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Trial record 55 of 91 for:    cervarix

Evaluation of the Immune and Safety Response of GlaxoSmithKline (GSK) Biologicals' HPV Vaccine in Healthy Indian Women

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: NCT00344032
Recruitment Status : Completed
First Posted : June 26, 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 VLP/AS04 Vaccine (Cervarix TM)
Enrollment 354
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cervarix Placebo
Hide Arm/Group Description Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months). Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
Period Title: Overall Study
Started 176 178
Completed 162 168
Not Completed 14 10
Reason Not Completed
Adverse Event             0             1
Withdrawal by Subject             6             2
Lost to Follow-up             4             6
Physician Decision             4             1
Arm/Group Title Cervarix Placebo Total
Hide Arm/Group Description Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months). Subjects who received 3 doses of Placebo (at 0, 1, 6 months). Total of all reporting groups
Overall Number of Baseline Participants 176 178 354
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 176 participants 178 participants 354 participants
28.5  (4.70) 28.5  (4.97) 28.5  (4.83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 176 participants 178 participants 354 participants
Female
176
 100.0%
178
 100.0%
354
 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 initially seronegative subjects from the According-to-Protocol (ATP) cohort for analysis of immunogenicity.
Arm/Group Title Cervarix Placebo
Hide Arm/Group Description:
Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
Overall Number of Participants Analyzed 124 139
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-HPV-16 Number Analyzed 124 participants 139 participants
124
 100.0%
16
  11.5%
Anti-HPV-18 Number Analyzed 117 participants 124 participants
117
 100.0%
4
   3.2%
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 Months 0 and 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 Placebo
Hide Arm/Group Description:
Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
Overall Number of Participants Analyzed 148 158
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-HPV-16 (Month 0) Number Analyzed 148 participants 158 participants
5.4
(4.7 to 6.1)
4.9
(4.4 to 5.5)
Anti-HPV-16 (Month 7) Number Analyzed 148 participants 156 participants
9813.8
(8605.4 to 11191.9)
6.0
(5.1 to 7.0)
Anti-HPV-18 (Month 0) Number Analyzed 148 participants 156 participants
4.7
(4.2 to 5.2)
4.6
(4.2 to 5.1)
Anti-HPV-18 (Month 7) Number Analyzed 148 participants 154 participants
4030.1
(3544.0 to 4582.8)
4.9
(4.3 to 5.5)
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 (Days 0 - 6) after 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 Placebo
Hide Arm/Group Description:
Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
Overall Number of Participants Analyzed 171 174
Measure Type: Count of Participants
Unit of Measure: Participants
Pain
137
  80.1%
105
  60.3%
Redness
56
  32.7%
24
  13.8%
Swelling
69
  40.4%
35
  20.1%
Arthralgia
19
  11.1%
16
   9.2%
Fatigue
84
  49.1%
83
  47.7%
Fever (above 37.5 degree Celsius)
51
  29.8%
48
  27.6%
Gastro-intestinal symptoms
25
  14.6%
28
  16.1%
Headache
72
  42.1%
71
  40.8%
Myalgia
10
   5.8%
11
   6.3%
Rash
5
   2.9%
8
   4.6%
Urticaria
4
   2.3%
6
   3.4%
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 (Days 0 - 29) after each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cervarix Placebo
Hide Arm/Group Description:
Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
Overall Number of Participants Analyzed 176 178
Measure Type: Count of Participants
Unit of Measure: Participants
20
  11.4%
26
  14.6%
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. Medically significant AEs assessed include AEs prompting emergency room or physician visits that are not related to common diseases 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 Placebo
Hide Arm/Group Description:
Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
Overall Number of Participants Analyzed 176 178
Measure Type: Count of Participants
Unit of Measure: Participants
NOCDs
0
   0.0%
2
   1.1%
Medically Significant AEs
13
   7.4%
24
  13.5%
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 Placebo
Hide Arm/Group Description:
Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
Overall Number of Participants Analyzed 176 178
Measure Type: Count of Participants
Unit of Measure: Participants
2
   1.1%
4
   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 non-systematic method are reported for the Total Vaccinated Cohort

 
Arm/Group Title Cervarix Placebo
Hide Arm/Group Description Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months). Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
All-Cause Mortality
Cervarix Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cervarix Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   2/176 (1.14%)   4/178 (2.25%) 
Congenital, familial and genetic disorders     
Bronchogenic cyst * 1  0/176 (0.00%)  1/178 (0.56%) 
Eye disorders     
Cataract * 1  0/176 (0.00%)  1/178 (0.56%) 
Infections and infestations     
Appendicitis * 1  1/176 (0.57%)  0/178 (0.00%) 
Lymph node tuberculosis * 1  1/176 (0.57%)  0/178 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Aborption spontaneous * 1  0/176 (0.00%)  1/178 (0.56%) 
Respiratory, thoracic and mediastinal disorders     
Pneumothorax * 1  0/176 (0.00%)  1/178 (0.56%) 
*
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 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   153/176 (86.93%)   132/178 (74.16%) 
General disorders     
Pain   137/176 (77.84%)  105/178 (58.99%) 
Redness   56/176 (31.82%)  24/178 (13.48%) 
Swelling   69/176 (39.20%)  35/178 (19.66%) 
Arthralgia   19/176 (10.80%)  16/178 (8.99%) 
Fatigue   84/176 (47.73%)  83/178 (46.63%) 
Fever (above 37.5 degree Celsius)   51/176 (28.98%)  48/178 (26.97%) 
Gastro-intestinal symptoms   25/176 (14.20%)  28/178 (15.73%) 
Headache   72/176 (40.91%)  71/178 (39.89%) 
Myalgia   10/176 (5.68%)  11/178 (6.18%) 
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: NCT00344032     History of Changes
Other Study ID Numbers: 104479
First Submitted: June 23, 2006
First Posted: June 26, 2006
Results First Submitted: November 12, 2009
Results First Posted: December 15, 2009
Last Update Posted: July 20, 2018