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Trial record 23 of 91 for:    cervarix

Effectiveness, Safety and Immunogenicity of GSK Biologicals' HPV Vaccine GSK580299 (Cervarix TM) Administered in Healthy Adolescents

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: NCT00534638
Recruitment Status : Completed
First Posted : September 26, 2007
Results First Posted : January 26, 2016
Last Update Posted : June 5, 2017
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: GSK Biologicals' HPV Vaccine GSK580299
Biological: Engerix-B™
Enrollment 34206
Recruitment Details

Immunisation phase (Visit 1 at Day 0 to Phone contact at Month 12) = adolescents (birth cohorts 1992-95) were vaccinated with Cervarix™ or Engerix™-B vaccine.

Effectiveness evaluation phase (Visit 5) = the impact of the vaccine intervention was assessed on female subjects of approximately 18.5 years of age.

Pre-assignment Details At study start, Cervarix™ vaccine was not licensed for use in boys so male subjects receiving the vaccine were considered as part of a Phase III trial. Although 34206 subjects were enrolled, only 32175 subjects were vaccinated and started the study.
Arm/Group Title Cervarix Pooled Group Engerix-B Pooled Group
Hide Arm/Group Description Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule. Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Period Title: Overall Study
Started 14837 17338
Completed 8346 5547
Not Completed 6491 11791
Reason Not Completed
Withdrawal by Subject             4             5
Migrated/moved from study area             14             13
Lost to Follow-up             4793             10875
Already received HPV vaccine             0             1
Urticaria             1             0
Blinded treatment broken             2             0
Pregnancy             6             4
Death             5             5
Mentally disabled             1             0
ICF not returned             0             1
Subject unable to read             0             1
Received without ICF             0             1
Rejected origin of signature             0             2
Refused participation to study             1665             883
Arm/Group Title Cervarix Pooled Group Engerix-B Pooled Group Total
Hide Arm/Group Description Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule. Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule. Total of all reporting groups
Overall Number of Baseline Participants 14837 17338 32175
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14837 participants 17338 participants 32175 participants
14.1  (0.75) 14.1  (0.76) 14.1  (0.76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14837 participants 17338 participants 32175 participants
Female
12399
  83.6%
8119
  46.8%
20518
  63.8%
Male
2438
  16.4%
9219
  53.2%
11657
  36.2%
1.Primary Outcome
Title Number of Female Subjects With Vaccine Overall Effectiveness Against Genital Infection With Human Papilloma Virus (HPV) 16/18 Serotypes
Hide Description The analysis of overall effectiveness was based on stratified Mantel-Haenszel adjusted for clustering. The effectiveness was computed as 1- the prevalence odd ratio in all subjects from the investigated group (prevalence rate in all subjects from the investigated arm/prevalence rate in all subjects from Arm C).
Time Frame At the time of visit 5 (at 18.5 years of age)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the female study participants from the Total Enrolled cohort on effectiveness, which included all study participants who were previously enrolled in the immunization phase, and those who joined the trial at Visit 5.
Arm/Group Title Cervarix/Engerix-B A Group Cervarix/Engerix-B B Group Engerix-B Group
Hide Arm/Group Description:
90% of male and female adolescents received Cervarix™ vaccine. Rest of the subjects received Engerix™-B vaccine. Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
90% of the female adolescents received Cervarix™ vaccine. Male adolescents and rest of the female adolescents received Engerix™-B vaccine. Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
All adolescents were vaccinated with Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 3629 4029 3168
Measure Type: Number
Unit of Measure: Subjects
139 117 329
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cervarix/Engerix-B A Group, Engerix-B Group
Comments The analysis of overall effectiveness of GSK’s HPV-16/18 vaccine against HPV-16/18 genital infection in Arm A versus Arm C was based on stratified Mantel-Haenszel adjusted for clustering.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.232
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter 1-Odds Ratio
Estimated Value 23.8
Confidence Interval (2-Sided) 95%
-19.0 to 51.1
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cervarix/Engerix-B B Group, Engerix-B Group
Comments The analysis of overall effectiveness of GSK’s HPV-16/18 vaccine against HPV-16/18 genital infection in Arm A versus Arm C was based on stratified Mantel-Haenszel adjusted for clustering.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter 1-Odds Ratio
Estimated Value 49.6
Confidence Interval (2-Sided) 95%
20.1 to 68.2
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Cervarix/Engerix-B A Group, Engerix-B Group
Comments The analysis of overall effectiveness of GSK’s HPV-16/18 vaccine against HPV-16/18 genital infection in Arm A versus Arm C was based on stratified Mantel-Haenszel adjusted for clustering.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.069
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter 1-Odds Ratio
Estimated Value -52.2
Confidence Interval 95%
-139.4 to 3.3
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Female Subjects With Vaccine Effectiveness Against Oropharyngeal Infection With HPV-16/18 Serotypes
Hide Description The analysis of total effectiveness was based on stratified Mantel-Haenszel adjusted for clustering. The effectiveness was computed as 1- the prevalence odd ratio in HPV vaccinated subjects from the investigated group (prevalence rate in HPV vaccinated subjects from the investigated arm/prevalence rate in all subjects from Arm C).
Time Frame At the time of visit 5 (at 18.5 years of age)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the female study participants from the Total Enrolled cohort on effectiveness, which included all study participants who were previously enrolled in the immunization phase, and those who joined the trial at Visit 5.
Arm/Group Title No-vaccine Group Cervarix/Engerix-B Pooled Group
Hide Arm/Group Description:
Subjects who were enrolled but not vaccinated.
Male and female subjects receiving Cervarix™/Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 3192 233
Measure Type: Number
Unit of Measure: Subjects
9 9
3.Secondary Outcome
Title Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects.
Hide Description Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed.
Time Frame Within 7 days (Days 0 - 6) after any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total vaccinated cohort - the Diary card subset, which included a subset of male adolescents from Cervarix/Engerix-B and Engerix-B groups, who were selected for active assessment of safety using diary cards.
Arm/Group Title Cervarix Pooled Group Engerix-B Pooled Group
Hide Arm/Group Description:
Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 603 1028
Measure Type: Number
Unit of Measure: Subjects
Pain, Any 506 251
Pain, Grade 3 26 2
Redness, Any 169 131
Redness, Grade 3 4 0
Swelling, Any 131 46
Swelling, Grade 3 8 0
4.Secondary Outcome
Title Number of Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects.
Hide Description Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastrointestinal symptoms, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time Frame Within 7 days (Days 0 - 6) after any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total vaccinated cohort - the Diary card subset, which included a subset of male adolescents from Cervarix/Engerix-B and Engerix-B groups, who were selected for active assessment of safety using diary cards.
Arm/Group Title Cervarix Pooled Group Engerix-B Pooled Group
Hide Arm/Group Description:
Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 604 1028
Measure Type: Number
Unit of Measure: Subjects
Arthralgia, Any 107 97
Arthralgia, Grade 3 1 4
Arthralgia, Related 87 81
Fatigue, Any 291 411
Fatigue, Grade 3 7 21
Fatigue, Related 233 351
Fever (axillary), Any 48 85
Fever (axillary), Grade 3 6 9
Fever (axillary), Related 28 53
Gastrointestinal, Any 106 163
Gastrointestinal, Grade 3 11 13
Gastrointestinal, Related 70 128
Headache, Any 261 371
Headache, Grade 3 15 14
Headache, Related 176 280
Myalgia, Any 321 250
Myalgia, Grade 3 12 3
Myalgia, Related 291 211
Rash, Any 29 33
Rash, Grade 3 0 0
Rash, Related 14 23
Urticaria, Any 4 15
Urticaria, Grade 3 0 0
Urticaria, Related 3 14
5.Secondary Outcome
Title Number of Subjects Reporting Any, Grade 3 and Related to Vaccination Unsolicited Adverse Events (AEs), in a Subset of Subjects.
Hide Description An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time Frame Within 30 days (Days 0 - 29) after any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was based on the Total Vaccinated Cohort - the Diary Card subset - a subset of male adolescents from Cervarix/Engerix-B A and Engerix-B Groups selected for active assessment of safety using diary cards.
Arm/Group Title Cervarix Pooled Group Engerix-B Pooled Group
Hide Arm/Group Description:
Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 643 1047
Measure Type: Number
Unit of Measure: Subjects
Subjects with any AEs 157 202
Subjects with Grade 3 AEs 31 46
Subjects with related AEs 12 19
6.Secondary Outcome
Title Number of Subjects Reporting Rash and Urticaria, in a Subset of Subjects.
Hide Description [Not Specified]
Time Frame Within 30 minutes following vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was based on the Total Vaccinated Cohort - the Diary Card subset - a subset of male adolescents from Cervarix/Engerix-B A and Engerix-B Groups selected for active assessment of safety using diary cards.
Arm/Group Title Cervarix Pooled Group Engerix-B Pooled Group
Hide Arm/Group Description:
Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 643 1047
Measure Type: Number
Unit of Measure: Subjects
Confirmed after Dose 1 (n=643, 1047) 0 0
Infirmed after Dose 1 (n=643, 1047) 643 1047
Confirmed after Dose 2 (n=634, 1042) 0 0
Infirmed after Dose 2 (n=634, 1042) 634 1042
Confirmed after Dose 3 (n=631, 1039) 0 0
Infirmed after Dose 3 (n=631,1039) 630 1039
Missing Confirmed after Dose 3 (n=631, 1039) 1 0
7.Secondary Outcome
Title Number of Subjects Reporting Medically Significant Conditions (MSCs), in a Subset of Subjects.
Hide Description MSCs are defined as 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. Common diseases include: upper respiratory infections sinusitis, pharyngitis, gastroenteritis, urinary tract infections and injury.
Time Frame From Dose 1 (at Day 0) until Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort - Diary Card subset - a subset of male adolescents from the Cervarix/Engerix-B and Engerix-B Groups, selected for active assessment of safety using diary cards.
Arm/Group Title Cervarix Pooled Group Engerix-B Pooled Group
Hide Arm/Group Description:
Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 643 1047
Measure Type: Number
Unit of Measure: Subjects
47 76
8.Secondary Outcome
Title Number of Subjects Reporting Any Serious Adverse Events (SAEs) and SAEs Causally Related to Vaccination, in a Subset of Subjects
Hide Description Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame From Dose 1 (at Day 0) until Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total Vaccinated Cohort subset of Male subjects with active follow-up Month 0-Month 12 for SAEs, which included the male subjects in the Diary Card subset and the remaining Cervarix/Engerix-B Group male subjects.
Arm/Group Title Cervarix Pooled Group Engerix-B Pooled Group
Hide Arm/Group Description:
Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 2436 1267
Measure Type: Number
Unit of Measure: Number
Subjects with any SAEs 58 25
Subjects with SAEs assessed as related to vaccine 4 1
9.Secondary Outcome
Title Number of Subjects Reporting SAEs Assessed by the Investigator as Possibly Related to Vaccination.
Hide Description Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame During the entire study period up to the Visit 5 (18.5 years of age)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title Cervarix Pooled Group Engerix-B Pooled Group
Hide Arm/Group Description:
Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 14837 17338
Measure Type: Number
Unit of Measure: Subjects
25 30
10.Secondary Outcome
Title Number of Subjects With HPV-16 and HPV-18 Antibody Concentrations Equal to or Above the Cut-off Values, by Gender, in a Subset of Subjects.
Hide Description The antibody concentrations against HPV-16 and HPV-18 were determined by Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 8 ELISA units per millilitre (EL.U/mL) for anti-HPV-16 and 7 EL.U/mL for anti-HPV-18 at Visits 1 and 4 and 19 EL.U/mL for HPV-16 and 18 EL.U/mL for HPV-18 at Visit 5. The Immunogenicity subset comprised the male study participants from the Cervarix/Engerix-B A Group plus female study participants from the same Cervarix/Engerix-B A Group.
Time Frame At the time of Visit 1 (at Day 0), Visit 4 (at Month 7) and Visit 5 (at 18.5 years of age)
Hide Outcome Measure Data
Hide Analysis Population Description
The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. Subjects who acquired either HPV-16 or HPV-18 infection during the trial were excluded from the ATP cohort for immunogenicity.
Arm/Group Title Cervarix Pooled Group
Hide Arm/Group Description:
male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 1163
Measure Type: Number
Unit of Measure: Subjects
anti-HPV-16 >=8 EL.U/mL males [Day 0] (N=536) 40
anti-HPV-16 >=8 EL.U/mL males [Month 7] (N=536) 536
anti-HPV-16 >=8 EL.U/mL females [Day 0] (N=1163) 86
anti-HPV-16 >=8 EL.U/mL females [Month 7] (N=1163) 1163
anti-HPV-18 >=7 EL.U/mL males [Day 0] (N=535) 31
anti-HPV-18 >=7 EL.U/mL males [Month 7] (N=535) 535
anti-HPV-18 >=7 EL.U/mL females [Day 0] (N=1160) 84
anti-HPV-18 >=7 EL.U/mL females [Month 7] (N=1160) 1160
anti-HPV-16 >=19 EL.U/mL males [18.5Y] (N=217) 217
anti-HPV-16 >=19 EL.U/mL females [18.5Y] (N=688) 688
anti-HPV-18 >=18 EL.U/mL males [18.5Y] (N=217) 217
anti-HPV-18 >=18 EL.U/mL females [18.5Y] (N=686) 685
11.Secondary Outcome
Title Titres for Anti-HPV-16 and Anti-HPV-18 Antibodies, by Gender, in a Subset of Subjects.
Hide Description The antibody concentrations against HPV-16 and HPV-18 were determined by Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 8 ELISA units per millilitre (EL.U/mL) for anti-HPV-16 and 7 EL.U/mL for anti-HPV-18 at Visits 1 and 4 and 19 EL.U/mL for HPV-16 and 18 EL.U/mL for HPV-18 at Visit 5. The Immunogenicity subset comprised the male study participants from the Cervarix/Engerix-B A Group plus female study participants from the same Cervarix/Engerix-B A Group.
Time Frame At the time of visits 1 and 4 (at Day 0 and Month 7) and at the time of Visit 5 (18.5 years of age)
Hide Outcome Measure Data
Hide Analysis Population Description
The According-To-Protocol (ATP) cohort for immunogenicity included evaluable subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. Subjects who acquired either HPV-16 or HPV-18 infection during the trial were excluded from the ATP cohort for immunogenicity.
Arm/Group Title Cervarix Pooled Group
Hide Arm/Group Description:
Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 1163
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titres
anti-HPV-16 >=8 EL.U/mL males [Day 0] (N=536)
4.5
(4.3 to 4.6)
anti-HPV-16 >=8 EL.U/mL males [Month 7] (N=536)
23959.1
(22301.0 to 25740.4)
anti-HPV-16 >=8 EL.U/mL females [Day 0] (N=1163)
4.5
(4.4 to 4.6)
anti-HPV-16 >=8 EL.U/mL females [Month 7] (N=1163)
21327.2
(20338.9 to 22363.5)
anti-HPV-18 >=7 EL.U/mL males [Day 0] (N=535)
3.8
(3.7 to 4.0)
anti-HPV-18 >=7 EL.U/mL males [Month 7] (N=535)
8583.9
(7974.7 to 9239.5)
anti-HPV-18 >=7 EL.U/mL females [Day 0] (N=1160)
3.9
(3.8 to 4.0)
anti-HPV-18 >=7 EL.U/mL females [Month 7] (N=1160)
8227.3
(7847.7 to 8625.4)
anti-HPV-16 >=19 EL.U/mL males [18.5Y] (N=217)
2759.5
(2432.1 to 3130.9)
anti-HPV-16 >=19 EL.U/mL females [18.5Y] (N=688)
2609.6
(2444.4 to 2785.9)
anti-HPV-18 >=18 EL.U/mL males [18.5Y] (N=217)
837.7
(727.3 to 964.9)
anti-HPV-18 >=18 EL.U/mL females [18.5Y] (N=686)
890.0
(826.2 to 958.7)
12.Secondary Outcome
Title Number of Subjects Reporting Pregnancies With Onset During the Study
Hide Description Pregnancies with onset during the study were classified by their outcome. Outcomes included live infant with no apparent congenital anomaly, elective termination with no apparent congenital anomaly, spontaneous abortion with no apparent congenital anomaly, ectopic pregnancy, stillbirth with no apparent congenital anomaly and molar pregnancy. One additional pregnant subject was lost to follow-up during the study.
Time Frame Between Visit 1 (at Day 0) and Visit 5 (at 18.5 years of age)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the total number of pregnant subjects reported, part of the Total Vaccinated cohort, which all vaccinated subjects for whom data were available.
Arm/Group Title Cervarix Pooled Group Engerix-B Pooled Group
Hide Arm/Group Description:
Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 728 524
Measure Type: Number
Unit of Measure: Subjects
Live infant no apparent anomaly 232 161
Elective termination no apparent anomaly 431 314
Ectopic pregnancy 5 5
Spontaneous abortion np apparent anomaly 58 41
Stillbirth no apparent congenital anomaly 0 1
Lost to follow up 0 1
Molar pregnancy 2 1
13.Secondary Outcome
Title Number of Female Subjects With New Onset of Autoimmune Diseases (NOADs).
Hide Description NOADs include colitis ulcerative, juvenile arthritis, type 1 diabetes mellitus, coeliac disease and Chron's disease, Basedow's disease, erythema nodosum VIIth nerve paralysis and psoriasis.
Time Frame Between Visit 1 (at Day 0) and Visit 5 (at 18.5 years of age)
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all vaccinated subjects for whom data were available.
Arm/Group Title Cervarix Pooled Group Engerix-B Pooled Group
Hide Arm/Group Description:
Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 14837 17338
Measure Type: Number
Unit of Measure: Subjects
144 176
14.Secondary Outcome
Title Number of Female Subjects Reporting Any SAEs That Are Causally Related to Vaccination, in a Female Subjects
Hide Description Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame During the entire study period (from Dose 1-Day 0 to Visit 5-18.5 years of age)
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all vaccinated subjects for whom data were available
Arm/Group Title Cervarix Pooled Group Engerix-B Pooled Group
Hide Arm/Group Description:
Female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 12399 8119
Measure Type: Number
Unit of Measure: Subjects
20 16
15.Secondary Outcome
Title Number of Male Subjects Reporting Any SAEs That Are Causally Related to Vaccination, in All Male Subjects
Hide Description Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame During the entire study period (from dose1-Day 0 to Visit 5-18.5 years of age)
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all vaccinated subjects for whom data were available.
Arm/Group Title Cervarix Pooled Group Engerix-B Pooled Group
Hide Arm/Group Description:
Male subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Male subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 2438 9219
Measure Type: Number
Unit of Measure: Subjects
5 14
Time Frame Solicited symptoms: up to Day 7 post vaccination. AEs: up to Day 30 post vaccination. SAEs up to Visit 5 at Month 96
Adverse Event Reporting Description Adverse Events were collected in the Total Vaccinated Cohort Diary Card subset (TVC-DcS = a subset of males from Cervarix/Engerix-B and Engerix-B groups selected for active safety assessment using diary cards). SAEs were collected in the TVC-DcS and remaining Cervarix/Engerix-B Group male subjects. Related SAEs were collected from the TVC.
 
Arm/Group Title Cervarix Pooled Group Engerix-B Pooled Group
Hide Arm/Group Description Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule. Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
All-Cause Mortality
Cervarix Pooled Group Engerix-B Pooled Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cervarix Pooled Group Engerix-B Pooled Group
Affected / at Risk (%) Affected / at Risk (%)
Total   58/2436 (2.38%)   25/1267 (1.97%) 
Blood and lymphatic system disorders     
Splenomegaly  1  1/2436 (0.04%)  0/1267 (0.00%) 
Congenital, familial and genetic disorders     
Vitello-intestinal duct remnant  1  1/2436 (0.04%)  0/1267 (0.00%) 
Gastrointestinal disorders     
Abdominal Pain  1  2/2436 (0.08%)  0/1267 (0.00%) 
Colitis ulcerative  1  1/2436 (0.04%)  0/1267 (0.00%) 
Constipation  1  1/2436 (0.04%)  0/1267 (0.00%) 
Food poisoning  1  1/2436 (0.04%)  0/1267 (0.00%) 
General disorders     
Chest pain  1  1/2436 (0.04%)  0/1267 (0.00%) 
Pyrexia  1  1/2436 (0.04%)  0/1267 (0.00%) 
Hepatobiliary disorders     
Cholecystitis  1  1/2436 (0.04%)  0/1267 (0.00%) 
Infections and infestations     
Appendicitis  1  5/2436 (0.21%)  3/1267 (0.24%) 
Infectious mononucleosis  1  4/2436 (0.16%)  1/1267 (0.08%) 
Tonsilitis  1  4/2436 (0.16%)  0/1267 (0.00%) 
Appendicitis perforated  1  1/2436 (0.04%)  1/1267 (0.08%) 
Peritonsillar abscess  1  1/2436 (0.04%)  1/1267 (0.08%) 
Pneumonia  1  2/2436 (0.08%)  0/1267 (0.00%) 
Bronchitis  1  0/2436 (0.00%)  1/1267 (0.08%) 
Gastroenteritis bacterial  1  0/2436 (0.00%)  1/1267 (0.08%) 
Pneumonia bacterial  1  1/2436 (0.04%)  0/1267 (0.00%) 
Salmonellosis  1  1/2436 (0.04%)  0/1267 (0.00%) 
Sinusitis  1  0/2436 (0.00%)  1/1267 (0.08%) 
Sinusitis bacterial  1  0/2436 (0.00%)  1/1267 (0.08%) 
Injury, poisoning and procedural complications     
Alcohol poisoning  1  3/2436 (0.12%)  1/1267 (0.08%) 
Concussion  1  4/2436 (0.16%)  0/1267 (0.00%) 
Hand Fracture  1  2/2436 (0.08%)  1/1267 (0.08%) 
Contusion  1  2/2436 (0.08%)  0/1267 (0.00%) 
Foot Fracture  1  0/2436 (0.00%)  2/1267 (0.16%) 
Forearm Fracture  1  1/2436 (0.04%)  1/1267 (0.08%) 
Radius fracture  1  2/2436 (0.08%)  0/1267 (0.00%) 
Upper limb fracture  1  2/2436 (0.08%)  0/1267 (0.00%) 
Cervical vertebral fracture  1  1/2436 (0.04%)  0/1267 (0.00%) 
Joint dislocation  1  0/2436 (0.00%)  1/1267 (0.08%) 
Limb injury  1  1/2436 (0.04%)  0/1267 (0.00%) 
Lower limb fracture  1  1/2436 (0.04%)  0/1267 (0.00%) 
Muscle rupture  1  1/2436 (0.04%)  0/1267 (0.00%) 
Neck injury  1  1/2436 (0.04%)  0/1267 (0.00%) 
Splenic rupture  1  0/2436 (0.00%)  1/1267 (0.08%) 
Tibia fracture  1  0/2436 (0.00%)  1/1267 (0.08%) 
Traumatic renal injury  1  0/2436 (0.00%)  1/1267 (0.08%) 
Metabolism and nutrition disorders     
Type 1 diabetes mellitus  1  1/2436 (0.04%)  1/1267 (0.08%) 
Musculoskeletal and connective tissue disorders     
Exostosis  1  1/2436 (0.04%)  0/1267 (0.00%) 
Juvenile arthritis  1  1/2436 (0.04%)  0/1267 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Astrocytoma, low grade  1  0/2436 (0.00%)  1/1267 (0.08%) 
Nervous system disorders     
Syncope  1  2/2436 (0.08%)  0/1267 (0.00%) 
Psychiatric disorders     
Anxiety  1  1/2436 (0.04%)  0/1267 (0.00%) 
Depression  1  0/2436 (0.00%)  1/1267 (0.08%) 
Disturbance in social behaviour  1  1/2436 (0.04%)  0/1267 (0.00%) 
Emotional disorder of childhood  1  1/2436 (0.04%)  0/1267 (0.00%) 
Panic disorder  1  0/2436 (0.00%)  1/1267 (0.08%) 
Psychotic disorder  1  1/2436 (0.04%)  0/1267 (0.00%) 
Suicide attempt  1  0/2436 (0.00%)  1/1267 (0.08%) 
Reproductive system and breast disorders     
Testicular torsion  1  1/2436 (0.04%)  0/1267 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  0/2436 (0.00%)  1/1267 (0.08%) 
Skin and subcutaneous tissue disorders     
Acne  1  1/2436 (0.04%)  0/1267 (0.00%) 
Dermatitis  1  1/2436 (0.04%)  0/1267 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cervarix Pooled Group Engerix-B Pooled Group
Affected / at Risk (%) Affected / at Risk (%)
Total   506/643 (78.69%)   411/1047 (39.26%) 
General disorders     
Pain  1  506/643 (78.69%)  251/1047 (23.97%) 
Redness  1  169/643 (26.28%)  131/1047 (12.51%) 
Swelling  1  131/643 (20.37%)  46/1047 (4.39%) 
Arthralgia  1  107/643 (16.64%)  97/1047 (9.26%) 
Fatigue  1  291/643 (45.26%)  411/1047 (39.26%) 
Fever (Axilarry)  1  48/643 (7.47%)  85/1047 (8.12%) 
Gastrointestinal  1  106/643 (16.49%)  163/1047 (15.57%) 
Headache  1  261/643 (40.59%)  371/1047 (35.43%) 
Myalgia  1  321/643 (49.92%)  250/1047 (23.88%) 
Infections and infestations     
Nasopharyngitis * 1  33/643 (5.13%)  17/1047 (1.62%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00534638     History of Changes
Other Study ID Numbers: 106636
2007-001731-55 ( EudraCT Number )
First Submitted: September 24, 2007
First Posted: September 26, 2007
Results First Submitted: December 17, 2015
Results First Posted: January 26, 2016
Last Update Posted: June 5, 2017