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A Single Centre Study to Evaluate the Safety and Immunogenicity of the Human Papillomavirus Vaccine (GSK-580299) in Chinese Females

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: NCT00549900
Recruitment Status : Completed
First Posted : October 26, 2007
Results First Posted : December 17, 2009
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Infections, Papillomavirus
Intervention Biological: GSK580299 (Cervarix™ , HPV -16/18 L1 VLP AS04 vaccine)
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cervarix Group
Hide Arm/Group Description Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
Period Title: Overall Study
Started 30
Completed 29
Not Completed 1
Reason Not Completed
Adverse Event             1
Arm/Group Title Cervarix Group
Hide Arm/Group Description Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
28.0  (9.03)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
30
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Number of Subjects Reporting Serious Adverse Events
Hide Description Serious adverse events are defined as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Time Frame Throughout the study period (up to Month 7)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cervarix Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
1
   3.3%
2.Primary Outcome
Title Number of Subjects Reporting Solicited Local Symptoms
Hide Description Solicited local symptoms assessed include pain, redness and swelling.
Time Frame During the 7-day (Day 0-6) period following each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cervarix Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
Pain
26
  86.7%
Redness
16
  53.3%
Swelling
9
  30.0%
3.Primary Outcome
Title Number of Subjects Reporting Solicited General Symptoms
Hide Description Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash, and urticaria.
Time Frame During the 7-day (Day 0-6) period following each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cervarix Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
Arthralgia
2
   6.7%
Fatigue
10
  33.3%
Axillary fever greater than 37 degrees Celcius
1
   3.3%
Gastrointestinal symptoms
4
  13.3%
Headache
8
  26.7%
Myalgia
7
  23.3%
Rash
1
   3.3%
Urticaria
0
   0.0%
4.Primary Outcome
Title Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Hide Description An unsolicited adverse event is defined as any adverse event (AE) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
Time Frame Within 30 days (Day 0-29) after any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cervarix Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
4
  13.3%
5.Primary Outcome
Title Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters
Hide Description

Hematological and biochemical parameters assessed in blood samples include alanine aminotransferase (ALT), basophils, creatinine, eosinophils, hematocrit, lymphocytes, monocytes, neutrophils, platelets, red blood cell, and white blood cells.

Abnormalities reported include values outside the normal ranges: values higher than normal are designated as "Above" and values lower than normal as "Below".

Time Frame At Month 0 and Month 7
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on subjects from the Total vaccinated cohort that completed the study.
Arm/Group Title Cervarix Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 29
Measure Type: Count of Participants
Unit of Measure: Participants
ALT Above [Month 0]
3
  10.3%
ALT Below [Month 0]
0
   0.0%
ALT Above [Month 7]
1
   3.4%
ALT Below [Month 7]
0
   0.0%
Basophils Above [Month 0]
0
   0.0%
Basophils Below [Month 0]
0
   0.0%
Basophils Above [Month 7]
0
   0.0%
Basophils Below [Month 7]
0
   0.0%
Creatinine Above [Month 0]
0
   0.0%
Creatinine Below [Month 0]
0
   0.0%
Creatinine Above [Month 7]
3
  10.3%
Creatinine Below [Month 7]
0
   0.0%
Eosinophils Above [Month 0]
2
   6.9%
Eosinophils Below [Month 0]
0
   0.0%
Eosinophils Above [Month 7]
0
   0.0%
Eosinophils Below [Month 7]
0
   0.0%
Hematocrit Above [Month 0]
0
   0.0%
Hematocrit Below [Month 0]
0
   0.0%
Hematocrit Above [Month 7]
0
   0.0%
Hematocrit Below [Month 7]
13
  44.8%
Lymphocytes Above [Month 0]
1
   3.4%
Lymphocytes Below [Month 0]
0
   0.0%
Lymphocytes Above [Month 7]
0
   0.0%
Lymphocytes Below [Month 7]
0
   0.0%
Monocytes Above [Month 0]
0
   0.0%
Monocytes Below [Month 0]
0
   0.0%
Monocytes Above [Month 7]
0
   0.0%
Monocytes Below [Month 7]
0
   0.0%
Neutrophils Above [Month 0]
1
   3.4%
Neutrophils Below [Month 0]
1
   3.4%
Neutrophils Above [Month 7]
2
   6.9%
Neutrophils Below [Month 7]
2
   6.9%
Platelets Above [Month 0]
3
  10.3%
Platelets Below [Month 0]
2
   6.9%
Platelets Above [Month 7]
1
   3.4%
Platelets Below [Month 7]
1
   3.4%
Red blood cells Above [Month 0]
0
   0.0%
Red blood cells Below [Month 0]
0
   0.0%
Red blood cells Above [Month 7]
0
   0.0%
Red blood cells Below [Month 7]
0
   0.0%
White blood cells Above [Month 0]
2
   6.9%
White blood cells Below [Month 0]
0
   0.0%
White blood cells Above [Month 7]
2
   6.9%
White blood cells Below [Month 7]
1
   3.4%
6.Primary Outcome
Title Number of Subjects Reporting Medically Significant Adverse Events
Hide Description Medically significant AEs were defined as AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or 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.
Time Frame Throughout the study period (up to Month7)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cervarix Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
2
   6.7%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cervarix Group
Hide Arm/Group Description Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
All-Cause Mortality
Cervarix Group
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Cervarix Group
Affected / at Risk (%)
Total   1/30 (3.33%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Breast cancer *  1/30 (3.33%) 
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cervarix Group
Affected / at Risk (%)
Total   26/30 (86.67%) 
General disorders   
Pain   26/30 (86.67%) 
Redness   16/30 (53.33%) 
Swelling   9/30 (30.00%) 
Arthralgia   2/30 (6.67%) 
Fatigue   10/30 (33.33%) 
Gastrointestinal symptoms   4/30 (13.33%) 
Headache   8/30 (26.67%) 
Myalgia   7/30 (23.33%) 
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
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00549900    
Other Study ID Numbers: 107336
First Submitted: October 18, 2007
First Posted: October 26, 2007
Results First Submitted: November 12, 2009
Results First Posted: December 17, 2009
Last Update Posted: July 20, 2018