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Evaluation of Safety and Immunogenicity of Co-administering Human Papillomavirus Vaccine With Another Vaccine in Healthy Female Subjects

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: NCT00578227
Recruitment Status : Completed
First Posted : December 21, 2007
Results First Posted : January 6, 2010
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: None (Open Label);   Primary Purpose: Prevention
Condition Infections, Papillomavirus
Interventions Biological: Cervarix™
Biological: Twinrix ™ Paediatric
Enrollment 814
Recruitment Details  
Pre-assignment Details Although the total number of enrolled subjects for this study was 814, one subject did not receive any study vaccine and was therefore not considered as started in the 'Participant Flow' section.
Arm/Group Title Cervarix™ & Twinrix™ Group Cervarix™ Group Twinrix™ Group
Hide Arm/Group Description Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6). Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6). Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
Period Title: Overall Study
Started 272 270 271
Completed 267 268 267
Not Completed 5 2 4
Reason Not Completed
Lost to Follow-up             0             1             1
Withdrawal by Subject             5             1             3
Arm/Group Title Cervarix™ & Twinrix™ Group Cervarix™ Group Twinrix™ Group Total
Hide Arm/Group Description Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6). Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6). Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6). Total of all reporting groups
Overall Number of Baseline Participants 272 270 271 813
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 272 participants 270 participants 271 participants 813 participants
11.2  (2.04) 11.2  (2.02) 11.2  (1.99) 11.2  (2.01)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 272 participants 270 participants 271 participants 813 participants
Female
272
 100.0%
270
 100.0%
271
 100.0%
813
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Subjects Seroconverted for Anti-hepatitis A (Anti-HAV) Antibodies
Hide Description Seroconversion is defined as the appearance of anti-HAV antibodies [i.e., antibody titer greater than or equal to 15 milli-international units/milliliter (mIU/mL)] in the sera of subjects seronegative (antibody titer below 15 mIU/mL) before vaccination.
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, in subjects seronegative for anti-HAV before vaccination (i.e. with antibody titer below 15 mIU/mL).
Arm/Group Title Cervarix™ & Twinrix™ Group Cervarix™ Group Twinrix™ Group
Hide Arm/Group Description:
Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
Overall Number of Participants Analyzed 240 0 242
Measure Type: Count of Participants
Unit of Measure: Participants
240
 100.0%
242
 100.0%
2.Primary Outcome
Title Anti-Heptatis A (HAV) Antibody Titers.
Hide Description Titers are given as Geometric Mean Titers (GMTs) expressed as mIU/mL.
Time Frame At Month 7
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects seronegative for anti-HAV before vaccination (i.e. with antibody titer below 15 mIU/mL).
Arm/Group Title Cervarix™ & Twinrix™ Group Cervarix™ Group Twinrix™ Group
Hide Arm/Group Description:
Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
Overall Number of Participants Analyzed 240 0 242
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
4504.2
(3993.0 to 5080.8)
5288.4
(4713.3 to 5933.7)
3.Primary Outcome
Title Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies
Hide Description A subject seroprotected against HBs is a subject with antibody titers greater than or equal to 10 mIU/mL.
Time Frame At Month 7
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects seronegative for anti-HBs before vaccination, i.e. with anti-HBs antibody titer greater than or equal to 3.3 mIU/mL.
Arm/Group Title Cervarix™ & Twinrix™ Group Cervarix™ Group Twinrix™ Group
Hide Arm/Group Description:
Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
Overall Number of Participants Analyzed 178 0 161
Measure Type: Count of Participants
Unit of Measure: Participants
175
  98.3%
161
 100.0%
4.Primary Outcome
Title Number of Subjects 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 subject seronegative before vaccination. Cut-off values = 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 ATP cohort for analysis of immunogenicity, in subjects seronegative for the corresponding HPV type before vaccination, i.e. with antibody titers below 8 EL.U/mL for anti-HPV-16 antibodies and below 7 EL.U/mL for anti-HPV-18 antibodies.
Arm/Group Title Cervarix™ & Twinrix™ Group Cervarix™ Group Twinrix™ Group
Hide Arm/Group Description:
Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
Overall Number of Participants Analyzed 239 241 0
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-HPV-16 Number Analyzed 229 participants 233 participants 0 participants
228
  99.6%
233
 100.0%
Anti-HPV-18 Number Analyzed 239 participants 241 participants 0 participants
238
  99.6%
241
 100.0%
5.Primary Outcome
Title Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibody Titers
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 7
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects seronegative for the corresponding HPV type before vaccination, i.e. with antibody titers below 8 EL.U/mL for anti-HPV-16 antibodies and below 7 EL.U/mL for anti-HPV-18 antibodies.
Arm/Group Title Cervarix™ & Twinrix™ Group Cervarix™ Group Twinrix™ Group
Hide Arm/Group Description:
Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
Overall Number of Participants Analyzed 239 241 0
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-HPV-16 GMTs Number Analyzed 229 participants 233 participants 0 participants
22993.5
(20093.4 to 26312.0)
26981.9
(23909.5 to 30449.1)
Anti-HPV-18 GMTs Number Analyzed 239 participants 241 participants 0 participants
8671.2
(7651.7 to 9826.6)
11182.7
(9924.8 to 12600.1)
6.Secondary Outcome
Title Anti-HBs Antibody Titers
Hide Description Titers are given as Geometric Mean Titers (GMTs)expressed as mIU/mL.
Time Frame At Month 7
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects seronegative for anti-HBs before vaccination, i.e. with anti-HBs antibody titers below 3.3 mIU/mL.
Arm/Group Title Cervarix™ & Twinrix™ Group Cervarix™ Group Twinrix™ Group
Hide Arm/Group Description:
Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
Overall Number of Participants Analyzed 178 0 161
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
3136.5
(2436.0 to 4038.4)
5646.5
(4481.3 to 7114.6)
7.Secondary Outcome
Title Number of Subjects Seroconverted for Anti-HBs Antibodies
Hide Description Seroconversion is defined as the appearance of anti-HBs antibodies (i.e., antibody titer greater than or equal to 3.3 mIU/mL) in the sera of subjects seronegative (with antibody titers below 3.3 mIU/mL) before vaccination.
Time Frame At month 7
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects seronegative for anti-HBs before vaccination.
Arm/Group Title Cervarix™ & Twinrix™ Group Cervarix™ Group Twinrix™ Group
Hide Arm/Group Description:
Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
Overall Number of Participants Analyzed 178 0 161
Measure Type: Count of Participants
Unit of Measure: Participants
175
  98.3%
161
 100.0%
8.Secondary Outcome
Title Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Vaccine Recipients Aged 9 Years
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 subject seronegative before vaccination. Cut-off values = 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 in 9-year old subjects from the ATP cohort for analysis of immunogenicity, who were seronegative for the corresponding HPV type before vaccination, i.e. with antibody titers below 8 EL.U/mL for anti-HPV-16 antibodies and below 7 EL.U/mL for anti-HPV-18 antibodies.
Arm/Group Title Cervarix™ & Twinrix™ Group Cervarix™ Group Twinrix™ Group 9-Year Old Cervarix Vaccine Recipients
Hide Arm/Group Description:
Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
Subjects received 3 doses of combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
All 9-year subjects who received 3 doses of HPV vaccine alone or co-administered with HAB vaccine.
Overall Number of Participants Analyzed 0 0 0 161
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-HPV-16 Number Analyzed 0 participants 0 participants 0 participants 156 participants
156
 100.0%
Anti-HPV-18 Number Analyzed 0 participants 0 participants 0 participants 161 participants
161
 100.0%
9.Secondary Outcome
Title Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibody Titers in Vaccine Recipients Aged 9 Years
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 7
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed in 9-year old subjects from the ATP cohort for analysis of immunogenicity, who were seronegative for the corresponding HPV type before vaccination, i.e. with antibody titers below 8 EL.U/mL for anti-HPV-16 antibodies and below 7 EL.U/mL for anti-HPV-18 antibodies.
Arm/Group Title Cervarix™ & Twinrix™ Group Cervarix™ Group Twinrix™ Group 9-Year Old Cervarix Vaccine Recipients
Hide Arm/Group Description:
Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
Subjects received 3 doses of combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
All 9-year subjects who received 3 doses of HPV vaccine alone or co-administered with HAB vaccine.
Overall Number of Participants Analyzed 0 0 0 161
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-HPV-16 GMTs Number Analyzed 0 participants 0 participants 0 participants 156 participants
32170.2
(27985.5 to 36980.7)
Anti-HPV-18 GMTs Number Analyzed 0 participants 0 participants 0 participants 161 participants
12257.1
(10644.6 to 14113.9)
10.Secondary Outcome
Title Number of Subjects Seroconverted for Anti-HAV Antibodies
Hide Description Seroconversion is defined as the appearance of anti-HAV antibodies (i.e., antibody titer greater than or equal to 15 mIU/mL) in the sera of subjects seronegative (antibody titer below 15 mIU/mL) before vaccination.
Time Frame One month after the second dose of vaccine
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on a subset from the ATP cohort for analysis of immunogenicity, in subjects for which a blood sample was taken at Month 2 and were seronegative for anti-HAV before vaccination, i.e. with anti-HAV antibody titers below 15 mIU/mL.
Arm/Group Title Cervarix™ & Twinrix™ Group Cervarix™ Group Twinrix™ Group
Hide Arm/Group Description:
Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
Overall Number of Participants Analyzed 113 0 113
Measure Type: Count of Participants
Unit of Measure: Participants
112
  99.1%
112
  99.1%
11.Secondary Outcome
Title Anti-HAV Antibody Titers
Hide Description Titers are given as geometric mean titers (GMTs) expressed as mIU/mL.
Time Frame One month after the second dose of vaccine
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on a subset from the ATP cohort for analysis of immunogenicity, in subjects for which a blood sample was taken at Month 2 and were seronegative for anti-HAV before vaccination, i.e. with anti-HAV antibody titers below 15 mIU/mL.
Arm/Group Title Cervarix™ & Twinrix™ Group Cervarix™ Group Twinrix™ Group
Hide Arm/Group Description:
Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
Overall Number of Participants Analyzed 113 0 113
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
467.0
(374.4 to 582.5)
513.9
(418.7 to 630.6)
12.Secondary Outcome
Title Number of Subjects Seroconverted and Number of Subjects Seroprotected for Anti-HBs Antibodies
Hide Description

Seroconversion is defined as the appearance of anti-HBs antibodies (i.e., antibody titer greater than or equal to 3.3 mIU/mL) in the sera of subjects seronegative (with antibody titers below 3.3 mIU/mL) before vaccination.

A seroprotected subject against HBs is a subject with antibody titers greater than or equal to 10 mIU/mL.

Time Frame One month after the second dose of vaccine
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on a subset from the ATP cohort for analysis of immunogenicity, in subjects for which a blood sample was taken at Month 2 and were seronegative for anti-HBs with antibody titers below 3.3 mIU/mL.
Arm/Group Title Cervarix™ & Twinrix™ Group Cervarix™ Group Twinrix™ Group
Hide Arm/Group Description:
Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
Overall Number of Participants Analyzed 70 0 58
Measure Type: Count of Participants
Unit of Measure: Participants
Seroconverted
68
  97.1%
56
  96.6%
Seroprotected
60
  85.7%
53
  91.4%
13.Secondary Outcome
Title Anti-HBs Antibody Titers
Hide Description Titers are given as geometric mean titers (GMTs) expressed as mIU/mL.
Time Frame One month after the second dose of vaccine
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on a subset from the ATP cohort for analysis of immunogenicity, in subjects for which a blood sample was taken at Month 2 and were seronegative for anti-HBs before vaccination, i.e. with antibody titers below 3.3 mIU/mL.
Arm/Group Title Cervarix™ & Twinrix™ Group Cervarix™ Group Twinrix™ Group
Hide Arm/Group Description:
Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
Overall Number of Participants Analyzed 70 0 58
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
33.7
(24.9 to 45.8)
43.0
(30.1 to 61.3)
14.Secondary Outcome
Title Number of Subjects 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 subject 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 One month after the second dose of vaccine
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on a subset from the ATP cohort for analysis of immunogenicity, in subjects for which a blood sample was taken at Month 2 and were seronegative for the corresponding HPV type before vaccination, i.e. with antibody titers below 8 EL.U/mL for anti-HPV-16 antibodies and below 7 EL.U/mL for anti-HPV-18 antibodies.
Arm/Group Title Cervarix™ & Twinrix™ Group Cervarix™ Group Twinrix™ Group
Hide Arm/Group Description:
Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
Overall Number of Participants Analyzed 112 112 0
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-HPV-16 Number Analyzed 105 participants 107 participants 0 participants
105
 100.0%
106
  99.1%
Anti-HPV-18 Number Analyzed 112 participants 112 participants 0 participants
112
 100.0%
111
  99.1%
15.Secondary Outcome
Title Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibody Titers
Hide Description Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.
Time Frame One month after the second dose of vaccine
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on a subset from the ATP cohort for analysis of immunogenicity, in subjects for which a blood sample was taken at Month 2 and were seronegative for the corresponding HPV type before vaccination, i.e. with antibody titers below 8 EL.U/mL for anti-HPV-16 antibodies and below 7 EL.U/mL for anti-HPV-18 antibodies.
Arm/Group Title Cervarix™ & Twinrix™ Group Cervarix™ Group Twinrix™ Group
Hide Arm/Group Description:
Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
Overall Number of Participants Analyzed 112 112 0
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-HPV-16 GMTs Number Analyzed 105 participants 107 participants 0 participants
5215.2
(4598.2 to 5915.0)
4967.2
(4142.5 to 5956.1)
Anti-HPV-18 GMTs Number Analyzed 112 participants 112 participants 0 participants
4496.8
(3899.4 to 5185.8)
4266.5
(3562.9 to 5109.0)
16.Secondary Outcome
Title Number of Subjects Reporting Solicited Local Symptoms
Hide Description Solicited local symptoms assessed include injection site pain, redness and swelling. Data are presented across doses.
Time Frame During the 7-day period (Day 0-6) following 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™ & Twinrix™ Group Cervarix™ Group Twinrix™ Group
Hide Arm/Group Description:
Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
Overall Number of Participants Analyzed 269 270 271
Measure Type: Count of Participants
Unit of Measure: Participants
Pain
251
  93.3%
250
  92.6%
202
  74.5%
Redness
155
  57.6%
170
  63.0%
74
  27.3%
Swelling
146
  54.3%
137
  50.7%
56
  20.7%
17.Secondary Outcome
Title Number of Subjects Reporting Solicited General Symptoms
Hide Description Solicited general symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, temperature [axillary route, greater than or equal to 37.5 degree Celsius (°C)] and urticaria.
Time Frame During the 7-day period following 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™ & Twinrix™ Group Cervarix™ Group Twinrix™ Group
Hide Arm/Group Description:
Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
Overall Number of Participants Analyzed 269 270 271
Measure Type: Count of Participants
Unit of Measure: Participants
Arthralgia
50
  18.6%
45
  16.7%
40
  14.8%
Fatigue
122
  45.4%
133
  49.3%
119
  43.9%
Fever
24
   8.9%
28
  10.4%
14
   5.2%
Gastrointestinal
70
  26.0%
65
  24.1%
72
  26.6%
Headache
125
  46.5%
124
  45.9%
110
  40.6%
Myalgia
103
  38.3%
99
  36.7%
75
  27.7%
Rash
18
   6.7%
21
   7.8%
12
   4.4%
Urticaria
6
   2.2%
11
   4.1%
9
   3.3%
18.Secondary Outcome
Title Number of Subjects Reporting Medically Significant Conditions
Hide Description Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or 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, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Time Frame Throughout the active phase of the study (up to Month 7)
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™ & Twinrix™ Group Cervarix™ Group Twinrix™ Group
Hide Arm/Group Description:
Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
Overall Number of Participants Analyzed 272 270 271
Measure Type: Count of Participants
Unit of Measure: Participants
22
   8.1%
23
   8.5%
31
  11.4%
19.Secondary Outcome
Title Number of Subjects Reporting Medically Significant Conditions
Hide Description Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or 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, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Time Frame Throughout the safety follow-up (from Month 7 up to Month 12)
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™ & Twinrix™ Group Cervarix™ Group Twinrix™ Group
Hide Arm/Group Description:
Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
Overall Number of Participants Analyzed 272 270 271
Measure Type: Count of Participants
Unit of Measure: Participants
2
   0.7%
2
   0.7%
1
   0.4%
20.Secondary Outcome
Title Number of Subjects Reporting Unsolicited Adverse Events
Hide Description Unsolicited adverse events include any adverse event 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.
Time Frame During the 30-day period following any 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™ & Twinrix™ Group Cervarix™ Group Twinrix™ Group
Hide Arm/Group Description:
Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
Overall Number of Participants Analyzed 272 270 271
Measure Type: Count of Participants
Unit of Measure: Participants
83
  30.5%
96
  35.6%
83
  30.6%
21.Secondary Outcome
Title Number of Subjects Reporting Serious Adverse Events (SAE)
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.
Time Frame Throughout the study (up to Month 12)
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™ & Twinrix™ Group Cervarix™ Group Twinrix™ Group
Hide Arm/Group Description:
Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
Overall Number of Participants Analyzed 272 270 271
Measure Type: Count of Participants
Unit of Measure: Participants
2
   0.7%
4
   1.5%
4
   1.5%
Time Frame From Day 0 up to Month 12
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cervarix™ & Twinrix™ Group Cervarix™ Group Twinrix™ Group
Hide Arm/Group Description Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6). Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6). Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
All-Cause Mortality
Cervarix™ & Twinrix™ Group Cervarix™ Group Twinrix™ Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cervarix™ & Twinrix™ Group Cervarix™ Group Twinrix™ Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/272 (0.74%)   4/270 (1.48%)   4/271 (1.48%) 
Gastrointestinal disorders       
Gastritis * 1  0/272 (0.00%)  0/270 (0.00%)  1/271 (0.37%) 
Infections and infestations       
Anal abscess * 1  0/272 (0.00%)  1/270 (0.37%)  0/271 (0.00%) 
Injury, poisoning and procedural complications       
Ankle fracture * 1  0/272 (0.00%)  1/270 (0.37%)  0/271 (0.00%) 
Concussion * 1  1/272 (0.37%)  0/270 (0.00%)  0/271 (0.00%) 
Head injury * 1  0/272 (0.00%)  0/270 (0.00%)  1/271 (0.37%) 
Tibia fracture * 1  0/272 (0.00%)  0/270 (0.00%)  1/271 (0.37%) 
Venous injury * 1  0/272 (0.00%)  0/270 (0.00%)  1/271 (0.37%) 
Metabolism and nutrition disorders       
Anorexia * 1  0/272 (0.00%)  1/270 (0.37%)  0/271 (0.00%) 
Nervous system disorders       
Epilepsy * 1  1/272 (0.37%)  0/270 (0.00%)  0/271 (0.00%) 
Syncope * 1  0/272 (0.00%)  1/270 (0.37%)  0/271 (0.00%) 
Psychiatric disorders       
Depression * 1  0/272 (0.00%)  0/270 (0.00%)  1/271 (0.37%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cervarix™ & Twinrix™ Group Cervarix™ Group Twinrix™ Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   258/272 (94.85%)   256/270 (94.81%)   224/271 (82.66%) 
General disorders       
Pain at injection site  1  251/272 (92.28%)  250/270 (92.59%)  202/271 (74.54%) 
Redness at injection site  1  155/272 (56.99%)  170/270 (62.96%)  74/271 (27.31%) 
Swelling at injection site  1  146/272 (53.68%)  137/270 (50.74%)  56/271 (20.66%) 
Arthralgia  1  50/272 (18.38%)  45/270 (16.67%)  40/271 (14.76%) 
Fever  1  24/272 (8.82%)  28/270 (10.37%)  14/271 (5.17%) 
Gastrointestinal symptoms  1  70/272 (25.74%)  65/270 (24.07%)  72/271 (26.57%) 
Headache  1  125/272 (45.96%)  124/270 (45.93%)  110/271 (40.59%) 
Myalgia  1  103/272 (37.87%)  99/270 (36.67%)  75/271 (27.68%) 
Rash  1  18/272 (6.62%)  21/270 (7.78%)  12/271 (4.43%) 
Fatigue  1  122/272 (44.85%)  133/270 (49.26%)  119/271 (43.91%) 
Infections and infestations       
Nasopharyngitis * 1  6/272 (2.21%)  21/270 (7.78%)  13/271 (4.80%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.0
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
Publications:
Pederson C et al. Co-administration of ASO4- adjuvanted human papillomavirus- 16/18 cervical cancer vaccine with inactivated hepatitis A ans B vaccine in girls aged 9-15 years. Abstract presented at the 6th World Congress of the World Society for Pediatric Infectious Diseases (WSPID). Beunos Aires, Argentina, 19-22 November 2009.
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00578227     History of Changes
Other Study ID Numbers: 110886
First Submitted: December 20, 2007
First Posted: December 21, 2007
Results First Submitted: November 27, 2009
Results First Posted: January 6, 2010
Last Update Posted: August 17, 2018