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Trial record 56 of 91 for:    cervarix

Study to Evaluate the Immune Response and Safety of GSK Biologicals' HPV Vaccine in Healthy Women Aged 18-35 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: NCT00345878
Recruitment Status : Completed
First Posted : June 29, 2006
Results First Posted : December 15, 2009
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Infections, Papillomavirus
Interventions Biological: Placebo
Biological: HPV-16/18 L1 VLP AS04 (Cervarix TM)
Enrollment 271
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cervarix Group Placebo Group
Hide Arm/Group Description Subjects received 3 doses of HPV-16/18 L1 VLP AS04 (Cervarix™) according to a 0, 1, 6-month schedule. Subjects received 3 doses of Placebo according to a 0, 1, 6-month schedule.
Period Title: Overall Study
Started 135 136
Completed 131 135
Not Completed 4 1
Reason Not Completed
Adverse Event             1             0
Lost to Follow-up             2             1
Other             1             0
Arm/Group Title Cervarix Group Placebo Group Total
Hide Arm/Group Description Subjects received 3 doses of HPV-16/18 L1 VLP AS04 (Cervarix™) according to a 0, 1, 6-month schedule. Subjects received 3 doses of Placebo according to a 0, 1, 6-month schedule. Total of all reporting groups
Overall Number of Baseline Participants 135 136 271
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 135 participants 136 participants 271 participants
24.8  (3.91) 25.0  (4.14) 24.9  (4.02)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 135 participants 136 participants 271 participants
Female
135
 100.0%
136
 100.0%
271
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Subjects Who 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 antibodies with titers greater than or equal to the predefined cut-off value in the serum of subjects seronegative before vaccination. Cut-off values assessed include 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 the According-to-Protocol (ATP) cohort for analysis of immunogenicity.
Arm/Group Title Cervarix Group Placebo Group
Hide Arm/Group Description:
Subjects received 3 doses of HPV-16/18 L1 VLP AS04 (Cervarix™) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Placebo according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 112 115
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-HPV16 Number Analyzed 112 participants 115 participants
112
 100.0%
4
   3.5%
Anti-HPV18 Number Analyzed 106 participants 113 participants
106
 100.0%
2
   1.8%
2.Secondary Outcome
Title Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Hide Description Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).
Time Frame At Month 0 and Month 7
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.
Arm/Group Title Cervarix Group Placebo Group
Hide Arm/Group Description:
Subjects received 3 doses of HPV-16/18 L1 VLP AS04 (Cervarix™) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Placebo according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 126 129
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-HPV16 (at Month 0) Number Analyzed 126 participants 129 participants
5.1
(4.3 to 6.0)
4.6
(4.2 to 5.0)
Anti-HPV16 (at Month 7) Number Analyzed 126 participants 127 participants
11133.3
(9817.6 to 12625.3)
4.7
(4.2 to 5.3)
Anti-HPV18 (at Month 0) Number Analyzed 122 participants 127 participants
4.3
(3.9 to 4.7)
4.2
(3.8 to 4.7)
Anti-HPV18 (at Month 7) Number Analyzed 122 participants 127 participants
4264.2
(3771.6 to 4821.2)
4.2
(3.8 to 4.7)
3.Secondary Outcome
Title Number of Subjects Reporting Solicited Symptoms
Hide Description Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include arthralgia, fatigue, fever, gastro-intestinal symptoms, headache, myalgia, rash and urticaria.
Time Frame During the 7 days after each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
Arm/Group Title Cervarix Group Placebo Group
Hide Arm/Group Description:
Subjects received 3 doses of HPV-16/18 L1 VLP AS04 (Cervarix™) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Placebo according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 132 135
Measure Type: Count of Participants
Unit of Measure: Participants
Pain
121
  91.7%
101
  74.8%
Redness
48
  36.4%
40
  29.6%
Swelling
42
  31.8%
25
  18.5%
Arthralgia
39
  29.5%
26
  19.3%
Fatigue
52
  39.4%
48
  35.6%
Fever (above 37.5 degree Celsius)
19
  14.4%
17
  12.6%
Gastro-intestinal symptoms
18
  13.6%
18
  13.3%
Headache
46
  34.8%
47
  34.8%
Myalgia
48
  36.4%
32
  23.7%
Rash
4
   3.0%
7
   5.2%
Urticaria
4
   3.0%
2
   1.5%
4.Secondary Outcome
Title Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Hide Description Unsolicited adverse event = 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 after any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cervarix Group Placebo Group
Hide Arm/Group Description:
Subjects received 3 doses of HPV-16/18 L1 VLP AS04 (Cervarix™) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Placebo according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 135 136
Measure Type: Count of Participants
Unit of Measure: Participants
30
  22.2%
36
  26.5%
5.Secondary Outcome
Title Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs) and Other Medically Significant Adverse Events (AEs)
Hide Description

NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes, allergies,...

Medically significant AEs assessed include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or SAEs that are not related to common diseases.

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 Placebo Group
Hide Arm/Group Description:
Subjects received 3 doses of HPV-16/18 L1 VLP AS04 (Cervarix™) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Placebo according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 135 136
Measure Type: Count of Participants
Unit of Measure: Participants
NOCDs
1
   0.7%
0
   0.0%
Medically significant AEs
10
   7.4%
11
   8.1%
6.Secondary Outcome
Title Number of Subjects Reporting Serious Adverse Events
Hide Description Serious adverse events assessed include medical occurrences that results in death, is 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 Placebo Group
Hide Arm/Group Description:
Subjects received 3 doses of HPV-16/18 L1 VLP AS04 (Cervarix™) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Placebo according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 135 136
Measure Type: Count of Participants
Unit of Measure: Participants
3
   2.2%
3
   2.2%
Time Frame [Not Specified]
Adverse Event Reporting Description

Events collected by systematic assessment are reported for subjects with a symptom diary card available.

Events collected by a non-systematic method are reported for the Total Vaccinated cohort.

 
Arm/Group Title Cervarix Group Placebo Group
Hide Arm/Group Description Subjects received 3 doses of HPV-16/18 L1 VLP AS04 (Cervarix™) according to a 0, 1, 6-month schedule. Subjects received 3 doses of Placebo 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   3/135 (2.22%)   3/136 (2.21%) 
Hepatobiliary disorders     
Cholelithiasis * 1  1/135 (0.74%)  0/136 (0.00%) 
Infections and infestations     
Dengue fever * 1  1/135 (0.74%)  1/136 (0.74%) 
Chronic tonsillitis * 1  1/135 (0.74%)  0/136 (0.00%) 
Injury, poisoning and procedural complications     
Overdose * 1  0/135 (0.00%)  1/136 (0.74%) 
Musculoskeletal and connective tissue disorders     
Intervertebral disc protrusion * 1  0/135 (0.00%)  1/136 (0.74%) 
Pregnancy, puerperium and perinatal conditions     
Abortion missed * 1  1/135 (0.74%)  0/136 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Nasal turbinate hypertrophy * 1  1/135 (0.74%)  0/136 (0.00%) 
*
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 Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   126/135 (93.33%)   114/136 (83.82%) 
General disorders     
Pain   121/135 (89.63%)  101/136 (74.26%) 
Redness   48/135 (35.56%)  40/136 (29.41%) 
Swelling   42/135 (31.11%)  25/136 (18.38%) 
Arthralgia   39/135 (28.89%)  26/136 (19.12%) 
Fatigue   52/135 (38.52%)  48/136 (35.29%) 
Fever (above 37.5 degree Celsius)   19/135 (14.07%)  17/136 (12.50%) 
Gastro-intestinal symptoms   18/135 (13.33%)  18/136 (13.24%) 
Headache   46/135 (34.07%)  47/136 (34.56%) 
Myalgia   48/135 (35.56%)  32/136 (23.53%) 
Rash   4/135 (2.96%)  7/136 (5.15%) 
Infections and infestations     
Upper respiratory tract infection * 1  8/135 (5.93%)  10/136 (7.35%) 
Influenza * 1  3/135 (2.22%)  8/136 (5.88%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
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: NCT00345878     History of Changes
Other Study ID Numbers: 105926
First Submitted: June 28, 2006
First Posted: June 29, 2006
Results First Submitted: November 12, 2009
Results First Posted: December 15, 2009
Last Update Posted: July 20, 2018