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Trial record 60 of 91 for:    cervarix

Evaluation of Immunogenicity and Safety of Human Papillomavirus (HPV) Vaccine Co-administered 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: NCT00652938
Recruitment Status : Completed
First Posted : April 4, 2008
Results First Posted : August 31, 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: HPV Vaccine (GSK580299) Cervarix TM
Biological: Engerix B
Enrollment 744
Recruitment Details  
Pre-assignment Details While the total numbers of subjects enrolled in the study was 744, the total number of subjects that entered the study was 741. The remaining 3 subjects received a subject number but no vaccine dose and were therefore excluded from the analysis and group assignment.
Arm/Group Title Cervarix&Engerix Group Cervarix Group Engerix Group
Hide Arm/Group Description Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule. Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule. Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
Period Title: Overall Study
Started 247 247 247
Completed 246 240 242
Not Completed 1 7 5
Reason Not Completed
Adverse Event             1             0             2
Withdrawal by Subject             0             6             1
Lost to Follow-up             0             0             2
fear of blood sampling             0             1             0
Arm/Group Title Cervarix&Engerix Group Cervarix Group Engerix Group Total
Hide Arm/Group Description Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule. Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule. Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule. Total of all reporting groups
Overall Number of Baseline Participants 247 247 247 741
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 247 participants 247 participants 247 participants 741 participants
11.4  (2.17) 11.3  (2.14) 11.4  (2.17) 11.4  (2.16)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 247 participants 247 participants 247 participants 741 participants
Female
247
 100.0%
247
 100.0%
247
 100.0%
741
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Subjects With Anti-Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off Value for Seroprotection
Hide Description

Only groups which had received the HBV vaccine were included in the analysis.

Subjects included were seronegative for anti-HBs (antibody titer < 3.3 milli International Units per milliliter (mIU/mL)) prior to vaccination.

Anti-HBs antibody cut-off value for seroprotection assessed included 10 mIU/mL.

Time Frame Month 7
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Arm/Group Title Cervarix&Engerix Group Cervarix Group Engerix Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 194 0 181
Measure Type: Count of Participants
Unit of Measure: Participants
190
  97.9%
181
 100.0%
2.Primary Outcome
Title Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Concentrations Above the Cut-off Value for Seroconversion
Hide Description

Only groups which had received the HPV vaccine were included in the analysis.

Anti-HPV-16 antibody cut-off value assessed included 8 Enzyme-linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL) and anti-HPV-18 antibody cut-off value assessed included 7 EL.U/mL.

Subjects included were seronegative for anti-HPV-16 (antibody titer < 8 EL.U/mL) and anti-HPV-18 (antibody titer < 7 EL.U/mL) prior to vaccination.

Time Frame Month 7
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Arm/Group Title Cervarix&Engerix Group Cervarix Group Engerix Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 207 202 0
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-HPV-16 Number Analyzed 207 participants 200 participants 0 participants
205
  99.0%
200
 100.0%
Anti-HPV-18 Number Analyzed 200 participants 202 participants 0 participants
199
  99.5%
202
 100.0%
3.Primary Outcome
Title Anti-HPV-16/18 Antibody Titres
Hide Description

Antibody titers for Anti-HPV-16 and Anti-HPV-18 are expressed as Geometric Mean Titers (GMTs).

Only groups which had received the HPV vaccine were included in the analysis.

Subjects included were seronegative for anti-HPV-16 (antibody titer < 8 EL.U/mL) and anti-HPV-18 (antibody titer < 7 EL.U/mL) prior to vaccination.

Time Frame Month 7
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Arm/Group Title Cervarix&Engerix Group Cervarix Group Engerix Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 207 202 0
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-HPV-16 Number Analyzed 207 participants 200 participants 0 participants
19819.8
(16856.9 to 23303.6)
21712.6
(19460.2 to 24225.6)
Anti-HPV-18 Number Analyzed 200 participants 202 participants 0 participants
8835.1
(7636.3 to 10222.1)
8838.6
(7948.5 to 9828.4)
4.Secondary Outcome
Title Number of Subjects With Anti-HBs Antibody Concentrations Above the Cut-off Value for Seroconversion
Hide Description

Only groups which had received the HBV vaccine were included in the analysis.

Subjects included were seronegative for anti-HBs (antibody titer < 3.3 mIU/mL) prior to vaccination.

Anti-HBs antibody cut-off value for seroconversion assessed included 3.3 mIU/mL.

Time Frame Month 7
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Arm/Group Title Cervarix&Engerix Group Cervarix Group Engerix Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 194 0 181
Measure Type: Count of Participants
Unit of Measure: Participants
192
  99.0%
181
 100.0%
5.Secondary Outcome
Title Anti-HBs Antibody Titres
Hide Description

Antibody titers for anti-HBs are given as Geometric Mean Titers (GMTs) in mIU/mL.

Only groups which had received the HBV vaccine were included in the analysis.

Subjects included were seronegative for anti-HBs (antibody titer < 3.3 mIU/mL) prior to vaccination.

Time Frame Month 7
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Arm/Group Title Cervarix&Engerix Group Cervarix Group Engerix Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 194 0 181
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
1280.9
(973.3 to 1685.7)
3107.7
(2473.1 to 3905.1)
6.Secondary Outcome
Title Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations Above the Cut-off Value for Seroconversion
Hide Description

Only groups which had received the HPV vaccine were included in the analysis.

Anti-HPV-16 antibody cut-off value assessed included 8 Enzyme-linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL) and anti-HPV-18 antibody cut-off value assessed included 7 EL.U/mL.

Subjects included were seronegative for anti-HPV-16 (antibody titer < 8 EL.U/mL) and anti-HPV-18 (antibody titer < 7 EL.U/mL) prior to vaccination.

Time Frame Month 2
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Arm/Group Title Cervarix&Engerix Group Cervarix Group Engerix Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 207 201 0
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-HPV-16 Number Analyzed 207 participants 199 participants 0 participants
207
 100.0%
199
 100.0%
Anti-HPV-18 Number Analyzed 200 participants 201 participants 0 participants
200
 100.0%
201
 100.0%
7.Secondary Outcome
Title Anti-HPV-16/18 Antibody Titres
Hide Description

Antibody titers for Anti-HPV-16 and Anti-HPV-18 are expressed as Geometric Mean Titers (GMTs).

Only groups which had received the HPV vaccine were included in the analysis.

Subjects included were seronegative for anti-HPV-16 (antibody titer < 8 EL.U/mL) and anti-HPV-18 (antibody titer < 7 EL.U/mL) prior to vaccination.

Time Frame Month 2
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Arm/Group Title Cervarix&Engerix Group Cervarix Group Engerix Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 207 201 0
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-HPV-16 Number Analyzed 207 participants 199 participants 0 participants
4894.7
(4472.5 to 5356.7)
5069.2
(4581.2 to 5609.1)
Anti-HPV-18 Number Analyzed 200 participants 201 participants 0 participants
4790.4
(4338.9 to 5288.8)
4663.8
(4228.2 to 5144.3)
8.Secondary Outcome
Title Number of Subjects With Anti-Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off Value for Seroconversion
Hide Description

Only groups which had received the HBV vaccine were included in the analysis.

Subjects included were seronegative for anti-HBs (antibody titer < 3.3 mIU/mL) prior to vaccination.

Anti-HBs antibody cut-off value for seroconversion assessed included 3.3 mIU/mL.

Time Frame Month 2
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Arm/Group Title Cervarix&Engerix Group Cervarix Group Engerix Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 194 0 178
Measure Type: Count of Participants
Unit of Measure: Participants
165
  85.1%
168
  94.4%
9.Secondary Outcome
Title Number of Subjects With Anti-Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off Value for Seroprotection
Hide Description

Only groups which had received the HBV vaccine were included in the analysis.

Subjects included were seronegative for anti-HBs (antibody titer < 3.3 milli International Units per milliliter (mIU/mL)) prior to vaccination vaccination.

Anti-HBs antibody cut-off value for seroprotection assessed included 10 mIU/mL.

Time Frame Month 2
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Arm/Group Title Cervarix&Engerix Group Cervarix Group Engerix Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 194 0 178
Measure Type: Count of Participants
Unit of Measure: Participants
128
  66.0%
142
  79.8%
10.Secondary Outcome
Title Anti-HBs Antibody Titers
Hide Description

Anti-HBs antibody titers are given as GMTs in mIU/mL.

Only groups which had received the HBV vaccine were included in the analysis.

Subjects included were seronegative for anti-HBs (antibody titer < 3.3 mIU/mL) prior to vaccination.

Time Frame Month 2
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Arm/Group Title Cervarix&Engerix Group Cervarix Group Engerix Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 194 0 178
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
13.6
(11.4 to 16.2)
26.9
(22.1 to 32.8)
11.Secondary Outcome
Title Number of Subjects Reporting Any Solicited Local Symptoms
Hide Description

Solicited local symptoms included injection site pain, redness and swelling.

Any solicited local symptom is occurence of a symptom regardless of its intensity.

Time Frame During the 7-day period (Days 0 - 6) following vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title Cervarix&Engerix Group Cervarix Group Engerix Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 247 245 246
Measure Type: Count of Participants
Unit of Measure: Participants
Pain
244
  98.8%
238
  97.1%
182
  74.0%
Redness
122
  49.4%
127
  51.8%
63
  25.6%
Swelling
120
  48.6%
111
  45.3%
47
  19.1%
12.Secondary Outcome
Title Number of Subjects Reporting Grade 3 Solicited Local Symptoms
Hide Description

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

Grade 3 pain is pain that prevented normal everyday activities. Grade 3 redness is redness that was > 50 mm. Grade 3 swelling is swelling that was > 50 mm.

Time Frame During the 7-day period (Days 0-6) following vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title Cervarix&Engerix Group Cervarix Group Engerix Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 247 245 246
Measure Type: Count of Participants
Unit of Measure: Participants
Pain
54
  21.9%
35
  14.3%
4
   1.6%
Redness
12
   4.9%
5
   2.0%
1
   0.4%
Swelling
17
   6.9%
13
   5.3%
1
   0.4%
13.Secondary Outcome
Title Number of Subjects Reporting Any Solicited General Symptoms
Hide Description

Solicited general symptoms included arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, temperature in degrees celsius (axillary) and urticaria.

Any solicited general symptom is the occurence of the symptom regardless of its intensity or relationship to study vaccination.

Time Frame During the 7-day (Days 0-6) period following vaccination.
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title Cervarix&Engerix Group Cervarix Group Engerix Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 247 245 246
Measure Type: Count of Participants
Unit of Measure: Participants
Arthralgia
31
  12.6%
23
   9.4%
26
  10.6%
Fatigue
130
  52.6%
107
  43.7%
104
  42.3%
Gastrointestinal
65
  26.3%
67
  27.3%
70
  28.5%
Headache
136
  55.1%
131
  53.5%
129
  52.4%
Myalgia
55
  22.3%
55
  22.4%
53
  21.5%
Rash
10
   4.0%
14
   5.7%
11
   4.5%
Temperature
32
  13.0%
23
   9.4%
36
  14.6%
Urticaria
5
   2.0%
5
   2.0%
6
   2.4%
14.Secondary Outcome
Title Number of Subjects Reporting Grade 3 Solicited General Symptoms
Hide Description

Solicited general symptoms included arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, temperature in degrees celsius (axillary) and urticaria.

Grade 3 arthralgia, fatigue, gastrointestinal, headache, myalgia and rash were symptoms that prevented normal activity.

Grade 3 temperature was temperature > 39 degrees Celsius. Grade 3 urticaria was urticaria distributed on at least 4 body areas.

Time Frame During the 7-day (Days 0-6) period following vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title Cervarix&Engerix Group Cervarix Group Engerix Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 247 245 246
Measure Type: Count of Participants
Unit of Measure: Participants
Arthralgia
1
   0.4%
0
   0.0%
0
   0.0%
Fatigue
8
   3.2%
8
   3.3%
9
   3.7%
Gastrointestinal
4
   1.6%
6
   2.4%
8
   3.3%
Headache
13
   5.3%
11
   4.5%
4
   1.6%
Myalgia
2
   0.8%
2
   0.8%
1
   0.4%
Rash
0
   0.0%
1
   0.4%
0
   0.0%
Temperature
3
   1.2%
2
   0.8%
3
   1.2%
Urticaria
0
   0.0%
0
   0.0%
1
   0.4%
15.Secondary Outcome
Title Number of Subjects Reporting Related Solicited General Symptoms
Hide Description

Solicited general symptoms included arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, temperature in degrees celsius (axillary) and urticaria.

Related solicited general symptoms were those symptoms assessed by the investigators as related to the study vaccination.

Time Frame During the 7-day period (Days 0 - 6) following vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title Cervarix&Engerix Group Cervarix Group Engerix Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 247 245 246
Measure Type: Count of Participants
Unit of Measure: Participants
Arthralgia
18
   7.3%
16
   6.5%
12
   4.9%
Fatigue
89
  36.0%
70
  28.6%
51
  20.7%
Gastrointestinal
35
  14.2%
40
  16.3%
25
  10.2%
Headache
77
  31.2%
71
  29.0%
57
  23.2%
Myalgia
40
  16.2%
40
  16.3%
20
   8.1%
Rash
8
   3.2%
8
   3.3%
4
   1.6%
Temperature
13
   5.3%
10
   4.1%
6
   2.4%
Urticaria
4
   1.6%
4
   1.6%
2
   0.8%
16.Secondary Outcome
Title Number of Subjects Reporting Any, Grade 3 and Causally Related to Vaccination Unsolicited Adverse Events (AEs)
Hide Description

Unsolicited AE covers any AE 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.

Grade 3 AE was an AE that prevented normal activities. Related AE was an AE that was assessed by the investigator as related to the study vaccination.

Time Frame During the 30-day period (Days 0 - 29) following any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title Cervarix&Engerix Group Cervarix Group Engerix Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 247 247 247
Measure Type: Count of Participants
Unit of Measure: Participants
Any AEs
130
  52.6%
99
  40.1%
99
  40.1%
Grade 3 AEs
19
   7.7%
19
   7.7%
16
   6.5%
Related AEs
43
  17.4%
19
   7.7%
25
  10.1%
17.Secondary Outcome
Title Number of Subjects Reporting Any and Causally Related to Vaccination Serious Adverse Events (SAEs)
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.

Related SAEs were SAEs assessed by the investigators as related to the vaccination.

* Grade 3 SAEs were not assessed.

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, which included all vaccinated subjects for whom data were available.
Arm/Group Title Cervarix&Engerix Group Cervarix Group Engerix Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 247 247 247
Measure Type: Count of Participants
Unit of Measure: Participants
Any
2
   0.8%
1
   0.4%
0
   0.0%
Related
0
   0.0%
0
   0.0%
0
   0.0%
18.Secondary Outcome
Title Number of Subjects Reporting Any and Causally Related to Vaccination SAEs
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.

* Grade 3 SAEs were not assessed.

Time Frame Throughout the safety follow-up (month 7 up to Month 12).
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title Cervarix&Engerix Group Cervarix Group Engerix Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 247 247 247
Measure Type: Count of Participants
Unit of Measure: Participants
Any
1
   0.4%
1
   0.4%
1
   0.4%
Related
0
   0.0%
0
   0.0%
0
   0.0%
19.Secondary Outcome
Title Number of Subjects Reporting Medically Significant Conditions
Hide Description Medically significant conditions (i.e., AEs prompting emergency room or physician visits that are not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that are not related to common diseases).
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, which included all vaccinated subjects for whom data were available.
Arm/Group Title Cervarix&Engerix Group Cervarix Group Engerix Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 247 247 247
Measure Type: Count of Participants
Unit of Measure: Participants
31
  12.6%
28
  11.3%
22
   8.9%
20.Secondary Outcome
Title Number of Subjects Reporting Medically Significant Conditions
Hide Description Medically significant conditions (i.e., AEs prompting emergency room or physician visits that are not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that are not related to common diseases).
Time Frame Throughout the safety follow-up (month 7 up to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title Cervarix&Engerix Group Cervarix Group Engerix Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule.
Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 247 247 247
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2
   0.8%
2
   0.8%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cervarix&Engerix Group Cervarix Group Engerix Group
Hide Arm/Group Description Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) co-administered with Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule. Subjects received 3 doses of Cervarix™ (Human Papillomavirus [HPV] vaccine) according to a 0, 1, 6-month schedule. Subjects received 3 doses of Engerix™ (Hepatitis B [HBV] vaccine) according to a 0, 1, 6-month schedule.
All-Cause Mortality
Cervarix&Engerix Group Cervarix Group Engerix Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cervarix&Engerix Group Cervarix Group Engerix Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/247 (1.21%)   2/247 (0.81%)   1/247 (0.40%) 
Infections and infestations       
Appendicitis * 1  1/247 (0.40%)  0/247 (0.00%)  0/247 (0.00%) 
Injury, poisoning and procedural complications       
Traumatic brain injury *  1/247 (0.40%)  0/247 (0.00%)  0/247 (0.00%) 
Ankle fracture * 1  0/247 (0.00%)  0/247 (0.00%)  1/247 (0.40%) 
Forearm fracture * 1  0/247 (0.00%)  1/247 (0.40%)  0/247 (0.00%) 
Renal and urinary disorders       
Nephrolithiasis *  0/247 (0.00%)  1/247 (0.40%)  0/247 (0.00%) 
Reproductive system and breast disorders       
Ovarian cyst *  1/247 (0.40%)  0/247 (0.00%)  0/247 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedRa
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cervarix&Engerix Group Cervarix Group Engerix Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   246/247 (99.60%)   239/247 (96.76%)   222/247 (89.88%) 
General disorders       
Pain   244/247 (98.79%)  238/247 (96.36%)  182/247 (73.68%) 
Redness   122/247 (49.39%)  127/247 (51.42%)  63/247 (25.51%) 
Swelling   120/247 (48.58%)  111/247 (44.94%)  47/247 (19.03%) 
Arthralgia   31/247 (12.55%)  23/247 (9.31%)  26/247 (10.53%) 
Fatigue   130/247 (52.63%)  107/247 (43.32%)  104/247 (42.11%) 
Gastrointestinal   65/247 (26.32%)  67/247 (27.13%)  70/247 (28.34%) 
Headache   136/247 (55.06%)  131/247 (53.04%)  129/247 (52.23%) 
Myalgia   55/247 (22.27%)  55/247 (22.27%)  53/247 (21.46%) 
Rash   10/247 (4.05%)  14/247 (5.67%)  11/247 (4.45%) 
Temperature   32/247 (12.96%)  23/247 (9.31%)  36/247 (14.57%) 
Nasopharyngitis *  29/247 (11.74%)  27/247 (10.93%)  26/247 (10.53%) 
Headache *  17/247 (6.88%)  19/247 (7.69%)  9/247 (3.64%) 
Oropharyngeal pain *  13/247 (5.26%)  13/247 (5.26%)  7/247 (2.83%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-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
Publications:
Schmeink C et al. Co-administration of AS04-adjuvanted human papillomavirus-16/18 vaccine with hepatitis B vaccine in healthy female subjects aged 9-15 years. Abstract presented at the 28th Annual Meeting of European Society for Paediatric Infectious Diseases (ESPID). Nice, France, 4-8 May 2010.
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00652938     History of Changes
Other Study ID Numbers: 111507
First Submitted: March 27, 2008
First Posted: April 4, 2008
Results First Submitted: August 4, 2010
Results First Posted: August 31, 2010
Last Update Posted: August 17, 2018