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Trial record 9 of 91 for:    cervarix

Safety Evaluation of the GSK-580299 Vaccine in Women From the Control Group in the Primary NCT00294047 Study

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ClinicalTrials.gov Identifier: NCT01190189
Recruitment Status : Completed
First Posted : August 27, 2010
Results First Posted : December 17, 2018
Last Update Posted : June 19, 2019
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 Biological: GSK580299 (Cervarix)
Enrollment 137
Recruitment Details This study was conducted by multiple investigators at 28 centers in Canada and the United States.
Pre-assignment Details All subjects enrolled were vaccinated and included in the Total Vaccinated cohort (TVc).
Arm/Group Title Cervarix Group
Hide Arm/Group Description Healthy female subjects who received control vaccine in the primary study HPV-015 (NCT00294047), were administered three doses of Cervarix vaccine intramuscularly, according to a 0,1,6-month schedule.
Period Title: Overall Study
Started 137
Completed 131
Not Completed 6
Reason Not Completed
Lost to Follow-up             4
Withdrawal by Subject             1
Migrated/moved from study area             1
Arm/Group Title Cervarix Group
Hide Arm/Group Description Healthy female subjects who received control vaccine in the primary study HPV-015 (NCT00294047), were administered three doses of Cervarix vaccine intramuscularly, according to a 0,1,6-month schedule.
Overall Number of Baseline Participants 137
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 137 participants
47.9  (7.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 137 participants
Female
137
 100.0%
Male
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Geographic Ancestry Number Analyzed 137 participants
African Heritage/African American
11
   8.0%
Asian - East Asian Heritage
1
   0.7%
Asian - Japanese Heritage
2
   1.5%
White - Arabic/North African Heritage
1
   0.7%
White - Caucasian/European Heritage
119
  86.9%
Native Canadian
2
   1.5%
Cuban
1
   0.7%
1.Primary Outcome
Title Number of Subjects Reporting Any, Grade 3 and Related Serious Adverse Events (SAEs)
Hide Description Assessed SAEs included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were congenital anomalies/birth defects in the offspring of a study subject. Any SAE = occurrence of the SAE regardless of intensity grade. Grade 3 SAE = an SAE which prevented normal, everyday activities. Related SAE = an 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 12)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.
Arm/Group Title Cervarix Group
Hide Arm/Group Description:
Healthy female subjects who received control vaccine in the primary study HPV-015 (NCT00294047), were administered three doses of Cervarix vaccine intramuscularly, according to a 0,1,6-month schedule.
Overall Number of Participants Analyzed 137
Measure Type: Count of Participants
Unit of Measure: Participants
Any SAE(s)
1
   0.7%
Grade 3 SAE(s)
1
   0.7%
Related SAE(s)
0
   0.0%
2.Primary Outcome
Title Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)
Hide Description Medically significant conditions were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases, or (2) not related to routine visits for physical examination or vaccination, or as SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury. Any MSC = occurrence of the MSC regardless of intensity grade. Grade 3 MSC = a MSC which prevented normal, everyday activities. Related MSC = MSC assessed by the investigator as related to the study vaccination.
Time Frame During the entire study period (from Day 0 up to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.
Arm/Group Title Cervarix Group
Hide Arm/Group Description:
Healthy female subjects who received control vaccine in the primary study HPV-015 (NCT00294047), were administered three doses of Cervarix vaccine intramuscularly, according to a 0,1,6-month schedule.
Overall Number of Participants Analyzed 137
Measure Type: Count of Participants
Unit of Measure: Participants
Any MSC(s)
24
  17.5%
Grade 3 MSC(s)
2
   1.5%
Related MSC(s)
1
   0.7%
3.Primary Outcome
Title Number of Subjects Reporting Any, Grade 3 and Related Potentially Immune-Mediated Diseases (pIMDs)
Hide Description pIMD(s) are a subset of medically significant conditions (MSCs) that included autoimmune diseases and other inflammatory and/or neurological disorders of interest which may or may not have had an autoimmune aetiology. Any pIMD = occurrence of the pIMD regardless of intensity grade. Grade 3 pIMD = a pIMD which prevented normal, everyday activities. Related pIMD = pIMD assessed by the investigator as related to the study vaccination.
Time Frame During the entire study period (from Day 0 up to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.
Arm/Group Title Cervarix Group
Hide Arm/Group Description:
Healthy female subjects who received control vaccine in the primary study HPV-015 (NCT00294047), were administered three doses of Cervarix vaccine intramuscularly, according to a 0,1,6-month schedule.
Overall Number of Participants Analyzed 137
Measure Type: Count of Participants
Unit of Measure: Participants
Any pIMD(s)
1
   0.7%
Grade 3 pIMD(s)
0
   0.0%
Related pIMD(s)
0
   0.0%
4.Primary Outcome
Title Number of Subjects Reporting Pregnancies and Outcomes of the Reported Pregnancies
Hide Description Pregnancy is the term used to describe the period in which a fetus develops inside a woman's womb or uterus. In this study, the number of subjects with pregnancies was calculated. The subjects with confirmed pregnancies were followed up to determine the outcomes of the reported pregnancies.
Time Frame During the entire study period (from Day 0 up to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.
Arm/Group Title Cervarix Group
Hide Arm/Group Description:
Healthy female subjects who received control vaccine in the primary study HPV-015 (NCT00294047), were administered three doses of Cervarix vaccine intramuscularly, according to a 0,1,6-month schedule.
Overall Number of Participants Analyzed 137
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
Time Frame During the entire study period (from Day 0 up to Month 12).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cervarix Group
Hide Arm/Group Description Healthy female subjects who received control vaccine in the primary study HPV-015 (NCT00294047), were administered three doses of Cervarix vaccine intramuscularly, according to a 0,1,6-month schedule.
All-Cause Mortality
Cervarix Group
Affected / at Risk (%)
Total   0/137 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Cervarix Group
Affected / at Risk (%) # Events
Total   1/137 (0.73%)    
Reproductive system and breast disorders   
Menorrhagia  1  1/137 (0.73%)  1
1
Term from vocabulary, MedDRA 20.1
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   24/137 (17.52%)    
Blood and lymphatic system disorders   
Anaemia  1  2/137 (1.46%)  2
Ear and labyrinth disorders   
Vertigo  1  1/137 (0.73%)  1
Eye disorders   
Conjunctivitis allergic  1  1/137 (0.73%)  1
Gastrointestinal disorders   
Crohn's disease  1  1/137 (0.73%)  1
Hepatobiliary disorders   
Cholelithiasis  1  1/137 (0.73%)  1
Infections and infestations   
Cellulitis  1  1/137 (0.73%)  1
Furuncle  1  1/137 (0.73%)  1
Mastitis  1  1/137 (0.73%)  1
Otitis media  1  1/137 (0.73%)  1
Pneumonia  1  1/137 (0.73%)  1
Staphylococcal infection  1  1/137 (0.73%)  1
Tooth infection  1  1/137 (0.73%)  1
Injury, poisoning and procedural complications   
Concussion  1  1/137 (0.73%)  1
Laceration  1  1/137 (0.73%)  1
Ulnar nerve injury  1  1/137 (0.73%)  1
Metabolism and nutrition disorders   
Hyperlipidaemia  1  1/137 (0.73%)  1
Type 2 diabetes mellitus  1  1/137 (0.73%)  1
Musculoskeletal and connective tissue disorders   
Arthritis  1  1/137 (0.73%)  1
Back pain  1  1/137 (0.73%)  1
Costochondritis  1  1/137 (0.73%)  1
Flank pain  1  1/137 (0.73%)  1
Muscle spasms  1  1/137 (0.73%)  1
Neck pain  1  1/137 (0.73%)  1
Tendonitis  1  1/137 (0.73%)  1
Nervous system disorders   
Complex regional pain syndrome  1  1/137 (0.73%)  1
Psychiatric disorders   
Anxiety  1  1/137 (0.73%)  1
Attention deficit/hyperactivity disorder  1  1/137 (0.73%)  1
Depression  1  1/137 (0.73%)  1
Renal and urinary disorders   
Pollakiuria  1  1/137 (0.73%)  1
Reproductive system and breast disorders   
Menorrhagia  1  1/137 (0.73%)  1
Ovarian cyst  1  2/137 (1.46%)  2
Vulvovaginal pruritus  1  1/137 (0.73%)  1
Skin and subcutaneous tissue disorders   
Chloasma  1  1/137 (0.73%)  1
Skin burning sensation  1  1/137 (0.73%)  1
Vascular disorders   
Hypertension  1  1/137 (0.73%)  1
1
Term from vocabulary, MedDRA 20.1
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: NCT01190189     History of Changes
Other Study ID Numbers: 113621
First Submitted: August 26, 2010
First Posted: August 27, 2010
Results First Submitted: November 22, 2018
Results First Posted: December 17, 2018
Last Update Posted: June 19, 2019