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Trial record 1 of 1 for:    20113920 [PUBMED-IDS]
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Evaluation of Safety and Immunogenicity of Co-administering Human Papillomavirus (HPV) Vaccine With Other Vaccines in Healthy Female Subjects

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ClinicalTrials.gov Identifier: NCT00426361
Recruitment Status : Completed
First Posted : January 24, 2007
Results First Posted : August 23, 2010
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: None (Open Label);   Primary Purpose: Prevention
Condition Infections, Papillomavirus
Interventions Biological: Boostrix ® Polio
Biological: GSK Biologicals' HPV-16/18 L1 AS04 vaccine (Cervarix TM)
Enrollment 751

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cervarix Group Cervarix + Boostrix Polio Group Boostrix Polio → Cervarix Group
Hide Arm/Group Description Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6. Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0. Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
Period Title: Overall Study
Started 248 255 248
Completed 244 250 243
Not Completed 4 5 5
Reason Not Completed
Lost to Follow-up             3             2             5
Withdrawal by Subject             1             3             0
Arm/Group Title Cervarix Group Cervarix + Boostrix Polio Group Boostrix Polio → Cervarix Group Total
Hide Arm/Group Description Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6. Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0. Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7. Total of all reporting groups
Overall Number of Baseline Participants 248 255 248 751
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 248 participants 255 participants 248 participants 751 participants
Active phase (up to Month 7/8) 13.9  (2.59) 14.0  (2.43) 13.9  (2.47) 13.9  (2.50)
Safety follow-up (up to Month 12/13) 13.9  (2.58) 13.9  (2.41) 13.8  (2.46) 13.9  (2.48)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 248 participants 255 participants 248 participants 751 participants
Female
248
 100.0%
255
 100.0%
248
 100.0%
751
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Subjects Seroprotected Against Diphtheria and Tetanus
Hide Description Seroprotection against diphtheria and tetanus is defined as anti-diphtheria and anti-tetanus antibody titres greater than or equal to 0.1 International Units per Milliliter (≥ 0.1 IU/mL).
Time Frame One month after vaccination with Boostrix Polio
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on those subjects vaccinated with Boostrix Polio.
Arm/Group Title Cervarix Group Cervarix + Boostrix Polio Group Boostrix Polio → Cervarix Group
Hide Arm/Group Description:
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
Overall Number of Participants Analyzed 0 240 233
Measure Type: Count of Participants
Unit of Measure: Participants
Diphtheria
238
  99.2%
233
 100.0%
Tetanus
240
 100.0%
233
 100.0%
2.Primary Outcome
Title Titers of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin Toxoid (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies
Hide Description Titers are given as geometric mean titers (GMTs) calculated on all subjects and expressed as Enzyme-linked Immunosorbent Assay Units per Milliliter (EL.U/mL).
Time Frame One month after vaccination with Boostrix Polio
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on those subjects vaccinated with Boostrix Polio.
Arm/Group Title Cervarix Group Cervarix + Boostrix Polio Group Boostrix Polio → Cervarix Group
Hide Arm/Group Description:
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
Overall Number of Participants Analyzed 0 240 233
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-PT Number Analyzed 0 participants 238 participants 229 participants
84.2
(73.6 to 96.4)
75.4
(65.6 to 86.8)
Anti-FHA Number Analyzed 0 participants 240 participants 233 participants
611.7
(553.6 to 675.9)
615.2
(552.3 to 685.2)
Anti-PRN Number Analyzed 0 participants 239 participants 233 participants
426.2
(368.1 to 493.4)
360.0
(299.3 to 433.1)
3.Primary Outcome
Title Number of Subjects Seroprotected Against Poliovirus Type 1 (Polio 1), Polio 2 and Polio 3
Hide Description Seroprotection against polio 1, 2 and 3 is defined as anti-polio 1, 2 and 3 antibody titers greater than or equal to 8 Effective Dose 50% (≥ 8 ED50).
Time Frame One month after vaccination with Boostrix Polio
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on those subjects vaccinated with Boostrix Polio and with available results for the defined antigen.
Arm/Group Title Cervarix Group Cervarix + Boostrix Polio Group Boostrix Polio → Cervarix Group
Hide Arm/Group Description:
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
Overall Number of Participants Analyzed 0 240 232
Measure Type: Count of Participants
Unit of Measure: Participants
Polio 1 Number Analyzed 0 participants 240 participants 231 participants
239
  99.6%
231
 100.0%
Polio 2 Number Analyzed 0 participants 240 participants 232 participants
240
 100.0%
232
 100.0%
Polio 3 Number Analyzed 0 participants 239 participants 232 participants
239
 100.0%
232
 100.0%
4.Secondary Outcome
Title Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-HPV-18 Antibodies After Completing the Cervarix Vaccination Course
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 post Cervarix Dose 3 (Month 7/8)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Month 7/8 According-to-Protocol (ATP) cohort for analysis of immunogenicity on subjects with available results for the defined antibody.
Arm/Group Title Cervarix Group Cervarix + Boostrix Polio Group Boostrix Polio → Cervarix Group
Hide Arm/Group Description:
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
Overall Number of Participants Analyzed 198 204 204
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-HPV-16 Number Analyzed 198 participants 202 participants 204 participants
198
 100.0%
201
  99.5%
204
 100.0%
Anti-HPV-18 Number Analyzed 191 participants 204 participants 203 participants
191
 100.0%
203
  99.5%
203
 100.0%
5.Secondary Outcome
Title Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies After Incomplete Cervarix Vaccination Course
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 post Dose 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on subjects from the Cervarix and Cervarix + Boostrix Polio groups with available results for the defined antibody.
Arm/Group Title Cervarix Group Cervarix + Boostrix Polio Group Boostrix Polio → Cervarix Group
Hide Arm/Group Description:
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
Overall Number of Participants Analyzed 198 204 0
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-HPV-16 Number Analyzed 198 participants 202 participants 0 participants
198
 100.0%
201
  99.5%
Anti-HPV-18 Number Analyzed 191 participants 204 participants 0 participants
191
 100.0%
203
  99.5%
6.Secondary Outcome
Title Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies After Completing the Cervarix Vaccination Course
Hide Description Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).
Time Frame One month post Cervarix Dose 3 (Month 7/8)]
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Month 7/8 According-to-Protocol (ATP) cohort for analysis of immunogenicity on subjects with available results for the defined antibody.
Arm/Group Title Cervarix Group Cervarix + Boostrix Polio Group Boostrix Polio → Cervarix Group
Hide Arm/Group Description:
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
Overall Number of Participants Analyzed 213 222 218
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-HPV-16 Number Analyzed 213 participants 222 participants 218 participants
18363.6
(16243.0 to 20761.0)
15370.2
(13350.9 to 17694.8)
14089.5
(12460.9 to 15930.9)
Anti-HPV-18 Number Analyzed 210 participants 218 participants 216 participants
7032.8
(6220.7 to 7950.9)
6630.4
(5768.0 to 7621.6)
5135.0
(4537.3 to 5811.5)
7.Secondary Outcome
Title Titers of Anti-diphtheria and Anti-tetanus Antibodies
Hide Description Titers are given as Geometric Mean Titers (GMTs) and expressed as IU/mL.
Time Frame One month after vaccination with Boostrix-Polio
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on those subjects vaccinated with Boostrix Polio.
Arm/Group Title Cervarix Group Cervarix + Boostrix Polio Group Boostrix Polio → Cervarix Group
Hide Arm/Group Description:
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
Overall Number of Participants Analyzed 0 240 233
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
Anti-diphtheria
5.085
(4.551 to 5.681)
5.466
(4.896 to 6.103)
Anti-tetanus
8.552
(7.889 to 9.272)
9.039
(8.321 to 9.818)
8.Secondary Outcome
Title Number of Subjects With Anti-diphtheria and Anti-tetanus Antibody Titers Above 1.0 International Units Per Milliliter (IU/mL)
Hide Description Anti-diphtheria and anti-tetanus antibodies cut-off value assessed include 1.0 IU/mL.
Time Frame One month after vaccination with Boostrix Polio
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on those subjects vaccinated with Boostrix Polio.
Arm/Group Title Cervarix Group Cervarix + Boostrix Polio Group Boostrix Polio → Cervarix Group
Hide Arm/Group Description:
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
Overall Number of Participants Analyzed 0 240 233
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-diphtheria
231
  96.3%
226
  97.0%
Anti-tetanus
239
  99.6%
233
 100.0%
9.Secondary Outcome
Title Anti-poliovirus Type 1 (Anti-polio 1), Anti-polio 2 and Anti-polio 3 Antibody Titers
Hide Description Titers are given as Geometric Mean Titers (GMTs). The titer is a serum dilution giving 50 percent reduction of signal compared to control without serum.
Time Frame One month after vaccination with Boostrix Polio
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on those subjects vaccinated with Boostrix Polio.
Arm/Group Title Cervarix Group Cervarix + Boostrix Polio Group Boostrix Polio → Cervarix Group
Hide Arm/Group Description:
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
Overall Number of Participants Analyzed 0 240 232
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
Anti-polio 1 Number Analyzed 0 participants 240 participants 231 participants
2045.1
(1714.7 to 2439.2)
2390.5
(2021.4 to 2826.9)
Anti-polio 2 Number Analyzed 0 participants 240 participants 232 participants
2151.1
(1806.5 to 2561.6)
2158.1
(1821.3 to 2557.1)
Anti-polio 3 Number Analyzed 0 participants 239 participants 232 participants
2777.2
(2376.5 to 3245.4)
2732.5
(2318.0 to 3221.2)
10.Secondary Outcome
Title Number of Subjects With Booster Response to Diphtheria and Tetanus
Hide Description

Booster responses to diphtheria and tetanus were defined as:

  • For initially seronegative subjects (pre-vaccination titer below cut-off value of 0.1 International Units per Milliliter): antibody titers at least four times the cut-off (post-vaccination titer greater than or equal to 0.4 IU/mL), and
  • For initially seropositive subjects (pre-vaccination titer greater than or equal to 0.1 IU/mL): an increase in antibody titers of at least four times the pre-vaccination titer.
Time Frame One month after vaccination with Boostrix Polio
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on those subjects vaccinated with Boostrix Polio.
Arm/Group Title Cervarix Group Cervarix + Boostrix Polio Group Boostrix Polio → Cervarix Group
Hide Arm/Group Description:
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
Overall Number of Participants Analyzed 0 240 232
Measure Type: Count of Participants
Unit of Measure: Participants
Diphtheria
160
  66.7%
159
  68.5%
Tetanus
167
  69.6%
161
  69.4%
11.Secondary Outcome
Title Number of Subjects With Booster Response to Pertussis Toxoid (PT), Pertactin Toxoid (PRN) and Filamentous Hemagglutinin (FHA)
Hide Description

Booster response to PT, FHA and PRN were defined as:

  • For initially seronegative subjects [pre-vaccination titer below cut-off value of 5 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL)]: antibody titers at least 4 times the cut-off,
  • For initially seropositive subjects with pre-vaccination titer above 5 EL.U/mL and < 20 EL.U/mL: an increase in antibody titers of at least 4 times the pre-vaccination titer,
  • For initially seropositive subjects with pre-vaccination titer above 20 EL.U/mL: an increase in antibody titers of at least 2 times the pre-vaccination titer.
Time Frame One month after vaccination with Boostrix Polio
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Month 1 According-to-Protocol (ATP) cohort for analysis of immunogenicity and only on those subjects vaccinated with Boostrix Polio.
Arm/Group Title Cervarix Group Cervarix + Boostrix Polio Group Boostrix Polio → Cervarix Group
Hide Arm/Group Description:
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
Overall Number of Participants Analyzed 0 238 230
Measure Type: Count of Participants
Unit of Measure: Participants
PT Number Analyzed 0 participants 236 participants 228 participants
199
  84.3%
182
  79.8%
FHA Number Analyzed 0 participants 235 participants 226 participants
210
  89.4%
205
  90.7%
PRN Number Analyzed 0 participants 238 participants 230 participants
222
  93.3%
207
  90.0%
12.Secondary Outcome
Title Number of Subjects Reporting Solicited Symptoms
Hide Description

Solicited local symptoms assessed include pain, redness and swelling at the injection site.

Solicited general symptoms assessed include arthralgia, fatigue, fever (above 37.5 degree Celsius), gastrointestinal symptoms, headache, myalgia, rash and urticaria.

Time Frame During the 7-day period (Day 0-6) following each vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
Arm/Group Title Cervarix Group Cervarix + Boostrix Polio Group Boostrix Polio → Cervarix Group
Hide Arm/Group Description:
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
Overall Number of Participants Analyzed 246 253 247
Measure Type: Count of Participants
Unit of Measure: Participants
Pain
225
  91.5%
237
  93.7%
233
  94.3%
Redness
110
  44.7%
128
  50.6%
140
  56.7%
Swelling
124
  50.4%
125
  49.4%
123
  49.8%
Arthralgia
58
  23.6%
71
  28.1%
77
  31.2%
Fatigue
109
  44.3%
135
  53.4%
121
  49.0%
Fever
30
  12.2%
46
  18.2%
37
  15.0%
Gastrointestinal symptoms
51
  20.7%
63
  24.9%
61
  24.7%
Headache
111
  45.1%
138
  54.5%
122
  49.4%
Myalgia
107
  43.5%
144
  56.9%
127
  51.4%
Rash
20
   8.1%
27
  10.7%
17
   6.9%
Urticaria
12
   4.9%
11
   4.3%
15
   6.1%
13.Secondary Outcome
Title Number of Subjects Reporting Unsolicited Adverse Events
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 During the 30-day period (Day 0-29) following vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cervarix Group Cervarix + Boostrix Polio Group Boostrix Polio → Cervarix Group
Hide Arm/Group Description:
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
Overall Number of Participants Analyzed 248 255 248
Measure Type: Count of Participants
Unit of Measure: Participants
85
  34.3%
74
  29.0%
99
  39.9%
14.Secondary Outcome
Title Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs) and Other Medically Significant Adverse Events (MSAEs)
Hide Description NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. MSAEs 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 During the active phase of the study (up to Month 7/8) and during the safety follow-up (up to Month 12/13)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated Cohort (for the active phase) and on the Extended Safety Follow-up Vaccinated Cohort (for the safety follow-up).
Arm/Group Title Cervarix Group Cervarix + Boostrix Polio Group Boostrix Polio → Cervarix Group
Hide Arm/Group Description:
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
Overall Number of Participants Analyzed 248 255 248
Measure Type: Count of Participants
Unit of Measure: Participants
NOCDs [Active phase] Number Analyzed 248 participants 255 participants 248 participants
5
   2.0%
9
   3.5%
9
   3.6%
NOCDs [Safety follow-up] Number Analyzed 244 participants 250 participants 243 participants
0
   0.0%
0
   0.0%
0
   0.0%
MSAEs [Active phase] Number Analyzed 248 participants 255 participants 248 participants
35
  14.1%
27
  10.6%
49
  19.8%
MSAEs [Safety follow-up] Number Analyzed 244 participants 250 participants 243 participants
7
   2.9%
3
   1.2%
5
   2.1%
15.Secondary Outcome
Title Number of Subjects Reporting Serious Adverse Events (SAEs)
Hide Description Serious adverse events assessed include medical occurrences that results 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 During the active phase of the study (up to Month 7/8) and during the safety follow-up (up to Month 12/13)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated Cohort (for the active phase) and on the Extended Safety Follow-up Vaccinated Cohort (for the safety follow-up).
Arm/Group Title Cervarix Group Cervarix + Boostrix Polio Group Boostrix Polio → Cervarix Group
Hide Arm/Group Description:
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
Overall Number of Participants Analyzed 248 255 248
Measure Type: Count of Participants
Unit of Measure: Participants
Active phase Number Analyzed 248 participants 255 participants 248 participants
2
   0.8%
4
   1.6%
2
   0.8%
Safety follow-up Number Analyzed 244 participants 250 participants 243 participants
1
   0.4%
0
   0.0%
1
   0.4%
Time Frame During the 7 day follow-up period after any vaccination for other (non-serious) adverse events. During the entire study period (12 months for Cervarix and Cervarix + Boostrix groups and 13 months for Cervarix → Boostrix group) for serious adverse events.
Adverse Event Reporting Description For other (non-serious) adverse events collected by systematic assessment, the number of subjects at risk corresponds to the number of subjects from the Total Vaccinated Cohort with a documented dose.
 
Arm/Group Title Cervarix Group Cervarix + Boostrix Polio Group Boostrix Polio → Cervarix Group
Hide Arm/Group Description Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6. Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0. Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
All-Cause Mortality
Cervarix Group Cervarix + Boostrix Polio Group Boostrix Polio → Cervarix Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cervarix Group Cervarix + Boostrix Polio Group Boostrix Polio → Cervarix Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/248 (1.21%)   4/255 (1.57%)   3/248 (1.21%) 
Infections and infestations       
Appendicitis * 1  0/248 (0.00%)  1/255 (0.39%)  0/248 (0.00%) 
Gastroenteritis * 1  1/248 (0.40%)  0/255 (0.00%)  0/248 (0.00%) 
Tonsillitis streptococcal * 1  0/248 (0.00%)  0/255 (0.00%)  1/248 (0.40%) 
Injury, poisoning and procedural complications       
Muscle rupture * 1  0/248 (0.00%)  1/255 (0.39%)  0/248 (0.00%) 
Musculoskeletal and connective tissue disorders       
Scoliosis * 1  0/248 (0.00%)  1/255 (0.39%)  0/248 (0.00%) 
Nervous system disorders       
Presyncope * 1  0/248 (0.00%)  0/255 (0.00%)  1/248 (0.40%) 
Pregnancy, puerperium and perinatal conditions       
Imminent abortion * 1  0/248 (0.00%)  1/255 (0.39%)  0/248 (0.00%) 
Psychiatric disorders       
Suicide attempt * 1  1/248 (0.40%)  0/255 (0.00%)  0/248 (0.00%) 
Reproductive system and breast disorders       
Ovarian cyst * 1  0/248 (0.00%)  0/255 (0.00%)  1/248 (0.40%) 
Ovarian cyst ruptured * 1  1/248 (0.40%)  0/255 (0.00%)  0/248 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cervarix Group Cervarix + Boostrix Polio Group Boostrix Polio → Cervarix Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   232/248 (93.55%)   245/255 (96.08%)   242/248 (97.58%) 
General disorders       
Pain   225/246 (91.46%)  237/253 (93.68%)  233/247 (94.33%) 
Redness   110/246 (44.72%)  128/253 (50.59%)  140/247 (56.68%) 
Swelling   124/246 (50.41%)  125/253 (49.41%)  123/247 (49.80%) 
Arthralgia   58/246 (23.58%)  71/253 (28.06%)  77/247 (31.17%) 
Fatigue   109/246 (44.31%)  135/253 (53.36%)  121/247 (48.99%) 
Fever (above 37.5 degree Celsius)   30/246 (12.20%)  46/253 (18.18%)  37/247 (14.98%) 
Gastrointestinal symptoms   51/246 (20.73%)  63/253 (24.90%)  61/247 (24.70%) 
Headache   111/246 (45.12%)  138/253 (54.55%)  122/247 (49.39%) 
Myalgia   107/246 (43.50%)  144/253 (56.92%)  127/247 (51.42%) 
Rash   20/246 (8.13%)  27/253 (10.67%)  17/247 (6.88%) 
Urticaria   12/246 (4.88%)  11/253 (4.35%)  15/247 (6.07%) 
Infections and infestations       
Upper respiratory tract infection * 1  14/248 (5.65%)  4/255 (1.57%)  10/248 (4.03%) 
Nervous system disorders       
Headache * 1  4/248 (1.61%)  6/255 (2.35%)  14/248 (5.65%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
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:
Schwarz T et al. Co-administration of AS04-adjuvanted HPV-16/18 cervical cancer vaccine with DTPA-IPV in 10-18 year old girls: Month 7 results from a randomized trial. Abstract presented at the 27th annual ESPID meeting, Brussels, Belgium, 9-13 June 2009.
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00426361     History of Changes
Other Study ID Numbers: 108464
First Submitted: January 23, 2007
First Posted: January 24, 2007
Results First Submitted: November 12, 2009
Results First Posted: August 23, 2010
Last Update Posted: July 20, 2018