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Trial record 7 of 91 for:    cervarix

Immunogenicity and Safety of GlaxoSmithKline Biologicals' Huma Papillomavirus (HPV) Vaccine 580299 in Healthy Females 15 - 25 Years of Age

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: NCT00552279
Recruitment Status : Completed
First Posted : November 1, 2007
Results First Posted : March 5, 2010
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Infections, Papillomavirus
Intervention Biological: Cervarix TM
Enrollment 805
Recruitment Details  
Pre-assignment Details A total of 805 subjects were enrolled and 804 subjects were vaccinated and included in the analyses.
Arm/Group Title Cervarix-12 Group Cervarix-6 Group
Hide Arm/Group Description Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule. Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
Period Title: Overall Study
Started 403 401
Completed 389 398
Not Completed 14 3
Reason Not Completed
Adverse Event             0             1
Withdrawal by Subject             12             1
Lost to Follow-up             1             0
Other             1             1
Arm/Group Title Cervarix-12 Group Cervarix-6 Group Total
Hide Arm/Group Description Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule. Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule. Total of all reporting groups
Overall Number of Baseline Participants 403 401 804
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 403 participants 401 participants 804 participants
18.6  (2.98) 18.7  (3.13) 18.6  (3.05)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 403 participants 401 participants 804 participants
Female
403
 100.0%
401
 100.0%
804
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Hide Description

Seroconversion is defined as the appearance of anti-HPV-16 and/or anti- HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination.

Cut-off values were 8 enzyme-linked immunosorbent assay 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 the third vaccine dose
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on initially seronegative subjects from the According-to-Protocol (ATP) cohort for analysis of immunogenicity
Arm/Group Title Cervarix-12 Group Cervarix-6 Group
Hide Arm/Group Description:
Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 346 346
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-HPV-16 Number Analyzed 337 participants 342 participants
337
 100.0%
342
 100.0%
Anti-HPV-18 Number Analyzed 346 participants 346 participants
345
  99.7%
346
 100.0%
2.Primary Outcome
Title Titer of Anti-HPV-16 and Anti-HPV-18 Antibodies
Hide Description Titer given as geometric mean titer (GMT).
Time Frame One month after the third vaccine dose
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on initially seronegative subjects from the ATP cohort for analysis of immunogenicity
Arm/Group Title Cervarix-12 Group Cervarix-6 Group
Hide Arm/Group Description:
Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 346 346
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-HPV-16 Number Analyzed 337 participants 342 participants
11337.2
(10238.2 to 12554.1)
10050.9
(9180.9 to 11003.3)
Anti-HPV-18 Number Analyzed 346 participants 346 participants
4526.7
(4110.1 to 4985.6)
3879.9
(3532.7 to 4261.2)
3.Secondary Outcome
Title Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies
Hide Description

Seroconversion is defined as the appearance of anti-HPV-16 and/or anti- HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination.

Cut-off values were 8 enzyme-linked immunosorbent assay 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 the second vaccine dose
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on initially seronegative subjects from the ATP cohort for analysis of immunogenicity
Arm/Group Title Cervarix-12 Group Cervarix-6 Group
Hide Arm/Group Description:
Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 346 346
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-HPV-16 Number Analyzed 337 participants 342 participants
337
 100.0%
342
 100.0%
Anti-HPV-18 Number Analyzed 346 participants 346 participants
346
 100.0%
346
 100.0%
4.Secondary Outcome
Title Titer of Anti-HPV-16 and Anti-HPV-18 Antibodies
Hide Description Titer given as GMT.
Time Frame One month after the second vaccine dose
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on initially seronegative subjects from the ATP cohort for analysis of immunogenicity
Arm/Group Title Cervarix-12 Group Cervarix-6 Group
Hide Arm/Group Description:
Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 346 346
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-HPV-16 Number Analyzed 337 participants 342 participants
3307.0
(3051.0 to 3584.5)
3184.1
(2938.3 to 3450.5)
Anti-HPV-18 Number Analyzed 346 participants 346 participants
2382.3
(2179.2 to 2604.3)
2256.3
(2070.7 to 2458.7)
5.Secondary Outcome
Title Number of Subjects Reporting Solicited Local Symptoms
Hide Description Solicited local symptoms assessed include pain, redness and swelling at the injection site.
Time Frame During the 7-day (Days 0-6) period following each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
Arm/Group Title Cervarix-12 Group Cervarix-6 Group
Hide Arm/Group Description:
Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 402 401
Measure Type: Count of Participants
Unit of Measure: Participants
Pain
385
  95.8%
386
  96.3%
Redness
201
  50.0%
182
  45.4%
Swelling
158
  39.3%
145
  36.2%
6.Secondary 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 (Days 0-6) period following each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
Arm/Group Title Cervarix-12 Group Cervarix-6 Group
Hide Arm/Group Description:
Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 402 401
Measure Type: Count of Participants
Unit of Measure: Participants
Arthralgia
85
  21.1%
78
  19.5%
Fatigue
245
  60.9%
237
  59.1%
Temperature ≥ 37.5°C
37
   9.2%
29
   7.2%
Gastro-intestinal symptoms
85
  21.1%
86
  21.4%
Headache
203
  50.5%
199
  49.6%
Myalgia
167
  41.5%
168
  41.9%
Rash
30
   7.5%
34
   8.5%
Urticaria
12
   3.0%
18
   4.5%
7.Secondary Outcome
Title Number of Subjects Reporting Unsolicited Adverse Events (AE)
Hide Description An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time Frame During the 30-day (Days 0-29) period following each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
Arm/Group Title Cervarix-12 Group Cervarix-6 Group
Hide Arm/Group Description:
Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 403 401
Measure Type: Count of Participants
Unit of Measure: Participants
117
  29.0%
129
  32.2%
8.Secondary Outcome
Title Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs), New Onset Autoimmune Diseases (NOADs), Serious Adverse Events (SAEs), and Medically Significant Conditions (MSCs)
Hide Description

Entire study period = up to Month 18 Cervarix-12 & Month 12 Cervarix-6.

NOCDs assessed include eg. autoimmune disorders (NOADs), asthma, type I diabetes. MSCs assessed include AEs prompting emergency room visits and physician office visits not related to common illnesses.

An SAE is any untoward medical occurrence that: results in death, is lifethreatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.

Time Frame During the entire study period (up to Month 18 or up to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cervarix-12 Group Cervarix-6 Group
Hide Arm/Group Description:
Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 403 401
Measure Type: Count of Participants
Unit of Measure: Participants
MSCs
42
  10.4%
44
  11.0%
NOCDs
0
   0.0%
5
   1.2%
NOADs
0
   0.0%
2
   0.5%
SAEs
12
   3.0%
9
   2.2%
9.Secondary Outcome
Title Number of Subjects With Pregnancies and Their Outcomes
Hide Description

Entire study period = up to Month 18 Cervarix-12 & Month 12 Cervarix-6

Number of pregnancies and pregnancy outcomes.

Time Frame During the entire study period (up to Month 18 or Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total vaccinated cohort, on pregnant subjects
Arm/Group Title Cervarix-12 Group Cervarix-6 Group
Hide Arm/Group Description:
Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 5 3
Measure Type: Count of Participants
Unit of Measure: Participants
Normal infant
2
  40.0%
1
  33.3%
Elective abortion
0
   0.0%
2
  66.7%
Abortion threatened
1
  20.0%
0
   0.0%
Ongoing
1
  20.0%
0
   0.0%
Foetal distress syndrome
1
  20.0%
0
   0.0%
10.Secondary Outcome
Title Number of Subjects Completing the 3-dose Vaccination Schedule
Hide Description [Not Specified]
Time Frame After the third vaccine dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cervarix-12 Group Cervarix-6 Group
Hide Arm/Group Description:
Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 403 401
Measure Type: Count of Participants
Unit of Measure: Participants
388
  96.3%
397
  99.0%
Time Frame [Not Specified]
Adverse Event Reporting Description Analysis for other adverse events were performed on the Total vaccinated cohort, on subjects with available data.
 
Arm/Group Title Cervarix-12 Group Cervarix-6 Group
Hide Arm/Group Description Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule. Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
All-Cause Mortality
Cervarix-12 Group Cervarix-6 Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cervarix-12 Group Cervarix-6 Group
Affected / at Risk (%) Affected / at Risk (%)
Total   12/403 (2.98%)   9/401 (2.24%) 
Ear and labyrinth disorders     
Vertigo *  0/403 (0.00%)  1/401 (0.25%) 
Endocrine disorders     
Thyroiditis *  0/403 (0.00%)  1/401 (0.25%) 
Gastrointestinal disorders     
Constipation *  1/403 (0.25%)  0/401 (0.00%) 
Abdominal pain *  2/403 (0.50%)  0/401 (0.00%) 
General disorders     
Cyst *  1/403 (0.25%)  0/401 (0.00%) 
Infections and infestations     
Appendicitis *  2/403 (0.50%)  1/401 (0.25%) 
Gastroenteritis *  0/403 (0.00%)  1/401 (0.25%) 
Pharyngitis *  1/403 (0.25%)  0/401 (0.00%) 
Sinusitis *  1/403 (0.25%)  0/401 (0.00%) 
Urinary tract infection *  1/403 (0.25%)  1/401 (0.25%) 
Tracheitis *  1/403 (0.25%)  0/401 (0.00%) 
Injury, poisoning and procedural complications     
Road traffic accident *  0/403 (0.00%)  1/401 (0.25%) 
Tendon injury *  1/403 (0.25%)  0/401 (0.00%) 
Multiple injuries *  1/403 (0.25%)  0/401 (0.00%) 
Musculoskeletal and connective tissue disorders     
Chondropathy *  0/403 (0.00%)  1/401 (0.25%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer female *  0/403 (0.00%)  1/401 (0.25%) 
Nervous system disorders     
Convulsion *  1/403 (0.25%)  0/401 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Abortion threatened *  1/403 (0.25%)  0/401 (0.00%) 
Cephalhaematoma *  1/403 (0.25%)  0/401 (0.00%) 
Foetal distress syndrome *  1/403 (0.25%)  0/401 (0.00%) 
Reproductive system and breast disorders     
Ovarian cyst ruptured *  1/403 (0.25%)  0/401 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Brain hypoxia *  1/403 (0.25%)  0/401 (0.00%) 
Skin and subcutaneous tissue disorders     
Urticaria *  0/403 (0.00%)  1/401 (0.25%) 
Vascular disorders     
Hypertension *  1/403 (0.25%)  0/401 (0.00%) 
*
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-12 Group Cervarix-6 Group
Affected / at Risk (%) Affected / at Risk (%)
Total   388/403 (96.28%)   389/401 (97.01%) 
General disorders     
Pain   385/403 (95.53%)  386/401 (96.26%) 
Redness   201/403 (49.88%)  182/401 (45.39%) 
Swelling   158/403 (39.21%)  145/401 (36.16%) 
Arthralgia   85/403 (21.09%)  78/401 (19.45%) 
Fatigue   245/403 (60.79%)  237/401 (59.10%) 
Temperature ≥ 37.5°C   37/403 (9.18%)  29/401 (7.23%) 
Gastrointestinal symptoms   85/403 (21.09%)  86/401 (21.45%) 
Headache   203/403 (50.37%)  199/401 (49.63%) 
Myalgia   167/403 (41.44%)  168/401 (41.90%) 
Rash   30/403 (7.44%)  34/401 (8.48%) 
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
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00552279     History of Changes
Other Study ID Numbers: 109179
First Submitted: October 30, 2007
First Posted: November 1, 2007
Results First Submitted: February 12, 2010
Results First Posted: March 5, 2010
Last Update Posted: June 25, 2018