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Safety and Immunogenicity of GSK Biologicals' HPV-16/18 L1 VLP AS04 Vaccine (GSK-580299) in Healthy Female Children 4-6 Years Old

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: NCT01627561
Recruitment Status : Completed
First Posted : June 26, 2012
Results First Posted : May 8, 2015
Last Update Posted : April 10, 2020
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Condition Infections, Papillomavirus
Interventions Biological: Cervarix
Biological: Priorix
Biological: Infanrix
Enrollment 148
Recruitment Details This study was conducted by multiple investigators at 7 centers in Colombia, Mexico and Panama.
Pre-assignment Details All 148 subjects enrolled in the study, received the study vaccination and were included in the Total Vaccinated cohort (TVC).
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description Healthy female subjects aged between, and including, 4 and 6 years, who received two doses of Cervarix vaccine at Day 0 and Month 6, administered intramuscularly in the deltoid muscle of the left upper arm. Healthy female subjects aged between, and including, 4 and 6 years, who received one dose of Priorix vaccine at Day 0 and one dose of Infanrix vaccine at Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Period Title: Overall Study
Started 74 74
Completed 73 71
Not Completed 1 3
Reason Not Completed
Lost to Follow-up             1             0
Withdrawal by Subject             0             1
Migrated/moved from study area             0             2
Arm/Group Title Cervarix Group Priorix + Infanrix Group Total
Hide Arm/Group Description Healthy female subjects aged between, and including, 4 and 6 years, who received two doses of Cervarix vaccine at Day 0 and Month 6, administered intramuscularly in the deltoid muscle of the left upper arm. Healthy female subjects aged between, and including, 4 and 6 years, who received one dose of Priorix vaccine at Day 0 and one dose of Infanrix vaccine at Month 6, administered intramuscularly in the deltoid muscle of the left upper arm. Total of all reporting groups
Overall Number of Baseline Participants 74 74 148
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 74 participants 74 participants 148 participants
4.3  (0.5) 4.4  (0.5) 4.3  (0.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 74 participants 148 participants
Female
74
 100.0%
74
 100.0%
148
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 74 participants 74 participants 148 participants
African Heritage / African American
4
   5.4%
2
   2.7%
6
   4.1%
White - Caucasian / European Heritage
2
   2.7%
4
   5.4%
6
   4.1%
Mixed origin
68
  91.9%
68
  91.9%
136
  91.9%
1.Primary Outcome
Title Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Hide Description Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.
Time Frame During the 7-day follow-up period (i.e. from the day of vaccination up to 6 subsequent days) after each vaccine dose and across doses
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study, who had their symptom sheet filled in and for whom data were available.
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description:
Healthy female subjects aged between, and including, 4 and 6 years, who received two doses of Cervarix vaccine at Day 0 and Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Healthy female subjects aged between, and including, 4 and 6 years, who received one dose of Priorix vaccine at Day 0 and one dose of Infanrix vaccine at Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Overall Number of Participants Analyzed 74 74
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain Dose 1 Number Analyzed 74 participants 74 participants
45
  60.8%
15
  20.3%
Grade 3 Pain Dose 1 Number Analyzed 74 participants 74 participants
2
   2.7%
0
   0.0%
Any Redness Dose 1 Number Analyzed 74 participants 74 participants
10
  13.5%
7
   9.5%
Grade 3 Redness Dose 1 Number Analyzed 74 participants 74 participants
1
   1.4%
0
   0.0%
Any Swelling Dose 1 Number Analyzed 74 participants 74 participants
6
   8.1%
6
   8.1%
Grade 3 Swelling Dose 1 Number Analyzed 74 participants 74 participants
1
   1.4%
0
   0.0%
Any Pain Dose 2 Number Analyzed 72 participants 71 participants
43
  59.7%
36
  50.7%
Grade 3 Pain Dose 2 Number Analyzed 72 participants 71 participants
2
   2.8%
1
   1.4%
Any Redness Dose 2 Number Analyzed 72 participants 71 participants
12
  16.7%
12
  16.9%
Grade 3 Redness Dose 2 Number Analyzed 72 participants 71 participants
0
   0.0%
4
   5.6%
Any Swelling Dose 2 Number Analyzed 72 participants 71 participants
16
  22.2%
15
  21.1%
Grade 3 Swelling Dose 2 Number Analyzed 72 participants 71 participants
3
   4.2%
7
   9.9%
Any Pain Across doses Number Analyzed 74 participants 74 participants
54
  73.0%
40
  54.1%
Grade 3 Pain Across doses Number Analyzed 74 participants 74 participants
4
   5.4%
1
   1.4%
Any Redness Across doses Number Analyzed 74 participants 74 participants
18
  24.3%
18
  24.3%
Grade 3 Redness Across doses Number Analyzed 74 participants 74 participants
1
   1.4%
4
   5.4%
Any Swelling Across doses Number Analyzed 74 participants 74 participants
19
  25.7%
18
  24.3%
Grade 3 Swelling Across doses Number Analyzed 74 participants 74 participants
4
   5.4%
7
   9.5%
2.Primary Outcome
Title Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Hide Description Assessed solicited general symptoms were arthralgia (only in joints which were distal from the injection site), drowsiness, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache, irritability/fussiness, loss of appetite, myalgia, rash (not urticaria, not measels/rubella-like rash), 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. Grade 3 irritability/fussiness = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = did not eat at all. Related = symptom assessed by the investigator as causally related to the study vaccination.
Time Frame During the 7-day follow-up period (i.e. from the day of vaccination up to 6 subsequent days) after each vaccine dose and across doses
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study, who had their symptom sheet filled in and for whom data were available.
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description:
Healthy female subjects aged between, and including, 4 and 6 years, who received two doses of Cervarix vaccine at Day 0 and Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Healthy female subjects aged between, and including, 4 and 6 years, who received one dose of Priorix vaccine at Day 0 and one dose of Infanrix vaccine at Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Overall Number of Participants Analyzed 74 74
Measure Type: Count of Participants
Unit of Measure: Participants
Any Arthralgia Dose 1 Number Analyzed 74 participants 74 participants
5
   6.8%
8
  10.8%
Grade 3 Arthralgia Dose 1 Number Analyzed 74 participants 74 participants
0
   0.0%
0
   0.0%
Related Arthralgia Dose 1 Number Analyzed 74 participants 74 participants
4
   5.4%
8
  10.8%
Any Drowsiness Dose 1 Number Analyzed 74 participants 74 participants
14
  18.9%
7
   9.5%
Grade 3 Drowsiness Dose 1 Number Analyzed 74 participants 74 participants
3
   4.1%
0
   0.0%
Related Drowsiness Dose 1 Number Analyzed 74 participants 74 participants
12
  16.2%
7
   9.5%
Any Fatigue Dose 1 Number Analyzed 74 participants 74 participants
8
  10.8%
7
   9.5%
Grade 3 Fatigue Dose 1 Number Analyzed 74 participants 74 participants
0
   0.0%
0
   0.0%
Related Fatigue Dose 1 Number Analyzed 74 participants 74 participants
7
   9.5%
7
   9.5%
Any Fever Dose 1 Number Analyzed 74 participants 74 participants
6
   8.1%
8
  10.8%
Grade 3 Fever Dose 1 Number Analyzed 74 participants 74 participants
1
   1.4%
0
   0.0%
Related Fever Dose 1 Number Analyzed 74 participants 74 participants
3
   4.1%
5
   6.8%
Any Gastrointestinal Dose 1 Number Analyzed 74 participants 74 participants
7
   9.5%
12
  16.2%
Grade 3 Gastrointestinal Dose 1 Number Analyzed 74 participants 74 participants
0
   0.0%
0
   0.0%
Related Gastrointestinal Dose 1 Number Analyzed 74 participants 74 participants
5
   6.8%
10
  13.5%
Any Headache Dose 1 Number Analyzed 74 participants 74 participants
11
  14.9%
19
  25.7%
Grade 3 Headache Dose 1 Number Analyzed 74 participants 74 participants
0
   0.0%
1
   1.4%
Related Headache Dose 1 Number Analyzed 74 participants 74 participants
9
  12.2%
17
  23.0%
Any Irritability/fussiness Dose 1 Number Analyzed 74 participants 74 participants
13
  17.6%
7
   9.5%
Grade 3 Irritability/fussiness Dose 1 Number Analyzed 74 participants 74 participants
1
   1.4%
0
   0.0%
Related Irritability/fussiness Dose 1 Number Analyzed 74 participants 74 participants
12
  16.2%
7
   9.5%
Any Loss of appetite Dose 1 Number Analyzed 74 participants 74 participants
15
  20.3%
7
   9.5%
Grade 3 Loss of appetite Dose 1 Number Analyzed 74 participants 74 participants
0
   0.0%
0
   0.0%
Related Loss of appetite Dose 1 Number Analyzed 74 participants 74 participants
13
  17.6%
7
   9.5%
Any Myalgia Dose 1 Number Analyzed 74 participants 74 participants
13
  17.6%
9
  12.2%
Grade 3 Myalgia Dose 1 Number Analyzed 74 participants 74 participants
0
   0.0%
0
   0.0%
Related Myalgia Dose 1 Number Analyzed 74 participants 74 participants
13
  17.6%
9
  12.2%
Any Rash Dose 1 Number Analyzed 74 participants 74 participants
3
   4.1%
1
   1.4%
Grade 3 Rash Dose 1 Number Analyzed 74 participants 74 participants
0
   0.0%
0
   0.0%
Related Rash Dose 1 Number Analyzed 74 participants 74 participants
2
   2.7%
1
   1.4%
Any Urticaria Dose 1 Number Analyzed 74 participants 74 participants
5
   6.8%
3
   4.1%
Grade 3 Urticaria Dose 1 Number Analyzed 74 participants 74 participants
0
   0.0%
0
   0.0%
Related Urticaria Dose 1 Number Analyzed 74 participants 74 participants
4
   5.4%
3
   4.1%
Any Arthralgia Dose 2 Number Analyzed 72 participants 71 participants
10
  13.9%
8
  11.3%
Grade 3 Arthralgia Dose 2 Number Analyzed 72 participants 71 participants
0
   0.0%
0
   0.0%
Related Arthralgia Dose 2 Number Analyzed 72 participants 71 participants
9
  12.5%
8
  11.3%
Any Drowsiness Dose 2 Number Analyzed 72 participants 71 participants
9
  12.5%
9
  12.7%
Grade 3 Drowsiness Dose 2 Number Analyzed 72 participants 71 participants
0
   0.0%
0
   0.0%
Related Drowsiness Dose 2 Number Analyzed 72 participants 71 participants
9
  12.5%
9
  12.7%
Any Fatigue Dose 2 Number Analyzed 72 participants 71 participants
9
  12.5%
7
   9.9%
Grade 3 Fatigue Dose 2 Number Analyzed 72 participants 71 participants
0
   0.0%
0
   0.0%
Related Fatigue Dose 2 Number Analyzed 72 participants 71 participants
9
  12.5%
7
   9.9%
Any Fever Dose 2 Number Analyzed 72 participants 71 participants
7
   9.7%
12
  16.9%
Grade 3 Fever Dose 2 Number Analyzed 72 participants 71 participants
0
   0.0%
0
   0.0%
Related Fever Dose 2 Number Analyzed 72 participants 71 participants
7
   9.7%
9
  12.7%
Any Gastrointestinal Dose 2 Number Analyzed 72 participants 71 participants
4
   5.6%
9
  12.7%
Grade 3 Gastrointestinal Dose 2 Number Analyzed 72 participants 71 participants
0
   0.0%
0
   0.0%
Related Gastrointestinal Dose 2 Number Analyzed 72 participants 71 participants
3
   4.2%
8
  11.3%
Any Headache Dose 2 Number Analyzed 72 participants 71 participants
12
  16.7%
13
  18.3%
Grade 3 Headache Dose 2 Number Analyzed 72 participants 71 participants
0
   0.0%
0
   0.0%
Related Headache Dose 2 Number Analyzed 72 participants 71 participants
12
  16.7%
12
  16.9%
Any Irritability/fussiness Dose 2 Number Analyzed 72 participants 71 participants
18
  25.0%
17
  23.9%
Grade 3 Irritability/fussiness Dose 2 Number Analyzed 72 participants 71 participants
0
   0.0%
0
   0.0%
Related Irritability/fussiness Dose 2 Number Analyzed 72 participants 71 participants
18
  25.0%
17
  23.9%
Any Loss of appetite Dose 2 Number Analyzed 72 participants 71 participants
9
  12.5%
8
  11.3%
Grade 3 Loss of appetite Dose 2 Number Analyzed 72 participants 71 participants
1
   1.4%
1
   1.4%
Related Loss of appetite Dose 2 Number Analyzed 72 participants 71 participants
9
  12.5%
8
  11.3%
Any Myalgia Dose 2 Number Analyzed 72 participants 71 participants
13
  18.1%
11
  15.5%
Grade 3 Myalgia Dose 2 Number Analyzed 72 participants 71 participants
0
   0.0%
0
   0.0%
Related Myalgia Dose 2 Number Analyzed 72 participants 71 participants
12
  16.7%
11
  15.5%
Any Rash Dose 2 Number Analyzed 72 participants 71 participants
3
   4.2%
4
   5.6%
Grade 3 Rash Dose 2 Number Analyzed 72 participants 71 participants
0
   0.0%
0
   0.0%
Related Rash Dose 2 Number Analyzed 72 participants 71 participants
3
   4.2%
3
   4.2%
Any Urticaria Dose 2 Number Analyzed 72 participants 71 participants
5
   6.9%
4
   5.6%
Grade 3 Urticaria Dose 2 Number Analyzed 72 participants 71 participants
0
   0.0%
0
   0.0%
Related Urticaria Dose 2 Number Analyzed 72 participants 71 participants
4
   5.6%
3
   4.2%
Any Arthralgia Across doses Number Analyzed 74 participants 74 participants
13
  17.6%
11
  14.9%
Grade 3 Arthralgia Across doses Number Analyzed 74 participants 74 participants
0
   0.0%
0
   0.0%
Related Arthralgia Across doses Number Analyzed 74 participants 74 participants
12
  16.2%
11
  14.9%
Any Drowsiness Across doses Number Analyzed 74 participants 74 participants
16
  21.6%
15
  20.3%
Grade 3 Drowsiness Across doses Number Analyzed 74 participants 74 participants
3
   4.1%
0
   0.0%
Related Drowsiness Across doses Number Analyzed 74 participants 74 participants
15
  20.3%
15
  20.3%
Any Fatigue Across doses Number Analyzed 74 participants 74 participants
15
  20.3%
10
  13.5%
Grade 3 Fatigue Across doses Number Analyzed 74 participants 74 participants
0
   0.0%
0
   0.0%
Related Fatigue Across doses Number Analyzed 74 participants 74 participants
14
  18.9%
10
  13.5%
Any Fever Across doses Number Analyzed 74 participants 74 participants
12
  16.2%
17
  23.0%
Grade 3 Fever Across doses Number Analyzed 74 participants 74 participants
1
   1.4%
0
   0.0%
Related Fever Across doses Number Analyzed 74 participants 74 participants
9
  12.2%
13
  17.6%
Any Gastrointestinal Across doses Number Analyzed 74 participants 74 participants
11
  14.9%
16
  21.6%
Grade 3 Gastrointestinal Across doses Number Analyzed 74 participants 74 participants
0
   0.0%
0
   0.0%
Related Gastrointestinal Across doses Number Analyzed 74 participants 74 participants
8
  10.8%
15
  20.3%
Any Headache Across doses Number Analyzed 74 participants 74 participants
18
  24.3%
25
  33.8%
Grade 3 Headache Across doses Number Analyzed 74 participants 74 participants
0
   0.0%
1
   1.4%
Related Headache Across doses Number Analyzed 74 participants 74 participants
16
  21.6%
23
  31.1%
Any Irritability/fussiness Across doses Number Analyzed 74 participants 74 participants
22
  29.7%
19
  25.7%
Grade 3 Irritability/fussiness Across doses Number Analyzed 74 participants 74 participants
1
   1.4%
0
   0.0%
Related Irritability/fussiness Across doses Number Analyzed 74 participants 74 participants
22
  29.7%
19
  25.7%
Any Loss of appetite Across doses Number Analyzed 74 participants 74 participants
21
  28.4%
13
  17.6%
Grade 3 Loss of appetite Across doses Number Analyzed 74 participants 74 participants
1
   1.4%
1
   1.4%
Related Loss of appetite Across doses Number Analyzed 74 participants 74 participants
19
  25.7%
13
  17.6%
Any Myalgia Across doses Number Analyzed 74 participants 74 participants
21
  28.4%
14
  18.9%
Grade 3 Myalgia Across doses Number Analyzed 74 participants 74 participants
0
   0.0%
0
   0.0%
Related Myalgia Across doses Number Analyzed 74 participants 74 participants
21
  28.4%
14
  18.9%
Any Rash Across doses Number Analyzed 74 participants 74 participants
6
   8.1%
5
   6.8%
Grade 3 Rash Across doses Number Analyzed 74 participants 74 participants
0
   0.0%
0
   0.0%
Related Rash Across doses Number Analyzed 74 participants 74 participants
5
   6.8%
4
   5.4%
Any Urticaria Across doses Number Analyzed 74 participants 74 participants
10
  13.5%
7
   9.5%
Grade 3 Urticaria Across doses Number Analyzed 74 participants 74 participants
0
   0.0%
0
   0.0%
Related Urticaria Across doses Number Analyzed 74 participants 74 participants
8
  10.8%
6
   8.1%
3.Primary Outcome
Title Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Reported During the 43-day Period Following the Vaccination at Day 0
Hide Description An unsolicited AE is 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. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. 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 = AE assessed by the investigator as causally related to the study vaccination.
Time Frame During the 43-day period (i.e. from the day of vaccination up to 42 subsequent days) following the vaccination at Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study and for whom data were available.
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description:
Healthy female subjects aged between, and including, 4 and 6 years, who received two doses of Cervarix vaccine at Day 0 and Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Healthy female subjects aged between, and including, 4 and 6 years, who received one dose of Priorix vaccine at Day 0 and one dose of Infanrix vaccine at Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Overall Number of Participants Analyzed 74 74
Measure Type: Count of Participants
Unit of Measure: Participants
Any AE(s)
40
  54.1%
40
  54.1%
Grade 3 AE(s)
3
   4.1%
2
   2.7%
Related AE(s)
1
   1.4%
5
   6.8%
4.Primary Outcome
Title Number of Subjects With Any, Grade 3 and Related Unsolicited AEs Reported During the 30-day Period Following the Vaccination at Month 6
Hide Description An unsolicited AE is 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. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. 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 = AE assessed by the investigator as causally related to the study vaccination.
Time Frame During the 30-day period (i.e. from the day of vaccination up to 29 subsequent days) following the vaccination at Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study and for whom data were available. Out of the 74 subjects present in the initial Priorix + Infanrix Group, 3 did not receive the second vaccination and were hence excluded from this analysis.
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description:
Healthy female subjects aged between, and including, 4 and 6 years, who received two doses of Cervarix vaccine at Day 0 and Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Healthy female subjects aged between, and including, 4 and 6 years, who received one dose of Priorix vaccine at Day 0 and one dose of Infanrix vaccine at Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Overall Number of Participants Analyzed 74 71
Measure Type: Count of Participants
Unit of Measure: Participants
Any AE(s)
18
  24.3%
13
  18.3%
Grade 3 AE(s)
0
   0.0%
0
   0.0%
Related AE(s)
0
   0.0%
1
   1.4%
5.Primary Outcome
Title Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
Hide Description

The parameters assessed were both biochemical (alanine aminotransferase = ALAT, creatinine = CREA, blood urea nitrogen = BUN) and haematological (basophils = BAS, eosinophils = EOS, red blood cells = RBC, hematocrit = HCT, hemoglobin = HGB, leukocytes [white blood cells] = WBC, lymphocytes = LYM, monocytes = MONO, neutrophils = NEU and platelets = PLA).

Abnormal laboratory values at Day 42 were Below, Within and Above normal ranges, as compared to the baseline status of the same parameter, at Day 0 (Unknown, Below, Within and Above normal ranges) [e.g. ALAT Below (baseline) - Within (Day 42) = ALAT with below normal value at baseline and within normal values at Day 42].
Time Frame At Day 42 (i.e. 42 days after the vaccination at Day 0)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study and for whom data were available at the specified time point.
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description:
Healthy female subjects aged between, and including, 4 and 6 years, who received two doses of Cervarix vaccine at Day 0 and Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Healthy female subjects aged between, and including, 4 and 6 years, who received one dose of Priorix vaccine at Day 0 and one dose of Infanrix vaccine at Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Overall Number of Participants Analyzed 74 73
Measure Type: Count of Participants
Unit of Measure: Participants
ALAT, Unknown (baseline) - Below (Day 42) Number Analyzed 2 participants 2 participants
0
   0.0%
0
   0.0%
ALAT, Unknown (baseline) - Within (Day 42) Number Analyzed 2 participants 2 participants
2
 100.0%
1
  50.0%
ALAT, Unknown (baseline) - Above (Day 42) Number Analyzed 2 participants 2 participants
0
   0.0%
1
  50.0%
ALAT, Below (baseline) - Below (Day 42) Number Analyzed 2 participants 1 participants
1
  50.0%
0
   0.0%
ALAT, Below (baseline) - Within (Day 42) Number Analyzed 2 participants 1 participants
1
  50.0%
1
 100.0%
ALAT, Below (baseline) - Above (Day 42) Number Analyzed 2 participants 1 participants
0
   0.0%
0
   0.0%
ALAT, Within (baseline) - Below (Day 42) Number Analyzed 66 participants 62 participants
0
   0.0%
0
   0.0%
ALAT, Within (baseline) - Within (Day 42) Number Analyzed 66 participants 62 participants
64
  97.0%
60
  96.8%
ALAT, Within (baseline) - Above (Day 42) Number Analyzed 66 participants 62 participants
2
   3.0%
2
   3.2%
ALAT, Above (baseline) - Below (Day 42) Number Analyzed 4 participants 7 participants
0
   0.0%
0
   0.0%
ALAT, Above (baseline) - Within (Day 42) Number Analyzed 4 participants 7 participants
1
  25.0%
4
  57.1%
ALAT, Above (baseline) - Above (Day 42) Number Analyzed 4 participants 7 participants
3
  75.0%
3
  42.9%
BAS, Unknown (baseline) - Below (Day 42) Number Analyzed 1 participants 0 participants
0
   0.0%
BAS, Unknown (baseline) - Within (Day 42) Number Analyzed 1 participants 0 participants
1
 100.0%
BAS, Unknown (baseline) - Above (Day 42) Number Analyzed 1 participants 0 participants
0
   0.0%
BAS, Below (baseline) - Below (Day 42) Number Analyzed 0 participants 0 participants
BAS, Below (baseline) - Within (Day 42) Number Analyzed 0 participants 0 participants
BAS, Below (baseline) - Above (Day 42) Number Analyzed 0 participants 0 participants
BAS, Within (baseline) - Below (Day 42) Number Analyzed 71 participants 69 participants
0
   0.0%
0
   0.0%
BAS, Within (baseline) - Within (Day 42) Number Analyzed 71 participants 69 participants
71
 100.0%
69
 100.0%
BAS, Within (baseline) - Above (Day 42) Number Analyzed 71 participants 69 participants
0
   0.0%
0
   0.0%
BAS, Above (baseline) - Below (Day 42) Number Analyzed 0 participants 4 participants
0
   0.0%
BAS, Above (baseline) - Within (Day 42) Number Analyzed 0 participants 4 participants
4
 100.0%
BAS, Above (baseline) - Above (Day 42) Number Analyzed 0 participants 4 participants
0
   0.0%
CREA, Unknown (baseline) - Below (Day 42) Number Analyzed 2 participants 1 participants
0
   0.0%
1
 100.0%
CREA, Unknown (baseline) - Within (Day 42) Number Analyzed 2 participants 1 participants
2
 100.0%
0
   0.0%
CREA, Unknown (baseline) - Above (Day 42) Number Analyzed 2 participants 1 participants
0
   0.0%
0
   0.0%
CREA, Below (baseline) - Below (Day 42) Number Analyzed 30 participants 27 participants
22
  73.3%
17
  63.0%
CREA, Below (baseline) - Within (Day 42) Number Analyzed 30 participants 27 participants
8
  26.7%
10
  37.0%
CREA, Below (baseline) - Above (Day 42) Number Analyzed 30 participants 27 participants
0
   0.0%
0
   0.0%
CREA, Within (baseline) - Below (Day 42) Number Analyzed 42 participants 45 participants
7
  16.7%
12
  26.7%
CREA, Within (baseline) - Within (Day 42) Number Analyzed 42 participants 45 participants
35
  83.3%
33
  73.3%
CREA, Within (baseline) - Above (Day 42) Number Analyzed 42 participants 45 participants
0
   0.0%
0
   0.0%
CREA, Above (baseline) - Below (Day 42) Number Analyzed 0 participants 0 participants
CREA, Above (baseline) - Within (Day 42) Number Analyzed 0 participants 0 participants
CREA, Above (baseline) - Above (Day 42) Number Analyzed 0 participants 0 participants
EOS, Unknown (baseline) - Below (Day 42) Number Analyzed 1 participants 0 participants
0
   0.0%
EOS, Unknown (baseline) - Within (Day 42) Number Analyzed 1 participants 0 participants
1
 100.0%
EOS, Unknown (baseline) - Above (Day 42) Number Analyzed 1 participants 0 participants
0
   0.0%
EOS, Below (baseline) - Below (Day 42) Number Analyzed 1 participants 0 participants
0
   0.0%
EOS, Below (baseline) - Within (Day 42) Number Analyzed 1 participants 0 participants
1
 100.0%
EOS, Below (baseline) - Above (Day 42) Number Analyzed 1 participants 0 participants
0
   0.0%
EOS, Within (baseline) - Below (Day 42) Number Analyzed 49 participants 50 participants
1
   2.0%
1
   2.0%
EOS, Within (baseline) - Within (Day 42) Number Analyzed 49 participants 50 participants
42
  85.7%
38
  76.0%
EOS, Within (baseline) - Above (Day 42) Number Analyzed 49 participants 50 participants
6
  12.2%
11
  22.0%
EOS, Above (baseline) - Below (Day 42) Number Analyzed 21 participants 23 participants
0
   0.0%
1
   4.3%
EOS, Above (baseline) - Within (Day 42) Number Analyzed 21 participants 23 participants
4
  19.0%
10
  43.5%
EOS, Above (baseline) - Above (Day 42) Number Analyzed 21 participants 23 participants
17
  81.0%
12
  52.2%
RBC, Unknown (baseline) - Below (Day 42) Number Analyzed 1 participants 0 participants
0
   0.0%
RBC, Unknown (baseline) - Within (Day 42) Number Analyzed 1 participants 0 participants
1
 100.0%
RBC, Unknown (baseline) - Above (Day 42) Number Analyzed 1 participants 0 participants
0
   0.0%
RBC, Below (baseline) - Below (Day 42) Number Analyzed 5 participants 5 participants
0
   0.0%
1
  20.0%
RBC, Below (baseline) - Within (Day 42) Number Analyzed 5 participants 5 participants
5
 100.0%
4
  80.0%
RBC, Below (baseline) - Above (Day 42) Number Analyzed 5 participants 5 participants
0
   0.0%
0
   0.0%
RBC, Within (baseline) - Below (Day 42) Number Analyzed 66 participants 66 participants
5
   7.6%
2
   3.0%
RBC, Within (baseline) - Within (Day 42) Number Analyzed 66 participants 66 participants
60
  90.9%
63
  95.5%
RBC, Within (baseline) - Above (Day 42) Number Analyzed 66 participants 66 participants
1
   1.5%
1
   1.5%
RBC, Above (baseline) - Below (Day 42) Number Analyzed 0 participants 2 participants
0
   0.0%
RBC, Above (baseline) - Within (Day 42) Number Analyzed 0 participants 2 participants
1
  50.0%
RBC, Above (baseline) - Above (Day 42) Number Analyzed 0 participants 2 participants
1
  50.0%
HCT, Unknown (baseline) - Below (Day 42) Number Analyzed 1 participants 0 participants
0
   0.0%
HCT, Unknown (baseline) - Within (Day 42) Number Analyzed 1 participants 0 participants
1
 100.0%
HCT, Unknown (baseline) - Above (Day 42) Number Analyzed 1 participants 0 participants
0
   0.0%
HCT, Below (baseline) - Below (Day 42) Number Analyzed 25 participants 24 participants
12
  48.0%
15
  62.5%
HCT, Below (baseline) - Within (Day 42) Number Analyzed 25 participants 24 participants
13
  52.0%
8
  33.3%
HCT, Below (baseline) - Above (Day 42) Number Analyzed 25 participants 24 participants
0
   0.0%
1
   4.2%
HCT, Within (baseline) - Below (Day 42) Number Analyzed 43 participants 45 participants
5
  11.6%
2
   4.4%
HCT, Within (baseline) - Within (Day 42) Number Analyzed 43 participants 45 participants
37
  86.0%
38
  84.4%
HCT, Within (baseline) - Above (Day 42) Number Analyzed 43 participants 45 participants
1
   2.3%
5
  11.1%
HCT, Above (baseline) - Below (Day 42) Number Analyzed 3 participants 4 participants
0
   0.0%
0
   0.0%
HCT, Above (baseline) - Within (Day 42) Number Analyzed 3 participants 4 participants
2
  66.7%
4
 100.0%
HCT, Above (baseline) - Above (Day 42) Number Analyzed 3 participants 4 participants
1
  33.3%
0
   0.0%
HGB, Unknown (baseline) - Below (Day 42) Number Analyzed 1 participants 0 participants
0
   0.0%
HGB, Unknown (baseline) - Within (Day 42) Number Analyzed 1 participants 0 participants
0
   0.0%
HGB, Unknown (baseline) - Above (Day 42) Number Analyzed 1 participants 0 participants
1
 100.0%
HGB, Below (baseline) - Below (Day 42) Number Analyzed 20 participants 14 participants
10
  50.0%
5
  35.7%
HGB, Below (baseline) - Within (Day 42) Number Analyzed 20 participants 14 participants
10
  50.0%
9
  64.3%
HGB, Below (baseline) - Above (Day 42) Number Analyzed 20 participants 14 participants
0
   0.0%
0
   0.0%
HGB, Within (baseline) - Below (Day 42) Number Analyzed 46 participants 53 participants
4
   8.7%
7
  13.2%
HGB, Within (baseline) - Within (Day 42) Number Analyzed 46 participants 53 participants
38
  82.6%
42
  79.2%
HGB, Within (baseline) - Above (Day 42) Number Analyzed 46 participants 53 participants
4
   8.7%
4
   7.5%
HGB, Above (baseline) - Below (Day 42) Number Analyzed 5 participants 6 participants
0
   0.0%
0
   0.0%
HGB, Above (baseline) - Within (Day 42) Number Analyzed 5 participants 6 participants
3
  60.0%
5
  83.3%
HGB, Above (baseline) - Above (Day 42) Number Analyzed 5 participants 6 participants
2
  40.0%
1
  16.7%
WBC, Unknown (baseline) - Below (Day 42) Number Analyzed 1 participants 0 participants
0
   0.0%
WBC, Unknown (baseline) - Within (Day 42) Number Analyzed 1 participants 0 participants
1
 100.0%
WBC, Unknown (baseline) - Above (Day 42) Number Analyzed 1 participants 0 participants
0
   0.0%
WBC, Below (baseline) - Below (Day 42) Number Analyzed 5 participants 7 participants
1
  20.0%
5
  71.4%
WBC, Below (baseline) - Within (Day 42) Number Analyzed 5 participants 7 participants
3
  60.0%
1
  14.3%
WBC, Below (baseline) - Above (Day 42) Number Analyzed 5 participants 7 participants
1
  20.0%
1
  14.3%
WBC, Within (baseline) - Below (Day 42) Number Analyzed 62 participants 59 participants
2
   3.2%
1
   1.7%
WBC, Within (baseline) - Within (Day 42) Number Analyzed 62 participants 59 participants
57
  91.9%
54
  91.5%
WBC, Within (baseline) - Above (Day 42) Number Analyzed 62 participants 59 participants
3
   4.8%
4
   6.8%
WBC, Above (baseline) - Below (Day 42) Number Analyzed 4 participants 7 participants
0
   0.0%
0
   0.0%
WBC, Above (baseline) - Within (Day 42) Number Analyzed 4 participants 7 participants
1
  25.0%
4
  57.1%
WBC, Above (baseline) - Above (Day 42) Number Analyzed 4 participants 7 participants
3
  75.0%
3
  42.9%
LYM, Unknown (baseline) - Below (Day 42) Number Analyzed 1 participants 0 participants
0
   0.0%
LYM, Unknown (baseline) - Within (Day 42) Number Analyzed 1 participants 0 participants
1
 100.0%
LYM, Unknown (baseline) - Above (Day 42) Number Analyzed 1 participants 0 participants
0
   0.0%
LYM, Below (baseline) - Below (Day 42) Number Analyzed 7 participants 10 participants
4
  57.1%
6
  60.0%
LYM, Below (baseline) - Within (Day 42) Number Analyzed 7 participants 10 participants
2
  28.6%
2
  20.0%
LYM, Below (baseline) - Above (Day 42) Number Analyzed 7 participants 10 participants
1
  14.3%
2
  20.0%
LYM, Within (baseline) - Below (Day 42) Number Analyzed 48 participants 42 participants
7
  14.6%
2
   4.8%
LYM, Within (baseline) - Within (Day 42) Number Analyzed 48 participants 42 participants
38
  79.2%
34
  81.0%
LYM, Within (baseline) - Above (Day 42) Number Analyzed 48 participants 42 participants
3
   6.3%
6
  14.3%
LYM, Above (baseline) - Below (Day 42) Number Analyzed 16 participants 21 participants
0
   0.0%
2
   9.5%
LYM, Above (baseline) - Within (Day 42) Number Analyzed 16 participants 21 participants
5
  31.3%
5
  23.8%
LYM, Above (baseline) - Above (Day 42) Number Analyzed 16 participants 21 participants
11
  68.8%
14
  66.7%
MONO, Unknown (baseline) - Below (Day 42) Number Analyzed 1 participants 0 participants
1
 100.0%
MONO, Unknown (baseline) - Within (Day 42) Number Analyzed 1 participants 0 participants
0
   0.0%
MONO, Unknown (baseline) - Above (Day 42) Number Analyzed 1 participants 0 participants
0
   0.0%
MONO, Below (baseline) - Below (Day 42) Number Analyzed 8 participants 9 participants
4
  50.0%
5
  55.6%
MONO, Below (baseline) - Within (Day 42) Number Analyzed 8 participants 9 participants
4
  50.0%
4
  44.4%
MONO, Below (baseline) - Above (Day 42) Number Analyzed 8 participants 9 participants
0
   0.0%
0
   0.0%
MONO, Within (baseline) - Below (Day 42) Number Analyzed 51 participants 55 participants
3
   5.9%
2
   3.6%
MONO, Within (baseline) - Within (Day 42) Number Analyzed 51 participants 55 participants
42
  82.4%
48
  87.3%
MONO, Within (baseline) - Above (Day 42) Number Analyzed 51 participants 55 participants
6
  11.8%
5
   9.1%
MONO, Above (baseline) - Below (Day 42) Number Analyzed 12 participants 9 participants
0
   0.0%
0
   0.0%
MONO, Above (baseline) - Within (Day 42) Number Analyzed 12 participants 9 participants
6
  50.0%
3
  33.3%
MONO, Above (baseline) - Above (Day 42) Number Analyzed 12 participants 9 participants
6
  50.0%
6
  66.7%
NEU, Unknown (baseline) - Below (Day 42) Number Analyzed 1 participants 0 participants
0
   0.0%
NEU, Unknown (baseline) - Within (Day 42) Number Analyzed 1 participants 0 participants
1
 100.0%
NEU, Unknown (baseline) - Above (Day 42) Number Analyzed 1 participants 0 participants
0
   0.0%
NEU, Below (baseline) - Below (Day 42) Number Analyzed 15 participants 21 participants
9
  60.0%
14
  66.7%
NEU, Below (baseline) - Within (Day 42) Number Analyzed 15 participants 21 participants
6
  40.0%
6
  28.6%
NEU, Below (baseline) - Above (Day 42) Number Analyzed 15 participants 21 participants
0
   0.0%
1
   4.8%
NEU, Within (baseline) - Below (Day 42) Number Analyzed 52 participants 46 participants
4
   7.7%
6
  13.0%
NEU, Within (baseline) - Within (Day 42) Number Analyzed 52 participants 46 participants
41
  78.8%
39
  84.8%
NEU, Within (baseline) - Above (Day 42) Number Analyzed 52 participants 46 participants
7
  13.5%
1
   2.2%
NEU, Above (baseline) - Below (Day 42) Number Analyzed 4 participants 6 participants
0
   0.0%
0
   0.0%
NEU, Above (baseline) - Within (Day 42) Number Analyzed 4 participants 6 participants
3
  75.0%
3
  50.0%
NEU, Above (baseline) - Above (Day 42) Number Analyzed 4 participants 6 participants
1
  25.0%
3
  50.0%
PLA, Unknown (baseline) - Below (Day 42) Number Analyzed 2 participants 0 participants
0
   0.0%
PLA, Unknown (baseline) - Within (Day 42) Number Analyzed 2 participants 0 participants
2
 100.0%
PLA, Unknown (baseline) - Above (Day 42) Number Analyzed 2 participants 0 participants
0
   0.0%
PLA, Below (baseline) - Below (Day 42) Number Analyzed 0 participants 2 participants
0
   0.0%
PLA, Below (baseline) - Within (Day 42) Number Analyzed 0 participants 2 participants
2
 100.0%
PLA, Below (baseline) - Above (Day 42) Number Analyzed 0 participants 2 participants
0
   0.0%
PLA, Within (baseline) - Below (Day 42) Number Analyzed 59 participants 56 participants
0
   0.0%
0
   0.0%
PLA, Within (baseline) - Within (Day 42) Number Analyzed 59 participants 56 participants
51
  86.4%
52
  92.9%
PLA, Within (baseline) - Above (Day 42) Number Analyzed 59 participants 56 participants
8
  13.6%
4
   7.1%
PLA, Above (baseline) - Below (Day 42) Number Analyzed 11 participants 15 participants
0
   0.0%
0
   0.0%
PLA, Above (baseline) - Within (Day 42) Number Analyzed 11 participants 15 participants
4
  36.4%
9
  60.0%
PLA, Above (baseline) - Above (Day 42) Number Analyzed 11 participants 15 participants
7
  63.6%
6
  40.0%
BUN, Unknown (baseline) - Below (Day 42) Number Analyzed 2 participants 1 participants
0
   0.0%
0
   0.0%
BUN, Unknown (baseline) - Within (Day 42) Number Analyzed 2 participants 1 participants
2
 100.0%
1
 100.0%
BUN, Unknown (baseline) - Above (Day 42) Number Analyzed 2 participants 1 participants
0
   0.0%
0
   0.0%
BUN, Below (baseline) - Below (Day 42) Number Analyzed 12 participants 4 participants
4
  33.3%
1
  25.0%
BUN, Below (baseline) - Within (Day 42) Number Analyzed 12 participants 4 participants
8
  66.7%
3
  75.0%
BUN, Below (baseline) - Above (Day 42) Number Analyzed 12 participants 4 participants
0
   0.0%
0
   0.0%
BUN, Within (baseline) - Below (Day 42) Number Analyzed 54 participants 62 participants
2
   3.7%
5
   8.1%
BUN, Within (baseline) - Within (Day 42) Number Analyzed 54 participants 62 participants
50
  92.6%
57
  91.9%
BUN, Within (baseline) - Above (Day 42) Number Analyzed 54 participants 62 participants
2
   3.7%
0
   0.0%
BUN, Above (baseline) - Below (Day 42) Number Analyzed 6 participants 6 participants
0
   0.0%
0
   0.0%
BUN, Above (baseline) - Within (Day 42) Number Analyzed 6 participants 6 participants
6
 100.0%
6
 100.0%
BUN, Above (baseline) - Above (Day 42) Number Analyzed 6 participants 6 participants
0
   0.0%
0
   0.0%
6.Primary Outcome
Title Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
Hide Description The parameters assessed were both biochemical (alanine aminotransferase = ALAT, creatinine = CREA, blood urea nitrogen = BUN) and haematological (basophils = BAS, eosinophils = EOS, red blood cells = RBC, hematocrit = HCT, hemoglobin = HGB, leukocytes [white blood cells] = WBC, lymphocytes = LYM, monocytes = MONO, neutrophils = NEU and platelets = PLA). Abnormal laboratory values at Month 7 were Below, Within and Above normal ranges, as compared to the baseline status of the same parameter, at Day 0 (Unknown, Below, Within and Above normal ranges) [e.g. ALAT Below (baseline) - Within (Month 7) = ALAT with below normal value at baseline and within normal values at Month 7].
Time Frame At Month 7 (i.e. 30 days after the vaccination at Month 6)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study and for whom data were available at the specified time point.
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description:
Healthy female subjects aged between, and including, 4 and 6 years, who received two doses of Cervarix vaccine at Day 0 and Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Healthy female subjects aged between, and including, 4 and 6 years, who received one dose of Priorix vaccine at Day 0 and one dose of Infanrix vaccine at Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Overall Number of Participants Analyzed 74 72
Measure Type: Count of Participants
Unit of Measure: Participants
ALAT, Unknown (baseline) - Below (Month 7) Number Analyzed 2 participants 2 participants
0
   0.0%
0
   0.0%
ALAT, Unknown (baseline) - Within (Month 7) Number Analyzed 2 participants 2 participants
2
 100.0%
2
 100.0%
ALAT, Unknown (baseline) - Above (Month 7) Number Analyzed 2 participants 2 participants
0
   0.0%
0
   0.0%
ALAT, Below (baseline) - Below (Month 7) Number Analyzed 2 participants 1 participants
1
  50.0%
0
   0.0%
ALAT, Below (baseline) - Within (Month 7) Number Analyzed 2 participants 1 participants
1
  50.0%
1
 100.0%
ALAT, Below (baseline) - Above (Month 7) Number Analyzed 2 participants 1 participants
0
   0.0%
0
   0.0%
ALAT, Within (baseline) - Below (Month 7) Number Analyzed 65 participants 62 participants
1
   1.5%
1
   1.6%
ALAT, Within (baseline) - Within (Month 7) Number Analyzed 65 participants 62 participants
64
  98.5%
60
  96.8%
ALAT, Within (baseline) - Above (Month 7) Number Analyzed 65 participants 62 participants
0
   0.0%
1
   1.6%
ALAT, Above (baseline) - Below (Month 7) Number Analyzed 4 participants 7 participants
0
   0.0%
0
   0.0%
ALAT, Above (baseline) - Within (Month 7) Number Analyzed 4 participants 7 participants
3
  75.0%
7
 100.0%
ALAT, Above (baseline) - Above (Month 7) Number Analyzed 4 participants 7 participants
1
  25.0%
0
   0.0%
BAS, Unknown (baseline) - Below (Month 7) Number Analyzed 1 participants 0 participants
0
   0.0%
BAS, Unknown (baseline) - Within (Month 7) Number Analyzed 1 participants 0 participants
1
 100.0%
BAS, Unknown (baseline) - Above (Month 7) Number Analyzed 1 participants 0 participants
0
   0.0%
BAS, Below (baseline) - Below (Month 7) Number Analyzed 0 participants 0 participants
BAS, Below (baseline) - Within (Month 7) Number Analyzed 0 participants 0 participants
BAS, Below (baseline) - Above (Month 7) Number Analyzed 0 participants 0 participants
BAS, Within (baseline) - Below (Month 7) Number Analyzed 73 participants 68 participants
0
   0.0%
0
   0.0%
BAS, Within (baseline) - Within (Month 7) Number Analyzed 73 participants 68 participants
72
  98.6%
67
  98.5%
BAS, Within (baseline) - Above (Month 7) Number Analyzed 73 participants 68 participants
1
   1.4%
1
   1.5%
BAS, Above (baseline) - Below (Month 7) Number Analyzed 0 participants 4 participants
0
   0.0%
BAS, Above (baseline) - Within (Month 7) Number Analyzed 0 participants 4 participants
2
  50.0%
BAS, Above (baseline) - Above (Month 7) Number Analyzed 0 participants 4 participants
2
  50.0%
CREA, Unknown (baseline) - Below (Month 7) Number Analyzed 2 participants 1 participants
1
  50.0%
1
 100.0%
CREA, Unknown (baseline) - Within (Month 7) Number Analyzed 2 participants 1 participants
1
  50.0%
0
   0.0%
CREA, Unknown (baseline) - Above (Month 7) Number Analyzed 2 participants 1 participants
0
   0.0%
0
   0.0%
CREA, Below (baseline) - Below (Month 7) Number Analyzed 29 participants 26 participants
23
  79.3%
21
  80.8%
CREA, Below (baseline) - Within (Month 7) Number Analyzed 29 participants 26 participants
6
  20.7%
5
  19.2%
CREA, Below (baseline) - Above (Month 7) Number Analyzed 29 participants 26 participants
0
   0.0%
0
   0.0%
CREA, Within (baseline) - Below (Month 7) Number Analyzed 42 participants 45 participants
8
  19.0%
9
  20.0%
CREA, Within (baseline) - Within (Month 7) Number Analyzed 42 participants 45 participants
34
  81.0%
36
  80.0%
CREA, Within (baseline) - Above (Month 7) Number Analyzed 42 participants 45 participants
0
   0.0%
0
   0.0%
CREA, Above (baseline) - Below (Month 7) Number Analyzed 0 participants 0 participants
CREA, Above (baseline) - Within (Month 7) Number Analyzed 0 participants 0 participants
CREA, Above (baseline) - Above (Month 7) Number Analyzed 0 participants 0 participants
EOS, Unknown (baseline) - Below (Month 7) Number Analyzed 1 participants 0 participants
0
   0.0%
EOS, Unknown (baseline) - Within (Month 7) Number Analyzed 1 participants 0 participants
1
 100.0%
EOS, Unknown (baseline) - Above (Month 7) Number Analyzed 1 participants 0 participants
0
   0.0%
EOS, Below (baseline) - Below (Month 7) Number Analyzed 1 participants 0 participants
0
   0.0%
EOS, Below (baseline) - Within (Month 7) Number Analyzed 1 participants 0 participants
1
 100.0%
EOS, Below (baseline) - Above (Month 7) Number Analyzed 1 participants 0 participants
0
   0.0%
EOS, Within (baseline) - Below (Month 7) Number Analyzed 51 participants 49 participants
0
   0.0%
1
   2.0%
EOS, Within (baseline) - Within (Month 7) Number Analyzed 51 participants 49 participants
42
  82.4%
38
  77.6%
EOS, Within (baseline) - Above (Month 7) Number Analyzed 51 participants 49 participants
9
  17.6%
10
  20.4%
EOS, Above (baseline) - Below (Month 7) Number Analyzed 21 participants 23 participants
0
   0.0%
0
   0.0%
EOS, Above (baseline) - Within (Month 7) Number Analyzed 21 participants 23 participants
3
  14.3%
10
  43.5%
EOS, Above (baseline) - Above (Month 7) Number Analyzed 21 participants 23 participants
18
  85.7%
13
  56.5%
RBC, Unknown (baseline) - Below (Month 7) Number Analyzed 1 participants 0 participants
0
   0.0%
RBC, Unknown (baseline) - Within (Month 7) Number Analyzed 1 participants 0 participants
1
 100.0%
RBC, Unknown (baseline) - Above (Month 7) Number Analyzed 1 participants 0 participants
0
   0.0%
RBC, Below (baseline) - Below (Month 7) Number Analyzed 5 participants 5 participants
1
  20.0%
2
  40.0%
RBC, Below (baseline) - Within (Month 7) Number Analyzed 5 participants 5 participants
4
  80.0%
3
  60.0%
RBC, Below (baseline) - Above (Month 7) Number Analyzed 5 participants 5 participants
0
   0.0%
0
   0.0%
RBC, Within (baseline) - Below (Month 7) Number Analyzed 68 participants 65 participants
4
   5.9%
4
   6.2%
RBC, Within (baseline) - Within (Month 7) Number Analyzed 68 participants 65 participants
63
  92.6%
61
  93.8%
RBC, Within (baseline) - Above (Month 7) Number Analyzed 68 participants 65 participants
1
   1.5%
0
   0.0%
RBC, Above (baseline) - Below (Month 7) Number Analyzed 0 participants 2 participants
0
   0.0%
RBC, Above (baseline) - Within (Month 7) Number Analyzed 0 participants 2 participants
1
  50.0%
RBC, Above (baseline) - Above (Month 7) Number Analyzed 0 participants 2 participants
1
  50.0%
HCT, Unknown (baseline) - Below (Month 7) Number Analyzed 1 participants 0 participants
0
   0.0%
HCT, Unknown (baseline) - Within (Month 7) Number Analyzed 1 participants 0 participants
0
   0.0%
HCT, Unknown (baseline) - Above (Month 7) Number Analyzed 1 participants 0 participants
1
 100.0%
HCT, Below (baseline) - Below (Month 7) Number Analyzed 26 participants 24 participants
15
  57.7%
15
  62.5%
HCT, Below (baseline) - Within (Month 7) Number Analyzed 26 participants 24 participants
11
  42.3%
9
  37.5%
HCT, Below (baseline) - Above (Month 7) Number Analyzed 26 participants 24 participants
0
   0.0%
0
   0.0%
HCT, Within (baseline) - Below (Month 7) Number Analyzed 44 participants 44 participants
2
   4.5%
4
   9.1%
HCT, Within (baseline) - Within (Month 7) Number Analyzed 44 participants 44 participants
41
  93.2%
40
  90.9%
HCT, Within (baseline) - Above (Month 7) Number Analyzed 44 participants 44 participants
1
   2.3%
0
   0.0%
HCT, Above (baseline) - Below (Month 7) Number Analyzed 3 participants 4 participants
0
   0.0%
0
   0.0%
HCT, Above (baseline) - Within (Month 7) Number Analyzed 3 participants 4 participants
3
 100.0%
4
 100.0%
HCT, Above (baseline) - Above (Month 7) Number Analyzed 3 participants 4 participants
0
   0.0%
0
   0.0%
HGB, Unknown (baseline) - Below (Month 7) Number Analyzed 1 participants 0 participants
0
   0.0%
HGB, Unknown (baseline) - Within (Month 7) Number Analyzed 1 participants 0 participants
0
   0.0%
HGB, Unknown (baseline) - Above (Month 7) Number Analyzed 1 participants 0 participants
1
 100.0%
HGB, Below (baseline) - Below (Month 7) Number Analyzed 21 participants 14 participants
10
  47.6%
7
  50.0%
HGB, Below (baseline) - Within (Month 7) Number Analyzed 21 participants 14 participants
11
  52.4%
7
  50.0%
HGB, Below (baseline) - Above (Month 7) Number Analyzed 21 participants 14 participants
0
   0.0%
0
   0.0%
HGB, Within (baseline) - Below (Month 7) Number Analyzed 47 participants 52 participants
1
   2.1%
7
  13.5%
HGB, Within (baseline) - Within (Month 7) Number Analyzed 47 participants 52 participants
40
  85.1%
44
  84.6%
HGB, Within (baseline) - Above (Month 7) Number Analyzed 47 participants 52 participants
6
  12.8%
1
   1.9%
HGB, Above (baseline) - Below (Month 7) Number Analyzed 5 participants 6 participants
0
   0.0%
0
   0.0%
HGB, Above (baseline) - Within (Month 7) Number Analyzed 5 participants 6 participants
3
  60.0%
5
  83.3%
HGB, Above (baseline) - Above (Month 7) Number Analyzed 5 participants 6 participants
2
  40.0%
1
  16.7%
WBC, Unknown (baseline) - Below (Month 7) Number Analyzed 1 participants 0 participants
0
   0.0%
WBC, Unknown (baseline) - Within (Month 7) Number Analyzed 1 participants 0 participants
1
 100.0%
WBC, Unknown (baseline) - Above (Month 7) Number Analyzed 1 participants 0 participants
0
   0.0%
WBC, Below (baseline) - Below (Month 7) Number Analyzed 5 participants 7 participants
3
  60.0%
4
  57.1%
WBC, Below (baseline) - Within (Month 7) Number Analyzed 5 participants 7 participants
2
  40.0%
3
  42.9%
WBC, Below (baseline) - Above (Month 7) Number Analyzed 5 participants 7 participants
0
   0.0%
0
   0.0%
WBC, Within (baseline) - Below (Month 7) Number Analyzed 63 participants 58 participants
1
   1.6%
7
  12.1%
WBC, Within (baseline) - Within (Month 7) Number Analyzed 63 participants 58 participants
59
  93.7%
48
  82.8%
WBC, Within (baseline) - Above (Month 7) Number Analyzed 63 participants 58 participants
3
   4.8%
3
   5.2%
WBC, Above (baseline) - Below (Month 7) Number Analyzed 5 participants 7 participants
0
   0.0%
0
   0.0%
WBC, Above (baseline) - Within (Month 7) Number Analyzed 5 participants 7 participants
3
  60.0%
5
  71.4%
WBC, Above (baseline) - Above (Month 7) Number Analyzed 5 participants 7 participants
2
  40.0%
2
  28.6%
LYM, Unknown (baseline) - Below (Month 7) Number Analyzed 1 participants 0 participants
0
   0.0%
LYM, Unknown (baseline) - Within (Month 7) Number Analyzed 1 participants 0 participants
1
 100.0%
LYM, Unknown (baseline) - Above (Month 7) Number Analyzed 1 participants 0 participants
0
   0.0%
LYM, Below (baseline) - Below (Month 7) Number Analyzed 7 participants 10 participants
5
  71.4%
6
  60.0%
LYM, Below (baseline) - Within (Month 7) Number Analyzed 7 participants 10 participants
1
  14.3%
3
  30.0%
LYM, Below (baseline) - Above (Month 7) Number Analyzed 7 participants 10 participants
1
  14.3%
1
  10.0%
LYM, Within (baseline) - Below (Month 7) Number Analyzed 49 participants 42 participants
6
  12.2%
5
  11.9%
LYM, Within (baseline) - Within (Month 7) Number Analyzed 49 participants 42 participants
37
  75.5%
36
  85.7%
LYM, Within (baseline) - Above (Month 7) Number Analyzed 49 participants 42 participants
6
  12.2%
1
   2.4%
LYM, Above (baseline) - Below (Month 7) Number Analyzed 17 participants 20 participants
1
   5.9%
1
   5.0%
LYM, Above (baseline) - Within (Month 7) Number Analyzed 17 participants 20 participants
10
  58.8%
8
  40.0%
LYM, Above (baseline) - Above (Month 7) Number Analyzed 17 participants 20 participants
6
  35.3%
11
  55.0%
MONO, Unknown (baseline) - Below (Month 7) Number Analyzed 1 participants 0 participants
1
 100.0%
MONO, Unknown (baseline) - Within (Month 7) Number Analyzed 1 participants 0 participants
0
   0.0%
MONO, Unknown (baseline) - Above (Month 7) Number Analyzed 1 participants 0 participants
0
   0.0%
MONO, Below (baseline) - Below (Month 7) Number Analyzed 8 participants 9 participants
2
  25.0%
4
  44.4%
MONO, Below (baseline) - Within (Month 7) Number Analyzed 8 participants 9 participants
6
  75.0%
4
  44.4%
MONO, Below (baseline) - Above (Month 7) Number Analyzed 8 participants 9 participants
0
   0.0%
1
  11.1%
MONO, Within (baseline) - Below (Month 7) Number Analyzed 53 participants 54 participants
4
   7.5%
3
   5.6%
MONO, Within (baseline) - Within (Month 7) Number Analyzed 53 participants 54 participants
49
  92.5%
51
  94.4%
MONO, Within (baseline) - Above (Month 7) Number Analyzed 53 participants 54 participants
0
   0.0%
0
   0.0%
MONO, Above (baseline) - Below (Month 7) Number Analyzed 12 participants 9 participants
0
   0.0%
0
   0.0%
MONO, Above (baseline) - Within (Month 7) Number Analyzed 12 participants 9 participants
11
  91.7%
7
  77.8%
MONO, Above (baseline) - Above (Month 7) Number Analyzed 12 participants 9 participants
1
   8.3%
2
  22.2%
NEU, Unknown (baseline) - Below (Month 7) Number Analyzed 1 participants 0 participants
0
   0.0%
NEU, Unknown (baseline) - Within (Month 7) Number Analyzed 1 participants 0 participants
1
 100.0%
NEU, Unknown (baseline) - Above (Month 7) Number Analyzed 1 participants 0 participants
0
   0.0%
NEU, Below (baseline) - Below (Month 7) Number Analyzed 16 participants 21 participants
5
  31.3%
10
  47.6%
NEU, Below (baseline) - Within (Month 7) Number Analyzed 16 participants 21 participants
10
  62.5%
10
  47.6%
NEU, Below (baseline) - Above (Month 7) Number Analyzed 16 participants 21 participants
1
   6.3%
1
   4.8%
NEU, Within (baseline) - Below (Month 7) Number Analyzed 53 participants 45 participants
4
   7.5%
4
   8.9%
NEU, Within (baseline) - Within (Month 7) Number Analyzed 53 participants 45 participants
43
  81.1%
35
  77.8%
NEU, Within (baseline) - Above (Month 7) Number Analyzed 53 participants 45 participants
6
  11.3%
6
  13.3%
NEU, Above (baseline) - Below (Month 7) Number Analyzed 4 participants 6 participants
0
   0.0%
1
  16.7%
NEU, Above (baseline) - Within (Month 7) Number Analyzed 4 participants 6 participants
2
  50.0%
2
  33.3%
NEU, Above (baseline) - Above (Month 7) Number Analyzed 4 participants 6 participants
2
  50.0%
3
  50.0%
PLA, Unknown (baseline) - Below (Month 7) Number Analyzed 2 participants 0 participants
0
   0.0%
PLA, Unknown (baseline) - Within (Month 7) Number Analyzed 2 participants 0 participants
2
 100.0%
PLA, Unknown (baseline) - Above (Month 7) Number Analyzed 2 participants 0 participants
0
   0.0%
PLA, Below (baseline) - Below (Month 7) Number Analyzed 0 participants 2 participants
0
   0.0%
PLA, Below (baseline) - Within (Month 7) Number Analyzed 0 participants 2 participants
2
 100.0%
PLA, Below (baseline) - Above (Month 7) Number Analyzed 0 participants 2 participants
0
   0.0%
PLA, Within (baseline) - Below (Month 7) Number Analyzed 60 participants 55 participants
0
   0.0%
0
   0.0%
PLA, Within (baseline) - Within (Month 7) Number Analyzed 60 participants 55 participants
56
  93.3%
53
  96.4%
PLA, Within (baseline) - Above (Month 7) Number Analyzed 60 participants 55 participants
4
   6.7%
2
   3.6%
PLA, Above (baseline) - Below (Month 7) Number Analyzed 12 participants 15 participants
0
   0.0%
0
   0.0%
PLA, Above (baseline) - Within (Month 7) Number Analyzed 12 participants 15 participants
7
  58.3%
8
  53.3%
PLA, Above (baseline) - Above (Month 7) Number Analyzed 12 participants 15 participants
5
  41.7%
7
  46.7%
BUN, Unknown (baseline) - Below (Month 7) Number Analyzed 2 participants 1 participants
0
   0.0%
0
   0.0%
BUN, Unknown (baseline) - Within (Month 7) Number Analyzed 2 participants 1 participants
2
 100.0%
1
 100.0%
BUN, Unknown (baseline) - Above (Month 7) Number Analyzed 2 participants 1 participants
0
   0.0%
0
   0.0%
BUN, Below (baseline) - Below (Month 7) Number Analyzed 12 participants 4 participants
5
  41.7%
0
   0.0%
BUN, Below (baseline) - Within (Month 7) Number Analyzed 12 participants 4 participants
7
  58.3%
4
 100.0%
BUN, Below (baseline) - Above (Month 7) Number Analyzed 12 participants 4 participants
0
   0.0%
0
   0.0%
BUN, Within (baseline) - Below (Month 7) Number Analyzed 52 participants 61 participants
4
   7.7%
10
  16.4%
BUN, Within (baseline) - Within (Month 7) Number Analyzed 52 participants 61 participants
47
  90.4%
51
  83.6%
BUN, Within (baseline) - Above (Month 7) Number Analyzed 52 participants 61 participants
1
   1.9%
0
   0.0%
BUN, Above (baseline) - Below (Month 7) Number Analyzed 6 participants 6 participants
0
   0.0%
0
   0.0%
BUN, Above (baseline) - Within (Month 7) Number Analyzed 6 participants 6 participants
6
 100.0%
6
 100.0%
BUN, Above (baseline) - Above (Month 7) Number Analyzed 6 participants 6 participants
0
   0.0%
0
   0.0%
7.Primary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs) From Day 0 up to Month 7
Hide Description SAEs assessed included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.
Time Frame From Day 0 up to Month 7 (i.e. from first vaccination at Day 0 up to 30 days after the second vaccination at Month 6)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study and for whom data were available.
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description:
Healthy female subjects aged between, and including, 4 and 6 years, who received two doses of Cervarix vaccine at Day 0 and Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Healthy female subjects aged between, and including, 4 and 6 years, who received one dose of Priorix vaccine at Day 0 and one dose of Infanrix vaccine at Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Overall Number of Participants Analyzed 74 74
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2
   2.7%
8.Primary Outcome
Title Number of Subjects With AEs and SAEs Leading to Withdrawal From Day 0 up to Month 7
Hide Description The number of subjects with AEs and SAEs leading to premature discontinuation of the study was assessed.
Time Frame From Day 0 up to Month 7 (i.e. from first vaccination at Day 0 up to 30 days after the second vaccination at Month 6)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study and for whom data were available.
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description:
Healthy female subjects aged between, and including, 4 and 6 years, who received two doses of Cervarix vaccine at Day 0 and Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Healthy female subjects aged between, and including, 4 and 6 years, who received one dose of Priorix vaccine at Day 0 and one dose of Infanrix vaccine at Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Overall Number of Participants Analyzed 74 74
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
9.Primary Outcome
Title Number of Subjects With Potential Immune-mediated Diseases (pIMDs) From Day 0 up to Month 7
Hide Description pIMDs were defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which might or might not have an autoimmune aetiology.
Time Frame From Day 0 up to Month 7 (i.e. from first vaccination at Day 0 up to 30 days after the second vaccination at Month 6)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study and for whom data were available.
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description:
Healthy female subjects aged between, and including, 4 and 6 years, who received two doses of Cervarix vaccine at Day 0 and Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Healthy female subjects aged between, and including, 4 and 6 years, who received one dose of Priorix vaccine at Day 0 and one dose of Infanrix vaccine at Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Overall Number of Participants Analyzed 74 74
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
10.Primary Outcome
Title Number of Subjects With Medically Significant Conditions (MSCs) From Day 0 up to Month 7
Hide Description MSCs were defined as AEs prompting emergency room or physician visits that were not related to common diseases or were not routine visits for physical examination or vaccination and as SAEs that were not related to common diseases. Common diseases included: upper respiratory tract infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections and injury.
Time Frame From Day 0 up to Month 7 (i.e. from first vaccination at Day 0 up to 30 days after the second vaccination at Month 6)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study and for whom data were available.
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description:
Healthy female subjects aged between, and including, 4 and 6 years, who received two doses of Cervarix vaccine at Day 0 and Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Healthy female subjects aged between, and including, 4 and 6 years, who received one dose of Priorix vaccine at Day 0 and one dose of Infanrix vaccine at Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Overall Number of Participants Analyzed 74 74
Measure Type: Count of Participants
Unit of Measure: Participants
37
  50.0%
28
  37.8%
11.Primary Outcome
Title Number of Seroconverted Subjects for HPV-16 and HPV-18 Antigens at Month 7
Hide Description Seroconversion was defined as a titer greater than or equal to the cut-off value in the serum of seronegative subjects, defined as subjects who had an antibody titer below the cut-off value before vaccination. Titers were measured by Enzyme Linked Immunosorbent Assay (ELISA) and the cut-offs were 19 ELISA Units per milliliter (EU/mL) for HPV-16 and 18 EU/mL for HPV-18.
Time Frame At Month 7 (i.e. 30 days after the vaccination at Month 6)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity at Month 7, which included all eligible subjects (i.e. meeting all eligibility criteria, complying with the procedures defined in the protocol) for whom data concerning immunogenicity outcome measures were available at the specified time point.
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description:
Healthy female subjects aged between, and including, 4 and 6 years, who received two doses of Cervarix vaccine at Day 0 and Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Healthy female subjects aged between, and including, 4 and 6 years, who received one dose of Priorix vaccine at Day 0 and one dose of Infanrix vaccine at Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Overall Number of Participants Analyzed 64 44
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-HPV-16 Number Analyzed 64 participants 43 participants
64
 100.0%
1
   2.3%
Anti-HPV-18 Number Analyzed 62 participants 44 participants
62
 100.0%
1
   2.3%
12.Primary Outcome
Title Anti-HPV-16/18 Antibody Concentrations at Month 7
Hide Description Antibody concentrations were assessed by ELISA and expressed as geometric mean concentrations (GMCs) in EU/mL.
Time Frame At Month 7 (i.e. 30 days after the vaccination at Month 6)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity at Month 7, which included all eligible subjects (i.e. meeting all eligibility criteria, complying with the procedures defined in the protocol) for whom data concerning immunogenicity outcome measures were available at the specified time point.
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description:
Healthy female subjects aged between, and including, 4 and 6 years, who received two doses of Cervarix vaccine at Day 0 and Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Healthy female subjects aged between, and including, 4 and 6 years, who received one dose of Priorix vaccine at Day 0 and one dose of Infanrix vaccine at Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Overall Number of Participants Analyzed 64 44
Geometric Mean (95% Confidence Interval)
Unit of Measure: EU/mL
Anti-HPV-16 Number Analyzed 64 participants 43 participants
20080.0
(16831.8 to 23954.9)
10.4
(8.7 to 12.5)
Anti-HPV-18 Number Analyzed 62 participants 44 participants
10621.8
(8865.3 to 12726.3)
9.6
(8.4 to 11.1)
13.Secondary Outcome
Title Number of Seroconverted Subjects for HPV-16 and HPV-18 Antigens at Month 7, Month 12 (for Both Groups) and at Month 18, Month 24 and Month 36 (Only for Cervarix Group)
Hide Description Seroconversion was defined as a titer greater than or equal to the cut-off value in the serum of seronegative subjects, defined as subjects who had an antibody titer below the cut-off value before vaccination. Titers were measured by ELISA and the cut-offs were 19 EU/mL for HPV-16 and 18 EU/mL for HPV-18. Note: Month 7 data are also reported in the Primary outcome measure.
Time Frame At Month 7, Month 12 (for both groups) and at Month 18, Month 24 and Month 36 (only for Cervarix Group)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects for whom data concerning immunogenicity outcome measures were available at the specified time point. Priorix+Infanrix Group data were only tabulated for the time points up to Month 12, since the follow-up phase for this group ended at Month 12.
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description:
Healthy female subjects aged between, and including, 4 and 6 years, who received two doses of Cervarix vaccine at Day 0 and Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Healthy female subjects aged between, and including, 4 and 6 years, who received one dose of Priorix vaccine at Day 0 and one dose of Infanrix vaccine at Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Overall Number of Participants Analyzed 67 49
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-HPV-16, Month 7 Number Analyzed 64 participants 43 participants
64
 100.0%
1
   2.3%
Anti-HPV-16, Month 12 Number Analyzed 65 participants 48 participants
65
 100.0%
1
   2.1%
Anti-HPV-16, Month 18 Number Analyzed 66 participants 0 participants
66
 100.0%
Anti-HPV-16, Month 24 Number Analyzed 67 participants 0 participants
67
 100.0%
Anti-HPV-16, Month 36 Number Analyzed 67 participants 0 participants
67
 100.0%
Anti-HPV-18, Month 7 Number Analyzed 62 participants 44 participants
62
 100.0%
1
   2.3%
Anti-HPV-18, Month 12 Number Analyzed 63 participants 49 participants
63
 100.0%
0
   0.0%
Anti-HPV-18, Month 18 Number Analyzed 64 participants 0 participants
64
 100.0%
Anti-HPV-18, Month 24 Number Analyzed 65 participants 0 participants
65
 100.0%
Anti-HPV-18, Month 36 Number Analyzed 65 participants 0 participants
65
 100.0%
14.Secondary Outcome
Title Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations at Month 7, Month 12 (for Both Groups) and at Month 18, Month 24 and Month 36 (Only for Cervarix Group)
Hide Description Antibody concentrations were assessed by ELISA and expressed as GMCs in EU/mL. Note: Month 7 data are also reported in the Primary outcome measure.
Time Frame At Month 7, Month 12 (for both groups) and at Month 18, Month 24 and Month 36 (only for Cervarix Group)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects for whom data concerning immunogenicity outcome measures were available at the specified time point. Priorix+Infanrix Group data were only tabulated for the time points up to Month 12, since the follow-up phase for this group ended at Month 12.
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description:
Healthy female subjects aged between, and including, 4 and 6 years, who received two doses of Cervarix vaccine at Day 0 and Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Healthy female subjects aged between, and including, 4 and 6 years, who received one dose of Priorix vaccine at Day 0 and one dose of Infanrix vaccine at Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Overall Number of Participants Analyzed 67 49
Geometric Mean (95% Confidence Interval)
Unit of Measure: EU/mL
Anti-HPV-16, Month 7 Number Analyzed 64 participants 43 participants
20080.0
(16831.8 to 23954.9)
10.4
(8.7 to 12.5)
Anti-HPV-16, Month 12 Number Analyzed 65 participants 48 participants
3246.5
(2617.4 to 4026.8)
9.7
(9.3 to 10.2)
Anti-HPV-16, Month 18 Number Analyzed 66 participants 0 participants
2800.5
(2325.8 to 3372.0)
Anti-HPV-16, Month 24 Number Analyzed 67 participants 0 participants
1951.9
(1553.7 to 2452.2)
Anti-HPV-16, Month 36 Number Analyzed 67 participants 0 participants
1680.6
(1384.2 to 2040.4)
Anti-HPV-18, Month 7 Number Analyzed 62 participants 44 participants
10621.8
(8865.3 to 12726.3)
9.6
(8.4 to 11.1)
Anti-HPV-18, Month 12 Number Analyzed 63 participants 49 participants
1216.6
(953.1 to 1553.0)
9.0
(9.0 to 9.0)
Anti-HPV-18, Month 18 Number Analyzed 64 participants 0 participants
802.9
(632.4 to 1019.5)
Anti-HPV-18, Month 24 Number Analyzed 65 participants 0 participants
766.6
(603.3 to 974.2)
Anti-HPV-18, Month 36 Number Analyzed 65 participants 0 participants
536.4
(420.6 to 684.0)
15.Secondary Outcome
Title Number of Seropositive Subjects for Measles Antigen
Hide Description A seropositive subject was defined as a subject whose anti-measles antibody titer was equal to or above (≥) 150 milli-International Units per milliliter (mIU/mL), as assessed by ELISA.
Time Frame At Day 0 and Day 42 (i.e. 42 days after the vaccination at Day 0)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all eligible subjects (i.e. meeting all eligibility criteria, complying with the procedures defined in the protocol) for whom data concerning immunogenicity outcome measures were available at Day 42.
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description:
Healthy female subjects aged between, and including, 4 and 6 years, who received two doses of Cervarix vaccine at Day 0 and Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Healthy female subjects aged between, and including, 4 and 6 years, who received one dose of Priorix vaccine at Day 0 and one dose of Infanrix vaccine at Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Overall Number of Participants Analyzed 68 58
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-measles, Day 0 Number Analyzed 66 participants 55 participants
65
  98.5%
50
  90.9%
Anti-measles, Day 42 Number Analyzed 68 participants 58 participants
67
  98.5%
58
 100.0%
16.Secondary Outcome
Title Anti-measles Antibody Concentrations
Hide Description Anti-measles antibody concentrations were measured by ELISA, expressed as GMCs, in mIU/mL. The cut-off of the assay was an anti-measles antibody concentration ≥ 150 mIU/mL.
Time Frame At Day 0 and Day 42 (i.e. 42 days after the vaccination at Day 0)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all eligible subjects (i.e. meeting all eligibility criteria, complying with the procedures defined in the protocol) for whom data concerning immunogenicity outcome measures were available at Day 42.
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description:
Healthy female subjects aged between, and including, 4 and 6 years, who received two doses of Cervarix vaccine at Day 0 and Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Healthy female subjects aged between, and including, 4 and 6 years, who received one dose of Priorix vaccine at Day 0 and one dose of Infanrix vaccine at Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Overall Number of Participants Analyzed 68 58
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
Anti-measles, Day 0 Number Analyzed 66 participants 55 participants
1029.8
(852.8 to 1243.6)
694.8
(524.0 to 921.3)
Anti-measles, Day 42 Number Analyzed 68 participants 58 participants
897.1
(748.8 to 1074.8)
2512.3
(2140.3 to 2949.0)
17.Secondary Outcome
Title Number of Seropositive Subjects for Mumps Antigen
Hide Description A seropositive subject was defined as a subject whose anti-mumps antibody titer was equal to or above (≥) 231 U/mL, as assessed by ELISA.
Time Frame At Day 0 and Day 42 (i.e. 42 days after the vaccination at Day 0)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all eligible subjects (i.e. meeting all eligibility criteria, complying with the procedures defined in the protocol) for whom data concerning immunogenicity outcome measures were available at Day 42.
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description:
Healthy female subjects aged between, and including, 4 and 6 years, who received two doses of Cervarix vaccine at Day 0 and Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Healthy female subjects aged between, and including, 4 and 6 years, who received one dose of Priorix vaccine at Day 0 and one dose of Infanrix vaccine at Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Overall Number of Participants Analyzed 68 58
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-mumps, Day 0 Number Analyzed 66 participants 55 participants
64
  97.0%
50
  90.9%
Anti-mumps, Day 42 Number Analyzed 68 participants 58 participants
66
  97.1%
57
  98.3%
18.Secondary Outcome
Title Anti-mumps Antibody Concentrations
Hide Description Anti-mumps antibody concentrations were measured by ELISA, expressed as GMCs, in U/mL. The cut-off of the assay was an anti-mumps antibody concentration ≥ 231 U/mL.
Time Frame At Day 0 and Day 42 (i.e. 42 days after the vaccination at Day 0)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all eligible subjects (i.e. meeting all eligibility criteria, complying with the procedures defined in the protocol) for whom data concerning immunogenicity outcome measures were available at Day 42.
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description:
Healthy female subjects aged between, and including, 4 and 6 years, who received two doses of Cervarix vaccine at Day 0 and Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Healthy female subjects aged between, and including, 4 and 6 years, who received one dose of Priorix vaccine at Day 0 and one dose of Infanrix vaccine at Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Overall Number of Participants Analyzed 68 58
Geometric Mean (95% Confidence Interval)
Unit of Measure: U/mL
Anti-mumps, Day 0 Number Analyzed 66 participants 55 participants
3613.7
(2742.1 to 4762.4)
2142.6
(1492.7 to 3075.5)
Anti-mumps, Day 42 Number Analyzed 68 participants 58 participants
3594.1
(2749.1 to 4698.8)
7001.1
(5414.9 to 9052.1)
19.Secondary Outcome
Title Number of Seropositive Subjects for Rubella Antigen
Hide Description A seropositive subject was defined as a subject whose anti-rubella antibody titer was ≥ 4 IU/mL, as assessed by ELISA.
Time Frame At Day 0 and Day 42 (i.e. 42 days after the vaccination at Day 0)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all eligible subjects (i.e. meeting all eligibility criteria, complying with the procedures defined in the protocol) for whom data concerning immunogenicity outcome measures were available at Day 42.
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description:
Healthy female subjects aged between, and including, 4 and 6 years, who received two doses of Cervarix vaccine at Day 0 and Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Healthy female subjects aged between, and including, 4 and 6 years, who received one dose of Priorix vaccine at Day 0 and one dose of Infanrix vaccine at Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Overall Number of Participants Analyzed 68 58
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-rubella, Day 0 Number Analyzed 66 participants 55 participants
66
 100.0%
53
  96.4%
Anti-rubella, Day 42 Number Analyzed 68 participants 58 participants
68
 100.0%
58
 100.0%
20.Secondary Outcome
Title Anti-rubella Antibody Concentrations
Hide Description Anti-rubella antibody concentrations were measured by ELISA, expressed as GMCs, in IU/mL. The cut-off of the assay was an anti-rubella antibody concentration ≥ 4 IU/mL.
Time Frame At Day 0 and Day 42 (i.e. 42 days after the vaccination at Day 0)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all eligible subjects (i.e. meeting all eligibility criteria, complying with the procedures defined in the protocol) for whom data concerning immunogenicity outcome measures were available at Day 42.
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description:
Healthy female subjects aged between, and including, 4 and 6 years, who received two doses of Cervarix vaccine at Day 0 and Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Healthy female subjects aged between, and including, 4 and 6 years, who received one dose of Priorix vaccine at Day 0 and one dose of Infanrix vaccine at Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Overall Number of Participants Analyzed 68 58
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
Anti-rubella, Day 0 Number Analyzed 66 participants 55 participants
82.0
(69.4 to 96.8)
48.9
(36.3 to 65.9)
Anti-rubella, Day 42 Number Analyzed 68 participants 58 participants
79.3
(67.3 to 93.6)
124.2
(107.0 to 144.2)
21.Secondary Outcome
Title Number of Seroprotected Subjects Against Diphtheria and Tetanus Antigens
Hide Description

A seroprotected subject against diphtheria antigen was defined as a subject with an anti-diphtheria (anti-D) antibody concentration ≥ the cut-off of 0.1 IU/mL, as measured by ELISA.

A seroprotected subject against tetanus antigen was defined as a subject with an anti-tetanus (anti-T) antibody concentration ≥ the cut-off of 0.1 IU/mL, as measured by ELISA.
Time Frame At Month 7 (i.e. 30 days after the vaccination at Month 6)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity at Month 7, which included all eligible subjects (i.e. meeting all eligibility criteria, complying with the procedures defined in the protocol) for whom data concerning immunogenicity outcome measures were available at Month 7.
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description:
Healthy female subjects aged between, and including, 4 and 6 years, who received two doses of Cervarix vaccine at Day 0 and Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Healthy female subjects aged between, and including, 4 and 6 years, who received one dose of Priorix vaccine at Day 0 and one dose of Infanrix vaccine at Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Overall Number of Participants Analyzed 65 47
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-D
45
  69.2%
47
 100.0%
Anti-T
60
  92.3%
47
 100.0%
22.Secondary Outcome
Title Number of Subjects With pIMDs From Day 0 up to Month 12
Hide Description pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which might or might not have an autoimmune aetiology.
Time Frame From Day 0 up to Month 12 (i.e. from first vaccination at Day 0 up to 6 months after the second vaccination at Month 6)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study and for whom data were available.
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description:
Healthy female subjects aged between, and including, 4 and 6 years, who received two doses of Cervarix vaccine at Day 0 and Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Healthy female subjects aged between, and including, 4 and 6 years, who received one dose of Priorix vaccine at Day 0 and one dose of Infanrix vaccine at Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Overall Number of Participants Analyzed 74 74
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
23.Secondary Outcome
Title Number of Subjects With MSCs From Day 0 up to Month 12
Hide Description MSCs were defined as AEs prompting emergency room or physician visits that were not related to common diseases or were not routine visits for physical examination or vaccination and as SAEs that were not related to common diseases. Common diseases included: upper respiratory tract infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections and injury.
Time Frame From Day 0 up to Month 12 (i.e. from first vaccination at Day 0 up to 6 months after the second vaccination at Month 6)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study and for whom data were available.
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description:
Healthy female subjects aged between, and including, 4 and 6 years, who received two doses of Cervarix vaccine at Day 0 and Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Healthy female subjects aged between, and including, 4 and 6 years, who received one dose of Priorix vaccine at Day 0 and one dose of Infanrix vaccine at Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Overall Number of Participants Analyzed 74 74
Measure Type: Count of Participants
Unit of Measure: Participants
38
  51.4%
29
  39.2%
24.Secondary Outcome
Title Number of Subjects With SAEs From Day 0 up to Month 12
Hide Description SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.
Time Frame From Day 0 up to Month 12 (i.e. from first vaccination at Day 0 up to 6 months after the second vaccination at Month 6)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study and for whom data were available.
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description:
Healthy female subjects aged between, and including, 4 and 6 years, who received two doses of Cervarix vaccine at Day 0 and Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Healthy female subjects aged between, and including, 4 and 6 years, who received one dose of Priorix vaccine at Day 0 and one dose of Infanrix vaccine at Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Overall Number of Participants Analyzed 74 74
Measure Type: Count of Participants
Unit of Measure: Participants
1
   1.4%
2
   2.7%
25.Secondary Outcome
Title Number of Subjects With SAEs Related to the Investigational Products or Any Fatal SAE
Hide Description SAEs assessed included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.
Time Frame Throughout the study period (i.e. from Day 0 up to Month 12 for Priorix + Infanrix Group and from Day 0 up to Month 36 for Cervarix Group)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study and for whom data were available.
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description:
Healthy female subjects aged between, and including, 4 and 6 years, who received two doses of Cervarix vaccine at Day 0 and Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Healthy female subjects aged between, and including, 4 and 6 years, who received one dose of Priorix vaccine at Day 0 and one dose of Infanrix vaccine at Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Overall Number of Participants Analyzed 74 74
Measure Type: Count of Participants
Unit of Measure: Participants
Related SAE(s)
0
   0.0%
0
   0.0%
Fatal SAE(s)
0
   0.0%
0
   0.0%
26.Secondary Outcome
Title Number of Subjects With AEs/SAEs Leading to Withdrawal Throughout the Study Period
Hide Description The number of subjects with AEs and SAEs leading to premature discontinuation of study was assessed.
Time Frame Throughout the study period (i.e from Day 0 up to Month 12 for Priorix + Infanrix Group and from Day 0 up to Month 36 for Cervarix Group)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study and for whom data were available.
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description:
Healthy female subjects aged between, and including, 4 and 6 years, who received two doses of Cervarix vaccine at Day 0 and Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Healthy female subjects aged between, and including, 4 and 6 years, who received one dose of Priorix vaccine at Day 0 and one dose of Infanrix vaccine at Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Overall Number of Participants Analyzed 74 74
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
27.Secondary Outcome
Title Number of Subjects Reporting the Intake of Concomitant Medication During the 43-day Period Following the Vaccination at Day 0
Hide Description Concomitant medication taken at least once during the 43-day period (i.e. from the day of vaccination up to 42 subsequent days) following the vaccination at Day 0 included: any type of medicines, antipyretics, prophylactic antipyretics and antibiotics.
Time Frame During the 43-day period (i.e. from the day of vaccination up to 42 subsequent days) following the vaccination at Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study and for whom data were available.
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description:
Healthy female subjects aged between, and including, 4 and 6 years, who received two doses of Cervarix vaccine at Day 0 and Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Healthy female subjects aged between, and including, 4 and 6 years, who received one dose of Priorix vaccine at Day 0 and one dose of Infanrix vaccine at Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Overall Number of Participants Analyzed 74 74
Measure Type: Count of Participants
Unit of Measure: Participants
Any medication
45
  60.8%
36
  48.6%
Any antipyretic
29
  39.2%
24
  32.4%
Prophylactic antipyretic
0
   0.0%
0
   0.0%
Any antibiotic
18
  24.3%
10
  13.5%
28.Secondary Outcome
Title Number of Subjects Reporting the Intake of Concomitant Medication During the 30-day Period Following the Vaccination at Month 6
Hide Description Concomitant medication taken at least once during the 30-day period (i.e. from the day of vaccination up to 29 subsequent days) following the vaccination at Month 6 included: any type of medicines, antipyretics, prophylactic antipyretics and antibiotics.
Time Frame During the 30-day period (i.e. from the day of vaccination up to 29 subsequent days) following the vaccination at Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study and for whom data were available. Out of the 74 subjects present in the initial Priorix + Infanrix Group, 3 did not receive the second vaccination and were hence excluded from this analysis.
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description:
Healthy female subjects aged between, and including, 4 and 6 years, who received two doses of Cervarix vaccine at Day 0 and Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Healthy female subjects aged between, and including, 4 and 6 years, who received one dose of Priorix vaccine at Day 0 and one dose of Infanrix vaccine at Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Overall Number of Participants Analyzed 74 71
Measure Type: Count of Participants
Unit of Measure: Participants
Any medication
19
  25.7%
23
  32.4%
Any antipyretic
10
  13.5%
8
  11.3%
Prophylactic antipyretic
0
   0.0%
0
   0.0%
Any antibiotic
6
   8.1%
6
   8.5%
29.Secondary Outcome
Title Percentage of Subjects Completing the Vaccination Schedule in Both Groups
Hide Description The percentage of subjects who received the specified total number of doses (dose 1, dose 2, any dose) is reported.
Time Frame From Day 0 up to Month 6 (i.e. from first vaccination at Day 0 up to the second vaccination at Month 6)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study and for whom data were available.
Arm/Group Title Cervarix Group Priorix + Infanrix Group
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Healthy female subjects aged between, and including, 4 and 6 years, who received two doses of Cervarix vaccine at Day 0 and Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Healthy female subjects aged between, and including, 4 and 6 years, who received one dose of Priorix vaccine at Day 0 and one dose of Infanrix vaccine at Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Overall Number of Participants Analyzed 74 74
Measure Type: Number
Unit of Measure: Percentage of subjects
Subjects receiving only 1 dose 0 4.1
Subjects receiving 2 doses 100 95.9
Subjects receiving at least 1 dose 100 100
30.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related to Vaccination Solicited Fever, Measles/Rubella-like Rash, Parotid Gland Swelling and Signs of Meningism Including Febrile Convulsion
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Measles/Rubella-like rash: presence of macules, discoloured small patches or spots of the skin, neither elevated nor depressed below the skin's surface and/or papules, raised bumps on the skin usually below (<) 1 cm in diameter.

Parotid/salivary gland swelling: swelling/tenderness in the mandibular/submandibular region.

Suspected signs of meningism including febrile convulsions: febrile convulsions or any other neurological signs or symptoms indicative of meningism.

Any = occurrence of any solicited symptom regardless of their intensity grade or relationship to vaccination. Any fever = axillary temperature equal to or above (≥) 37.5°C. Grade 3 AE = AE which prevented normal, everyday activities. Grade 3 measles/rubella-like rash = more than 150 lesions. Grade 3 parotid gland swelling = swelling with accompanying general symptoms. Grade 3 fever = axillary temperature above (>) 39.0°C. Related = any symptom assessed by the investigator as causally related to the vaccination.
Time Frame During the 43-day period (i.e. from the day of vaccination up to 42 subsequent days) following the vaccination at Day 0
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Hide Analysis Population Description
The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study and for whom data were available.
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description:
Healthy female subjects aged between, and including, 4 and 6 years, who received two doses of Cervarix vaccine at Day 0 and Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Healthy female subjects aged between, and including, 4 and 6 years, who received one dose of Priorix vaccine at Day 0 and one dose of Infanrix vaccine at Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
Overall Number of Participants Analyzed 74 74
Measure Type: Count of Participants
Unit of Measure: Participants
Any Fever
30
  40.5%
27
  36.5%
Grade 3 Fever
7
   9.5%
2
   2.7%
Related Fever
6
   8.1%
7
   9.5%
Any Measles/Rubella-like rash
1
   1.4%
1
   1.4%
Grade 3 Measles/Rubella-like rash
0
   0.0%
0
   0.0%
Related Measles/Rubella-like rash
1
   1.4%
1
   1.4%
Any Parotid gland swelling
0
   0.0%
0
   0.0%
Grade 3 Parotid gland swelling
0
   0.0%
0
   0.0%
Related Parotid gland swelling
0
   0.0%
0
   0.0%
Any Signs of meningism
0
   0.0%
1
   1.4%
Grade 3 Signs of meningism
0
   0.0%
0
   0.0%
Related Signs of meningism
0
   0.0%
1
   1.4%
Time Frame Solicited AEs: During the 7-day period after each vaccination. Unsolicited AEs: During the 43-day period after the vaccination at Day 0 and during the 30-day period after the vaccination at Month 6. SAEs: From Day 0 up to Month 12.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description Healthy female subjects aged between, and including, 4 and 6 years, who received two doses of Cervarix vaccine at Day 0 and Month 6, administered intramuscularly in the deltoid muscle of the left upper arm. Healthy female subjects aged between, and including, 4 and 6 years, who received one dose of Priorix vaccine at Day 0 and one dose of Infanrix vaccine at Month 6, administered intramuscularly in the deltoid muscle of the left upper arm.
All-Cause Mortality
Cervarix Group Priorix + Infanrix Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/74 (0.00%)      0/74 (0.00%)    
Hide Serious Adverse Events
Cervarix Group Priorix + Infanrix Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/74 (1.35%)      2/74 (2.70%)    
Infections and infestations     
Abscess limb † 1  0/74 (0.00%)  0 1/74 (1.35%)  1
Gastroenteritis † 1  1/74 (1.35%)  1 1/74 (1.35%)  1
Metabolism and nutrition disorders     
Dehydration † 1  0/74 (0.00%)  0 1/74 (1.35%)  1
1
Term from vocabulary, MedDRA 20.1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cervarix Group Priorix + Infanrix Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   70/74 (94.59%)      65/74 (87.84%)    
Blood and lymphatic system disorders     
Anaemia † 1  0/74 (0.00%)  0 1/74 (1.35%)  1
Lymphadenopathy † 1  0/74 (0.00%)  0 1/74 (1.35%)  1
Ear and labyrinth disorders     
Ear pain † 1  1/74 (1.35%)  1 0/74 (0.00%)  0
Eye disorders     
Conjunctivitis allergic † 1  1/74 (1.35%)  1 0/74 (0.00%)  0
Eye allergy † 1  1/74 (1.35%)  1 0/74 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain upper † 1  1/74 (1.35%)  1 1/74 (1.35%)  1
Anal fissure † 1  1/74 (1.35%)  1 0/74 (0.00%)  0
Constipation † 1  1/74 (1.35%)  1 0/74 (0.00%)  0
Diarrhoea † 1  0/74 (0.00%)  0 2/74 (2.70%)  2
Dyspepsia † 1  0/74 (0.00%)  0 1/74 (1.35%)  1
Food poisoning † 1  1/74 (1.35%)  1 0/74 (0.00%)  0
Gastrointestinal disorder † 1  11/74 (14.86%)  11 16/74 (21.62%)  21
Nausea † 1  0/74 (0.00%)  0 1/74 (1.35%)  1
Vomiting † 1  0/74 (0.00%)  0 1/74 (1.35%)  1
General disorders     
Pain † 1  54/74 (72.97%)  88 40/74 (54.05%)  51
Swelling † 1  19/74 (25.68%)  22 18/74 (24.32%)  21
Fatigue † 1  15/74 (20.27%)  17 10/74 (13.51%)  14
Influenza like illness † 1  0/74 (0.00%)  0 1/74 (1.35%)  1
Pyrexia † 1  36/74 (48.65%)  39 33/74 (44.59%)  39
Infections and infestations     
Acarodermatitis † 1  2/74 (2.70%)  2 0/74 (0.00%)  0
Bronchitis † 1  1/74 (1.35%)  1 0/74 (0.00%)  0
Conjunctivitis † 1  1/74 (1.35%)  1 0/74 (0.00%)  0
Ear infection † 1  0/74 (0.00%)  0 1/74 (1.35%)  1
Gastroenteritis † 1  5/74 (6.76%)  5 7/74 (9.46%)  7
Giardiasis † 1  1/74 (1.35%)  1 0/74 (0.00%)  0
Gingival abscess † 1  0/74 (0.00%)  0 1/74 (1.35%)  1
Hordeolum † 1  0/74 (0.00%)  0 1/74 (1.35%)  1
Impetigo † 1  3/74 (4.05%)  3 0/74 (0.00%)  0
Infection parasitic † 1  1/74 (1.35%)  1 2/74 (2.70%)  2
Influenza † 1  1/74 (1.35%)  1 0/74 (0.00%)  0
Lice infestation † 1  0/74 (0.00%)  0 1/74 (1.35%)  1
Nasopharyngitis † 1  24/74 (32.43%)  28 27/74 (36.49%)  33
Otitis externa † 1  1/74 (1.35%)  1 0/74 (0.00%)  0
Otitis media † 1  0/74 (0.00%)  0 1/74 (1.35%)  1
Otitis media acute † 1  2/74 (2.70%)  2 1/74 (1.35%)  1
Pharyngitis † 1  6/74 (8.11%)  6 4/74 (5.41%)  4
Pneumonia † 1  0/74 (0.00%)  0 1/74 (1.35%)  1
Pyoderma † 1  0/74 (0.00%)  0 1/74 (1.35%)  1
Rhinitis † 1  1/74 (1.35%)  1 2/74 (2.70%)  2
Sinusitis † 1  4/74 (5.41%)  4 0/74 (0.00%)  0
Tinea pedis † 1  1/74 (1.35%)  1 0/74 (0.00%)  0
Tooth abscess † 1  2/74 (2.70%)  2 1/74 (1.35%)  1
Urinary tract infection † 1  0/74 (0.00%)  0 1/74 (1.35%)  1
Viral infection † 1  2/74 (2.70%)  2 2/74 (2.70%)  3
Vulvovaginitis † 1  1/74 (1.35%)  1 1/74 (1.35%)  1
Injury, poisoning and procedural complications     
Burns second degree † 1  1/74 (1.35%)  1 0/74 (0.00%)  0
Clavicle fracture † 1  1/74 (1.35%)  1 0/74 (0.00%)  0
Contusion † 1  0/74 (0.00%)  0 1/74 (1.35%)  1
Head injury † 1  1/74 (1.35%)  1 1/74 (1.35%)  1
Mouth injury † 1  1/74 (1.35%)  1 0/74 (0.00%)  0
Multiple injuries † 1  1/74 (1.35%)  1 0/74 (0.00%)  0
Stab wound † 1  0/74 (0.00%)  0 1/74 (1.35%)  1
Metabolism and nutrition disorders     
Decreased appetite † 1  21/74 (28.38%)  24 13/74 (17.57%)  15
Musculoskeletal and connective tissue disorders     
Arthralgia † 1  13/74 (17.57%)  15 11/74 (14.86%)  16
Myalgia † 1  21/74 (28.38%)  26 14/74 (18.92%)  20
Neck pain † 1  1/74 (1.35%)  1 0/74 (0.00%)  0
Pain in extremity † 1  1/74 (1.35%)  1 1/74 (1.35%)  1
Nervous system disorders     
Headache † 1  18/74 (24.32%)  25 25/74 (33.78%)  35
Meningism † 1  0/74 (0.00%)  0 1/74 (1.35%)  1
Somnolence † 1  16/74 (21.62%)  23 15/74 (20.27%)  16
Psychiatric disorders     
Irritability † 1  22/74 (29.73%)  31 19/74 (25.68%)  24
Respiratory, thoracic and mediastinal disorders     
Adenoidal hypertrophy † 1  3/74 (4.05%)  3 0/74 (0.00%)  0
Asthma † 1  2/74 (2.70%)  2 3/74 (4.05%)  3
Asthmatic crisis † 1  0/74 (0.00%)  0 1/74 (1.35%)  1
Bronchial hyperreactivity † 1  1/74 (1.35%)  1 0/74 (0.00%)  0
Cough † 1  2/74 (2.70%)  3 1/74 (1.35%)  1
Epistaxis † 1  0/74 (0.00%)  0 1/74 (1.35%)  1
Nasal congestion † 1  1/74 (1.35%)  1 0/74 (0.00%)  0
Oropharyngeal pain † 1  0/74 (0.00%)  0 1/74 (1.35%)  1
Rhinitis allergic † 1  1/74 (1.35%)  2 1/74 (1.35%)  1
Rhinorrhoea † 1  0/74 (0.00%)  0 1/74 (1.35%)  1
Vasomotor rhinitis † 1  1/74 (1.35%)  1 1/74 (1.35%)  1
Skin and subcutaneous tissue disorders     
Alopecia † 1  0/74 (0.00%)  0 1/74 (1.35%)  1
Dermatitis † 1  3/74 (4.05%)  4 1/74 (1.35%)  1
Dermatitis atopic † 1  1/74 (1.35%)  1 0/74 (0.00%)  0
Erythema † 1  18/74 (24.32%)  22 18/74 (24.32%)  19
Rash † 1  6/74 (8.11%)  6 5/74 (6.76%)  5
Rash morbilliform † 1  1/74 (1.35%)  1 1/74 (1.35%)  1
Skin lesion † 1  0/74 (0.00%)  0 1/74 (1.35%)  1
Urticaria † 1  10/74 (13.51%)  10 7/74 (9.46%)  7
1
Term from vocabulary, MedDRA 20.1
†
Indicates events were collected by systematic assessment
[Not Specified]
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
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Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
EMail: GSKClinicalSupportHD@gsk.com
Publications:
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01627561    
Other Study ID Numbers: 115887
2011-005604-15 ( EudraCT Number )
First Submitted: June 14, 2012
First Posted: June 26, 2012
Results First Submitted: April 23, 2015
Results First Posted: May 8, 2015
Last Update Posted: April 10, 2020