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Trial record 70 of 91 for:    cervarix

Immunogenicity and Safety Study of GSK Biologicals' Human Papillomavirus 580299 Vaccine in Healthy Female Subjects

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ClinicalTrials.gov Identifier: NCT00996125
Recruitment Status : Completed
First Posted : October 16, 2009
Results First Posted : June 27, 2012
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, Care Provider, Investigator);   Primary Purpose: Prevention
Condition Infections, Papillomavirus
Interventions Biological: CervarixTM
Other: Control
Enrollment 750
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cervarix Group Placebo Group
Hide Arm/Group Description Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule. Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
Period Title: Overall Study
Started 374 376
Completed 369 365
Not Completed 5 11
Reason Not Completed
Adverse Event             0             2
Lost to Follow-up             1             6
Withdrawal by Subject             4             3
Arm/Group Title Cervarix Group Placebo Group Total
Hide Arm/Group Description Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule. Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule. Total of all reporting groups
Overall Number of Baseline Participants 374 376 750
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 374 participants 376 participants 750 participants
13.1  (2.44) 13.1  (2.42) 13.1  (2.43)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 374 participants 376 participants 750 participants
Female
374
 100.0%
376
 100.0%
750
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Geometric Mean Titers (GMTs) for Antibodies Against Human Papillomavirus (HPV)-16/18 Antigens
Hide Description Titers were given as geometric mean titers and were measured by Enzyme-linked Immunosorbent Assay (ELISA) and expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).
Time Frame One month after the third dose (at Month 7)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included subjects who received 3 doses of the study vaccine or placebo and for whom data concerning immunogenicity measures were available.
Arm/Group Title Cervarix Group Placebo Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 362 363
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-HPV-16
18347.1
(16915.2 to 19900.2)
5.0
(4.7 to 5.3)
Anti-HPV-18
7960.2
(7181.3 to 8823.6)
4.1
(3.8 to 4.3)
2.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 At Month 7
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity on initially seronegative subjects for whom data concerning immunogenicity measures were available.
Arm/Group Title Cervarix Group Placebo Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 338 344
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-HPV-16 Number Analyzed 326 participants 323 participants
326
 100.0%
8
   2.5%
Anti-HPV-18 Number Analyzed 338 participants 344 participants
336
  99.4%
10
   2.9%
3.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. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeter (mm).
Time Frame During the 7 days (Days 0 – 6) following each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.
Arm/Group Title Cervarix Group Placebo Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 373 376
Measure Type: Count of Participants
Unit of Measure: Participants
Any pain
350
  93.8%
299
  79.5%
Grade 3 pain
38
  10.2%
16
   4.3%
Any redness
113
  30.3%
52
  13.8%
Grade 3 redness
2
   0.5%
1
   0.3%
Any swelling
113
  30.3%
54
  14.4%
Grade 3 swelling
13
   3.5%
2
   0.5%
4.Secondary Outcome
Title Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Hide Description Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (= axillary temperature above 37.0 degrees Celsius (°C). Grade 3 fever = axillary temperature above 39.0°C. Grade 3 urticaria = urticaria distributed on at least 4 body areas. For other symptoms, any = occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 = a general symptom that prevented normal activity. Related was a general symptom assessed by the investigator as causally related to the study vaccination.
Time Frame During the 7 days (Days 0 – 6) following each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.
Arm/Group Title Cervarix Group Placebo Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 373 376
Measure Type: Count of Participants
Unit of Measure: Participants
Any arthralgia
38
  10.2%
33
   8.8%
Grade 3 arthralgia
0
   0.0%
2
   0.5%
Related arthralgia
25
   6.7%
23
   6.1%
Any fatigue
137
  36.7%
126
  33.5%
Grade 3 fatigue
2
   0.5%
4
   1.1%
Related fatigue
106
  28.4%
98
  26.1%
Any gastrointestinal symptoms
57
  15.3%
45
  12.0%
Grade 3 gastrointestinal symptoms
2
   0.5%
2
   0.5%
Related gastrointestinal symptoms
21
   5.6%
31
   8.2%
Any headache
123
  33.0%
99
  26.3%
Grade 3 headache
5
   1.3%
3
   0.8%
Related headache
80
  21.4%
70
  18.6%
Any myalgia
110
  29.5%
93
  24.7%
Grade 3 myalgia
1
   0.3%
1
   0.3%
Related myalgia
96
  25.7%
83
  22.1%
Any rash
9
   2.4%
4
   1.1%
Grade 3 rash
0
   0.0%
0
   0.0%
Related rash
3
   0.8%
2
   0.5%
Any fever
86
  23.1%
74
  19.7%
Grade 3 fever
2
   0.5%
0
   0.0%
Related fever
40
  10.7%
27
   7.2%
Any urticaria
8
   2.1%
3
   0.8%
Grade 3 urticaria
0
   0.0%
0
   0.0%
Related urticaria
7
   1.9%
1
   0.3%
5.Secondary Outcome
Title Number of Subjects Reporting Medically Significant Conditions (MSCs)
Hide Description

Medically significant conditions (MSCs) are defined as: adverse events (AEs) prompting emergency room or physician visits that are not (1) related to common diseases or (2) 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, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.

MSCs were collected regardless of causal relationship to vaccination and intensity.

Time Frame Throughout the study period (from Day 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 the vaccine administration documented.
Arm/Group Title Cervarix Group Placebo Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 374 376
Measure Type: Count of Participants
Unit of Measure: Participants
14
   3.7%
11
   2.9%
6.Secondary Outcome
Title Number of Subjects Reporting Pregnancies and Pregnancy Outcomes
Hide Description [Not Specified]
Time Frame Throughout the study period (from Day 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 the vaccine administration documented.
Arm/Group Title Cervarix Group Placebo Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 374 376
Measure Type: Count of Participants
Unit of Measure: Participants
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 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 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 Total Vaccinated cohort which included all subjects with the vaccine administration documented.
Arm/Group Title Cervarix Group Placebo Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 374 376
Measure Type: Count of Participants
Unit of Measure: Participants
Any AEs
139
  37.2%
125
  33.2%
Grade 3 AEs
0
   0.0%
3
   0.8%
Related AEs
2
   0.5%
3
   0.8%
8.Secondary Outcome
Title Number of Subjects Reporting Any 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 and related was an event assessed by the investigator as causally related to the study vaccination.
Time Frame Throughout the study period (from Day 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 the vaccine administration documented.
Arm/Group Title Cervarix Group Placebo Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 374 376
Measure Type: Count of Participants
Unit of Measure: Participants
Any SAEs
5
   1.3%
2
   0.5%
Related SAEs
0
   0.0%
0
   0.0%
Time Frame Serious adverse events were assessed from Day 0 up to Month 12. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 days and 30 days post vaccination period respectively.
Adverse Event Reporting Description For the systematically assessed other (non-serious) adverse events, the total participants at risk in Cervarix Group included those from Total Vaccinated cohort who had the symptom sheet completed and with at least one documented dose.
 
Arm/Group Title Cervarix Group Placebo Group
Hide Arm/Group Description Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule. Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
All-Cause Mortality
Cervarix Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cervarix Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   5/374 (1.34%)   2/376 (0.53%) 
Blood and lymphatic system disorders     
Lymphadenopathy *  1/374 (0.27%)  0/376 (0.00%) 
Gastrointestinal disorders     
Abdominal adhesions *  1/374 (0.27%)  0/376 (0.00%) 
Food poisoning *  1/374 (0.27%)  0/376 (0.00%) 
Infections and infestations     
Bronchopneumonia *  1/374 (0.27%)  0/376 (0.00%) 
Injury, poisoning and procedural complications     
Hand fracture *  0/374 (0.00%)  1/376 (0.27%) 
Multiple fractures *  0/374 (0.00%)  1/376 (0.27%) 
Ulna fracture *  0/374 (0.00%)  1/376 (0.27%) 
Reproductive system and breast disorders     
Adnexa uteri cyst *  1/374 (0.27%)  0/376 (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 Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   360/374 (96.26%)   339/376 (90.16%) 
General disorders     
Pain   350/373 (93.83%)  299/376 (79.52%) 
Redness   113/373 (30.29%)  52/376 (13.83%) 
Swelling   113/373 (30.29%)  54/376 (14.36%) 
Arthralgia   38/373 (10.19%)  33/376 (8.78%) 
Fatigue   137/373 (36.73%)  126/376 (33.51%) 
Gastrointestinal symptoms   57/373 (15.28%)  45/376 (11.97%) 
Headache   123/373 (32.98%)  99/376 (26.33%) 
Myalgia   110/373 (29.49%)  93/376 (24.73%) 
Fever  [1]  86/373 (23.06%)  74/376 (19.68%) 
Infections and infestations     
Upper respiratory tract infection *  101/374 (27.01%)  86/376 (22.87%) 
Nasopharyngitis *  22/374 (5.88%)  18/376 (4.79%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
Fever is defined as axillary temperate above 37.0 degrees Celsius.
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: NCT00996125     History of Changes
Other Study ID Numbers: 112022
First Submitted: October 15, 2009
First Posted: October 16, 2009
Results First Submitted: May 24, 2012
Results First Posted: June 27, 2012
Last Update Posted: August 17, 2018