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Trial record 50 of 91 for:    cervarix

Complementary Testing to Evaluate Immunogenicity of Human Papillomavirus (HPV) Vaccine (580299) in Healthy Female Subjects Aged >/= 26 Years

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ClinicalTrials.gov Identifier: NCT00456807
Recruitment Status : Completed
First Posted : April 5, 2007
Results First Posted : July 30, 2010
Last Update Posted : December 16, 2016
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: Cervarix TM
Enrollment 100
Recruitment Details Subjects enrolled at pre-selected sites in the primary study HPV-015 (NCT00294047) who were in the immunogenicity subset and have received all three doses of vaccine/control were asked to participate in the present ancillary study.
Pre-assignment Details This ancillary study will consist of supplemental testing of serological and cervical samples obtained at Visit 5 (Month 12) and Visit 6 (Month 18) of the primary study HPV-015 (NCT00294047) from pre-selected sites.
Arm/Group Title Cervarix Group Placebo Group
Hide Arm/Group Description Subjects who received 3 doses of Cervarix during the primary study (NCT00294047). Subjects who received 3 doses of placebo during the primary study (NCT00294047).
Period Title: Overall Study
Started 53 47
Completed 52 47
Not Completed 1 0
Arm/Group Title Cervarix Group Placebo Group Total
Hide Arm/Group Description Subjects who received 3 doses of Cervarix during the primary study (NCT00294047). Subjects who received 3 doses of placebo during the primary study (NCT00294047). Total of all reporting groups
Overall Number of Baseline Participants 53 47 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 53 participants 47 participants 100 participants
40.9  (8.44) 40.3  (8.83) 40.6  (8.63)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 47 participants 100 participants
Female
53
 100.0%
47
 100.0%
100
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Cytokine-positive CD4/CD8 Cells Per Million in Tests Producing at Least 2 Different Cytokines
Hide Description The geometric mean and 95% confidence interval of the number of Human Papilloma Virus type 16 (HPV-16) and HPV-18 specific CD4 and CD8 cells producing at least 2 different cytokines is reported per million of CD4 or CD8 T-cells, respectively.
Time Frame At Month 12 and Month 18 after first vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on subjects from the Total Vaccinated Cohort with available results.
Arm/Group Title Cervarix Group Placebo Group
Hide Arm/Group Description:
Subjects who received 3 doses of Cervarix during the primary study (NCT00294047).
Subjects who received 3 doses of placebo during the primary study (NCT00294047).
Overall Number of Participants Analyzed 52 47
Geometric Mean (95% Confidence Interval)
Unit of Measure: cells per million CD4/CD8 T-cells
HPV-16 specific CD4 [Month 12] (n=52,46)
877.4
(665.0 to 1157.7)
19.5
(9.4 to 40.5)
HPV-16 specific CD4 [Month 18] (n=52,47)
738.5
(512.9 to 1063.3)
22.3
(11.3 to 44.0)
HPV-16 specific CD8 [Month 12] (n=52,46)
2.0
(1.3 to 3.1)
2.0
(1.2 to 3.1)
HPV-16 specific CD8 [Month 18] (n=50,47)
2.9
(1.8 to 4.7)
2.7
(1.6 to 4.6)
HPV-18 specific CD4 [Month 12] (n=52,46)
581.2
(428.0 to 789.2)
11.5
(5.7 to 23.4)
HPV-18 specific CD4 [Month 18] (n=52,47)
300.1
(171.9 to 524.1)
16.8
(9.1 to 31.2)
HPV-18 specific CD8 [Month 12] (n=52,46)
2.1
(1.3 to 3.3)
1.8
(1.1 to 2.7)
HPV-18 specific CD8 [Month 18] (n=50,47)
2.8
(1.7 to 4.6)
4.7
(2.6 to 8.7)
2.Primary Outcome
Title Number of B-cells Per Million Showing a Specific Memory Response for HPV-16 and HPV-18
Hide Description

The geometric mean and 95% confidence interval of the number of HPV-16 and HPV-18 specific memory B-cells is reported per million of B-cells.

An arbitrary value of 0 was given for subjects with antibody concentration below the limit of quantification.

Time Frame At Month 12 and Month 18 after first vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on subjects from the Total Vaccinated Cohort with available results.
Arm/Group Title Cervarix Group Placebo Group
Hide Arm/Group Description:
Subjects who received 3 doses of Cervarix during the primary study (NCT00294047).
Subjects who received 3 doses of placebo during the primary study (NCT00294047).
Overall Number of Participants Analyzed 51 45
Geometric Mean (95% Confidence Interval)
Unit of Measure: cells per million B-cells
HPV-16 specific [Month 12] (n=51,44)
517.1
(361.4 to 739.9)
101.4
(45.1 to 227.9)
HPV-16 specific [Month 18] (n=51,45)
304.4
(210.0 to 441.1)
33.1
(6.7 to 163.0)
HPV-18 specific [Month 12] (n=51,44)
354.7
(253.1 to 497.1)
68.4
(27.0 to 173.2)
HPV-18 specific [Month 18] (n=51,45)
301.5
(223.9 to 406.0)
0.0
(0 to 0)
3.Primary Outcome
Title Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations Above Pre-defined Cut-off Values
Hide Description 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 12 and Month 18 after first vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on subjects from the Total Vaccinated Cohort with available results.
Arm/Group Title Cervarix Group Placebo Group
Hide Arm/Group Description:
Subjects who received 3 doses of Cervarix during the primary study (NCT00294047).
Subjects who received 3 doses of placebo during the primary study (NCT00294047).
Overall Number of Participants Analyzed 52 46
Measure Type: Number
Unit of Measure: Subjects
Anti-HPV-16 [Month 12] (n=52, 45) 52 14
Anti-HPV-16 [Month 18] (n=49, 46) 49 14
Anti-HPV-18 [Month 12] (n=52, 45) 52 7
Anti-HPV-18 [Month 18] (n=49, 46) 49 7
4.Primary Outcome
Title Titers of Anti-HPV-16 and Anti-HPV-18 Antibodies
Hide Description Titers are presented as Geometric Mean Titers (GMTs).
Time Frame At Month 12 and Month 18 after first vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on subjects from the Total Vaccinated Cohort with available results.
Arm/Group Title Cervarix Group Placebo Group
Hide Arm/Group Description:
Subjects who received 3 doses of Cervarix during the primary study (NCT00294047).
Subjects who received 3 doses of placebo during the primary study (NCT00294047).
Overall Number of Participants Analyzed 52 46
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
Anti-HPV-16 [Month 12] (n=52, 45)
2050.4
(1456.1 to 2887.3)
6.9
(5.3 to 9.0)
Anti-HPV-16 [Month 18] (n=49, 46)
1517.1
(1067.4 to 2156.4)
7.2
(5.4 to 9.5)
Anti-HPV-18 [Month 12] (n=52, 45)
761.4
(538.0 to 1077.5)
4.8
(3.5 to 6.7)
Anti-HPV-18 [Month 18] (n=49, 46)
551.4
(387.5 to 784.6)
4.9
(3.6 to 6.6)
5.Primary Outcome
Title Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) Immunoglobulin G (IgG) Antibodies
Hide Description Titers given as Geometric Mean Titers (GMTs). An arbitrary value of 0 was given for subjects with antibody concentration below the limit of quantification.
Time Frame At Month 12 and Month 18 after first vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated Cohort, on subjects with available data. None of the subjects in the Placebo Group had detectable antibodies against HPV-16 at Months 12 and 18 and against HPV-18 at Month 12.
Arm/Group Title Cervarix Group Placebo Group
Hide Arm/Group Description:
Subjects who received 3 doses of Cervarix during the primary study (NCT00294047).
Subjects who received 3 doses of placebo during the primary study (NCT00294047).
Overall Number of Participants Analyzed 26 20
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
Anti-HPV16 [Month 12] (n=12, 10)
129.5
(58.0 to 289.2)
0
(0 to 0)
Anti-HPV16 [Month 18] (n=26, 20)
99.9
(48.9 to 203.8)
0
(0 to 0)
Anti-HPV18 [Month 12] (n=12, 10)
67.2
(28.6 to 158.0)
0
(0 to 0)
Anti-HPV18 [Month 18] (n=26, 20)
42.8
(23.1 to 79.6)
5.8
(5.8 to 5.8)
6.Primary Outcome
Title Correlation of Anti-HPV-16 and Anti-HPV-18 Antibodies in Serum and in Cervical Secretion (CVS) Samples
Hide Description Pearson coefficients of correlation between serum and CVS for anti-HPV-16 and anti-HPV-18 titers standardized for total IgG were calculated.
Time Frame At Month 12 and Month 18 after first vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated Cohort, only on those subjects from the Cervarix group with CVS sample results available.
Arm/Group Title Cervarix Group Placebo Group
Hide Arm/Group Description:
Subjects who received 3 doses of Cervarix during the primary study (NCT00294047).
Subjects who received 3 doses of placebo during the primary study (NCT00294047).
Overall Number of Participants Analyzed 26 0
Measure Type: Number
Unit of Measure: correlation coefficient
Anti-HVP-16 (Month 12) 0.903
Anti- HPV-16 (Month 18) 0.898
Anti-HPV-18 (Month 12) 0.901
Anti-HPV-18 (Month 18) 0.876
Time Frame [Not Specified]
Adverse Event Reporting Description No safety data were collected in the framework of this ancillary study.
 
Arm/Group Title Cervarix Group Placebo Group
Hide Arm/Group Description Subjects who received 3 doses of Cervarix during the primary study (NCT00294047). Subjects who received 3 doses of placebo during the primary study (NCT00294047).
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   0/0   0/0 
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   0/0   0/0 
No safety data were collected in the framework of this ancillary study.
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: NCT00456807     History of Changes
Other Study ID Numbers: 109801
First Submitted: April 4, 2007
First Posted: April 5, 2007
Results First Submitted: November 12, 2009
Results First Posted: July 30, 2010
Last Update Posted: December 16, 2016