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Trial record 11 of 91 for:    cervarix

Safety Study of GSK Biologicals' HPV Vaccine (GSK-580299) in Healthy Female Subjects.

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ClinicalTrials.gov Identifier: NCT00811798
Recruitment Status : Completed
First Posted : December 19, 2008
Results First Posted : October 13, 2011
Last Update Posted : October 20, 2016
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: Cervarix
Enrollment 92
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cervarix Group
Hide Arm/Group Description Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid of the non-dominant arm according to a 0, 1, 6-month schedule.
Period Title: Overall Study
Started 92
Completed 92
Not Completed 0
Arm/Group Title Cervarix Group
Hide Arm/Group Description Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Number of Baseline Participants 92
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 92 participants
30.8  (4.14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants
Female
92
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Number of Subjects Reporting Any Serious Adverse Event (SAE) and SAE(s) With a Causal Relationship to Vaccination as Assessed by the Investigator.
Hide Description SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Time Frame During the entire study period (Day 0 up to the telephone contact at Month 12).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cervarix Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 92
Measure Type: Number
Unit of Measure: Subjects
Any 3
Related 0
Time Frame Serious adverse events: Throughout the study period from Day 0 up to Month 12.
Adverse Event Reporting Description Only serious advers events have been assessed during the study and no other symptoms.
 
Arm/Group Title Cervarix Group
Hide Arm/Group Description Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid of the non-dominant arm according to a 0, 1, 6-month schedule.
All-Cause Mortality
Cervarix Group
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cervarix Group
Affected / at Risk (%)
Total   3/92 (3.26%) 
Investigations   
Hepatic enzyme increased *  1/92 (1.09%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Benign hydatidiform mole *  1/92 (1.09%) 
Pregnancy, puerperium and perinatal conditions   
Abortion missed *  1/92 (1.09%) 
*
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 Group
Affected / at Risk (%)
Total   0/0 
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: NCT00811798     History of Changes
Other Study ID Numbers: 111712
First Submitted: December 18, 2008
First Posted: December 19, 2008
Results First Submitted: September 8, 2011
Results First Posted: October 13, 2011
Last Update Posted: October 20, 2016