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A Study to Assess the Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine (Cervarix) in Healthy Female Filipino Subjects Vaccinated According to the Prescribing Information From the Age of 10 Years Onwards.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00730847
Recruitment Status : Terminated (GSK received exemption from PDFDA on conduct of this post-marketing surveillance (PMS) study.)
First Posted : August 8, 2008
Results First Posted : December 21, 2012
Last Update Posted : May 30, 2018
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 Human Papillomavirus Infection Leading to Cervical Cancer
Intervention Biological: Cervarix
Enrollment 743
Recruitment Details Since this was a post-marketing study (PMS), subjects may have received one or two doses of Cervarix outside of the PMS.
Pre-assignment Details

Out of 743 subjects enrolled in the study, only 596 subjects received study vaccination.

The whole set of data was not cleaned for this study. Analysis was performed on subjects with cleaned data and on subjects with missing data or unresolved data queries, or both. The overall group includes both cleaned and not cleaned data.

Arm/Group Title Cervarix Group
Hide Arm/Group Description Healthy female subjects who received three doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.
Period Title: Overall Study
Started 596
Completed 465
Not Completed 131
Reason Not Completed
Adverse Event             1
Protocol Violation             2
Withdrawal by Subject             16
Lost to Follow-up             67
Unknown completion status             21
Other             24
Arm/Group Title Cervarix Group
Hide Arm/Group Description Healthy female subjects who received three doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.
Overall Number of Baseline Participants 596
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 596 participants
32.8  (10.27)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 596 participants
Female
596
 100.0%
Male
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 596 participants
South Asian
594
  99.7%
Chinese
1
   0.2%
Not specified
1
   0.2%
1.Primary Outcome
Title Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Hide Description Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity grade. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness and swelling above 50 millimeters (mm).
Time Frame During the 7-day follow-up period (Days 0-6) after each dose and across doses
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and had the symptom sheet completed.
Arm/Group Title Cervarix Group
Hide Arm/Group Description:
Healthy female subjects who received three doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.
Overall Number of Participants Analyzed 578
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain, Dose 1 Number Analyzed 576 participants
402
  69.8%
Grade 3 Pain, Dose 1 Number Analyzed 576 participants
25
   4.3%
Any Redness, Dose 1 Number Analyzed 576 participants
116
  20.1%
Grade 3 Redness, Dose 1 Number Analyzed 576 participants
0
   0.0%
Any Swelling, Dose 1 Number Analyzed 576 participants
76
  13.2%
Grade 3 Swelling, Dose 1 Number Analyzed 576 participants
3
   0.5%
Any Pain, Dose 2 Number Analyzed 531 participants
309
  58.2%
Grade 3 Pain, Dose 2 Number Analyzed 531 participants
16
   3.0%
Any Redness, Dose 2 Number Analyzed 531 participants
106
  20.0%
Grade 3 Redness, Dose 2 Number Analyzed 531 participants
0
   0.0%
Any Swelling, Dose 2 Number Analyzed 531 participants
60
  11.3%
Grade 3 Swelling, Dose 2 Number Analyzed 531 participants
0
   0.0%
Any Pain, Dose 3 Number Analyzed 482 participants
211
  43.8%
Grade 3 Pain, Dose 3 Number Analyzed 482 participants
7
   1.5%
Any Redness, Dose 3 Number Analyzed 482 participants
69
  14.3%
Grade 3 Redness, Dose 3 Number Analyzed 482 participants
2
   0.4%
Any Swelling, Dose 3 Number Analyzed 482 participants
47
   9.8%
Grade 3 Swelling, Dose 3 Number Analyzed 482 participants
1
   0.2%
Any Pain, Across doses Number Analyzed 578 participants
430
  74.4%
Grade 3 Pain, Across doses Number Analyzed 578 participants
38
   6.6%
Any Redness, Across doses Number Analyzed 578 participants
168
  29.1%
Grade 3 Redness, Across doses Number Analyzed 578 participants
2
   0.3%
Any Swelling, Across doses Number Analyzed 578 participants
119
  20.6%
Grade 3 Swelling, Across doses Number Analyzed 578 participants
4
   0.7%
2.Primary Outcome
Title Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Hide Description Solicited general symptoms assessed were arthralgia, fatigue, fever, gastrointestinal, headache, myalgia, rash and urticaria. Any fever = axillary temperature ≥ 37.5 degrees Celsius (°C). For other symptoms: Any = any solicited general symptom reported irrespective of intensity and relationship to study vaccination. Related = symptoms considered by the investigator as causally related to study vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = axillary temperature > 39.0°C.
Time Frame During the 7-day follow-up period (Days 0-6) after each dose and across doses
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and had the symptom sheet completed.
Arm/Group Title Cervarix Group
Hide Arm/Group Description:
Healthy female subjects who received three doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.
Overall Number of Participants Analyzed 576
Measure Type: Count of Participants
Unit of Measure: Participants
Any Arthralgia, Dose 1 Number Analyzed 575 participants
76
  13.2%
Grade 3 Arthralgia, Dose 1 Number Analyzed 575 participants
2
   0.3%
Related Arthralgia, Dose 1 Number Analyzed 575 participants
35
   6.1%
Any Fatigue, Dose 1 Number Analyzed 575 participants
120
  20.9%
Grade 3 Fatigue, Dose 1 Number Analyzed 575 participants
4
   0.7%
Related Fatigue, Dose 1 Number Analyzed 575 participants
53
   9.2%
Any Fever, Dose 1 Number Analyzed 575 participants
17
   3.0%
Grade 3 Fever, Dose 1 Number Analyzed 575 participants
1
   0.2%
Related Fever, Dose 1 Number Analyzed 575 participants
7
   1.2%
Any Gastrointestinal, Dose 1 Number Analyzed 575 participants
46
   8.0%
Grade 3 Gastrointestinal, Dose 1 Number Analyzed 575 participants
3
   0.5%
Related Gastrointestinal, Dose 1 Number Analyzed 575 participants
10
   1.7%
Any Headache, Dose 1 Number Analyzed 575 participants
90
  15.7%
Grade 3 Headache, Dose 1 Number Analyzed 575 participants
3
   0.5%
Related Headache, Dose 1 Number Analyzed 575 participants
29
   5.0%
Any Myalgia, Dose 1 Number Analyzed 575 participants
91
  15.8%
Grade 3 Myalgia, Dose 1 Number Analyzed 575 participants
4
   0.7%
Related Myalgia, Dose 1 Number Analyzed 575 participants
39
   6.8%
Any Rash, Dose 1 Number Analyzed 575 participants
9
   1.6%
Grade 3 Rash, Dose 1 Number Analyzed 575 participants
0
   0.0%
Related Rash, Dose 1 Number Analyzed 575 participants
4
   0.7%
Any Urticaria, Dose 1 Number Analyzed 575 participants
8
   1.4%
Grade 3 Urticaria, Dose 1 Number Analyzed 575 participants
0
   0.0%
Related Urticaria, Dose 1 Number Analyzed 575 participants
3
   0.5%
Any Arthralgia, Dose 2 Number Analyzed 529 participants
43
   8.1%
Grade 3 Arthralgia, Dose 2 Number Analyzed 529 participants
1
   0.2%
Related Arthralgia, Dose 2 Number Analyzed 529 participants
15
   2.8%
Any Fatigue, Dose 2 Number Analyzed 529 participants
81
  15.3%
Grade 3 Fatigue, Dose 2 Number Analyzed 529 participants
6
   1.1%
Related Fatigue, Dose 2 Number Analyzed 529 participants
35
   6.6%
Any Fever, Dose 2 Number Analyzed 529 participants
11
   2.1%
Grade 3 Fever, Dose 2 Number Analyzed 529 participants
0
   0.0%
Related Fever, Dose 2 Number Analyzed 529 participants
9
   1.7%
Any Gastrointestinal, Dose 2 Number Analyzed 529 participants
32
   6.0%
Grade 3 Gastrointestinal, Dose 2 Number Analyzed 529 participants
1
   0.2%
Related Gastrointestinal, Dose 2 Number Analyzed 529 participants
9
   1.7%
Any Headache, Dose 2 Number Analyzed 529 participants
55
  10.4%
Grade 3 Headache, Dose 2 Number Analyzed 529 participants
3
   0.6%
Related Headache, Dose 2 Number Analyzed 529 participants
20
   3.8%
Any Myalgia, Dose 2 Number Analyzed 529 participants
52
   9.8%
Grade 3 Myalgia, Dose 2 Number Analyzed 529 participants
2
   0.4%
Related Myalgia, Dose 2 Number Analyzed 529 participants
20
   3.8%
Any Rash, Dose 2 Number Analyzed 529 participants
7
   1.3%
Grade 3 Rash, Dose 2 Number Analyzed 529 participants
1
   0.2%
Related Rash, Dose 2 Number Analyzed 529 participants
3
   0.6%
Any Urticaria, Dose 2 Number Analyzed 529 participants
6
   1.1%
Grade 3 Urticaria, Dose 2 Number Analyzed 529 participants
1
   0.2%
Related Urticaria, Dose 2 Number Analyzed 529 participants
1
   0.2%
Any Arthralgia, Dose 3 Number Analyzed 481 participants
30
   6.2%
Grade 3 Arthralgia, Dose 3 Number Analyzed 481 participants
3
   0.6%
Related Arthralgia, Dose 3 Number Analyzed 481 participants
13
   2.7%
Any Fatigue, Dose 3 Number Analyzed 481 participants
57
  11.9%
Grade 3 Fatigue, Dose 3 Number Analyzed 481 participants
3
   0.6%
Related Fatigue, Dose 3 Number Analyzed 481 participants
28
   5.8%
Any Fever, Dose 3 Number Analyzed 481 participants
12
   2.5%
Grade 3 Fever, Dose 3 Number Analyzed 481 participants
0
   0.0%
Related Fever, Dose 3 Number Analyzed 481 participants
8
   1.7%
Any Gastrointestinal, Dose 3 Number Analyzed 481 participants
15
   3.1%
Grade 3 Gastrointestinal, Dose 3 Number Analyzed 481 participants
0
   0.0%
Related Gastrointestinal, Dose 3 Number Analyzed 481 participants
6
   1.2%
Any Headache, Dose 3 Number Analyzed 481 participants
39
   8.1%
Grade 3 Headache, Dose 3 Number Analyzed 481 participants
2
   0.4%
Related Headache, Dose 3 Number Analyzed 481 participants
13
   2.7%
Any Myalgia, Dose 3 Number Analyzed 481 participants
30
   6.2%
Grade 3 Myalgia, Dose 3 Number Analyzed 481 participants
1
   0.2%
Related Myalgia, Dose 3 Number Analyzed 481 participants
13
   2.7%
Any Rash, Dose 3 Number Analyzed 481 participants
4
   0.8%
Grade 3 Rash, Dose 3 Number Analyzed 481 participants
1
   0.2%
Related Rash, Dose 3 Number Analyzed 481 participants
2
   0.4%
Any Urticaria, Dose 3 Number Analyzed 481 participants
2
   0.4%
Grade 3 Urticaria, Dose 3 Number Analyzed 481 participants
0
   0.0%
Related Urticaria, Dose 3 Number Analyzed 481 participants
0
   0.0%
Any Arthralgia, Across doses Number Analyzed 576 participants
102
  17.7%
Grade 3 Arthralgia, Across doses Number Analyzed 576 participants
6
   1.0%
Related Arthralgia, Across doses Number Analyzed 576 participants
48
   8.3%
Any Fatigue, Across doses Number Analyzed 576 participants
165
  28.6%
Grade 3 Fatigue, Across doses Number Analyzed 576 participants
11
   1.9%
Related Fatigue, Across doses Number Analyzed 576 participants
72
  12.5%
Any Fever, Across doses Number Analyzed 576 participants
32
   5.6%
Grade 3 Fever, Across doses Number Analyzed 576 participants
1
   0.2%
Related Fever, Across doses Number Analyzed 576 participants
19
   3.3%
Any Gastrointestinal, Across doses Number Analyzed 576 participants
68
  11.8%
Grade 3 Gastrointestinal, Across doses Number Analyzed 576 participants
4
   0.7%
Related Gastrointestinal, Across doses Number Analyzed 576 participants
19
   3.3%
Any Headache, Across doses Number Analyzed 576 participants
127
  22.0%
Grade 3 Headache, Across doses Number Analyzed 576 participants
6
   1.0%
Related Headache, Across doses Number Analyzed 576 participants
47
   8.2%
Any Myalgia, Across doses Number Analyzed 576 participants
115
  20.0%
Grade 3 Myalgia, Across doses Number Analyzed 576 participants
7
   1.2%
Related Myalgia, Across doses Number Analyzed 576 participants
51
   8.9%
Any Rash, Across doses Number Analyzed 576 participants
17
   3.0%
Grade 3 Rash, Across doses Number Analyzed 576 participants
2
   0.3%
Related Rash, Across doses Number Analyzed 576 participants
8
   1.4%
Any Urticaria, Across doses Number Analyzed 576 participants
14
   2.4%
Grade 3 Urticaria, Across doses Number Analyzed 576 participants
1
   0.2%
Related Urticaria, Across doses Number Analyzed 576 participants
4
   0.7%
3.Primary Outcome
Title Number of Subjects Reporting Any, Grade 3, Related and Grade 3 and Related Unsolicited Adverse Events (AEs)
Hide Description An unsolicited AE covers any AE 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. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to study vaccination. Grade 3 = event which prevented normal, everyday activities. Related = event assessed by the investigator as causally related to the study vaccination. Grade 3 and Related = grade 3 event assessed by the investigator as causally related to the study vaccination.
Time Frame During the 30-day (Days 0-29) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vacinated subjects for whom data were available.
Arm/Group Title Cervarix Group
Hide Arm/Group Description:
Healthy female subjects who received three doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.
Overall Number of Participants Analyzed 596
Measure Type: Count of Participants
Unit of Measure: Participants
Any AE(s)
20
   3.4%
Grade 3 AE(s)
3
   0.5%
Related AE(s)
2
   0.3%
Grade 3 and Related AE(s)
0
   0.0%
4.Primary Outcome
Title Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)
Hide Description SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade. Grade 3 SAE = SAE which prevented normal, everyday activities. Related SAE = SAE assessed by the investigator as causally related to the study vaccination.
Time Frame During the entire study period (from Day 0 up to Month 7)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vacinated subjects for whom data were available.
Arm/Group Title Cervarix Group
Hide Arm/Group Description:
Healthy female subjects who received three doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.
Overall Number of Participants Analyzed 596
Measure Type: Count of Participants
Unit of Measure: Participants
Any SAE(s)
4
   0.7%
Grade 3 SAE(s)
1
   0.2%
Related SAE(s)
0
   0.0%
Time Frame Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; Serious adverse events: during the entire study period (from Day 0 up to Month 7).
Adverse Event Reporting Description For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported and one (Uterine leiomyoma) was assessed as severe (Grade 3).
 
Arm/Group Title Cervarix Group
Hide Arm/Group Description Healthy female subjects who received three doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.
All-Cause Mortality
Cervarix Group
Affected / at Risk (%)
Total   0/596 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Cervarix Group
Affected / at Risk (%) # Events
Total   4/596 (0.67%)    
Blood and lymphatic system disorders   
Iron deficiency anaemia  1  1/596 (0.17%) 
Cardiac disorders   
Mitral valve prolapse  1  1/596 (0.17%) 
Infections and infestations   
Bronchitis  1  1/596 (0.17%) 
Typhoid fever  1  1/596 (0.17%) 
Urinary tract infection  1  1/596 (0.17%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Uterine leiomyoma  1  1/596 (0.17%) 
Reproductive system and breast disorders   
Ovarian cyst  1  1/596 (0.17%) 
1
Term from vocabulary, MedDRA 15.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cervarix Group
Affected / at Risk (%) # Events
Total   443/596 (74.33%)    
Gastrointestinal disorders   
Abdominal pain lower  1  1/596 (0.17%)  1
Gastrointestinal disorder  1  68/596 (11.41%)  93
General disorders   
Chills  1  1/596 (0.17%)  1
Fatigue  1  165/596 (27.68%)  258
Injection site erythema  1  1/596 (0.17%)  1
Oedema peripheral  1  1/596 (0.17%)  1
Pain  1  430/596 (72.15%)  922
Pyrexia  1  32/596 (5.37%)  42
Swelling  1  119/596 (19.97%)  183
Infections and infestations   
Herpes zoster  1  1/596 (0.17%)  1
Nasopharyngitis  1  1/596 (0.17%)  1
Upper respiratory tract infection  1  2/596 (0.34%)  2
Urinary tract infection  1  7/596 (1.17%)  7
Vaginitis bacterial  1  1/596 (0.17%)  1
Injury, poisoning and procedural complications   
Limb injury  1  1/596 (0.17%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia  1  102/596 (17.11%)  149
Back pain  1  1/596 (0.17%)  1
Myalgia  1  115/596 (19.30%)  173
Nervous system disorders   
Headache  1  127/596 (21.31%)  184
Reproductive system and breast disorders   
Polycystic ovaries  1  1/596 (0.17%)  1
Respiratory, thoracic and mediastinal disorders   
Asthma  1  1/596 (0.17%)  1
Cough  1  4/596 (0.67%)  4
Skin and subcutaneous tissue disorders   
Erythema  1  168/596 (28.19%)  291
Pruritus  1  1/596 (0.17%)  1
Rash  1  17/596 (2.85%)  20
Urticaria  1  14/596 (2.35%)  16
1
Term from vocabulary, MedDRA 15.0
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: NCT00730847     History of Changes
Other Study ID Numbers: 108160
First Submitted: August 6, 2008
First Posted: August 8, 2008
Results First Submitted: November 21, 2012
Results First Posted: December 21, 2012
Last Update Posted: May 30, 2018