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Trial record 24 of 91 for:    cervarix

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

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: NCT01249365
Recruitment Status : Completed
First Posted : November 29, 2010
Results First Posted : July 16, 2018
Last Update Posted : July 16, 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 Infections, Papillomavirus
Intervention Biological: GSK580299 (Cervarix)
Enrollment 199
Recruitment Details  
Pre-assignment Details  
Arm/Group Title HPV Vaccine
Hide Arm/Group Description Healthy female subjects aged 26 years and above, who received control vaccine in the primary study NCT00294047, were administrated 3 intramuscular injections of Cervarix vaccine into the deltoid of the non-dominant arm, according to a 0, 1, 6-month schedule in the current study.
Period Title: Overall Study
Started 199
Completed 198
Not Completed 1
Reason Not Completed
Lost to Follow-up             1
Arm/Group Title HPV Vaccine
Hide Arm/Group Description Healthy female subjects aged 26 years and above, who received control vaccine in the primary study NCT00294047, were administrated 3 intramuscular injections of Cervarix vaccine into the deltoid of the non-dominant arm, according to a 0, 1, 6-month schedule in the current study.
Overall Number of Baseline Participants 199
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 199 participants
46.9  (7.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 199 participants
Female
199
 100.0%
Male
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Geographic ancestry Number Analyzed 199 participants
African Heritage/African American
1
   0.5%
Asian - Central/South Asian Heritage
2
   1.0%
Asian - East Asian Heritage
2
   1.0%
Asian - South East Asian Heritage
78
  39.2%
White - Caucasian/European Heritage
116
  58.3%
1.Primary Outcome
Title Number of Subjects Reporting Serious Adverse Events
Hide Description Serious adverse events (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 the occurrence of any SAE regardless of intensity grade or relation to vaccination. Grade 3 SAE = SAE which prevented normal, everyday activities (in adults/adolescents, such an SAE, for example, prevented attendance at work/school and necessitated the administration of corrective therapy). Related SAE = SAE assessed by the investigator as causally related to the study vaccination.
Time Frame Throughout the study (from Month 0 to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total Vaccinated cohort, which included all subjects with the study vaccine administered.
Arm/Group Title HPV Vaccine
Hide Arm/Group Description:
Healthy female subjects aged 26 years and above, who received control vaccine in the primary study NCT00294047, were administrated 3 intramuscular injections of Cervarix vaccine into the deltoid of the non-dominant arm, according to a 0, 1, 6-month schedule in the current study.
Overall Number of Participants Analyzed 199
Measure Type: Count of Participants
Unit of Measure: Participants
Any SAE(s)
6
   3.0%
Grade 3 SAE(s)
2
   1.0%
Related SAE(s)
0
   0.0%
2.Primary Outcome
Title Number of Subjects Reporting Medically Significant Conditions (MSCs) and Potential Immune-mediated Diseases (pIMDs)
Hide Description

Medically significant conditions (MSCs) are defined as:

AEs prompting emergency room or physician visits that were not related to common diseases, or not related to routine visits for physical examination or vaccination; SAEs that were not related to common diseases. Common diseases include: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.

Potential immune-mediated diseases (pIMDs) are a subset of medically significant conditions that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.

Any was defined as the occurrence of any MSC or pIMD regardless of intensity grade or relation to vaccination. Grade 3 MSC or pIMD = a MSC or pIMD which prevented normal, everyday activities. Related MSC or pIMD = a MSC or pIMD assessed by the investigator as related to the vaccination.

Time Frame Throughout the study (from Month 0 to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total Vaccinated cohort, which included all subjects with the study vaccine administered.
Arm/Group Title HPV Vaccine
Hide Arm/Group Description:
Healthy female subjects aged 26 years and above, who received control vaccine in the primary study NCT00294047, were administrated 3 intramuscular injections of Cervarix vaccine into the deltoid of the non-dominant arm, according to a 0, 1, 6-month schedule in the current study.
Overall Number of Participants Analyzed 199
Measure Type: Count of Participants
Unit of Measure: Participants
Any MSCs
16
   8.0%
Grade 3 MSCs
2
   1.0%
Related MSCs
0
   0.0%
Any pIMDs
1
   0.5%
Grade 3 pIMDs
0
   0.0%
Related pIMDs
0
   0.0%
3.Primary Outcome
Title Number of Subjects Reporting Pregnancies and Outcome of Reported Pregnancies
Hide Description Live infant NO apparent congenital anomaly; Live infant congenital anomaly; Premature live infant NO apparent congenital anomaly; Premature live infant congenital anomaly; Elective termination NO apparent congenital anomaly; Elective termination congenital anomaly; Therapeutic abortion; Ectopic pregnancy; Spontaneous abortion NO apparent congenital anomaly; Spontaneous abortion congenital anomaly; Stillbirth NO apparent congenital anomaly; Stillbirth congenital anomaly; Molar pregnancy; Pregnancy ongoing; Lost to follow up.
Time Frame Throughout the study (from Month 0 to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total Vaccinated cohort, which included all subjects with the study vaccine administered and who reported any pregnancies and outcomes of reported pregnancies.
Arm/Group Title HPV Vaccine
Hide Arm/Group Description:
Healthy female subjects aged 26 years and above, who received control vaccine in the primary study NCT00294047, were administrated 3 intramuscular injections of Cervarix vaccine into the deltoid of the non-dominant arm, according to a 0, 1, 6-month schedule in the current study.
Overall Number of Participants Analyzed 1
Measure Type: Count of Participants
Unit of Measure: Participants
Live infant NO apparent congenital anomaly
1
 100.0%
Live infant congenital anomaly
0
   0.0%
Premature live infant NO apparent congen. anomaly
0
   0.0%
Premature live infant congenital anomaly
0
   0.0%
Elective termination NO apparent congen. anomaly
0
   0.0%
Elective termination congenital anomaly
0
   0.0%
Therapeutic abortion
0
   0.0%
Ectopic pregnancy
0
   0.0%
Spontaneous abortion NO apparent congen. anomaly
0
   0.0%
Spontaneous abortion congenital anomaly
0
   0.0%
Stillbirth NO apparent congenital anomaly
0
   0.0%
Stillbirth congenital anomaly
0
   0.0%
Molar pregnancy
0
   0.0%
Pregnancy ongoing
0
   0.0%
Lost to follow up
0
   0.0%
Time Frame Adverse Events were reported from the first receipt of study vaccine (Month 0) until 6 months following administration of the last dose of study vaccine (i.e. at study conclusion, Month 12).
Adverse Event Reporting Description Non-serious solicited adverse events were not collected in this study. Non-serious unsolicited events collected in this study did not exceed the threshold of 5%.
 
Arm/Group Title HPV Vaccine
Hide Arm/Group Description Healthy female subjects aged 26 years and above, who received control vaccine in the primary study NCT00294047, were administrated 3 intramuscular injections of Cervarix vaccine into the deltoid of the non-dominant arm, according to a 0, 1, 6-month schedule in the current study.
All-Cause Mortality
HPV Vaccine
Affected / at Risk (%)
Total   0/199 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
HPV Vaccine
Affected / at Risk (%) # Events
Total   6/199 (3.02%)    
Musculoskeletal and connective tissue disorders   
Joint range of motion decreased  1  1/199 (0.50%)  1
Osteoarthritis  1  1/199 (0.50%)  1
Trigger finger  1  1/199 (0.50%)  1
Nervous system disorders   
Migraine  1  1/199 (0.50%)  1
Nerve root compression  1  1/199 (0.50%)  1
Psychiatric disorders   
Agitated depression  1  1/199 (0.50%)  2
Major depression  1  1/199 (0.50%)  2
Post-traumatic stress disorder  1  1/199 (0.50%)  1
Reproductive system and breast disorders   
Dysfunctional uterine bleeding  1  1/199 (0.50%)  1
Ovarian cyst  1  1/199 (0.50%)  1
1
Term from vocabulary, MedDRA 20.0
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 5%
HPV Vaccine
Affected / at Risk (%) # Events
Total   0/199 (0.00%)    
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: NCT01249365     History of Changes
Other Study ID Numbers: 113618
2010-020227-48 ( EudraCT Number )
First Submitted: November 24, 2010
First Posted: November 29, 2010
Results First Submitted: December 22, 2017
Results First Posted: July 16, 2018
Last Update Posted: July 16, 2018