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Study to Assess Immune Responses and Safety of the GSK-580299 Vaccine in Healthy Women (26 to 45 Years)

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: NCT01277042
Recruitment Status : Completed
First Posted : January 14, 2011
Results First Posted : December 3, 2013
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Infections, Papillomavirus
Interventions Biological: GSK580299 (CervarixTM)
Biological: Engerix-BTM
Enrollment 1212
Recruitment Details  
Pre-assignment Details The study comprised a Primary Vaccination Phase from Day 0 to Month 7, followed by a Long-Term Safety Follow-up Phase, up to Month 12.
Arm/Group Title Cervarix Group Engerix Group
Hide Arm/Group Description Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule. Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Period Title: Overall Study
Started 606 606
Completed 598 601
Not Completed 8 5
Reason Not Completed
Adverse Event             4             3
Lost to Follow-up             2             2
Withdrawal by Subject             2             0
Arm/Group Title Cervarix Group Engerix Group Total
Hide Arm/Group Description Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule. Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule. Total of all reporting groups
Overall Number of Baseline Participants 606 606 1212
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 606 participants 606 participants 1212 participants
35.8  (4.92) 35.6  (5.06) 35.7  (4.99)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 606 participants 606 participants 1212 participants
Female
606
 100.0%
606
 100.0%
1212
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) and HPV-18
Hide Description A seroconverted subject was defined as a subject seronegative at baseline whose concentration for anti-HPV-16/18 antibodies, as measured by Enzyme-linked Immunosorbent assay (ELISA) , was higher than or equal to (≥) cut-off value. A seronegative subject was defined as a subject whose antibody concentration was below (<) cut-off value. Cut-off values were 8 ELISA units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.
Time Frame One month after third vaccination (Month 7)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title Cervarix Group Engerix Group
Hide Arm/Group Description:
Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 365 401
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16 Number Analyzed 345 participants 344 participants
345
 100.0%
67
  19.5%
HPV-18 Number Analyzed 365 participants 401 participants
363
  99.5%
135
  33.7%
2.Secondary Outcome
Title Number of Subjects Seropositive Against HPV-16 and HPV-18
Hide Description A seropositive subject was defined as a subject whose anti-HPV-16/18 antibody concentration, as measured by ELISA, was higher than or equal to (≥) cut-off value. Cut-off values were 8 ELISA units per milliliter (EL.U/mL) for anti-HPV-16 antibodies, and 7 EL.U/mL for anti-HPV-18 antibodies.
Time Frame Before vaccination (Month 0) and one month after third vaccination (Month 7)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title Cervarix Group Engerix Group
Hide Arm/Group Description:
Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 596 601
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16, Day 0
251
  42.1%
257
  42.8%
HPV-16, Month 7
596
 100.0%
322
  53.6%
HPV-18, Day 0
231
  38.8%
200
  33.3%
HPV-18, Month 7
594
  99.7%
312
  51.9%
3.Secondary Outcome
Title Concentrations for Anti-HPV-16 and Anti-HPV-18 Antibodies
Hide Description Concentrations are given as geometric mean titers (GMTs), expressed in ELISA units per milliliter (EL.U/mL). Cut-off values were 8 EL.U/mL for anti-HPV-16 antibodies, and 7 EL.U/mL for anti-HPV-18 antibodies.
Time Frame Before vaccination (Month 0) and one month after third vaccination (Month 7)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title Cervarix Group Engerix Group
Hide Arm/Group Description:
Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 596 601
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
HPV-16, Day 0
9.7
(8.8 to 10.6)
9.3
(8.5 to 10.2)
HPV-16, Month 7
6439.8
(6039.8 to 6866.3)
12.1
(11.0 to 13.4)
HPV-18, Day 0
6.4
(6.0 to 6.9)
6.0
(5.6 to 6.5)
HPV-18, Month 7
3563.3
(3310.0 to 3836.0)
8.7
(8.0 to 9.5)
4.Secondary Outcome
Title Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Hide Description Solicited local symptoms assessed were pain, redness and swelling. Grade 3 redness and swelling were redness and swelling above 50 millimeters (mm) and grade 3 pain was defined as pain that prevented normal activity. Any was defined as the incidence of a symptom regardless of intensity grade.
Time Frame During the 7 days (Days 0 - 6) after any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and symptom sheet completed.
Arm/Group Title Cervarix Group Engerix Group
Hide Arm/Group Description:
Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 604 606
Measure Type: Count of Participants
Unit of Measure: Participants
Any pain
470
  77.8%
296
  48.8%
Grade 3 pain
36
   6.0%
5
   0.8%
Any redness
156
  25.8%
88
  14.5%
Grade 3 redness
2
   0.3%
1
   0.2%
Any swelling
146
  24.2%
58
   9.6%
Grade 3 swelling
11
   1.8%
1
   0.2%
5.Secondary Outcome
Title Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Hide Description Solicited symptoms were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and temperature [axillary temperature above (>)37 degrees Celsius(°C)].Grade 3 temperature= temperature >39°C. Grade 3 utricaria= distributed on at least 4 body areas. Grade 3 symptom=prevented normal activity. Gastrointestinal symptoms=nausea, vomiting, diarrhoea and/or abdominal pain. Arthralgia (joint pain): in joints distal from injection site. Any=incidence of a symptom regardless of intensity grade or relationship to vaccination. Related = incidence of a symptom assessed by investigator as related to vaccination.
Time Frame During the 7 days (Days 0 - 6) after any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and symptom sheet completed.
Arm/Group Title Cervarix Group Engerix Group
Hide Arm/Group Description:
Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 604 606
Measure Type: Count of Participants
Unit of Measure: Participants
Any arthralgia
19
   3.1%
14
   2.3%
Grade 3 arthralgia
0
   0.0%
0
   0.0%
Related arthralgia
17
   2.8%
12
   2.0%
Any fatigue
100
  16.6%
68
  11.2%
Grade 3 fatigue
1
   0.2%
1
   0.2%
Related fatigue
93
  15.4%
59
   9.7%
Any gastrointestinal symptoms
33
   5.5%
24
   4.0%
Grade 3 gastrointestinal symptoms
1
   0.2%
0
   0.0%
Related gastrointestinal symptoms
24
   4.0%
11
   1.8%
Any headache
71
  11.8%
46
   7.6%
Grade 3 headache
4
   0.7%
0
   0.0%
Related headache
64
  10.6%
38
   6.3%
Any myalgia
69
  11.4%
42
   6.9%
Grade 3 myalgia
1
   0.2%
0
   0.0%
Related myalgia
66
  10.9%
39
   6.4%
Any rash
2
   0.3%
1
   0.2%
Grade 3 rash
0
   0.0%
0
   0.0%
Related rash
1
   0.2%
1
   0.2%
Temperature >37.0°C
28
   4.6%
24
   4.0%
Temperature >39.0°C
0
   0.0%
0
   0.0%
Related temperature
15
   2.5%
13
   2.1%
Any urticaria
4
   0.7%
1
   0.2%
Grade 3 urticaria
2
   0.3%
0
   0.0%
Related urticaria
3
   0.5%
1
   0.2%
6.Secondary Outcome
Title Number of Subjects Reporting Any, Grade 3 and Related Serious Adverse Events (SAEs)
Hide Description SAEs assessed include 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. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination, grade 3 was a SAE that prevented normal activities, and related was defined as a SAE assessed by the investigator to be causally related to the study vaccination. and related was an event assessed by the investigator as causally related to the study vaccination.
Time Frame Throughout the study (from Month 0 up to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.
Arm/Group Title Cervarix Group Engerix Group
Hide Arm/Group Description:
Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 606 606
Measure Type: Count of Participants
Unit of Measure: Participants
Any SAE(s)
3
   0.5%
3
   0.5%
Grade 3 SAE(s)
2
   0.3%
0
   0.0%
Related SAE(s)
0
   0.0%
0
   0.0%
7.Secondary Outcome
Title Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Hide Description An unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.
Time Frame Within 30 days (Days 0 - 29) after any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.
Arm/Group Title Cervarix Group Engerix Group
Hide Arm/Group Description:
Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 606 606
Measure Type: Count of Participants
Unit of Measure: Participants
Any AE(s)
32
   5.3%
36
   5.9%
Grade 3 AE(s)
2
   0.3%
2
   0.3%
Related AE(s)
0
   0.0%
1
   0.2%
8.Secondary Outcome
Title Number of Subjects Reporting Medically Significant Conditions (MSCs) Including Potential Immune Mediated Diseases (pIMDs)
Hide Description MSCs were AEs prompting emergency room or physician visits that were not related to common diseases (upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury), or not related to routine visits for physical examination or vaccination. It also included SAEs not related to common diseases. MSCs included pIMDs, a subset of MSCs that included autoimmune diseases and other inflammatory and/or neurological disorders of interest which might or might not have had an autoimmune etiology.
Time Frame Throughout the study (from Month 0 up to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.
Arm/Group Title Cervarix Group Engerix Group
Hide Arm/Group Description:
Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 606 606
Measure Type: Count of Participants
Unit of Measure: Participants
5
   0.8%
7
   1.2%
9.Secondary Outcome
Title Number of Subjects With Outcome of Pregnancies
Hide Description The sole pregnancy outcome reported was elective termination with no apparent congenital anomaly.
Time Frame Throughout the study (from Month 0 up to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented, solely on subjects with outcome of pregnancies.
Arm/Group Title Cervarix Group Engerix-B Group
Hide Arm/Group Description:
Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 4 1
Measure Type: Count of Participants
Unit of Measure: Participants
4
 100.0%
1
 100.0%
Time Frame Serious adverse events were assessed from Month 0 up to Month 12. Systematically assessed frequent adverse events were assessed during 7 days (Days 0-6) post vaccination period.
Adverse Event Reporting Description For the systematically assessed other (non-serious) adverse events the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
 
Arm/Group Title Cervarix Group Engerix Group
Hide Arm/Group Description Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule. Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
All-Cause Mortality
Cervarix Group Engerix Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Cervarix Group Engerix Group
Affected / at Risk (%) Affected / at Risk (%)
Total   3/606 (0.50%)   3/606 (0.50%) 
Cardiac disorders     
Aortic valve incompetence *  0/606 (0.00%)  1/606 (0.17%) 
Mitral valve incompetence *  0/606 (0.00%)  1/606 (0.17%) 
Tricuspid valve incompetence *  0/606 (0.00%)  1/606 (0.17%) 
Congenital, familial and genetic disorders     
Atrial septal defect *  0/606 (0.00%)  1/606 (0.17%) 
Hepatobiliary disorders     
Cholecystitis *  1/606 (0.17%)  0/606 (0.00%) 
Cholelithiasis *  1/606 (0.17%)  0/606 (0.00%) 
Infections and infestations     
Gastroenteritis shigella *  0/606 (0.00%)  1/606 (0.17%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Fibroadenoma of breast *  0/606 (0.00%)  1/606 (0.17%) 
Breast cancer *  1/606 (0.17%)  0/606 (0.00%) 
Nervous system disorders     
Haemorrhage intracranial *  1/606 (0.17%)  0/606 (0.00%) 
*
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 Engerix Group
Affected / at Risk (%) Affected / at Risk (%)
Total   490/606 (80.86%)   318/606 (52.48%) 
General disorders     
Pain   470/606 (77.56%)  296/606 (48.84%) 
Redness   156/606 (25.74%)  88/606 (14.52%) 
Swelling   146/606 (24.09%)  58/606 (9.57%) 
Fatigue   100/606 (16.50%)  68/606 (11.22%) 
Gastrointestinal   33/606 (5.45%)  24/606 (3.96%) 
Headache   71/606 (11.72%)  46/606 (7.59%) 
Myalgia   69/606 (11.39%)  42/606 (6.93%) 
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: NCT01277042    
Other Study ID Numbers: 114590
First Submitted: January 13, 2011
First Posted: January 14, 2011
Results First Submitted: September 6, 2012
Results First Posted: December 3, 2013
Last Update Posted: August 17, 2018