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Trial record 57 of 91 for:    cervarix

Human Papilloma Virus (HPV) Vaccine Trial in Young Adolescent Women With GlaxoSmithKline Biologicals' (GSK Bio) HPV-16/18 Vaccine

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ClinicalTrials.gov Identifier: NCT00316706
Recruitment Status : Completed
First Posted : April 21, 2006
Results First Posted : March 1, 2010
Last Update Posted : September 18, 2012
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Cervical Intraepithelial Neoplasia
Papillomavirus Infection
Interventions Biological: GSK Biologicals' HPV-16/18 Vaccine (Cervarix™)
Biological: Havrix™
Enrollment 1245
Recruitment Details  
Pre-assignment Details Subjects from the Cervarix group continued the long-term follow-up study until Month 48 while subjects from the Havrix group completed the study at Month 24.
Arm/Group Title Cervarix Group Havrix Group
Hide Arm/Group Description Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48. Subjects received 3 doses of Havrix™ (hepatitis A vaccine [HAV]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.
Period Title: Overall Study
Started 626 619
Completed 588 [1] 571 [2]
Not Completed 38 48
Reason Not Completed
Lost to Follow-up             38             48
[1]
Subjects in Cervarix group that completed the study at Month 48
[2]
Subjects in Havrix group that completed the study at Month 24
Arm/Group Title Cervarix Group Havrix Group Total
Hide Arm/Group Description Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48. Subjects received 3 doses of Havrix™ (hepatitis A vaccine [HAV]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24. Total of all reporting groups
Overall Number of Baseline Participants 626 619 1245
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 626 participants 619 participants 1245 participants
12.1  (1.4) 12.1  (1.4) 12.1  (1.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 626 participants 619 participants 1245 participants
Female
626
 100.0%
619
 100.0%
1245
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary 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 18, 24, 36 and 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on those subjects from the Cervarix Group with available data for the defined time point.
Arm/Group Title Cervarix Group Havrix Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.
Subjects received 3 doses of Havrix™ (hepatitis A vaccine [HAV]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.
Overall Number of Participants Analyzed 588 0
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-HPV-16 at Month 18 (n= 588)
3901.6
(3626.2 to 4198.0)
Anti-HPV-16 at Month 24 (n= 549)
3226.3
(2988.4 to 3483.1)
Anti-HPV-16 at Month 36 (n= 571)
2688.6
(2503.6 to 2887.3)
Anti-HPV-16 at Month 48 (n= 559)
2395.8
(2230.5 to 2573.3)
Anti-HPV-18 at Month 18 (n= 587)
1570.8
(1448.3 to 1703.7)
Anti-HPV-18 at Month 24 (n= 548)
1263.4
(1165.1 to 1370.1)
Anti-HPV-18 at Month 36 (n= 570)
995.0
(918.1 to 1078.4)
Anti-HPV-18 at Month 48 (n= 559)
885.6
(816.3 to 960.8)
2.Secondary Outcome
Title Titers of Anti-3-O-desacyl-4'-Monophosphoryl Lipid A (Anti-MPL) Antibodies During the Initial 2 Years Follow-up
Hide Description Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.
Time Frame At Months 18 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data for the defined time point.
Arm/Group Title Cervarix Group Havrix Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.
Subjects received 3 doses of Havrix™ (hepatitis A vaccine [HAV]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.
Overall Number of Participants Analyzed 551 338
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Month 18 (n= 128, 129)
347.2
(297.8 to 404.7)
117.7
(101.3 to 136.8)
Month 24 (n= 551, 338)
271.5
(252.2 to 292.3)
74.0
(66.3 to 82.6)
3.Secondary Outcome
Title Titers of Anti-3-O-desacyl 4'-Monophosphoryl Lipid A (Anti-MPL) Antibodies During the Last 2 Years Follow-up
Hide Description Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.
Time Frame At Month 36 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data for the defined time point. Analysis was only done for subjects in the Cervarix Group, as all subjects from the Havrix Group completed the study at Month 24.
Arm/Group Title Cervarix Group Havrix Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.
Subjects received 3 doses of Havrix™ (hepatitis A vaccine [HAV]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.
Overall Number of Participants Analyzed 571 0
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Month 36 (n= 571)
224.7
(204.8 to 246.6)
Month 48 (n= 558)
170.0
(156.6 to 184.4)
4.Secondary Outcome
Title Number of Subjects Reporting Pregnancies, Serious Adverse Events (SAEs), New Onset Chronic Diseases (NOCDs), and Conditions Prompting Emergency Room (ER) Visits or Physician Visits That Are Not Related to Common Diseases During the First 2 Years Follow-up
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.

New onset of chronic diseases (NOCDs) assessed include e.g. autoimmune disorders, asthma, type I diabetes.

Time Frame From Month 18 to Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses were performed on the Total Vaccinated Cohort, on subjects with available data at the defined time point.
Arm/Group Title Cervarix Group Havrix Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.
Subjects received 3 doses of Havrix™ (hepatitis A vaccine [HAV]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.
Overall Number of Participants Analyzed 626 619
Measure Type: Number
Unit of Measure: Subjects
Pregnancies (n=626, 619) 8 1
NOCDs (n=617, 571) 5 3
ER visits (n=617, 571) 40 21
SAEs (n=617, 571) 8 5
5.Secondary Outcome
Title Number of Subjects Reporting Pregnancies, Serious Adverse Events (SAEs), New Onset Chronic Diseases (NOCDs), and Conditions Prompting Emergency Room During the Last 2 Years Follow-up
Hide Description

Serious adverse events assessed include medical occurrences that result 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.

New onset of chronic diseases (NOCDs) assessed include e.g. autoimmune disorders, asthma, type I diabetes.

Time Frame From Month 24 to Month 48
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses were performed on the Total Vaccinated Cohort, on subjects with available data at the defined time point. Analysis was only done for subjects in the Cervarix Group, as all subjects from the Havrix Group completed the study at Month 24.
Arm/Group Title Cervarix Group Havrix Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.
Subjects received 3 doses of Havrix™ (hepatitis A vaccine [HAV]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.
Overall Number of Participants Analyzed 626 0
Measure Type: Number
Unit of Measure: Subjects
Pregnancies (Month 24 to 36) (n=626,0) 3
Pregnancies (Month 36 to 48) (n=588,0) 11
NOCDs (Month 24 to 36) (n=601,0) 7
NOCDs (Month 36 to 48) (n=588,0) 6
ER visits (Month 24 to 36) (n=601,0) 41
ER visits (Month 36 to 48) (n=588,0) 50
SAEs (Month 24 to 36) (n=601,0) 10
SAEs (Month 36 to 48) (n=588,0) 15
Time Frame From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group
Adverse Event Reporting Description Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.
 
Arm/Group Title Cervarix Group Havrix Group
Hide Arm/Group Description Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48. Subjects received 3 doses of Havrix™ (hepatitis A vaccine [HAV]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.
All-Cause Mortality
Cervarix Group Havrix Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cervarix Group Havrix Group
Affected / at Risk (%) Affected / at Risk (%)
Total   33/626 (5.27%)   5/619 (0.81%) 
Congenital, familial and genetic disorders     
Dermoid cyst of ovary *  0/626 (0.00%)  1/619 (0.16%) 
Gastrointestinal disorders     
Abdominal pain *  3/626 (0.48%)  0/619 (0.00%) 
Constipation *  2/626 (0.32%)  0/619 (0.00%) 
Umbilical hernia *  1/626 (0.16%)  0/619 (0.00%) 
Malocclusion *  1/626 (0.16%)  0/619 (0.00%) 
General disorders     
Pyrexia *  1/626 (0.16%)  0/619 (0.00%) 
Hepatobiliary disorders     
Cholelithiasis *  1/626 (0.16%)  0/619 (0.00%) 
Infections and infestations     
Cellulitis *  1/626 (0.16%)  0/619 (0.00%) 
Pneumonia *  0/626 (0.00%)  1/619 (0.16%) 
Appendicitis *  5/626 (0.80%)  0/619 (0.00%) 
Campylobacter gastroenteritis *  1/626 (0.16%)  0/619 (0.00%) 
Helicobacter gastritis *  1/626 (0.16%)  0/619 (0.00%) 
Subcutaneous abscess *  1/626 (0.16%)  0/619 (0.00%) 
Acute tonsilitis *  1/626 (0.16%)  0/619 (0.00%) 
Gastroenteritis *  1/626 (0.16%)  0/619 (0.00%) 
Gastroenteritis viral *  1/626 (0.16%)  0/619 (0.00%) 
Meningitis viral *  1/626 (0.16%)  0/619 (0.00%) 
Injury, poisoning and procedural complications     
Skull fractured base *  1/626 (0.16%)  0/619 (0.00%) 
Splenic rupture *  0/626 (0.00%)  1/619 (0.16%) 
Traumatic brain injury *  1/626 (0.16%)  0/619 (0.00%) 
Alcohol poisoning *  1/626 (0.16%)  0/619 (0.00%) 
Concussion *  1/626 (0.16%)  0/619 (0.00%) 
Lower limb fracture *  1/626 (0.16%)  0/619 (0.00%) 
Investigations     
Investigation *  1/626 (0.16%)  0/619 (0.00%) 
Metabolism and nutrition disorders     
Dehydration *  1/626 (0.16%)  0/619 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Uterine leiomyoma *  1/626 (0.16%)  0/619 (0.00%) 
Nervous system disorders     
Loss of consciousness *  0/626 (0.00%)  1/619 (0.16%) 
Pregnancy, puerperium and perinatal conditions     
Premature labor *  1/626 (0.16%)  0/619 (0.00%) 
Abortion spontaneous incomplete *  1/626 (0.16%)  0/619 (0.00%) 
Pre-eclampsia *  1/626 (0.16%)  0/619 (0.00%) 
Psychiatric disorders     
Suicide attempt *  1/626 (0.16%)  0/619 (0.00%) 
Depressed mood *  1/626 (0.16%)  0/619 (0.00%) 
Reproductive system and breast disorders     
Ovarian cyst *  1/626 (0.16%)  1/619 (0.16%) 
Ovarian cyst torsion *  1/626 (0.16%)  0/619 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthmatic crisis *  1/626 (0.16%)  0/619 (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 Havrix Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/626 (0.00%)   0/619 (0.00%) 
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: NCT00316706     History of Changes
Other Study ID Numbers: 104896 (month 18 FU)
104902 ( Other Identifier: GSK )
104904 ( Other Identifier: GSK )
104918 ( Other Identifier: GSK )
First Submitted: April 19, 2006
First Posted: April 21, 2006
Results First Submitted: November 12, 2009
Results First Posted: March 1, 2010
Last Update Posted: September 18, 2012