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Trial record 34 of 91 for:    cervarix

Human Papilloma Virus (HPV) Vaccine Immunogenicity and Safety Trial in Young and Adult Women With GSK Biologicals' HPV-16/18

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ClinicalTrials.gov Identifier: NCT00196937
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : August 6, 2010
Last Update Posted : January 11, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Infections, Papillomavirus
Intervention Biological: Cervarix™
Enrollment 667
Recruitment Details  
Pre-assignment Details One subject that was enrolled into this study was not vaccinated and hence not counted as "started" here below.
Arm/Group Title Cervarix (15-25 Years) Group Cervarix (26-45 Years) Group Cervarix (46-55 Years) Group
Hide Arm/Group Description Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule. Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule. Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
Period Title: Overall Study
Started 229 226 211
Completed 220 221 204
Not Completed 9 5 7
Reason Not Completed
Adverse Event             2             1             1
Subject did not come due to holidays             3             1             0
Lost to Follow-up             4             3             3
Withdrawal by Subject             0             0             3
Arm/Group Title Cervarix (15-25 Years) Group Cervarix (26-45 Years) Group Cervarix (46-55 Years) Group Total
Hide Arm/Group Description Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule. Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule. Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule. Total of all reporting groups
Overall Number of Baseline Participants 229 226 211 666
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 229 participants 226 participants 211 participants 666 participants
20.9  (2.67) 35.5  (6.02) 49.6  (2.80) 34.9  (12.38)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 229 participants 226 participants 211 participants 666 participants
Female
229
 100.0%
226
 100.0%
211
 100.0%
666
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies, in Women 15 to 25 Years of Age and Women 26 to 45 Years of Age
Hide Description

Seroconversion is defined as the appearance of anti-HPV-16 and/or anti- HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination.

Cut-off values were 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.

Seroconversion at Month 7 was a secondary outcome measure as per protocol for Cervarix (46-55 Years) Group.

Time Frame At Month 7
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on initially seronegative subjects from the According-to-Protocol (ATP) cohort for analysis of immunogenicity. Data for the Cervarix (46-55 Years) Group are presented in the Outcome #6.
Arm/Group Title Cervarix (15-25 Years) Group Cervarix (26-45 Years) Group Cervarix (46-55 Years) Group
Hide Arm/Group Description:
Women of 15-25 years of age received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine)administered according to a 0, 1, 6-month schedule
Women of 26-45 years of age received 3 doses of Cervarix™ (HPV vaccine)administered according to a 0, 1, 6-month schedule
Women of 46-55 years of age received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule
Overall Number of Participants Analyzed 202 185 0
Measure Type: Number
Unit of Measure: subjects
Anti-HPV-16 (N=191;164) 191 164
Anti-HPV-18 (N=202;185) 202 185
2.Primary Outcome
Title Titer of Anti-HPV-16 and Anti-HPV-18 Antibodies
Hide Description

Titer given as geometric mean titer (GMT).

Primary outcome measure assessed at Month 18, 24, 36, and 48.

Time Frame Before vaccination (PRE) and at Months 2, 7, 12, 18, 24, 36 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data at the defined timepoint.
Arm/Group Title Cervarix (15-25 Years) Group Cervarix (26-45 Years) Group Cervarix (46-55 Years) Group
Hide Arm/Group Description:
Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule.
Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 224 219 201
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-HPV-16 (PRE) (N=224;219;199)
5.1
(4.6 to 5.6)
7.5
(6.4 to 8.8)
7.1
(6.1 to 8.2)
Anti-HPV-16 (Month 2) (N=224;219;199)
3162.2
(2875.7 to 3477.4)
2379.1
(2067.8 to 2737.3)
1768.7
(1522.3 to 2055.0)
Anti-HPV-16 (Month 7) (N=219;217;196)
7790.3
(6849.2 to 8860.7)
4060.0
(3510.8 to 4695.0)
2835.8
(2450.9 to 3281.2)
Anti-HPV-16 (Month 12) (N=208;214;193)
3057.9
(2657.1 to 3519.2)
1740.7
(1490.9 to 2032.5)
1182.0
(1015.1 to 1376.4)
Anti-HPV-16 (Month 18) (N=169;172;174)
2220.1
(1912.0 to 2577.7)
1068.9
(899.2 to 1270.6)
809.0
(681.2 to 960.7)
Anti-HPV-16 (Month 24) (N=166;178;175)
1752.8
(1496.8 to 2052.6)
858.1
(717.8 to 1025.9)
646.2
(544.5 to 766.9)
Anti-HPV-16 (Month 36) (N=161;172;167)
1517.7
(1299.7 to 1772.1)
725.0
(608.8 to 863.5)
503.3
(420.4 to 602.6)
Anti-HPV-16 (Month 48) (N=168;186;175)
1377.3
(1177.0 to 1611.8)
638.2
(537.8 to 757.3)
450.5
(376.7 to 538.6)
Anti-HPV-18 (PRE) (N=223;218;201)
3.9
(3.7 to 4.2)
4.5
(4.1 to 4.9)
4.4
(4.0 to 4.9)
Anti-HPV-18 (Month 2) (N=223;218;201)
2234.4
(2009.6 to 2484.2)
1441.7
(1284.6 to 1617.9)
1015.8
(898.7 to 1148.1)
Anti-HPV-18 (Month 7) (N=218;216;198)
3452.9
(3071.8 to 3881.3)
1880.9
(1660.7 to 2130.3)
1377.5
(1212.8 to 1564.6)
Anti-HPV-18 (Month 12) (N=207;213;195)
1291.3
(1124.1 to 1483.4)
658.4
(567.9 to 763.3)
480.1
(416.1 to 554.0)
Anti-HPV-18 (Month 18) (N=168;171;176)
828.2
(708.8 to 967.7)
354.7
(301.1 to 417.8)
275.5
(234.8 to 323.2)
Anti-HPV-18 (Month 24) (N=165;178;177)
676.6
(574.2 to 797.2)
304.1
(258.2 to 358.0)
212.2
(179.5 to 250.9)
Anti-HPV-18 (Month 36) (N=160;172;169)
489.7
(413.7 to 579.7)
238.8
(202.8 to 281.0)
156.6
(132.0 to 185.7)
Anti-HPV-18 (Month 48) (N=167;185;177)
486.6
(413.1 to 573.2)
205.6
(175.8 to 240.4)
137.5
(115.5 to 163.7)
3.Secondary Outcome
Title Titer of Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervical Samples
Hide Description Titer given as GMT.
Time Frame At Months 18 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on subjects from the Total vaccinated for whom cervical secretions results were available for Months 18 and/or 24.
Arm/Group Title Cervarix (15-25 Years) Group Cervarix (26-45 Years) Group Cervarix (46-55 Years) Group
Hide Arm/Group Description:
Women of 15-25 years of age received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine)administered according to a 0, 1, 6-month schedule
Women of 26-45 years of age received 3 doses of Cervarix™ (HPV vaccine)administered according to a 0, 1, 6-month schedule
Women of 46-55 years of age received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule
Overall Number of Participants Analyzed 59 51 41
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-HPV-16 (Mth18) (N=41;47;39)
63.6
(43.0 to 94.2)
50.7
(32.7 to 78.5)
56.1
(36.3 to 86.7)
Anti-HPV-16 (Mth24) (N=59;51;41)
59.2
(44.3 to 79.3)
52.7
(36.5 to 76.2)
68.8
(41.0 to 115.4)
Anti-HPV-18 (Mth18) (N=41;47;39)
28.4
(17.5 to 46.0)
38.5
(21.5 to 68.9)
21.2
(15.2 to 29.6)
Anti-HPV-18 (Mth24) (N=59;51;41)
23.3
(17.4 to 31.3)
32.4
(21.5 to 48.8)
31.2
(19.2 to 50.5)
4.Secondary Outcome
Title Number of Subjects Seropositive for Total Immunoglobulin-G (IgG) in Blood (Serum) and in Cervical Samples (Secretion)
Hide Description Seropositivity is defined as total IgG above or equal to 0 microgram per milliliter (µg/mL).
Time Frame At Months 18 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Cervicovaginal samples subset cohort, including subjects for whom cervicovaginal secretion samples with less than 80 erythrocytes per milliliter were collected and results were available for Months 18 and/or 24.
Arm/Group Title Cervarix (15-25 Years) Group Cervarix (26-45 Years) Group Cervarix (46-55 Years) Group
Hide Arm/Group Description:
Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule.
Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 59 51 51
Measure Type: Number
Unit of Measure: subjects
IgG serum (Month 18) (N=44;51;51) 44 51 51
IgG serum (Month 24) (N=59;51;41) 59 51 41
IgG secretion (Month 18) (N=41;47;39) 39 47 39
IgG secretion (Month 24) (N=59;51;41) 57 50 41
5.Secondary Outcome
Title Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies, in Women 46 - 55 Years of Age
Hide Description

Seroconversion is defined as the appearance of anti-HPV-16 and/or anti- HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination.

Cut-off values were 8 EL.U/mL for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.

Seroconversion results at Month 7 for the other 2 groups are already presented in the primary outcome measure #1.

Time Frame At Month 7
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on initially seronegative subjects from the ATP cohort for analysis of immunogenicity with available data.
Arm/Group Title Cervarix (46-55 Years) Group Cervarix (15-25 Years) Group Cervarix (26-45 Years) Group
Hide Arm/Group Description:
Women of 46-55 years of age received 3 doses of Cervarix™ (HPV vaccine)administered according to a 0, 1, 6-month schedule
Women of 15-25 years of age received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule
Women of 26-45 years of age received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule
Overall Number of Participants Analyzed 172 0 0
Measure Type: Number
Unit of Measure: subjects
Anti-HPV-16 (N=136;0;0) 136
Anti-HPV-18 (N=172;0;0) 172
6.Secondary Outcome
Title Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies After 2 Vaccine Doses and 6 Months Following the Complete Vaccination Course
Hide Description

Seroconversion is defined as the appearance of anti-HPV-16 and/or anti- HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination.

Cut-off values were 8 EL.U/mL for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.

Seroconversion results at Month 7 (1 month after the complete vaccination course) are already presented above as primary outcome measure #1 for Cervarix (15-25 Years) Group and Cervarix (26-45 Years) Group and as secondary outcome measure #6 for Cervarix (46-55 Years) Group.

Time Frame At Month 2 and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on initially seronegative subjects from the ATP cohort for analysis of immunogenicity.
Arm/Group Title Cervarix (15-25 Years) Group Cervarix (26-45 Years) Group Cervarix (46-55 Years) Group
Hide Arm/Group Description:
Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule.
Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 207 186 175
Measure Type: Number
Unit of Measure: subjects
Anti-HPV-16 (Month 2) (N=195;164;139) 195 164 139
Anti-HPV-16 (Month 12) (N=183;163;134) 183 163 134
Anti-HPV-18 (Month 2) (N=207;186;175) 207 186 175
Anti-HPV-18 (Month 12) (N=192;182;169) 192 182 169
7.Secondary Outcome
Title Number of Subjects Reporting Solicited Local Symptoms
Hide Description Solicited local symptoms assessed include pain, redness and swelling at the injection site.
Time Frame During the 7-day (Days 0-6) period following each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total vaccinated cohort on subjects with a documented dose.
Arm/Group Title Cervarix (15-25 Years) Group Cervarix (26-45 Years) Group Cervarix (46-55 Years) Group
Hide Arm/Group Description:
Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule.
Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 227 226 207
Measure Type: Number
Unit of Measure: subjects
Pain 220 210 171
Redness 133 126 101
Swelling 96 100 83
8.Secondary Outcome
Title Number of Subjects Reporting Solicited General Symptoms
Hide Description Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash, and urticaria.
Time Frame During the 7-day (Days 0-6) period following each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total vaccinated cohort on subjects with a documented dose.
Arm/Group Title Cervarix (15-25 Years) Group Cervarix (26-45 Years) Group Cervarix (46-55 Years) Group
Hide Arm/Group Description:
Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule.
Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 227 226 207
Measure Type: Number
Unit of Measure: subjects
Arthralgia 45 43 47
Fatigue 128 116 81
Fever 21 19 5
Gastrointestinal 51 33 31
Headache 123 100 82
Myalgia 126 97 83
Rash 16 14 7
Urticaria 10 7 3
9.Secondary Outcome
Title Number of Subjects Reporting Unsolicited Adverse Events (AE)
Hide Description An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time Frame During the 30-day (Days 0-29) period following each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cervarix (15-25 Years) Group Cervarix (26-45 Years) Group Cervarix (46-55 Years) Group
Hide Arm/Group Description:
Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule.
Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 229 226 211
Measure Type: Number
Unit of Measure: subjects
43 46 28
10.Secondary Outcome
Title Number of Subjects Reporting Serious Adverse Events (SAE)
Hide Description An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Time Frame During the entire study period (up to Month 48)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total vaccinated cohort (for data up to Month 7) or on the Total vaccinated cohort of the extension follow-up phase (for the remaining data).
Arm/Group Title Cervarix (15-25 Years) Group Cervarix (26-45 Years) Group Cervarix (46-55 Years) Group
Hide Arm/Group Description:
Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule.
Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 229 226 211
Measure Type: Number
Unit of Measure: subjects
Up to Month 7 (N=229;226;211) 3 1 2
From Month 7 to 12 (N=213;221;201) 0 0 1
From Month 12 to 18 (N=169;175;180) 1 1 4
From Month 18 to 24 (N=169;181;181) 0 1 0
From Month 24 to 36 (N=162;176;175) 3 0 1
From Month 36 to 48 (N=169;191;181) 0 5 3
11.Secondary Outcome
Title Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions (MSAEs)
Hide Description NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. MSAEs assessed include AEs prompting emergency room visits and physician office visits not related to common illnesses.
Time Frame During the entire study period (up to Month 48)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total vaccinated cohort (for data up to Month 7) or on the Total vaccinated cohort of the extension follow-up phase (for the remaining data).
Arm/Group Title Cervarix (15-25 Years) Group Cervarix (26-45 Years) Group Cervarix (46-55 Years) Group
Hide Arm/Group Description:
Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule.
Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 229 226 211
Measure Type: Number
Unit of Measure: subjects
NOCDs up to Month 7 (N=229;226;211) 3 1 0
NOCDs from Month 7 to 12 (N=213;221;201) 0 0 0
NOCDs from Month 12 to 18 (N=169;175;180) 1 1 2
NOCDs from Month 18 to 24 (N=169;181;181) 0 0 0
NOCDs from Month 24 to 36 (N=162;176;175) 2 2 1
NOCDs from Month 36 to 48 (N=169;191;181) 1 0 0
MSAEs from Day 0 to 29 (N=229;226;211) 12 12 11
MSAEs from Day 30 to Month 7 (N=229;226;211) 8 8 10
MSAEs from Month 7 to 12 (N=213;221;201) 1 3 1
MSAEs from Month 12 to 18 (N=169;175;180) 3 5 6
MSAEs from Month 18 to 24 (N=169;181;181) 3 3 2
MSAEs from Month 24 to 36 (N=162;176;175) 5 4 6
MSAEs from Month 36 to 48 (N=169;191;181) 1 7 4
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cervarix (15-25 Years) Group Cervarix (26-45 Years) Group Cervarix (46-55 Years) Group
Hide Arm/Group Description Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule. Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule. Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
All-Cause Mortality
Cervarix (15-25 Years) Group Cervarix (26-45 Years) Group Cervarix (46-55 Years) Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cervarix (15-25 Years) Group Cervarix (26-45 Years) Group Cervarix (46-55 Years) Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/229 (1.31%)   5/226 (2.21%)   3/211 (1.42%) 
Ear and labyrinth disorders       
Vestibular neuronitis *  0/229 (0.00%)  0/226 (0.00%)  1/211 (0.47%) 
Gastrointestinal disorders       
Irritable bowel syndrome *  0/229 (0.00%)  0/226 (0.00%)  1/211 (0.47%) 
Abdominal hernia *  0/229 (0.00%)  0/226 (0.00%)  1/211 (0.47%) 
Gastroduodenitis *  1/229 (0.44%)  0/226 (0.00%)  0/211 (0.00%) 
Infections and infestations       
Viral infection *  1/229 (0.44%)  0/226 (0.00%)  0/211 (0.00%) 
Bronchitis *  0/229 (0.00%)  1/226 (0.44%)  0/211 (0.00%) 
Injury, poisoning and procedural complications       
Thermal burn *  1/229 (0.44%)  0/226 (0.00%)  0/211 (0.00%) 
Ligament rupture *  0/229 (0.00%)  1/226 (0.44%)  0/211 (0.00%) 
Musculoskeletal and connective tissue disorders       
Intervertebral disc protrusion *  0/229 (0.00%)  0/226 (0.00%)  1/211 (0.47%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Breast cancer *  0/229 (0.00%)  0/226 (0.00%)  3/211 (1.42%) 
Nervous system disorders       
Multiple sclerosis *  1/229 (0.44%)  0/226 (0.00%)  0/211 (0.00%) 
Optic neuritis *  0/229 (0.00%)  1/226 (0.44%)  0/211 (0.00%) 
Carotid artery dissection *  0/229 (0.00%)  0/226 (0.00%)  1/211 (0.47%) 
Pregnancy, puerperium and perinatal conditions       
Abortion missed *  0/229 (0.00%)  2/226 (0.88%)  0/211 (0.00%) 
Abortion spontaneous complete *  0/229 (0.00%)  2/226 (0.88%)  0/211 (0.00%) 
Psychiatric disorders       
Depression *  0/229 (0.00%)  0/226 (0.00%)  2/211 (0.95%) 
Depression *  0/229 (0.00%)  0/226 (0.00%)  1/211 (0.47%) 
Reproductive system and breast disorders       
Ovarian cyst *  1/229 (0.44%)  0/226 (0.00%)  0/211 (0.00%) 
Cervical polyp *  0/229 (0.00%)  1/226 (0.44%)  0/211 (0.00%) 
Uterine prolapse *  0/229 (0.00%)  0/226 (0.00%)  1/211 (0.47%) 
Abortion spontaneous *  1/229 (0.44%)  1/226 (0.44%)  0/211 (0.00%) 
Premature labour *  1/229 (0.44%)  0/226 (0.00%)  0/211 (0.00%) 
Vascular disorders       
Venous thrombosis limb *  0/229 (0.00%)  0/226 (0.00%)  1/211 (0.47%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cervarix (15-25 Years) Group Cervarix (26-45 Years) Group Cervarix (46-55 Years) Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   220/229 (96.07%)   210/226 (92.92%)   171/211 (81.04%) 
General disorders       
Pain   220/229 (96.07%)  210/226 (92.92%)  171/211 (81.04%) 
Redness   133/229 (58.08%)  126/226 (55.75%)  101/211 (47.87%) 
Swelling   96/229 (41.92%)  100/226 (44.25%)  83/211 (39.34%) 
Arthralgia   45/229 (19.65%)  43/226 (19.03%)  47/211 (22.27%) 
Fatigue   128/229 (55.90%)  116/226 (51.33%)  81/211 (38.39%) 
Fever   21/229 (9.17%)  19/226 (8.41%)  5/211 (2.37%) 
Gastrointestinal symptoms   51/229 (22.27%)  33/226 (14.60%)  31/211 (14.69%) 
Headache   123/229 (53.71%)  100/226 (44.25%)  82/211 (38.86%) 
Myalgia   126/229 (55.02%)  97/226 (42.92%)  83/211 (39.34%) 
Rash   16/229 (6.99%)  14/226 (6.19%)  7/211 (3.32%) 
Indicates events were collected by systematic assessment
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: NCT00196937     History of Changes
Obsolete Identifiers: NCT00332358, NCT00332475, NCT00332501, NCT00332527
Other Study ID Numbers: 103514
105879 ( Other Identifier: GSK )
105880 ( Other Identifier: GSK )
105881 ( Other Identifier: GSK )
105882 ( Other Identifier: GSK )
First Submitted: September 13, 2005
First Posted: September 20, 2005
Results First Submitted: November 12, 2009
Results First Posted: August 6, 2010
Last Update Posted: January 11, 2017