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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 : February 12, 2018
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 149
Recruitment Details  
Pre-assignment Details Out of the 149 subjects who were enrolled for the study, only 148 were registered, hence 148 started the study.
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6 Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
Period Title: Overall Study
Started 74 74
Completed 74 71
Not Completed 0 3
Reason Not Completed
Migrated/moved from study area             0             1
Withdrawal by Subject             0             2
Arm/Group Title Cervarix Group Priorix + Infanrix Group Total
Hide Arm/Group Description Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6 Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6 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  (0.48) 4.4  (0.52) 4.35  (0.50)
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%
1.Primary Outcome
Title Number of Subjects With Any, Grade 3 and Related 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 = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed.
Time Frame During the 7-day period (Days 0-6) following each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description:
Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
Overall Number of Participants Analyzed 74 74
Measure Type: Number
Unit of Measure: Subjects
Any Pain Dose 1 (N=74,74) 45 15
Grade 3 Pain Dose 1 (N=74,74) 2 0
Any Redness Dose 1 (N=74,74) 10 7
Grade 3 Redness Dose 1 (N=74,74) 1 0
Any Swelling Dose 1 (N=74,74) 6 6
Grade 3 Swelling Dose 1 (N=74,74) 1 0
Any Pain Dose 2 (N=72,71) 43 36
Grade 3 Pain Dose 2 (N=72,71) 2 1
Any Redness Dose 2 (N=72,71) 12 12
Grade 3 Redness Dose 2 (N=72,71) 0 4
Any Swelling Dose 2 (N=72,71) 16 15
Grade 3 Swelling Dose 2 (N=72,71) 3 7
Any Pain Across doses (N=74,74) 54 40
Grade 3 Pain Across doses (N=74,74) 4 1
Any Redness Across doses (N=74,74) 18 18
Grade 3 Redness Across doses (N=74,74) 1 4
Any Swelling Across doses (N=74,74) 19 18
Grade 3 Swelling Across doses (N=74,74) 4 7
2.Primary Outcome
Title Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Hide Description Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache, myalgia, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time Frame During the 7-day period (Days 0-6) following each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description:
Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
Overall Number of Participants Analyzed 74 74
Measure Type: Number
Unit of Measure: Subjects
Any Arthralgia Dose 1 (N=74,74) 5 8
Grade 3 Arthralgia Dose 1 (N=74,74) 0 0
Related Arthralgia Dose 1 (N=74,74) 4 8
Any Drowsiness Dose 1 (N=74,74) 14 7
Grade 3 Drowsiness Dose 1 (N=74,74) 3 0
Related Drowsiness Dose 1 (N=74,74) 12 7
Any Fatigue Dose 1 (N=74,74) 8 7
Grade 3 Fatigue Dose 1 (N=74,74) 0 0
Related Fatigue Dose 1 (N=74,74) 7 7
Any Fever Dose 1 (N=74,74) 6 8
Grade 3 Fever Dose 1 (N=74,74) 1 0
Related Fever Dose 1 (N=74,74) 3 5
Any Gastrointestinal Dose 1 (N=74,74) 7 12
Grade 3 Gastrointestinal Dose 1 (N=74,74) 0 0
Related Gastrointestinal Dose 1 (N=74,74) 5 10
Any Headache Dose 1 (N=74,74) 11 19
Grade 3 Headache Dose 1 (N=74,74) 0 1
Related Headache Dose 1 (N=74,74) 9 16
Any Irritability Dose 1 (N=74,74) 13 7
Grade 3 Irritability Dose 1 (N=74,74) 1 0
Related Irritability Dose 1 (N=74,74) 12 7
Any Loss of appetite Dose 1 (N=74,74) 15 7
Grade 3 Loss of appetite Dose 1 (N=74,74) 0 0
Related Loss of appetite Dose 1 (N=74,74) 13 7
Any Myalgia Dose 1 (N=74,74) 13 9
Grade 3 Myalgia Dose 1 (N=74,74) 0 0
Related Myalgia Dose 1 (N=74,74) 13 9
Any Rash Dose 1 (N=74,74) 3 1
Grade 3 Rash Dose 1 (N=74,74) 0 0
Related Rash Dose 1 (N=74,74) 2 1
Any Urticaria Dose 1 (N=74,74) 5 3
Grade 3 Urticaria Dose 1 (N=74,74) 0 0
Related Urticaria Dose 1 (N=74,74) 4 2
Any Arthralgia Dose 2 (N=72,71) 10 8
Grade 3 Arthralgia Dose 2 (N=72,71) 0 0
Related Arthralgia Dose 2 (N=72,71) 9 8
Any Drowsiness Dose 2 (N=72,71) 9 9
Grade 3 Drowsiness Dose 2 (N=72,71) 0 0
Related Drowsiness Dose 2 (N=72,71) 9 9
Any Fatigue Dose 2 (N=72,71) 9 7
Grade 3 Fatigue Dose 2 (N=72,71) 0 0
Related Fatigue Dose 2 (N=72,71) 8 7
Any Fever Dose 2 (N=72,71) 7 12
Grade 3 Fever Dose 2 (N=72,71) 0 0
Related Fever Dose 2 (N=72,71) 6 9
Any Gastrointestinal Dose 2 (N=72,71) 4 9
Grade 3 Gastrointestinal Dose 2 (N=72,71) 0 0
Related Gastrointestinal Dose 2 (N=72,71) 2 8
Any Headache Dose 2 (N=72,71) 12 13
Grade 3 Headache Dose 2 (N=72,71) 0 0
Related Headache Dose 2 (N=72,71) 12 12
Any Irritability Dose 2 (N=72,71) 18 17
Grade 3 Irritability Dose 2 (N=72,71) 0 0
Related Irritability Dose 2 (N=72,71) 18 17
Any Loss of appetite Dose 2 (N=72,71) 9 8
Grade 3 Loss of appetite Dose 2 (N=72,71) 1 1
Related Loss of appetite Dose 2 (N=72,71) 8 8
Any Myalgia Dose 2 (N=72,71) 13 11
Grade 3 Myalgia Dose 2 (N=72,71) 0 0
Related Myalgia Dose 2 (N=72,71) 12 11
Any Rash Dose 2 (N=72,71) 3 4
Grade 3 Rash Dose 2 (N=72,71) 0 0
Related Rash Dose 2 (N=72,71) 3 3
Any Urticaria Dose 2 (N=72,71) 5 4
Grade 3 Urticaria Dose 2 (N=72,71) 0 0
Related Urticaria Dose 2 (N=72,71) 4 3
Any Arthralgia Across doses (N=74,74) 13 11
Grade 3 Arthralgia Across doses (N=74,74) 0 0
Related Arthralgia Across doses (N=74,74) 12 11
Any Drowsiness Across doses (N=74,74) 16 15
Grade 3 Drowsiness Across doses (N=74,74) 3 0
Related Drowsiness Across doses (N=74,74) 15 15
Any Fatigue Across doses (N=74,74) 15 10
Grade 3 Fatigue Across doses (N=74,74) 0 0
Related Fatigue Across doses (N=74,74) 13 10
Any Fever Across doses (N=74,74) 12 17
Grade 3 Fever Across doses (N=74,74) 1 0
Related Fever Across doses (N=74,74) 8 13
Any Gastrointestinal Across doses (N=74,74) 11 16
Grade 3 Gastrointestinal Across doses (N=74,74) 0 0
Related Gastrointestinal Across doses (N=74,74) 7 15
Any Headache Across doses (N=74,74) 18 25
Grade 3 Headache Across doses (N=74,74) 0 1
Related Headache Across doses (N=74,74) 16 22
Any Irritability Across doses (N=74,74) 22 19
Grade 3 Irritability Across doses (N=74,74) 1 0
Related Irritability Across doses (N=74,74) 22 19
Any Loss of appetite Across doses (N=74,74) 21 13
Grade 3 Loss of appetite Across doses (N=74,74) 1 1
Related Loss of appetite Across doses (N=74,74) 18 13
Any Myalgia Across doses (N=74,74) 21 14
Grade 3 Myalgia Across doses (N=74,74) 0 0
Related Myalgia Across doses (N=74,74) 21 14
Any Rash Across doses (N=74,74) 6 5
Grade 3 Rash Across doses (N=74,74) 0 0
Related Rash Across doses (N=74,74) 5 4
Any Urticaria Across doses (N=74,74) 10 7
Grade 3 Urticaria Across doses (N=74,74) 0 0
Related Urticaria Across doses (N=74,74) 8 5
3.Primary Outcome
Title Number of Subjects With Unsolicited Any, Grade 3 and Related Adverse Events (AEs).
Hide Description An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time Frame During the 43-day period (Days 0-42) post vaccination Dose 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description:
Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
Overall Number of Participants Analyzed 74 74
Measure Type: Number
Unit of Measure: Subjects
Any AEs 40 40
Grade 3 AEs 3 2
Related AEs 1 5
4.Primary Outcome
Title Number of Subjects With Unsolicited Any, Grade 3 and Related Adverse Events (AEs).
Hide Description An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time Frame During the 30-day period (Days 0-29) post vaccination Dose 2 at Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Note: Out of the 74 subjects present in the initial Priorix + Infanrix Group, 3 did not receive the second vaccination and were hence excluded from the TVc.
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description:
Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
Overall Number of Participants Analyzed 74 71
Measure Type: Number
Unit of Measure: Subjects
Any AEs 18 13
Grade 3 AEs 0 0
Related AEs 1 1
5.Primary Outcome
Title Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters.
Hide Description The parameters assessed were both biochemical (alanine aminotransferase = ALAT, creatinine = CREA, urea nitrogen = BUN) and haematological (basophils = BAS, eosinophils = EOS, red blood cells = RBC, hematocrit = HCT, hemoglobin, leukocytes [white blood cells] = WBC, lymphocytes, monocytes, neutrophils and platelets). Results were split into 2 outcomes due to the table size.
Time Frame 42 days post dose 1 (PRE) and at 30 days post dose 2 (POST)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects (i.e. subjects who received at least one dose of vaccine in this study) for whom data were available.
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description:
Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
Overall Number of Participants Analyzed 72 69
Measure Type: Number
Unit of Measure: Subjects
ALAT, PRE Unknown Unknown [N=2;2] 0 0
ALAT, PRE Unknown Below [N=2;2] 0 0
ALAT, PRE Unknown Within [N=2;2] 2 2
ALAT, PRE Unknown Above [N=2;2] 0 0
ALAT, PRE Below Unknown [N=2;1] 0 0
ALAT, PRE Below Below [N=2;1] 1 0
ALAT, PRE Below Within [N=2;1] 1 1
ALAT, PRE Below Above [N=2;1] 0 0
ALAT, PRE Within Unknown [N=67;64] 0 0
ALAT, PRE Within Below [N=67;64] 0 0
ALAT, PRE Within Within [N=67;64] 64 62
ALAT, PRE Within Above [N=67;64] 3 2
ALAT, PRE Above Unknown [N=3;5] 0 0
ALAT, PRE Above Below [N=3;5] 0 0
ALAT, PRE Above Within [N=3;5] 1 3
ALAT, PRE Above Above [N=3;5] 2 2
ALAT, POST Unknown Unknown [N=2;2] 0 0
ALAT, POST Unknown Below [N=2;2] 0 0
ALAT, POST Unknown Within [N=2;2] 2 2
ALAT, POST Unknown Above [N=2;2] 0 0
ALAT, POST Below Unknown [N=2;1] 0 0
ALAT, POST Below Below [N=2;1] 1 0
ALAT, POST Below Within [N=2;1] 1 1
ALAT, POST Below Above [N=2;1] 0 0
ALAT, POST Within Unknown [N=66;64] 0 0
ALAT, POST Within Below [N=66;64] 2 2
ALAT, POST Within Within [N=66;64] 64 61
ALAT, POST Within Above [N=66;64] 0 1
ALAT, POST Above Unknown [N=3;5] 0 0
ALAT, POST Above Below [N=3;5] 0 0
ALAT, POST Above Within [N=3;5] 2 5
ALAT, POST Above Above [N=3;5] 1 0
BAS, PRE Unknown Unknown [N=2;0] 0 NA [1] 
BAS, PRE Unknown Below [N=2;0] 0 NA [1] 
BAS, PRE Unknown Within [N=2;0] 2 NA [1] 
BAS, PRE Unknown Above [N=2;0] 0 NA [1] 
BAS, PRE Below Unknown [N=0;0] NA [1]  NA [1] 
BAS, PRE Below Below [N=0;0] NA [1]  NA [1] 
BAS, PRE Below Within [N=0;0] NA [1]  NA [1] 
BAS, PRE Below Above [N=0;0] NA [1]  NA [1] 
BAS, PRE Within Unknown [N=70;69] 0 0
BAS, PRE Within Below [N=70;69] 0 0
BAS, PRE Within Within [N=70;69] 70 69
BAS, PRE Within Above [N=70;69] 0 0
BAS, PRE Above Unknown [N=0;4] NA [1]  0
BAS, PRE Above Below [N=0;4] NA [1]  0
BAS, PRE Above Within [N=0;4] NA [1]  4
BAS, PRE Above Above [N=0;4] NA [1]  0
BAS, POST Unknown Unknown [N=2;0] 0 NA [1] 
BAS, POST Unknown Below [N=2;0] 0 NA [1] 
BAS, POST Unknown Within [N=2;0] 2 NA [1] 
BAS, POST Unknown Above [N=2;0] 0 NA [1] 
BAS, POST Below Unknown [N=0;0] NA [1]  NA [1] 
BAS, POST Below Below [N=0;0] NA [1]  NA [1] 
BAS, POST Below Within [N=0;0] NA [1]  NA [1] 
BAS, POST Below Above [N=0;0] NA [1]  NA [1] 
BAS, POST Within Unknown [N=72;68] 0 0
BAS, POST Within Below [N=72;68] 0 0
BAS, POST Within Within [N=72;68] 71 67
BAS, POST Within Above [N=72;68] 1 1
BAS, POST Above Unknown [N=0;4] NA [1]  0
BAS, POST Above Below [N=0;4] NA [1]  0
BAS, POST Above Within [N=0;4] NA [1]  2
BAS, POST Above Above [N=0;4] NA [1]  2
CREA, PRE Unknown Unknown [N=2;1] 0 0
CREA, PRE Unknown Below [N=2;1] 0 0
CREA, PRE Unknown Within [N=2;1] 2 1
CREA, PRE Unknown Above [N=2;1] 0 0
CREA, PRE Below Unknown [N=27;22] 0 0
CREA, PRE Below Below [N=27;22] 20 15
CREA, PRE Below Within [N=27;22] 7 7
CREA, PRE Below Above [N=27;22] 0 0
CREA, PRE Within Unknown [N=45;49] 0 1
CREA, PRE Within Below [N=45;49] 7 12
CREA, PRE Within Within [N=45;49] 38 36
CREA, PRE Within Above [N=45;49] 0 0
CREA, PRE Above Unknown [N=0;1] NA [1]  0
CREA, PRE Above Below [N=0;1] NA [1]  0
CREA, PRE Above Within [N=0;1] NA [1]  1
CREA, PRE Above Above [N=0;1] NA [1]  0
CREA, POST Unknown Unknown [N=2;1] 0 0
CREA, POST Unknown Below [N=2;1] 1 0
CREA, POST Unknown Within [N=2;1] 1 1
CREA, POST Unknown Above [N=2;1] 0 0
CREA, POST Below Unknown [N=26;22] 0 0
CREA, POST Below Below [N=26;22] 20 18
CREA, POST Below Within [N=26;22] 6 4
CREA, POST Below Above [N=26;22] 0 0
CREA, POST Within Unknown [N=45;48] 0 1
CREA, POST Within Below [N=45;48] 11 11
CREA, POST Within Within [N=45;48] 34 36
CREA, POST Within Above [N=45;48] 0 0
CREA, POST Above Unknown [N=0;1] NA [1]  0
CREA, POST Above Below [N=0;1] NA [1]  1
CREA, POST Above Within [N=0;1] NA [1]  0
CREA, POST Above Above [N=0;1] NA [1]  0
EOS, PRE Unknown Unknown [N=2;0] 0 NA [1] 
EOS, PRE Unknown Below [N=2;0] 0 NA [1] 
EOS, PRE Unknown Within [N=2;0] 2 NA [1] 
EOS, PRE Unknown Above [N=2;0] 0 NA [1] 
EOS, PRE Below Unknown [N=1;0] 0 NA [1] 
EOS, PRE Below Below [N=1;0] 0 NA [1] 
EOS, PRE Below Within [N=1;0] 1 NA [1] 
EOS, PRE Below Above [N=1;0] 0 NA [1] 
EOS, PRE Within Unknown [N=49;50] 0 0
EOS, PRE Within Below [N=49;50] 1 1
EOS, PRE Within Within [N=49;50] 41 38
EOS, PRE Within Above [N=49;50] 7 11
EOS, PRE Above Unknown [N=20;23] 0 0
EOS, PRE Above Below [N=20;23] 0 1
EOS, PRE Above Within [N=20;23] 3 10
EOS, PRE Above Above [N=20;23] 17 12
EOS, POST Unknown Unknown [N=2;0] 0 NA [1] 
EOS, POST Unknown Below [N=2;0] 0 NA [1] 
EOS, POST Unknown Within [N=2;0] 2 NA [1] 
EOS, POST Unknown Above [N=2;0] 0 NA [1] 
EOS, POST Below Unknown [N=1;0] 0 NA [1] 
EOS, POST Below Below [N=1;0] 0 NA [1] 
EOS, POST Below Within [N=1;0] 1 NA [1] 
EOS, POST Below Above [N=1;0] 0 NA [1] 
EOS, POST Within Unknown [N=51;49] 0 0
EOS, POST Within Below [N=51;49] 0 1
EOS, POST Within Within [N=51;49] 42 35
EOS, POST Within Above [N=51;49] 9 13
EOS, POST Above Unknown [N=20;23] 0 0
EOS, POST Above Below [N=20;23] 0 0
EOS, POST Above Within [N=20;23] 2 10
EOS, POST Above Above [N=20;23] 18 13
RBC, PRE Unknown Unknown [N=2;0] 0 NA [1] 
RBC, PRE Unknown Below [N=2;0] 0 NA [1] 
RBC, PRE Unknown Within [N=2;0] 2 NA [1] 
RBC, PRE Unknown Above [N=2;0] 0 NA [1] 
RBC, PRE Below Unknown [N=4;4] 0 0
RBC, PRE Below Below [N=4;4] 0 0
RBC, PRE Below Within [N=4;4] 4 4
RBC, PRE Below Above [N=4;4] 0 0
RBC, PRE Within Unknown [N=66;66] 0 0
RBC, PRE Within Below [N=66;66] 3 2
RBC, PRE Within Within [N=66;66] 61 63
RBC, PRE Within Above [N=66;66] 2 1
RBC, PRE Above Unknown [N=0;3] NA [1]  0
RBC, PRE Above Below [N=0;3] NA [1]  0
RBC, PRE Above Within [N=0;3] NA [1]  2
RBC, PRE Above Above [N=0;3] NA [1]  1
RBC, POST Unknown Unknown [N=2;0] 0 NA [1] 
RBC, POST Unknown Below [N=2;0] 0 NA [1] 
RBC, POST Unknown Within [N=2;0] 2 NA [1] 
RBC, POST Unknown Above [N=2;0] 0 NA [1] 
RBC, POST Below Unknown [N=4;4] 0 0
RBC, POST Below Below [N=4;4] 0 2
RBC, POST Below Within [N=4;4] 4 2
RBC, POST Below Above [N=4;4] 0 0
RBC, POST Within Unknown [N=68;65] 0 0
RBC, POST Within Below [N=68;65] 2 2
RBC, POST Within Within [N=68;65] 65 63
RBC, POST Within Above [N=68;65] 1 0
RBC, POST Above Unknown [N=0;3] NA [1]  0
RBC, POST Above Below [N=0;3] NA [1]  0
RBC, POST Above Within [N=0;3] NA [1]  2
RBC, POST Above Above [N=0;3] NA [1]  1
HCT, PRE Unknown Unknown [N=2;0] 0 NA [1] 
HCT, PRE Unknown Below [N=2;0] 0 NA [1] 
HCT, PRE Unknown Within [N=2;0] 2 NA [1] 
HCT, PRE Unknown Above [N=2;0] 0 NA [1] 
HCT, PRE Below Unknown [N=19;21] 0 0
HCT, PRE Below Below [N=19;21] 8 12
HCT, PRE Below Within [N=19;21] 11 8
HCT, PRE Below Above [N=19;21] 0 1
HCT, PRE Within Unknown [N=48;48] 0 0
HCT, PRE Within Below [N=48;48] 5 1
HCT, PRE Within Within [N=48;48] 41 42
HCT, PRE Within Above [N=48;48] 2 5
HCT, PRE Above Unknown [N=3;4] 0 0
HCT, PRE Above Below [N=3;4] 0 0
HCT, PRE Above Within [N=3;4] 2 4
HCT, PRE Above Above [N=3;4] 1 0
HCT, POST Unknown Unknown [N=2;0] 0 NA [1] 
HCT, POST Unknown Below [N=2;0] 0 NA [1] 
HCT, POST Unknown Within [N=2;0] 1 NA [1] 
HCT, POST Unknown Above [N=2;0] 1 NA [1] 
HCT, POST Below Unknown [N=20;21] 0 0
HCT, POST Below Below [N=20;21] 5 10
HCT, POST Below Within [N=20;21] 15 11
HCT, POST Below Above [N=20;21] 0 0
HCT, POST Within Unknown [N=49;47] 0 0
HCT, POST Within Below [N=49;47] 3 3
HCT, POST Within Within [N=49;47] 45 44
HCT, POST Within Above [N=49;47] 1 0
HCT, POST Above Unknown [N=3;4] 0 0
HCT, POST Above Below [N=3;4] 0 0
HCT, POST Above Within [N=3;4] 3 4
HCT, POST Above Above [N=3;4] 0 0
Hemoglobin, PRE Unknown Unknown [N=2;0] 0 NA [1] 
Hemoglobin, PRE Unknown Below [N=2;0] 0 NA [1] 
Hemoglobin, PRE Unknown Within [N=2;0] 1 NA [1] 
Hemoglobin, PRE Unknown Above [N=2;0] 1 NA [1] 
Hemoglobin, PRE Below Unknown [N=15;11] 0 0
Hemoglobin, PRE Below Below [N=15;11] 7 2
Hemoglobin, PRE Below Within [N=15;11] 8 9
Hemoglobin, PRE Below Above [N=15;11] 0 0
Hemoglobin, PRE Within Unknown [N=50;56] 0 0
Hemoglobin, PRE Within Below [N=50;56] 3 6
Hemoglobin, PRE Within Within [N=50;56] 43 46
Hemoglobin, PRE Within Above [N=50;56] 4 4
Hemoglobin, PRE Above Unknown [N=5;6] 0 0
Hemoglobin, PRE Above Below [N=5;6] 0 0
Hemoglobin, PRE Above Within [N=5;6] 3 5
Hemoglobin, PRE Above Above [N=5;6] 2 1
Hemoglobin, POST Unknown Unknown [N=2;0] 0 NA [1] 
Hemoglobin, POST Unknown Below [N=2;0] 0 NA [1] 
Hemoglobin, POST Unknown Within [N=2;0] 1 NA [1] 
Hemoglobin, POST Unknown Above [N=2;0] 1 NA [1] 
Hemoglobin, POST Below Unknown [N=16;11] 0 0
Hemoglobin, POST Below Below [N=16;11] 1 2
Hemoglobin, POST Below Within [N=16;11] 15 9
Hemoglobin, POST Below Above [N=16;11] 0 0
Hemoglobin, POST Within Unknown [N=51;55] 0 0
Hemoglobin, POST Within Below [N=51;55] 1 4
Hemoglobin, POST Within Within [N=51;55] 44 50
Hemoglobin, POST Within Above [N=51;55] 6 1
Hemoglobin, POST Above Unknown [N=5;6] 0 0
Hemoglobin, POST Above Below [N=5;6] 0 0
Hemoglobin, POST Above Within [N=5;6] 3 5
Hemoglobin, POST Above Above [N=5;6] 2 1
WBC, PRE Unknown Unknown [N=2;0] 0 NA [1] 
WBC, PRE Unknown Below [N=2;0] 0 NA [1] 
WBC, PRE Unknown Within [N=2;0] 1 NA [1] 
WBC, PRE Unknown Above [N=2;0] 1 NA [1] 
WBC, PRE Below Unknown [N=5;7] 0 0
WBC, PRE Below Below [N=5;7] 1 5
WBC, PRE Below Within [N=5;7] 3 1
WBC, PRE Below Above [N=5;7] 1 1
WBC, PRE Within Unknown [N=62;61] 0 0
WBC, PRE Within Below [N=62;61] 3 1
WBC, PRE Within Within [N=62;61] 56 57
WBC, PRE Within Above [N=62;61] 3 3
WBC, PRE Above Unknown [N=3;5] 0 0
WBC, PRE Above Below [N=3;5] 0 0
WBC, PRE Above Within [N=3;5] 1 3
WBC, PRE Above Above [N=3;5] 2 2
WBC, POST Unknown Unknown [N=2;0] 0 NA [1] 
WBC, POST Unknown Below [N=2;0] 0 NA [1] 
WBC, POST Unknown Within [N=2;0] 2 NA [1] 
WBC, POST Unknown Above [N=2;0] 0 NA [1] 
WBC, POST Below Unknown [N=5;7] 0 0
WBC, POST Below Below [N=5;7] 3 4
WBC, POST Below Within [N=5;7] 2 3
WBC, POST Below Above [N=5;7] 0 0
WBC, POST Within Unknown [N=63;60] 0 0
WBC, POST Within Below [N=63;60] 1 7
WBC, POST Within Within [N=63;60] 60 50
WBC, POST Within Above [N=63;60] 2 3
WBC, POST Above Unknown [N=4;5] 0 0
WBC, POST Above Below [N=4;5] 0 0
WBC, POST Above Within [N=4;5] 2 4
WBC, POST Above Above [N=4;5] 2 1
Lymphocytes, PRE Unknown Unknown [N=2;0] 0 NA [1] 
Lymphocytes, PRE Unknown Below [N=2;0] 0 NA [1] 
Lymphocytes, PRE Unknown Within [N=2;0] 1 NA [1] 
Lymphocytes, PRE Unknown Above [N=2;0] 1 NA [1] 
Lymphocytes, PRE Below Unknown [N=7;10] 0 0
Lymphocytes, PRE Below Below [N=7;10] 4 6
Lymphocytes, PRE Below Within [N=7;10] 2 2
Lymphocytes, PRE Below Above [N=7;10] 1 2
Lymphocytes, PRE Within Unknown [N=48;42] 0 0
Lymphocytes, PRE Within Below [N=48;42] 7 2
Lymphocytes, PRE Within Within [N=48;42] 38 34
Lymphocytes, PRE Within Above [N=48;42] 3 6
Lymphocytes, PRE Above Unknown [N=15;21] 0 0
Lymphocytes, PRE Above Below [N=15;21] 0 2
Lymphocytes, PRE Above Within [N=15;21] 6 5
Lymphocytes, PRE Above Above [N=15;21] 9 14
Lymphocytes, POST Unknown Unknown [N=2;0] 0 NA [1] 
Lymphocytes, POST Unknown Below [N=2;0] 0 NA [1] 
Lymphocytes, POST Unknown Within [N=2;0] 2 NA [1] 
Lymphocytes, POST Unknown Above [N=2;0] 0 NA [1] 
Lymphocytes, POST Below Unknown [N=7;10] 0 0
Lymphocytes, POST Below Below [N=7;10] 6 6
Lymphocytes, POST Below Within [N=7;10] 1 4
Lymphocytes, POST Below Above [N=7;10] 0 0
Lymphocytes, POST Within Unknown [N=49;42] 0 0
Lymphocytes, POST Within Below [N=49;42] 6 5
Lymphocytes, POST Within Within [N=49;42] 38 37
Lymphocytes, POST Within Above [N=49;42] 5 0
Lymphocytes, POST Above Unknown [N=16;20] 0 0
Lymphocytes, POST Above Below [N=16;20] 0 1
Lymphocytes, POST Above Within [N=16;20] 16 15
Lymphocytes, POST Above Above [N=16;20] 0 4
Monocytes, PRE Unknown Unknown [N=2;0] 0 NA [1] 
Monocytes, PRE Unknown Below [N=2;0] 1 NA [1] 
Monocytes, PRE Unknown Within [N=2;0] 1 NA [1] 
Monocytes, PRE Unknown Above [N=2;0] 0 NA [1] 
Monocytes, PRE Below Unknown [N=7;9] 0 0
Monocytes, PRE Below Below [N=7;9] 4 5
Monocytes, PRE Below Within [N=7;9] 3 4
Monocytes, PRE Below Above [N=7;9] 0 0
Monocytes, PRE Within Unknown [N=51;55] 0 0
Monocytes, PRE Within Below [N=51;55] 3 2
Monocytes, PRE Within Within [N=51;55] 42 48
Monocytes, PRE Within Above [N=51;55] 6 5
Monocytes, PRE Above Unknown [N=12;9] 0 0
Monocytes, PRE Above Below [N=12;9] 0 0
Monocytes, PRE Above Within [N=12;9] 6 3
Monocytes, PRE Above Above [N=12;9] 6 6
Monocytes, POST Unknown Unknown [N=2;0] 0 NA [1] 
Monocytes, POST Unknown Below [N=2;0] 1 NA [1] 
Monocytes, POST Unknown Within [N=2;0] 1 NA [1] 
Monocytes, POST Unknown Above [N=2;0] 0 NA [1] 
Monocytes, POST Below Unknown [N=7;9] 0 0
Monocytes, POST Below Below [N=7;9] 2 4
Monocytes, POST Below Within [N=7;9] 5 4
Monocytes, POST Below Above [N=7;9] 0 1
Monocytes, POST Within Unknown [N=53;54] 0 0
Monocytes, POST Within Below [N=53;54] 4 3
Monocytes, POST Within Within [N=53;54] 49 51
Monocytes, POST Within Above [N=53;54] 0 0
Monocytes, POST Above Unknown [N=12;9] 0 0
Monocytes, POST Above Below [N=12;9] 0 0
Monocytes, POST Above Within [N=12;9] 12 7
Monocytes, POST Above Above [N=12;9] 0 2
Neutrophils, PRE Unknown Unknown [N=2;0] 0 NA [1] 
Neutrophils, PRE Unknown Below [N=2;0] 1 NA [1] 
Neutrophils, PRE Unknown Within [N=2;0] 1 NA [1] 
Neutrophils, PRE Unknown Above [N=2;0] 0 NA [1] 
Neutrophils, PRE Below Unknown [N=14;21] 0 0
Neutrophils, PRE Below Below [N=14;21] 8 14
Neutrophils, PRE Below Within [N=14;21] 6 6
Neutrophils, PRE Below Above [N=14;21] 0 1
Neutrophils, PRE Within Unknown [N=52;46] 0 0
Neutrophils, PRE Within Below [N=52;46] 4 6
Neutrophils, PRE Within Within [N=52;46] 41 39
Neutrophils, PRE Within Above [N=52;46] 7 1
Neutrophils, PRE Above Unknown [N=4;6] 0 0
Neutrophils, PRE Above Below [N=4;6] 0 0
Neutrophils, PRE Above Within [N=4;6] 3 3
Neutrophils, PRE Above Above [N=4;6] 1 3
Neutrophils, POST Unknown Unknown [N=2;0] 0 NA [1] 
Neutrophils, POST Unknown Below [N=2;0] 0 NA [1] 
Neutrophils, POST Unknown Within [N=2;0] 2 NA [1] 
Neutrophils, POST Unknown Above [N=2;0] 0 NA [1] 
Neutrophils, POST Below Unknown [N=15;21] 0 0
Neutrophils, POST Below Below [N=15;21] 1 4
Neutrophils, POST Below Within [N=15;21] 13 16
Neutrophils, POST Below Above [N=15;21] 1 1
Neutrophils, POST Within Unknown [N=53;45] 0 0
Neutrophils, POST Within Below [N=53;45] 4 4
Neutrophils, POST Within Within [N=53;45] 43 35
Neutrophils, POST Within Above [N=53;45] 6 6
Neutrophils, POST Above Unknown [N=4;6] 0 0
Neutrophils, POST Above Below [N=4;6] 0 0
Neutrophils, POST Above Within [N=4;6] 2 3
Neutrophils, POST Above Above [N=4;6] 2 3
[1]
The number of subjects in this category was 0, hence the statistical analysis could not be performed.
6.Primary Outcome
Title Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
Hide Description The parameters assessed were both biochemical (alanine aminotransferase = ALAT, creatinine = CREA, urea nitrogen = BUN) and haematological (basophils = BAS, eosinophils = EOS, red blood cells = RBC, hematocrit = HCT, hemoglobin, leukocytes [white blood cells] = WBC, lymphocytes, monocytes, neutrophils and platelets). Results were split into 2 outcomes due to the table size.
Time Frame 42 days post dose 1 (PRE) and at 30 days post dose 2 (POST)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects (i.e. subjects who received at least one dose of vaccine in this study) for whom data were available.
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description:
Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
Overall Number of Participants Analyzed 61 64
Measure Type: Number
Unit of Measure: Subjects
Platelets, PRE Unknown Unknown [N=3;0] 0 NA [1] 
Platelets, PRE Unknown Below [N=3;0] 0 NA [1] 
Platelets, PRE Unknown Within [N=3;0] 2 NA [1] 
Platelets, PRE Unknown Above [N=3;0] 1 NA [1] 
Platelets, PRE Below Unknown [N=0;2] NA [1]  0
Platelets, PRE Below Below [N=0;2] NA [1]  0
Platelets, PRE Below Within [N=0;2] NA [1]  2
Platelets, PRE Below Above [N=0;2] NA [1]  0
Platelets, PRE Within Unknown [N=60;58] 0 0
Platelets, PRE Within Below [N=60;58] 0 0
Platelets, PRE Within Within [N=60;58] 53 54
Platelets, PRE Within Above [N=60;58] 7 4
Platelets, PRE Above Unknown [N=9;13] 0 0
Platelets, PRE Above Below [N=9;13] 0 0
Platelets, PRE Above Within [N=9;13] 3 8
Platelets, PRE Above Above [N=9;13] 6 5
Platelets, POST Unknown Unknown [N=3;0] 0 NA [1] 
Platelets, POST Unknown Below [N=3;0] 0 NA [1] 
Platelets, POST Unknown Within [N=3;0] 2 NA [1] 
Platelets, POST Unknown Above [N=3;0] 1 NA [1] 
Platelets, POST Below Unknown [N=0;2] NA [1]  0
Platelets, POST Below Below [N=0;2] NA [1]  0
Platelets, POST Below Within [N=0;2] NA [1]  2
Platelets, POST Below Above [N=0;2] NA [1]  0
Platelets, POST Within Unknown [N=61;57] 0 0
Platelets, POST Within Below [N=61;57] 0 0
Platelets, POST Within Within [N=61;57] 58 56
Platelets, POST Within Above [N=61;57] 3 1
Platelets, POST Above Unknown [N=10;13] 0 0
Platelets, POST Above Below [N=10;13] 0 0
Platelets, POST Above Within [N=10;13] 6 7
Platelets, POST Above Above [N=10;13] 4 6
BUN, PRE Unknown Unknown [N=2;1] 0 0
BUN, PRE Unknown Below [N=2;1] 0 0
BUN, PRE Unknown Within [N=2;1] 2 1
BUN, PRE Unknown Above [N=2;1] 0 0
BUN, PRE Below Unknown [N=12;4] 0 0
BUN, PRE Below Below [N=12;4] 4 1
BUN, PRE Below Within [N=12;4] 8 3
BUN, PRE Below Above [N=12;4] 0 0
BUN, PRE Within Unknown [N=57;64] 0 0
BUN, PRE Within Below [N=57;64] 2 7
BUN, PRE Within Within [N=57;64] 54 57
BUN, PRE Within Above [N=57;64] 1 0
BUN, PRE Above Unknown [N=3;4] 0 0
BUN, PRE Above Below [N=3;4] 0 0
BUN, PRE Above Within [N=3;4] 3 4
BUN, PRE Above Above [N=3;4] 0 0
BUN, POST Unknown Unknown [N=2;1] 0 0
BUN, POST Unknown Below [N=2;1] 0 0
BUN, POST Unknown Within [N=2;1] 2 1
BUN, POST Unknown Above [N=2;1] 0 0
BUN, POST Below Unknown [N=12;4] 0 0
BUN, POST Below Below [N=12;4] 5 0
BUN, POST Below Within [N=12;4] 7 4
BUN, POST Below Above [N=12;4] 0 0
BUN, POST Within Unknown [N=55;63] 0 0
BUN, POST Within Below [N=55;63] 3 10
BUN, POST Within Within [N=55;63] 52 53
BUN, POST Within Above [N=55;63] 0 0
BUN, POST Above Unknown [N=3;4] 0 0
BUN, POST Above Below [N=3;4] 0 0
BUN, POST Above Within [N=3;4] 3 4
BUN, POST Above Above [N=3;4] 0 0
[1]
The number of subjects in this category was 0, hence the statistical analysis could not be performed.
7.Primary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs)
Hide Description Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame From first vaccination to one month after the last vaccine dose (from Day 0 up to Month 7)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description:
Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
Overall Number of Participants Analyzed 74 74
Measure Type: Number
Unit of Measure: Subjects
0 2
8.Primary Outcome
Title Number of Subjects With AEs and SAEs Leading to Withdrawal
Hide Description [Not Specified]
Time Frame From first vaccination to one month after the last vaccine dose (from Day 0 up to Month 7)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description:
Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
Overall Number of Participants Analyzed 74 74
Measure Type: Number
Unit of Measure: Subjects
0 2
9.Primary Outcome
Title Number of Subjects With Potential Immune-mediated Diseases (pIMDs)
Hide Description Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology
Time Frame From first vaccination to one month after the last vaccine dose (from Day 0 up to Month 7)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description:
Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
Overall Number of Participants Analyzed 74 74
Measure Type: Number
Unit of Measure: Subjects
0 0
10.Primary Outcome
Title Number of Subjects With Medically Significant Conditions (MSCs)
Hide Description MSCs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Time Frame From first vaccination to one month after the last vaccine dose (from Day 0 up to Month 7)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description:
Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
Overall Number of Participants Analyzed 74 74
Measure Type: Number
Unit of Measure: Subjects
38 28
11.Primary Outcome
Title Number of Serconverted Subjects for Anti-HPV-16/18
Hide Description A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer.
Time Frame One month after the last dose of study vaccine (Month 7)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all 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.
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description:
Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
Overall Number of Participants Analyzed 65 44
Measure Type: Number
Unit of Measure: Subjects
HPV-16 65 1
HPV-18 63 1
12.Primary Outcome
Title Anti-HPV-16/18 Antibody Concentrations
Hide Description Antibody concentrations were assessed by Enzyme-linked-Immunosorbent Assay (ELISA) and expressed as geometric mean titers (GMTs) in ELISA units per milliliter (EU/mL).
Time Frame One month after the last dose of study vaccine (Month 7)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, 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.
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description:
Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
Overall Number of Participants Analyzed 65 45
Geometric Mean (95% Confidence Interval)
Unit of Measure: EU/mL
HPV-16
19677.4
(16463.7 to 23518.4)
10.9
(8.9 to 13.4)
HPV-18
10509.1
(8818.9 to 12523.2)
9.6
(8.4 to 11.0)
13.Secondary Outcome
Title Number of Subjects Seroconverted for Anti-HPV-16/18 Antibodies
Hide Description

Seroconversion is defined as the appearance of antibodies (i.e. titre greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.

Values for Month 7 were primary outcomes and presented as such. Values past month 7 were not available at the time of posting this record and will be added once validated results become available.

Time Frame At Day 0, Month 7 and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was based on the ATP cohort for immunogenicity, 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.
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description:
Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
Overall Number of Participants Analyzed 65 45
Measure Type: Number
Unit of Measure: Subjects
HPV-16, Day 0 0 1
HPV-18, Day 0 2 0
14.Secondary Outcome
Title Anti-HPV-16/18 Antibody Concentrations
Hide Description

Antibody concentrations were calculated as geometric mean concentrations (GMCs), assessed by ELISA for the respective groups and expressed as ELISA units per milliliter (EU/mL).

Values for Month 7 were primary outcomes and presented as such. Values past month 7 were not available at the time of posting this record and will be added once validated results become available.

Time Frame At Day 0, Month 7 and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, 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.
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description:
Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
Overall Number of Participants Analyzed 65 45
Geometric Mean (95% Confidence Interval)
Unit of Measure: EU/mL
HPV-16, Day 0
9.5
(9.5 to 9.5)
10.3
(8.8 to 12.1)
HPV-18, Day 0
9.2
(8.9 to 9.6)
9.0
(9.0 to 9.0)
15.Secondary Outcome
Title Anti-HPV-16/18 Seroconversion Rates Assessed by ELISA in Groups HPV_2D, HPV_2D CO and HPV_3D.
Hide Description [Not Specified]
Time Frame At Day 0 and Months 7, 12, 18, 24 and 36
Outcome Measure Data Not Reported
16.Secondary Outcome
Title Anti-HPV-16/18 Antibody Titres Assessed by ELISA in Groups HPV_2D, HPV_2D CO and HPV_3D.
Hide Description [Not Specified]
Time Frame At Day 0 and Months 7, 12, 18, 24 and 36
Outcome Measure Data Not Reported
17.Secondary Outcome
Title Anti-HPV-16/18 Seroconversion Rates Assessed by Pseudovirion-Based Neutralization Assay (PBNA) in a Sub-cohort in Group MMR_DTPa
Hide Description [Not Specified]
Time Frame At Day 0, Month 7 and Month 12
Outcome Measure Data Not Reported
18.Secondary Outcome
Title Anti-HPV-16/18 Antibody Titres Assessed by PBNA in a Sub-cohort in Group MMR_DTPa
Hide Description [Not Specified]
Time Frame At Day 0, Month 7 and Month 12
Outcome Measure Data Not Reported
19.Secondary Outcome
Title Anti-HPV-16/18 Seroconversion Rates Assessed by PBNA in a Sub-cohort in Groups HPV_2D, HPV_2D CO and HPV_3D.
Hide Description [Not Specified]
Time Frame At Day 0 and Months 7, 12, 18, 24 and 36
Outcome Measure Data Not Reported
20.Secondary Outcome
Title Anti-HPV-16/18 Antibody Titres Assessed by PBNA in a Sub-cohort in Groups HPV_2D, HPV_2D CO and HPV_3D.
Hide Description [Not Specified]
Time Frame At Day 0 and Months 7, 12, 18, 24 and 36
Outcome Measure Data Not Reported
21.Secondary Outcome
Title Anti-measles, Mumps and Rubella Seropositivity Rates in Groups HPV_2D, MMR_DTPa and HPV_2D CO.
Hide Description [Not Specified]
Time Frame On Days 0 and 42
Outcome Measure Data Not Reported
22.Secondary Outcome
Title Anti-measles, Mumps and Rubella Antibody Titres in Groups HPV_2D, MMR_DTPa and HPV_2D CO.
Hide Description [Not Specified]
Time Frame On Days 0 and 42
Outcome Measure Data Not Reported
23.Secondary Outcome
Title Vaccine Response Rates to Filamentous Haemagglutinin (FHA), Pertactin (PRN) and Pertussis Toxoid (PT) Antigens in Groups HPV_2D, MMR_DTPa and HPV_2D CO.
Hide Description [Not Specified]
Time Frame At Month 7
Outcome Measure Data Not Reported
24.Secondary Outcome
Title Seroprotection Rates to Diphtheria (D) and Tetanus (T) Antigens in Groups HPV_2D, MMR_DTPa and HPV_2D CO.
Hide Description [Not Specified]
Time Frame At Month 7
Outcome Measure Data Not Reported
25.Secondary Outcome
Title The Number of Subjects With Solicited Fever, Measles/Rubella-like Rash, Parotid Gland Swelling and Signs of Meningism, Including Febrile Convulsion
Hide Description [Not Specified]
Time Frame During the 43-day period (Days 0-42) following vaccination on Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description:
Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
Overall Number of Participants Analyzed 74 74
Measure Type: Number
Unit of Measure: Subjects
Fever ≥37.5°C 30 26
Fever >39.0°C 7 2
Related Fever 6 7
Any rash 1 1
Rash with fever 0 0
Grade 3 rash 0 0
Related rash 1 1
Any Parotid gland swelling 0 0
Any Signs of Meningism 0 1
Grade 3 Signs of Meningism 0 0
Related Signs of Meningism 0 1
26.Secondary Outcome
Title Number of Subjects With Potential Immune-mediated Diseases (pIMDs)
Hide Description Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology
Time Frame From first vaccination to 6 months after the last vaccine dose (from Day 0 up to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description:
Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
Overall Number of Participants Analyzed 74 74
Measure Type: Number
Unit of Measure: Subjects
0 0
27.Secondary Outcome
Title Number of Subjects With Medically Significant Conditions (MSCs)
Hide Description MSCs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Time Frame From first vaccination to 6 months after the last vaccine dose (from Day 0 up to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description:
Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
Overall Number of Participants Analyzed 74 74
Measure Type: Number
Unit of Measure: Subjects
38 28
28.Secondary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs)
Hide Description Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame From first vaccination to 6 months after the last vaccine dose (from Day 0 up to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description:
Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
Overall Number of Participants Analyzed 74 74
Measure Type: Number
Unit of Measure: Subjects
1 2
29.Secondary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs)
Hide Description [Not Specified]
Time Frame Throughout the study period (From Day 0 to Month 36)
Outcome Measure Data Not Reported
30.Secondary Outcome
Title Number of Subjects With of AEs/SAEs Leading to Withdrawal
Hide Description [Not Specified]
Time Frame Throughout the study period (From Day 0 to Month 36)
Outcome Measure Data Not Reported
31.Secondary Outcome
Title Number of Subjects Reporting the Intake of Concomitant Medication
Hide Description [Not Specified]
Time Frame During the 43-day period (Days 0-42) following vaccination on Day 0 and during the 30-day period (Days 0-29) following vaccination at Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description:
Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
Overall Number of Participants Analyzed 74 74
Measure Type: Number
Unit of Measure: Subjects
Any medication, Dose 1 (N=74,74) 43 36
Any antipyretic, Dose 1 (N=74,74) 27 22
Prophylactic antipyretic, Dose 1 (N=74,74) 0 0
Any antibiotic, Dose 1 (N=74,74) 17 10
Any medication, Dose 2 (N=74,71) 19 23
Any antipyretic, Dose 2 (N=74,71) 10 8
Prophylactic antipyretic, Dose 2 (N=74,71) 0 0
Any antibiotic, Dose 2 (N=74,71) 6 6
Any medication, Accross doses (N=74,74) 49 43
Any antipyretic, Accross doses (N=74,74) 30 25
Prophylactic antipyretic, Accross doses (N=74,74) 0 0
Any antibiotic, Accross doses (N=74,74) 20 15
32.Secondary Outcome
Title The Number of Subjects Completing the Vaccination Schedule in All Groups.
Hide Description [Not Specified]
Time Frame From first vaccination to the last vaccine dose (from Day 0 up to Month 6)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description:
Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
Overall Number of Participants Analyzed 74 74
Measure Type: Number
Unit of Measure: Subjects
Subjects receiving 1 dose 0 3
Subjects receiving 2 doses 74 71
Subjects receiving any dose 74 74
33.Secondary Outcome
Title Number of Subjects With of AEs/SAEs Leading to Withdrawal
Hide Description [Not Specified]
Time Frame From Day 0 to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description:
Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
Overall Number of Participants Analyzed 74 74
Measure Type: Number
Unit of Measure: Subjects
0 0
Time Frame The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cervarix Group Priorix + Infanrix Group
Hide Arm/Group Description Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6 Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
All-Cause Mortality
Cervarix Group Priorix + Infanrix Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cervarix Group Priorix + Infanrix Group
Affected / at Risk (%) Affected / at Risk (%)
Total   1/74 (1.35%)   2/74 (2.70%) 
Infections and infestations     
Abscess limb * 1  0/74 (0.00%)  1/74 (1.35%) 
Gastroenteritis * 1  1/74 (1.35%)  1/74 (1.35%) 
Metabolism and nutrition disorders     
Dehydration * 1  0/74 (0.00%)  1/74 (1.35%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cervarix Group Priorix + Infanrix Group
Affected / at Risk (%) Affected / at Risk (%)
Total   54/74 (72.97%)   40/74 (54.05%) 
General disorders     
Pain  1  54/74 (72.97%)  40/74 (54.05%) 
Redness  1  18/74 (24.32%)  18/74 (24.32%) 
Swelling  1  19/74 (25.68%)  18/74 (24.32%) 
Arthralgia  1  13/74 (17.57%)  11/74 (14.86%) 
Drowsiness  1  16/74 (21.62%)  15/74 (20.27%) 
Fatigue  1  15/74 (20.27%)  10/74 (13.51%) 
Fever/(Axillary)  1  12/74 (16.22%)  17/74 (22.97%) 
Gastrointestinal  1  11/74 (14.86%)  16/74 (21.62%) 
Headache  1  18/74 (24.32%)  25/74 (33.78%) 
Irritability / fussiness  1  22/74 (29.73%)  19/74 (25.68%) 
Loss of appetite  1  21/74 (28.38%)  13/74 (17.57%) 
Myalgia  1  21/74 (28.38%)  14/74 (18.92%) 
Rash  1  6/74 (8.11%)  5/74 (6.76%) 
Urticaria  1  10/74 (13.51%)  7/74 (9.46%) 
Infections and infestations     
Nasopharyngitis * 1  21/74 (28.38%)  23/74 (31.08%) 
Pharyngitis * 1  4/74 (5.41%)  3/74 (4.05%) 
Gastroenteritis * 1  3/74 (4.05%)  5/74 (6.76%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01627561     History of Changes
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: February 12, 2018