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Trial record 68 of 91 for:    cervarix

Safety Evaluation of a Human Papillomavirus (HPV) Vaccine in Healthy Female Control Subjects From the GSK HPV 023 Study

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ClinicalTrials.gov Identifier: NCT01418937
Recruitment Status : Completed
First Posted : August 17, 2011
Results First Posted : August 21, 2015
Last Update Posted : July 12, 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: CervarixTM (GSK580299)
Enrollment 164
Recruitment Details  
Pre-assignment Details During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Arm/Group Title Cervarix Group
Hide Arm/Group Description Subjects received 3 intramuscular injections of Cervarix™ vaccine according to a 0, 1, 6-month schedule.
Period Title: Overall Study
Started 164
Completed 156
Not Completed 8
Reason Not Completed
Lost to Follow-up             5
Protocol Violation             1
Pregnancy             1
Withdrawal by Subject             1
Arm/Group Title Cervarix Group
Hide Arm/Group Description Subjects received 3 intramuscular injections of Cervarix™ vaccine according to a 0, 1, 6-month schedule.
Overall Number of Baseline Participants 164
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 164 participants
30.8  (2.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 164 participants
Female
164
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs)
Hide Description Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame Throughout the study period (from Month 0 up 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 Cervarix Group
Hide Arm/Group Description:
Subjects received 3 intramuscular injections of Cervarix™ vaccine according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 164
Measure Type: Number
Unit of Measure: Subjects
Any SAEs 1
Grade 3 SAEs 1
Related SAEs 0
2.Primary Outcome
Title Number of Subjects With Potential Immune-mediated Disease (pIMDs)
Hide Description [Not Specified]
Time Frame Throughout the study period (from Month 0 up 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 Cervarix Group
Hide Arm/Group Description:
Subjects received 3 intramuscular injections of Cervarix™ vaccine according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 164
Measure Type: Number
Unit of Measure: Subjects
Any pIMDs 0
Grade 3 pIMDs 0
Related pIMDs 0
3.Primary Outcome
Title Number of Subjects With Medically Significant Conditions (MSCs)
Hide Description MSCs include 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 Throughout the study period (from Month 0 up 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 Cervarix Group
Hide Arm/Group Description:
Subjects received 3 intramuscular injections of Cervarix™ vaccine according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 164
Measure Type: Number
Unit of Measure: Subjects
Any MSCs 8
Grade 3 MSCs 1
Vaccine-related MSCs 0
4.Primary Outcome
Title Number of Pregnant Subjects Reporting Pregnancy Outcomes
Hide Description The pregnancy outcomes were based on reports from pregnant subjects in the study population. Pregnancy outcomes are pregnancies resulting in live births.
Time Frame Throughout the study period (from Month 0 up to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the number of pregnant subjects participating in the study.
Arm/Group Title Cervarix Group
Hide Arm/Group Description:
Subjects received 3 intramuscular injections of Cervarix™ vaccine according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: Subjects
5
Time Frame SAEs were collected throughout the entire study period (from Day 0 to Month 12)
Adverse Event Reporting Description Non-serious solicited and unsolicited adverse events were not collected in this study.
 
Arm/Group Title Cervarix Group
Hide Arm/Group Description Subjects received 3 intramuscular injections of Cervarix™ vaccine 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   1/164 (0.61%) 
Psychiatric disorders   
Depression suicidal * 1  1/164 (0.61%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
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: NCT01418937     History of Changes
Other Study ID Numbers: 114379
First Submitted: August 12, 2011
First Posted: August 17, 2011
Results First Submitted: July 27, 2015
Results First Posted: August 21, 2015
Last Update Posted: July 12, 2018