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Trial record 61 of 91 for:    cervarix

Immunogenicity and Safety of a Commercially Available Vaccine Co-administered With GSK HPV Vaccine (580299)

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ClinicalTrials.gov Identifier: NCT00637195
Recruitment Status : Completed
First Posted : March 17, 2008
Results First Posted : December 18, 2009
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Infections, Papillomavirus
Interventions Biological: Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™)
Biological: Engerix™
Enrollment 152
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cervarix™ & Engerix™ Group Engerix™ Group
Hide Arm/Group Description Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12). Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
Period Title: Overall Study
Started 76 76
Completed 73 75
Not Completed 3 1
Reason Not Completed
Lost to Follow-up             1             0
Other             2             0
Withdrawal by Subject             0             1
Arm/Group Title Cervarix™ & Engerix™ Group Engerix™ Group Total
Hide Arm/Group Description Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12). Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12). Total of all reporting groups
Overall Number of Baseline Participants 76 76 152
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 76 participants 76 participants 152 participants
22.4  (1.51) 22.1  (1.32) 22.3  (1.42)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants 76 participants 152 participants
Female
76
 100.0%
76
 100.0%
152
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Subjects Seroprotected Against Hepatitis B Following 3 Doses of Engerix
Hide Description A subject seroprotected against hepatitis B is a subject with anti-hepatitis B surface antigen (HBs) antibody titers greater than or equal to 10 milli-international units per milliliter (mIU/mL).
Time Frame Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, in subjects with available data and who were negative for anti-hepatitis B core antigen (anti-HBc) before vaccination .
Arm/Group Title Cervarix™ & Engerix™ Group Engerix™ Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
Overall Number of Participants Analyzed 72 75
Measure Type: Count of Participants
Unit of Measure: Participants
70
  97.2%
73
  97.3%
2.Primary Outcome
Title Anti-hepatitis B Surface Antigen (HBs) Antibody Titers Following 3 Doses of Engerix
Hide Description Titers are given as Geometric Mean Titers (GMTs) expressed as milli-international units per milliliter (mIU/mL).
Time Frame Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, in subjects with available data and who were negative for anti-hepatitis B core antigen (anti-HBc) before vaccination.
Arm/Group Title Cervarix™ & Engerix™ Group Engerix™ Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
Overall Number of Participants Analyzed 72 75
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
156.1
(83.7 to 291.3)
146.2
(86.6 to 246.9)
3.Secondary Outcome
Title Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibodies
Hide Description

Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination.

Cut-off values assessed include 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.

Time Frame Months 2 and 7
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, only for subjects receiving Cervarix™ vaccine and with available data.
Arm/Group Title Cervarix™ & Engerix™ Group Engerix™ Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
Overall Number of Participants Analyzed 68 0
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-HPV-16, Month 2 Number Analyzed 62 participants 0 participants
62
 100.0%
Anti-HPV-16, Month 7 Number Analyzed 61 participants 0 participants
61
 100.0%
Anti-HPV-18, Month 2 Number Analyzed 68 participants 0 participants
68
 100.0%
Anti-HPV-18, Month 7 Number Analyzed 67 participants 0 participants
67
 100.0%
4.Secondary Outcome
Title Anti-HPV-16/18 Antibody Titers
Hide Description Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).
Time Frame Months 2 and 7
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ATP cohort for analysis of immunogenicity, only for subjects receiving Cervarix™ vaccine with available data.
Arm/Group Title Cervarix™ & Engerix™ Group Engerix™ Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
Overall Number of Participants Analyzed 68 0
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-HPV-16, Month 2 Number Analyzed 62 participants 0 participants
3497.2
(2902.3 to 4214.1)
Anti-HPV-16, Month 7 Number Analyzed 61 participants 0 participants
8725.2
(7105.7 to 10714.0)
Anti-HPV-18, Month 2 Number Analyzed 68 participants 0 participants
2775.6
(2306.5 to 3340.1)
Anti-HPV-18, Month 7 Number Analyzed 67 participants 0 participants
4664.4
(3709.9 to 5864.3)
5.Secondary Outcome
Title Number of Subjects Seroconverted for Anti-hepatitis B (HBs) Antibodies
Hide Description Anti-HBs seroconversion is defined as the appearance [i.e. titer greater than or equal to the cut-off value of 3.3 milli-international units/milliliter (mIU/mL)] of anti-HBs antibodies in the sera of subjects seronegative (with titers below the cut-off value) before vaccination.
Time Frame Months 2, 3 and 13
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects with available data and who were negative for anti-hepatitis B core antigen (anti-HBc) before vaccination.
Arm/Group Title Cervarix™ & Engerix™ Group Engerix™ Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
Overall Number of Participants Analyzed 55 64
Measure Type: Count of Participants
Unit of Measure: Participants
Month 2 Number Analyzed 55 participants 64 participants
46
  83.6%
54
  84.4%
Month 3 Number Analyzed 55 participants 64 participants
55
 100.0%
63
  98.4%
Month 13 Number Analyzed 52 participants 63 participants
52
 100.0%
63
 100.0%
6.Secondary Outcome
Title Number of Subjects Seroprotected Against Anti-Hepatitis B (HBs) Antibodies Following 2 Doses of Engerix and After Completing the 4-dose Engerix Vaccination Course
Hide Description A subject seroprotected against Hepatitis B is a subject with anti-HBs antibody titers greater than or equal to 10 mIU/mL.
Time Frame Months 2 and 13
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects with available data and who were negative for anti-hepatitis B core antigen (anti-HBc) before vaccination.
Arm/Group Title Cervarix™ & Engerix™ Group Engerix™ Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
Overall Number of Participants Analyzed 72 75
Measure Type: Count of Participants
Unit of Measure: Participants
Month 2 Number Analyzed 72 participants 75 participants
63
  87.5%
65
  86.7%
Month 13 Number Analyzed 69 participants 74 participants
69
 100.0%
74
 100.0%
7.Secondary Outcome
Title Anti-HBs Antibody Titers Following 2 Doses of Engerix and After Completing the 4-dose Engerix Vaccination Course
Hide Description Titers are given as Geometric Mean Titers (GMTs) expressed as mIU/mL.
Time Frame At Months 2 and 13
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects with available data and who were negative for anti-hepatitis B core antigen (anti-HBc) before vaccination.
Arm/Group Title Cervarix™ & Engerix™ Group Engerix™ Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
Overall Number of Participants Analyzed 72 75
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
Month 2 Number Analyzed 72 participants 75 participants
34.4
(17.1 to 69.5)
35.7
(18.9 to 67.1)
Month 13 Number Analyzed 69 participants 74 participants
19888.4
(13042.6 to 30327.5)
16927.5
(11854.1 to 24172.3)
8.Secondary Outcome
Title Number of Subjects Reporting Solicited Local Symptoms
Hide Description

Solicited local symptoms assessed include injection site pain, redness and swelling.

Data are presented across doses.

Time Frame During the 7-day period following any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.
Arm/Group Title Cervarix™ & Engerix™ Group Engerix™ Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
Overall Number of Participants Analyzed 76 76
Measure Type: Count of Participants
Unit of Measure: Participants
Pain
76
 100.0%
62
  81.6%
Redness
26
  34.2%
12
  15.8%
Swelling
26
  34.2%
10
  13.2%
9.Secondary Outcome
Title Number of Subjects Reporting Solicited Local Symptoms
Hide Description

Solicited local symptoms assessed include injection site pain, redness and swelling.

Data are presented across doses.

Time Frame During the 7-day period following the 4th dose of HBV vaccine
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.
Arm/Group Title Cervarix™ & Engerix™ Group Engerix™ Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
Overall Number of Participants Analyzed 74 75
Measure Type: Count of Participants
Unit of Measure: Participants
Pain
36
  48.6%
44
  58.7%
Redness
8
  10.8%
13
  17.3%
Swelling
12
  16.2%
10
  13.3%
10.Secondary Outcome
Title Number of Subjects Reporting Solicited General Symptoms
Hide Description

Solicited general symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, temperature [axillary route, ≥ 37.5 degree Celsius (°C)] and urticaria.

Data are presented across doses.

Time Frame During the 7-day period following any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.
Arm/Group Title Cervarix™ & Engerix™ Group Engerix™ Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
Overall Number of Participants Analyzed 76 76
Measure Type: Count of Participants
Unit of Measure: Participants
Arthralgia
9
  11.8%
10
  13.2%
Fatigue
49
  64.5%
52
  68.4%
Gastro-intestinal symptoms
24
  31.6%
31
  40.8%
Headache
49
  64.5%
42
  55.3%
Myalgia
28
  36.8%
33
  43.4%
Rash
3
   3.9%
5
   6.6%
Temperature ≥ 37.5°C
9
  11.8%
5
   6.6%
Urticaria
1
   1.3%
3
   3.9%
11.Secondary Outcome
Title Number of Subjects Reporting Solicited General Symptoms
Hide Description

Solicited general symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, temperature [axillary route, ≥ 37.5 degree Celsius (°C)] and urticaria.

Data are presented across doses.

Time Frame During the 7-day period following the 4th dose of HBV vaccine
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.
Arm/Group Title Cervarix™ & Engerix™ Group Engerix™ Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
Overall Number of Participants Analyzed 74 75
Measure Type: Count of Participants
Unit of Measure: Participants
Arthralgia
1
   1.4%
4
   5.3%
Fatigue
26
  35.1%
34
  45.3%
Gastro-intestinal symptoms
3
   4.1%
13
  17.3%
Headache
21
  28.4%
25
  33.3%
Myalgia
4
   5.4%
18
  24.0%
Rash
1
   1.4%
0
   0.0%
Temperature ≥ 37.5°C
3
   4.1%
0
   0.0%
Urticaria
0
   0.0%
0
   0.0%
12.Secondary Outcome
Title Number of Subjects Reporting Unsolicited Adverse Events
Hide Description Unsolicited adverse event covers any adverse event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time Frame During the 30-day period following any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.
Arm/Group Title Cervarix™ & Engerix™ Group Engerix™ Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
Overall Number of Participants Analyzed 76 76
Measure Type: Count of Participants
Unit of Measure: Participants
56
  73.7%
47
  61.8%
13.Secondary Outcome
Title Number of Subjects Reporting Unsolicited Adverse Events
Hide Description Unsolicited adverse event covers any adverse event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time Frame During the 30-day period following the 4th dose of HBV vaccine
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.
Arm/Group Title Cervarix™ & Engerix™ Group Engerix™ Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
Overall Number of Participants Analyzed 74 75
Measure Type: Count of Participants
Unit of Measure: Participants
20
  27.0%
22
  29.3%
14.Secondary Outcome
Title Number of Subjects Reporting Serious Adverse Events (SAE)
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 Up to study end (Month 13)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.
Arm/Group Title Cervarix™ & Engerix™ Group Engerix™ Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
Overall Number of Participants Analyzed 76 76
Measure Type: Count of Participants
Unit of Measure: Participants
2
   2.6%
2
   2.6%
15.Secondary Outcome
Title Number of Subjects Reporting Medically Significant Conditions
Hide Description Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Time Frame Up to study end (Month 13)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.
Arm/Group Title Cervarix™ & Engerix™ Group Engerix™ Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12).
Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
Overall Number of Participants Analyzed 74 75
Measure Type: Count of Participants
Unit of Measure: Participants
37
  50.0%
32
  42.7%
Time Frame From Month 0 up to Month 13.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cervarix™ & Engerix™ Group Engerix™ Group
Hide Arm/Group Description Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 & 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 & 12). Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 & 12).
All-Cause Mortality
Cervarix™ & Engerix™ Group Engerix™ Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cervarix™ & Engerix™ Group Engerix™ Group
Affected / at Risk (%) Affected / at Risk (%)
Total   2/76 (2.63%)   2/76 (2.63%) 
Endocrine disorders     
Graves-Basedow's disease * 1  1/76 (1.32%)  0/76 (0.00%) 
Infections and infestations     
Gastroenteritis viral * 1  0/76 (0.00%)  1/76 (1.32%) 
Metabolism and nutrition disorders     
Type 1 diabetes mellitus * 1  0/76 (0.00%)  1/76 (1.32%) 
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous complete * 1  1/76 (1.32%)  0/76 (0.00%) 
Reproductive system and breast disorders     
Endometriosis * 1  1/76 (1.32%)  0/76 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cervarix™ & Engerix™ Group Engerix™ Group
Affected / at Risk (%) Affected / at Risk (%)
Total   76/76 (100.00%)   73/76 (96.05%) 
Gastrointestinal disorders     
Headache  1  49/76 (64.47%)  42/76 (55.26%) 
Abdominal pain * 1  0/76 (0.00%)  5/76 (6.58%) 
General disorders     
Pain at injection site  1  76/76 (100.00%)  62/76 (81.58%) 
Redness at injection site  1  26/76 (34.21%)  12/76 (15.79%) 
Swelling at injection site  1  26/76 (34.21%)  10/76 (13.16%) 
Arthralgia  1  9/76 (11.84%)  10/76 (13.16%) 
Fatigue  1  49/76 (64.47%)  52/76 (68.42%) 
Gastrointestinal symptom  1  24/76 (31.58%)  31/76 (40.79%) 
Myalgia  1  28/76 (36.84%)  33/76 (43.42%) 
Rash  1  3/76 (3.95%)  5/76 (6.58%) 
Temperature  1  9/76 (11.84%)  5/76 (6.58%) 
Influenza like illness * 1  1/76 (1.32%)  4/76 (5.26%) 
Immune system disorders     
Pharyngitis * 1  1/76 (1.32%)  4/76 (5.26%) 
Infections and infestations     
Upper respiratory tract infection * 1  7/76 (9.21%)  5/76 (6.58%) 
Cystitis * 1  5/76 (6.58%)  4/76 (5.26%) 
Nasopharyngitis * 1  6/76 (7.89%)  3/76 (3.95%) 
Nervous system disorders     
Headache * 1  12/76 (15.79%)  13/76 (17.11%) 
Reproductive system and breast disorders     
Dysmenorrhoea * 1  7/76 (9.21%)  6/76 (7.89%) 
Respiratory, thoracic and mediastinal disorders     
Oropharyngeal pain * 1  7/76 (9.21%)  2/76 (2.63%) 
Rhinitis * 1  6/76 (7.89%)  1/76 (1.32%) 
Cough * 1  4/76 (5.26%)  1/76 (1.32%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.0
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: NCT00637195     History of Changes
Other Study ID Numbers: 111567
First Submitted: February 28, 2008
First Posted: March 17, 2008
Results First Submitted: November 12, 2009
Results First Posted: December 18, 2009
Last Update Posted: August 17, 2018