Unit of Measure: Subjects
anti-HPV-16 Month 96 [N=473] 473
anti-HPV-18 Month 96 [N=477] 477
5.Primary Outcome
Title Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
Hide Description Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).
Time Frame At Month 60
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 60 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 60 blood sampling timepoint.
Arm/Group Title Cervarix Group
Hide Arm/Group Description:
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
Overall Number of Participants Analyzed 376
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
anti-HPV-16 Month 60 [N=376]
2262.9
(2069.1 to 2475.0)
anti-HPV-18 Month 60 [N=376]
778.6
(703.1 to 862.1)
6.Primary Outcome
Title Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
Hide Description Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).
Time Frame At month 72
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 72 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 72 blood sampling timepoint.
Arm/Group Title Cervarix Group
Hide Arm/Group Description:
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
Overall Number of Participants Analyzed 502
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
anti-HPV-16 Month 72 [N=502]
1973.9
(1827.9 to 2131.6)
anti-HPV-18 Month 72 [N=502]
762.8
(701.0 to 830.1)
7.Primary Outcome
Title Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
Hide Description Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).
Time Frame At Month 84
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 84 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 84 blood sampling timepoint.
Arm/Group Title Cervarix Group
Hide Arm/Group Description:
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
Overall Number of Participants Analyzed 494
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
anti-HPV-016 Month 84 [N=494]
1756.7
(1622.7 to 1901.7)
anti-HPV-018 Month 84 [N=494]
609.7
(559.0 to 664.9)
8.Primary Outcome
Title Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
Hide Description Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).
Time Frame At Month 96
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 96 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 96 blood sampling timepoint.
Arm/Group Title Cervarix Group
Hide Arm/Group Description:
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
Overall Number of Participants Analyzed 499
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
anti-HPV-16 Month 96 [N=499]
1671.0
(1548.1 to 1803.7)
anti-HPV-18 Month 96 [N=499]
679.0
(623.5 to 739.4)
9.Primary Outcome
Title Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
Hide Description Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination. A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination.
Time Frame At Month 108
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 108 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 108 blood sampling timepoint.
Arm/Group Title Cervarix Group
Hide Arm/Group Description:
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
Overall Number of Participants Analyzed 374
Measure Type: Number
Unit of Measure: Subjects
Anti-HPV-16 Month 108 [N=374] 372
Anti-HPV-18 Month 108 [N=370] 368
10.Primary Outcome
Title Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
Hide Description Anti-HPV-16 and 18 antibody titers are given in Geometric Mean Titers (GMTs) in Enzyme-linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).
Time Frame At Month 108
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 108 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 108 blood sampling timepoint.
Arm/Group Title Cervarix Group
Hide Arm/Group Description:
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
Overall Number of Participants Analyzed 392
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/ML
Anti-HPV-16 Month 108 [N=392]
1946.5
(1779.7 to 2128.9)
Anti-HPV-18 Month 108 [N=391]
754.0
(685.4 to 829.4)
11.Primary Outcome
Title Anti-human Papillomavirus-16 and 18 (Anti-HPV-16/18) Antibody Titers
Hide Description Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination. A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination.
Time Frame At Month 120
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 120 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 120 blood sampling timepoint.
Arm/Group Title Cervarix Group
Hide Arm/Group Description:
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
Overall Number of Participants Analyzed 416
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-HPV-16 Month 120 [N=416]
1607.9
(1480.8 to 1746.1)
Anti-HPV-18 Month 120 [N=415]
608
(552.5 to 669.1)
12.Primary Outcome
Title Number of Seroconverted Subjects With Anti-HPV-16/18 Antibody Titers Equal to or Above Cut-off Values.
Hide Description Anti-HPV-16 assay cut-off value was defined as 8 ELISA units per milliliter (EL.U/mL). Anti-HPV-18 assay cut-off value was defined as 7 EL.U/mL. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject with antibody titer < 8 or 7 EL.U/mL prior to vaccination. A seropositive subject is a subject with antibody titer >= 8 or 7 EL.U/mL prior to vaccination.
Time Frame At Month 120
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity Month 120 which included all evaluable subjects from the primary study (NCT00196924) for whom serology results were available at the Month 120 blood sampling timepoint.
Arm/Group Title Cervarix Group
Hide Arm/Group Description:
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
Overall Number of Participants Analyzed 395
Measure Type: Number
Unit of Measure: Subjects
Anti-HPV-16 Month 120 [N=393] 393
Anti-HPV-18 Month 120 [N=395] 395
13.Secondary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs)
Hide Description 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.
Time Frame From Month 48 to Month 60
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Month 60 Total Vaccinated cohort, which included all vaccinated subjects (who had received 3 doses during the primary study (NCT00196924)) for whom data were available for the Month 60 time point.
Arm/Group Title Cervarix Group
Hide Arm/Group Description:
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
Overall Number of Participants Analyzed 397
Measure Type: Number
Unit of Measure: Subjects
9
14.Secondary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs)
Hide Description 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.
Time Frame From Month 60 to Month 72
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Month 72 Total Vaccinated cohort, which included all vaccinated subjects (who had received 3 doses during the primary study (NCT00196924)) for whom data were available for the Month 72 time point.
Arm/Group Title Cervarix Group
Hide Arm/Group Description:
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
Overall Number of Participants Analyzed 529
Measure Type: Number
Unit of Measure: Subjects
20
15.Secondary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs)
Hide Description 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.
Time Frame From Month 72 to Month 84
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Month 84 Total Vaccinated cohort, which included all vaccinated subjects (who had received 3 doses during the primary study (NCT00196924)) for whom data were available for the Month 84 time point.
Arm/Group Title Cervarix Group
Hide Arm/Group Description:
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
Overall Number of Participants Analyzed 523
Measure Type: Number
Unit of Measure: Subjects
20
16.Secondary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs)
Hide Description 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.
Time Frame From Month 84 to Month 96
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cervarix Group
Hide Arm/Group Description:
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
Overall Number of Participants Analyzed 522
Measure Type: Number
Unit of Measure: Subjects
8
17.Secondary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs)
Hide Description 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.
Time Frame From Month 96 to Month 108
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cervarix Group
Hide Arm/Group Description:
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
Overall Number of Participants Analyzed 507
Measure Type: Number
Unit of Measure: Subjects
15
18.Secondary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs)
Hide Description 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.
Time Frame From Month 108 to Month 120
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cervarix Group
Hide Arm/Group Description:
Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
Overall Number of Participants Analyzed 495
Measure Type: Number
Unit of Measure: Subjects
6
Time Frame Serious Adverse Events were assessed by time intervals: Months 48-60, Months 60-72, Months 72-84, Months 84-96, Months 96-108 and Months 108-120.
Adverse Event Reporting Description Other (non-serious) Adverse Events were not collected/assessed during this long-term follow-up study.
 
Arm/Group Title Cervarix Group From Month 48 Until Month 60 Cervarix Group From Month 60 Until Month 72 Cervarix Group From Month 72 to Month 84 Cervarix Group From Month 84 to Month 96 Cervarix Group From Month 96 to Month 108 Cervarix Group From Month 108 to Month 120
Hide Arm/Group Description Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule and for whom serious adverse events were collected from Month 48 until Month 60. Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule and for whom serious adverse events were collected from Month 60 until Month 72. Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule and for whom serious adverse events were collected from Month 72 until Month 84. Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule and for whom serious adverse events were collected from Month 84 until Month 96. Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule and for whom serious adverse events were collected from Month 96 until Month 108. Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule and for whom serious adverse events were collected from Month 108 until Month 120.
All-Cause Mortality
Cervarix Group From Month 48 Until Month 60 Cervarix Group From Month 60 Until Month 72 Cervarix Group From Month 72 to Month 84 Cervarix Group From Month 84 to Month 96 Cervarix Group From Month 96 to Month 108 Cervarix Group From Month 108 to Month 120
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cervarix Group From Month 48 Until Month 60 Cervarix Group From Month 60 Until Month 72 Cervarix Group From Month 72 to Month 84 Cervarix Group From Month 84 to Month 96 Cervarix Group From Month 96 to Month 108 Cervarix Group From Month 108 to Month 120
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/397 (2.27%)   20/529 (3.78%)   20/523 (3.82%)   8/522 (1.53%)   15/507 (2.96%)   6/495 (1.21%) 
Congenital, familial and genetic disorders             
Skull malformation * 1  1/397 (0.25%)  0/529 (0.00%)  0/523 (0.00%)  0/522 (0.00%)  0/507 (0.00%)  0/495 (0.00%) 
Congenital megaureter * 1  0/397 (0.00%)  0/529 (0.00%)  1/523 (0.19%)  0/522 (0.00%)  0/507 (0.00%)  0/495 (0.00%) 
Talipes * 1  0/397 (0.00%)  0/529 (0.00%)  1/523 (0.19%)  0/522 (0.00%)  0/507 (0.00%)  0/495 (0.00%) 
Heart disease congenital  0/397 (0.00%)  0/529 (0.00%)  0/523 (0.00%)  0/522 (0.00%)  1/507 (0.20%)  0/495 (0.00%) 
Pulmonary malformation  0/397 (0.00%)  0/529 (0.00%)  0/523 (0.00%)  0/522 (0.00%)  1/507 (0.20%)  0/495 (0.00%) 
Gastrointestinal disorders             
Duodenal ulcer * 1  1/397 (0.25%)  0/529 (0.00%)  1/523 (0.19%)  0/522 (0.00%)  0/507 (0.00%)  0/495 (0.00%) 
Peritonitis * 1  0/397 (0.00%)  1/529 (0.19%)  0/523 (0.00%)  0/522 (0.00%)  0/507 (0.00%)  0/495 (0.00%) 
Crohn’s disease * 1  0/397 (0.00%)  0/529 (0.00%)  1/523 (0.19%)  0/522 (0.00%)  0/507 (0.00%)  0/495 (0.00%) 
Diverticulum intestinal * 1  0/397 (0.00%)  0/529 (0.00%)  1/523 (0.19%)  0/522 (0.00%)  0/507 (0.00%)  0/495 (0.00%) 
Gastritis * 1  0/397 (0.00%)  0/529 (0.00%)  1/523 (0.19%)  0/522 (0.00%)  0/507 (0.00%)  0/495 (0.00%) 
Coeliac disease  0/397 (0.00%)  0/529 (0.00%)  0/523 (0.00%)  0/522 (0.00%)  1/507 (0.20%)  0/495 (0.00%) 
Enteritis  0/397 (0.00%)  0/529 (0.00%)  0/523 (0.00%)  0/522 (0.00%)  1/507 (0.20%)  0/495 (0.00%) 
Irritable bowel syndrome *  0/397 (0.00%)  0/529 (0.00%)  0/523 (0.00%)  0/522 (0.00%)  0/507 (0.00%)  1/495 (0.20%) 
General disorders             
Pain * 1  0/397 (0.00%)  1/529 (0.19%)  0/523 (0.00%)  0/522 (0.00%)  0/507 (0.00%)  0/495 (0.00%) 
Infections and infestations             
Abscess * 1  1/397 (0.25%)  0/529 (0.00%)  0/523 (0.00%)  0/522 (0.00%)  0/507 (0.00%)  0/495 (0.00%) 
Appendicitis * 1  1/397 (0.25%)  1/529 (0.19%)  1/523 (0.19%)  0/522 (0.00%)  0/507 (0.00%)  0/495 (0.00%) 
Cystitis * 1  1/397 (0.25%)  0/529 (0.00%)  0/523 (0.00%)  0/522 (0.00%)  0/507 (0.00%)  0/495 (0.00%) 
Pyelonephritis * 1  1/397 (0.25%)  0/529 (0.00%)  0/523 (0.00%)  0/522 (0.00%)  0/507 (0.00%)  0/495 (0.00%) 
Dengue fever * 1  0/397 (0.00%)  2/529 (0.38%)  0/523 (0.00%)  0/522 (0.00%)  0/507 (0.00%)  0/495 (0.00%) 
Pharyngeal abscess * 1  0/397 (0.00%)  2/529 (0.38%)  0/523 (0.00%)  0/522 (0.00%)  0/507 (0.00%)  0/495 (0.00%) 
Breast abscess * 1  0/397 (0.00%)  1/529 (0.19%)  0/523 (0.00%)  0/522 (0.00%)  0/507 (0.00%)  0/495 (0.00%) 
Chronic sinusitis * 1  0/397 (0.00%)  1/529 (0.19%)  0/523 (0.00%)  0/522 (0.00%)  0/507 (0.00%)  0/495 (0.00%) 
Endometritis * 1  0/397 (0.00%)  1/529 (0.19%)  0/523 (0.00%)  0/522 (0.00%)  0/507 (0.00%)  0/495 (0.00%) 
Endometritis decidual * 1  0/397 (0.00%)  0/529 (0.00%)  1/523 (0.19%)  0/522 (0.00%)  0/507 (0.00%)  0/495 (0.00%) 
Gastroenteritis * 1  0/397 (0.00%)  0/529 (0.00%)  1/523 (0.19%)  0/522 (0.00%)  0/507 (0.00%)  0/495 (0.00%) 
Upper respiratory tract infection * 1  0/397 (0.00%)  0/529 (0.00%)  1/523 (0.19%)  0/522 (0.00%)  0/507 (0.00%)  0/495 (0.00%) 
Urinary tract infection *  0/397 (0.00%)  0/529 (0.00%)  0/523 (0.00%)  2/522 (0.38%)  0/507 (0.00%)  1/495 (0.20%) 
Peritonsillar abscess *  0/397 (0.00%)  0/529 (0.00%)  0/523 (0.00%)  1/522 (0.19%)  0/507 (0.00%)  0/495 (0.00%) 
Endometritis  0/397 (0.00%)  0/529 (0.00%)  0/523 (0.00%)  0/522 (0.00%)  1/507 (0.20%)  0/495 (0.00%) 
Pilonidal cyst  0/397 (0.00%)  0/529 (0.00%)  0/523 (0.00%)  0/522 (0.00%)  1/507 (0.20%)  0/495 (0.00%) 
Postoperative wound infection  0/397 (0.00%)  0/529 (0.00%)  0/523 (0.00%)  0/522 (0.00%)  1/507 (0.20%)  0/495 (0.00%) 
Pneumonia mycoplasmal *  0/397 (0.00%)  0/529 (0.00%)  0/523 (0.00%)  0/522 (0.00%)  0/507 (0.00%)  1/495 (0.20%) 
Injury, poisoning and procedural complications             
Alcohol poisoning * 1  0/397 (0.00%)  1/529 (0.19%)  0/523 (0.00%)  0/522 (0.00%)  0/507 (0.00%)  0/495 (0.00%) 
Burns third degree * 1  0/397 (0.00%)  1/529 (0.19%)  0/523 (0.00%)  0/522 (0.00%)  0/507 (0.00%)  0/495 (0.00%) 
Multiple injuries * 1  0/397 (0.00%)  1/529 (0.19%)  2/523 (0.38%)  0/522 (0.00%)  0/507 (0.00%)  0/495 (0.00%) 
Joint dislocation * 1  0/397 (0.00%)  0/529 (0.00%)  1/523 (0.19%)  0/522 (0.00%)  0/507 (0.00%)  0/495 (0.00%) 
Stab wound * 1  0/397 (0.00%)  0/529 (0.00%)  1/523 (0.19%)  0/522 (0.00%)  0/507 (0.00%)  0/495 (0.00%) 
Abdominal injury *  0/397 (0.00%)  0/529 (0.00%)  0/523 (0.00%)  1/522 (0.19%)  0/507 (0.00%)  0/495 (0.00%) 
Ligament rupture *  0/397 (0.00%)  0/529 (0.00%)  0/523 (0.00%)  1/522 (0.19%)  0/507 (0.00%)  0/495 (0.00%) 
Contusion  0/397 (0.00%)  0/529 (0.00%)  0/523 (0.00%)  0/522 (0.00%)  1/507 (0.20%)  0/495 (0.00%) 
Excoriation  0/397 (0.00%)  0/529 (0.00%)  0/523 (0.00%)  0/522 (0.00%)  1/507 (0.20%)  0/495 (0.00%) 
Metabolism and nutrition disorders             
Type 1 diabetes mellitus * 1  0/397 (0.00%)  1/529 (0.19%)  0/523 (0.00%)  0/522 (0.00%)  0/507 (0.00%)  0/495 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Ovarian germ cell teratoma benign * 1  0/397 (0.00%)  1/529 (0.19%)  0/523 (0.00%)  0/522 (0.00%)  0/507 (0.00%)  0/495 (0.00%) 
Fibroadenoma of breast * 1  0/397 (0.00%)  0/529 (0.00%)  1/523 (0.19%)  0/522 (0.00%)  0/507 (0.00%)  0/495 (0.00%) 
Ovarian neoplasm  0/397 (0.00%)  0/529 (0.00%)  0/523 (0.00%)  0/522 (0.00%)  1/507 (0.20%)  0/495 (0.00%) 
Hodgkin’s disease *  0/397 (0.00%)  0/529 (0.00%)  0/523 (0.00%)  0/522 (0.00%)  0/507 (0.00%)  1/495 (0.20%) 
Nervous system disorders             
Brain injury * 1  0/397 (0.00%)  1/529 (0.19%)  0/523 (0.00%)  0/522 (0.00%)  0/507 (0.00%)  0/495 (0.00%) 
Cerebral cyst * 1  0/397 (0.00%)  0/529 (0.00%)  1/523 (0.19%)  0/522 (0.00%)  0/507 (0.00%)  0/495 (0.00%) 
Syncope  0/397 (0.00%)  0/529 (0.00%)  0/523 (0.00%)  0/522 (0.00%)  1/507 (0.20%)  0/495 (0.00%) 
Tension headache  0/397 (0.00%)  0/529 (0.00%)  0/523 (0.00%)  0/522 (0.00%)  1/507 (0.20%)  0/495 (0.00%) 
Pregnancy, puerperium and perinatal conditions             
Abortion spontaneous complete * 1  1/397 (0.25%)  0/529 (0.00%)  0/523 (0.00%)  0/522 (0.00%)  0/507 (0.00%)  0/495 (0.00%) 
Abortion spontaneous incomplete * 1  1/397 (0.25%)  3/529 (0.57%)  2/523 (0.38%)  1/522 (0.19%)  0/507 (0.00%)  0/495 (0.00%) 
Threatened labour * 1  1/397 (0.25%)  1/529 (0.19%)  0/523 (0.00%)  0/522 (0.00%)  0/507 (0.00%)  0/495 (0.00%) 
Pre-eclampsia * 1  0/397 (0.00%)  1/529 (0.19%)  0/523 (0.00%)  0/522 (0.00%)  1/507 (0.20%)  0/495 (0.00%) 
Olygohydramnios * 1  0/397 (0.00%)  0/529 (0.00%)  2/523 (0.38%)  0/522 (0.00%)  0/507 (0.00%)  0/495 (0.00%) 
Foetal death * 1  0/397 (0.00%)  0/529 (0.00%)  1/523 (0.19%)  0/522 (0.00%)  0/507 (0.00%)  0/495 (0.00%) 
Cervical incompetence *  0/397 (0.00%)  0/529 (0.00%)  0/523 (0.00%)  1/522 (0.19%)  0/507 (0.00%)  0/495 (0.00%) 
Gestational diabetes *  0/397 (0.00%)  0/529 (0.00%)  0/523 (0.00%)  1/522 (0.19%)  0/507 (0.00%)  0/495 (0.00%) 
Abortion spontaneous  0/397 (0.00%)  0/529 (0.00%)  0/523 (0.00%)  0/522 (0.00%)  1/507 (0.20%)  0/495 (0.00%) 
Ectopic pregnancy  0/397 (0.00%)  0/529 (0.00%)  0/523 (0.00%)  0/522 (0.00%)  1/507 (0.20%)  1/495 (0.20%) 
Premature baby  0/397 (0.00%)  0/529 (0.00%)  0/523 (0.00%)  0/522 (0.00%)  1/507 (0.20%)  0/495 (0.00%) 
Stillbirth  0/397 (0.00%)  0/529 (0.00%)  0/523 (0.00%)  0/522 (0.00%)  1/507 (0.20%)  0/495 (0.00%) 
Psychiatric disorders             
Suicide attempt * 1  0/397 (0.00%)  1/529 (0.19%)  0/523 (0.00%)  1/522 (0.19%)  0/507 (0.00%)  0/495 (0.00%) 
Depression * 1  0/397 (0.00%)  0/529 (0.00%)  1/523 (0.19%)  0/522 (0.00%)  0/507 (0.00%)  0/495 (0.00%) 
Drug abuse *  0/397 (0.00%)  0/529 (0.00%)  0/523 (0.00%)  1/522 (0.19%)  0/507 (0.00%)  0/495 (0.00%) 
Renal and urinary disorders             
Hydronephrosis * 1  0/397 (0.00%)  0/529 (0.00%)  1/523 (0.19%)  0/522 (0.00%)  0/507 (0.00%)  0/495 (0.00%) 
Reproductive system and breast disorders             
Ovarian cyst * 1  1/397 (0.25%)  0/529 (0.00%)  0/523 (0.00%)  0/522 (0.00%)  0/507 (0.00%)  0/495 (0.00%) 
Ovarian cyst ruptured  0/397 (0.00%)  0/529 (0.00%)  0/523 (0.00%)  0/522 (0.00%)  1/507 (0.20%)  0/495 (0.00%) 
Inguinal hernia *  0/397 (0.00%)  0/529 (0.00%)  0/523 (0.00%)  0/522 (0.00%)  0/507 (0.00%)  1/495 (0.20%) 
Respiratory, thoracic and mediastinal disorders             
Neonatal asphyxia  0/397 (0.00%)  0/529 (0.00%)  0/523 (0.00%)  0/522 (0.00%)  1/507 (0.20%)  0/495 (0.00%) 
Neonatal respiratory distress syndrome  0/397 (0.00%)  0/529 (0.00%)  0/523 (0.00%)  0/522 (0.00%)  1/507 (0.20%)  0/495 (0.00%) 
Neonatal tachypnoea  0/397 (0.00%)  0/529 (0.00%)  0/523 (0.00%)  0/522 (0.00%)  1/507 (0.20%)  0/495 (0.00%) 
Surgical and medical procedures             
Abortion induced * 1  0/397 (0.00%)  0/529 (0.00%)  1/523 (0.19%)  0/522 (0.00%)  0/507 (0.00%)  0/495 (0.00%) 
Vascular disorders             
Circulatory collapse * 1  0/397 (0.00%)  1/529 (0.19%)  0/523 (0.00%)  0/522 (0.00%)  0/507 (0.00%)  0/495 (0.00%) 
Hypertension *  0/397 (0.00%)  0/529 (0.00%)  0/523 (0.00%)  1/522 (0.19%)  0/507 (0.00%)  0/495 (0.00%) 
Hypovolaemic shock  0/397 (0.00%)  0/529 (0.00%)  0/523 (0.00%)  0/522 (0.00%)  1/507 (0.20%)  0/495 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cervarix Group From Month 48 Until Month 60 Cervarix Group From Month 60 Until Month 72 Cervarix Group From Month 72 to Month 84 Cervarix Group From Month 84 to Month 96 Cervarix Group From Month 96 to Month 108 Cervarix Group From Month 108 to Month 120
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00877877     History of Changes
Other Study ID Numbers: 111375
First Submitted: March 26, 2009
First Posted: April 8, 2009
Results First Submitted: March 31, 2011
Results First Posted: April 27, 2011
Last Update Posted: September 23, 2016