Trial Outcomes & Findings for Safety and Immunogenicity of GSK Biologicals' HPV-16/18 L1 VLP AS04 Vaccine (GSK-580299) in Healthy Female Children 4-6 Years Old (NCT NCT01627561)
NCT ID: NCT01627561
Last Updated: 2020-04-10
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
148 participants
Primary outcome timeframe
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
Results posted on
2020-04-10
Participant Flow
This study was conducted by multiple investigators at 7 centers in Colombia, Mexico and Panama.
All 148 subjects enrolled in the study, received the study vaccination and were included in the Total Vaccinated cohort (TVC).
Participant milestones
| Measure |
Cervarix Group
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.
|
Priorix + Infanrix Group
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 Study
STARTED
|
74
|
74
|
|
Overall Study
COMPLETED
|
73
|
71
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
Cervarix Group
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.
|
Priorix + Infanrix Group
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 Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Migrated/moved from study area
|
0
|
2
|
Baseline Characteristics
Safety and Immunogenicity of GSK Biologicals' HPV-16/18 L1 VLP AS04 Vaccine (GSK-580299) in Healthy Female Children 4-6 Years Old
Baseline characteristics by cohort
| Measure |
Cervarix Group
n=74 Participants
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.
|
Priorix + Infanrix Group
n=74 Participants
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
n=148 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
4.3 Years
STANDARD_DEVIATION 0.5 • n=5 Participants
|
4.4 Years
STANDARD_DEVIATION 0.5 • n=7 Participants
|
4.3 Years
STANDARD_DEVIATION 0.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African Heritage / African American
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - Caucasian / European Heritage
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed origin
|
68 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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 dosesPopulation: 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.
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.
Outcome measures
| Measure |
Cervarix Group
n=74 Participants
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.
|
Priorix + Infanrix Group
n=74 Participants
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.
|
|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness Across doses
|
1 Participants
|
4 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain Dose 1
|
45 Participants
|
15 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain Dose 1
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness Dose 1
|
10 Participants
|
7 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness Dose 1
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling Dose 1
|
6 Participants
|
6 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling Dose 1
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain Dose 2
|
43 Participants
|
36 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain Dose 2
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness Dose 2
|
12 Participants
|
12 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness Dose 2
|
0 Participants
|
4 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling Dose 2
|
16 Participants
|
15 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling Dose 2
|
3 Participants
|
7 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain Across doses
|
54 Participants
|
40 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain Across doses
|
4 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness Across doses
|
18 Participants
|
18 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling Across doses
|
19 Participants
|
18 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling Across doses
|
4 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: 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 dosesPopulation: 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.
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.
Outcome measures
| Measure |
Cervarix Group
n=74 Participants
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.
|
Priorix + Infanrix Group
n=74 Participants
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.
|
|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal Dose 1
|
5 Participants
|
10 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Arthralgia Dose 2
|
10 Participants
|
8 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Arthralgia Dose 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness Dose 2
|
9 Participants
|
9 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue Dose 2
|
9 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache Dose 2
|
12 Participants
|
12 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite Dose 2
|
9 Participants
|
8 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Rash Dose 2
|
3 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Urticaria Across doses
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever Dose 2
|
7 Participants
|
9 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal Dose 2
|
4 Participants
|
9 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal Dose 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal Dose 2
|
3 Participants
|
8 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache Dose 2
|
12 Participants
|
13 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache Dose 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Irritability/fussiness Dose 2
|
18 Participants
|
17 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability/fussiness Dose 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Irritability/fussiness Dose 2
|
18 Participants
|
17 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite Dose 2
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite Dose 2
|
9 Participants
|
8 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia Dose 2
|
13 Participants
|
11 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia Dose 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia Dose 2
|
12 Participants
|
11 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Rash Dose 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Rash Dose 2
|
3 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Urticaria Dose 2
|
5 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Urticaria Dose 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Urticaria Dose 2
|
4 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Arthralgia Across doses
|
13 Participants
|
11 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Arthralgia Across doses
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Arthralgia Across doses
|
12 Participants
|
11 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness Across doses
|
16 Participants
|
15 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness Across doses
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness Across doses
|
15 Participants
|
15 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue Across doses
|
15 Participants
|
10 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue Across doses
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue Across doses
|
14 Participants
|
10 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever Across doses
|
12 Participants
|
17 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever Across doses
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever Across doses
|
9 Participants
|
13 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal Across doses
|
11 Participants
|
16 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal Across doses
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal Across doses
|
8 Participants
|
15 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache Across doses
|
18 Participants
|
25 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache Across doses
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache Across doses
|
16 Participants
|
23 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Irritability/fussiness Across doses
|
22 Participants
|
19 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability/fussiness Across doses
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Irritability/fussiness Across doses
|
22 Participants
|
19 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite Across doses
|
21 Participants
|
13 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite Across doses
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite Across doses
|
19 Participants
|
13 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia Across doses
|
21 Participants
|
14 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia Across doses
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia Across doses
|
21 Participants
|
14 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Rash Across doses
|
6 Participants
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Rash Across doses
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Rash Across doses
|
5 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Urticaria Across doses
|
10 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Urticaria Across doses
|
8 Participants
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Arthralgia Dose 1
|
5 Participants
|
8 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Arthralgia Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Arthralgia Dose 1
|
4 Participants
|
8 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness Dose 1
|
14 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness Dose 1
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness Dose 1
|
12 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue Dose 1
|
8 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue Dose 1
|
7 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever Dose 1
|
6 Participants
|
8 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever Dose 1
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever Dose 1
|
3 Participants
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal Dose 1
|
7 Participants
|
12 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache Dose 1
|
11 Participants
|
19 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache Dose 1
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache Dose 1
|
9 Participants
|
17 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Irritability/fussiness Dose 1
|
13 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability/fussiness Dose 1
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Irritability/fussiness Dose 1
|
12 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite Dose 1
|
15 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite Dose 1
|
13 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia Dose 1
|
13 Participants
|
9 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia Dose 1
|
13 Participants
|
9 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Rash Dose 1
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Rash Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Rash Dose 1
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Urticaria Dose 1
|
5 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Urticaria Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Urticaria Dose 1
|
4 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Arthralgia Dose 2
|
9 Participants
|
8 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness Dose 2
|
9 Participants
|
9 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness Dose 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue Dose 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue Dose 2
|
9 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever Dose 2
|
7 Participants
|
12 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever Dose 2
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: During the 43-day period (i.e. from the day of vaccination up to 42 subsequent days) following the vaccination at Day 0Population: 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.
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.
Outcome measures
| Measure |
Cervarix Group
n=74 Participants
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.
|
Priorix + Infanrix Group
n=74 Participants
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.
|
|---|---|---|
|
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
Any AE(s)
|
40 Participants
|
40 Participants
|
|
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
Grade 3 AE(s)
|
3 Participants
|
2 Participants
|
|
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
Related AE(s)
|
1 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: During the 30-day period (i.e. from the day of vaccination up to 29 subsequent days) following the vaccination at Month 6Population: 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.
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.
Outcome measures
| Measure |
Cervarix Group
n=74 Participants
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.
|
Priorix + Infanrix Group
n=71 Participants
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.
|
|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited AEs Reported During the 30-day Period Following the Vaccination at Month 6
Any AE(s)
|
18 Participants
|
13 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited AEs Reported During the 30-day Period Following the Vaccination at Month 6
Grade 3 AE(s)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited AEs Reported During the 30-day Period Following the Vaccination at Month 6
Related AE(s)
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: At Day 42 (i.e. 42 days after the vaccination at Day 0)Population: 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.
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) \[e.g. ALAT Below (baseline) - Within (Day 42) = ALAT with below normal value at baseline and within normal values at Day 42\].
Outcome measures
| Measure |
Cervarix Group
n=74 Participants
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.
|
Priorix + Infanrix Group
n=73 Participants
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.
|
|---|---|---|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
ALAT, Unknown (baseline) - Below (Day 42)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
ALAT, Within (baseline) - Within (Day 42)
|
64 Participants
|
60 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
ALAT, Above (baseline) - Above (Day 42)
|
3 Participants
|
3 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
EOS, Unknown (baseline) - Below (Day 42)
|
0 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
EOS, Below (baseline) - Below (Day 42)
|
0 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
RBC, Below (baseline) - Above (Day 42)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
HGB, Below (baseline) - Below (Day 42)
|
10 Participants
|
5 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
HGB, Above (baseline) - Above (Day 42)
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
LYM, Within (baseline) - Above (Day 42)
|
3 Participants
|
6 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
NEU, Within (baseline) - Within (Day 42)
|
41 Participants
|
39 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
PLA, Within (baseline) - Below (Day 42)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
PLA, Within (baseline) - Within (Day 42)
|
51 Participants
|
52 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
BUN, Unknown (baseline) - Below (Day 42)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
ALAT, Unknown (baseline) - Within (Day 42)
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
ALAT, Unknown (baseline) - Above (Day 42)
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
ALAT, Below (baseline) - Below (Day 42)
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
ALAT, Below (baseline) - Within (Day 42)
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
ALAT, Below (baseline) - Above (Day 42)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
ALAT, Within (baseline) - Below (Day 42)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
ALAT, Within (baseline) - Above (Day 42)
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
ALAT, Above (baseline) - Below (Day 42)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
ALAT, Above (baseline) - Within (Day 42)
|
1 Participants
|
4 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
BAS, Unknown (baseline) - Below (Day 42)
|
0 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
BAS, Unknown (baseline) - Within (Day 42)
|
1 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
BAS, Unknown (baseline) - Above (Day 42)
|
0 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
BAS, Within (baseline) - Below (Day 42)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
BAS, Within (baseline) - Within (Day 42)
|
71 Participants
|
69 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
BAS, Within (baseline) - Above (Day 42)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
BAS, Above (baseline) - Below (Day 42)
|
—
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
BAS, Above (baseline) - Within (Day 42)
|
—
|
4 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
BAS, Above (baseline) - Above (Day 42)
|
—
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
CREA, Unknown (baseline) - Below (Day 42)
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
CREA, Unknown (baseline) - Within (Day 42)
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
CREA, Unknown (baseline) - Above (Day 42)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
CREA, Below (baseline) - Below (Day 42)
|
22 Participants
|
17 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
CREA, Below (baseline) - Within (Day 42)
|
8 Participants
|
10 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
CREA, Below (baseline) - Above (Day 42)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
CREA, Within (baseline) - Below (Day 42)
|
7 Participants
|
12 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
CREA, Within (baseline) - Within (Day 42)
|
35 Participants
|
33 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
CREA, Within (baseline) - Above (Day 42)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
EOS, Unknown (baseline) - Within (Day 42)
|
1 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
EOS, Unknown (baseline) - Above (Day 42)
|
0 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
EOS, Below (baseline) - Within (Day 42)
|
1 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
EOS, Below (baseline) - Above (Day 42)
|
0 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
EOS, Within (baseline) - Below (Day 42)
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
EOS, Within (baseline) - Within (Day 42)
|
42 Participants
|
38 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
EOS, Within (baseline) - Above (Day 42)
|
6 Participants
|
11 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
EOS, Above (baseline) - Below (Day 42)
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
EOS, Above (baseline) - Within (Day 42)
|
4 Participants
|
10 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
EOS, Above (baseline) - Above (Day 42)
|
17 Participants
|
12 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
RBC, Unknown (baseline) - Below (Day 42)
|
0 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
RBC, Unknown (baseline) - Within (Day 42)
|
1 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
RBC, Unknown (baseline) - Above (Day 42)
|
0 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
RBC, Below (baseline) - Below (Day 42)
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
RBC, Below (baseline) - Within (Day 42)
|
5 Participants
|
4 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
RBC, Within (baseline) - Below (Day 42)
|
5 Participants
|
2 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
RBC, Within (baseline) - Within (Day 42)
|
60 Participants
|
63 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
RBC, Within (baseline) - Above (Day 42)
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
RBC, Above (baseline) - Below (Day 42)
|
—
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
RBC, Above (baseline) - Within (Day 42)
|
—
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
RBC, Above (baseline) - Above (Day 42)
|
—
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
HCT, Unknown (baseline) - Below (Day 42)
|
0 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
HCT, Unknown (baseline) - Within (Day 42)
|
1 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
HCT, Unknown (baseline) - Above (Day 42)
|
0 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
HCT, Below (baseline) - Below (Day 42)
|
12 Participants
|
15 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
HCT, Below (baseline) - Within (Day 42)
|
13 Participants
|
8 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
HCT, Below (baseline) - Above (Day 42)
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
HCT, Within (baseline) - Below (Day 42)
|
5 Participants
|
2 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
HCT, Within (baseline) - Within (Day 42)
|
37 Participants
|
38 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
HCT, Within (baseline) - Above (Day 42)
|
1 Participants
|
5 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
HCT, Above (baseline) - Below (Day 42)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
HCT, Above (baseline) - Within (Day 42)
|
2 Participants
|
4 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
HCT, Above (baseline) - Above (Day 42)
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
HGB, Unknown (baseline) - Below (Day 42)
|
0 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
HGB, Unknown (baseline) - Within (Day 42)
|
0 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
HGB, Unknown (baseline) - Above (Day 42)
|
1 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
HGB, Below (baseline) - Within (Day 42)
|
10 Participants
|
9 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
HGB, Below (baseline) - Above (Day 42)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
HGB, Within (baseline) - Below (Day 42)
|
4 Participants
|
7 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
HGB, Within (baseline) - Within (Day 42)
|
38 Participants
|
42 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
HGB, Within (baseline) - Above (Day 42)
|
4 Participants
|
4 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
HGB, Above (baseline) - Below (Day 42)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
HGB, Above (baseline) - Within (Day 42)
|
3 Participants
|
5 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
WBC, Unknown (baseline) - Below (Day 42)
|
0 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
WBC, Unknown (baseline) - Within (Day 42)
|
1 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
WBC, Unknown (baseline) - Above (Day 42)
|
0 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
WBC, Below (baseline) - Below (Day 42)
|
1 Participants
|
5 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
WBC, Below (baseline) - Within (Day 42)
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
WBC, Below (baseline) - Above (Day 42)
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
WBC, Within (baseline) - Below (Day 42)
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
WBC, Within (baseline) - Within (Day 42)
|
57 Participants
|
54 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
WBC, Within (baseline) - Above (Day 42)
|
3 Participants
|
4 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
WBC, Above (baseline) - Below (Day 42)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
WBC, Above (baseline) - Within (Day 42)
|
1 Participants
|
4 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
WBC, Above (baseline) - Above (Day 42)
|
3 Participants
|
3 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
LYM, Unknown (baseline) - Below (Day 42)
|
0 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
LYM, Unknown (baseline) - Within (Day 42)
|
1 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
LYM, Unknown (baseline) - Above (Day 42)
|
0 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
LYM, Below (baseline) - Below (Day 42)
|
4 Participants
|
6 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
LYM, Below (baseline) - Within (Day 42)
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
LYM, Below (baseline) - Above (Day 42)
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
LYM, Within (baseline) - Below (Day 42)
|
7 Participants
|
2 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
LYM, Within (baseline) - Within (Day 42)
|
38 Participants
|
34 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
LYM, Above (baseline) - Below (Day 42)
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
LYM, Above (baseline) - Within (Day 42)
|
5 Participants
|
5 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
LYM, Above (baseline) - Above (Day 42)
|
11 Participants
|
14 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
MONO, Unknown (baseline) - Below (Day 42)
|
1 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
MONO, Unknown (baseline) - Within (Day 42)
|
0 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
MONO, Unknown (baseline) - Above (Day 42)
|
0 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
MONO, Below (baseline) - Below (Day 42)
|
4 Participants
|
5 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
MONO, Below (baseline) - Within (Day 42)
|
4 Participants
|
4 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
MONO, Below (baseline) - Above (Day 42)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
MONO, Within (baseline) - Below (Day 42)
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
MONO, Within (baseline) - Within (Day 42)
|
42 Participants
|
48 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
MONO, Within (baseline) - Above (Day 42)
|
6 Participants
|
5 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
MONO, Above (baseline) - Below (Day 42)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
MONO, Above (baseline) - Within (Day 42)
|
6 Participants
|
3 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
MONO, Above (baseline) - Above (Day 42)
|
6 Participants
|
6 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
NEU, Unknown (baseline) - Below (Day 42)
|
0 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
NEU, Unknown (baseline) - Within (Day 42)
|
1 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
NEU, Unknown (baseline) - Above (Day 42)
|
0 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
NEU, Below (baseline) - Below (Day 42)
|
9 Participants
|
14 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
NEU, Below (baseline) - Within (Day 42)
|
6 Participants
|
6 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
NEU, Below (baseline) - Above (Day 42)
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
NEU, Within (baseline) - Below (Day 42)
|
4 Participants
|
6 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
NEU, Within (baseline) - Above (Day 42)
|
7 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
NEU, Above (baseline) - Below (Day 42)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
NEU, Above (baseline) - Within (Day 42)
|
3 Participants
|
3 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
NEU, Above (baseline) - Above (Day 42)
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
PLA, Unknown (baseline) - Below (Day 42)
|
0 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
PLA, Unknown (baseline) - Within (Day 42)
|
2 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
PLA, Unknown (baseline) - Above (Day 42)
|
0 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
PLA, Below (baseline) - Below (Day 42)
|
—
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
PLA, Below (baseline) - Within (Day 42)
|
—
|
2 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
PLA, Below (baseline) - Above (Day 42)
|
—
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
PLA, Within (baseline) - Above (Day 42)
|
8 Participants
|
4 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
PLA, Above (baseline) - Below (Day 42)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
PLA, Above (baseline) - Within (Day 42)
|
4 Participants
|
9 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
PLA, Above (baseline) - Above (Day 42)
|
7 Participants
|
6 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
BUN, Unknown (baseline) - Within (Day 42)
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
BUN, Unknown (baseline) - Above (Day 42)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
BUN, Below (baseline) - Below (Day 42)
|
4 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
BUN, Below (baseline) - Within (Day 42)
|
8 Participants
|
3 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
BUN, Below (baseline) - Above (Day 42)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
BUN, Within (baseline) - Below (Day 42)
|
2 Participants
|
5 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
BUN, Within (baseline) - Within (Day 42)
|
50 Participants
|
57 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
BUN, Within (baseline) - Above (Day 42)
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
BUN, Above (baseline) - Below (Day 42)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
BUN, Above (baseline) - Within (Day 42)
|
6 Participants
|
6 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
BUN, Above (baseline) - Above (Day 42)
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Month 7 (i.e. 30 days after the vaccination at Month 6)Population: 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.
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) \[e.g. ALAT Below (baseline) - Within (Month 7) = ALAT with below normal value at baseline and within normal values at Month 7\].
Outcome measures
| Measure |
Cervarix Group
n=74 Participants
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.
|
Priorix + Infanrix Group
n=72 Participants
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.
|
|---|---|---|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
ALAT, Below (baseline) - Below (Month 7)
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
ALAT, Below (baseline) - Within (Month 7)
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
ALAT, Within (baseline) - Above (Month 7)
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
ALAT, Above (baseline) - Above (Month 7)
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
BAS, Unknown (baseline) - Below (Month 7)
|
0 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
BAS, Within (baseline) - Below (Month 7)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
BAS, Above (baseline) - Below (Month 7)
|
—
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
CREA, Unknown (baseline) - Within (Month 7)
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
CREA, Unknown (baseline) - Above (Month 7)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
CREA, Below (baseline) - Below (Month 7)
|
23 Participants
|
21 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
CREA, Below (baseline) - Within (Month 7)
|
6 Participants
|
5 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
CREA, Within (baseline) - Above (Month 7)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
EOS, Unknown (baseline) - Below (Month 7)
|
0 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
EOS, Unknown (baseline) - Within (Month 7)
|
1 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
EOS, Below (baseline) - Above (Month 7)
|
0 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
BUN, Unknown (baseline) - Below (Month 7)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
BUN, Unknown (baseline) - Within (Month 7)
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
BUN, Unknown (baseline) - Above (Month 7)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
BUN, Below (baseline) - Below (Month 7)
|
5 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
BUN, Below (baseline) - Within (Month 7)
|
7 Participants
|
4 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
BUN, Below (baseline) - Above (Month 7)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
BUN, Within (baseline) - Below (Month 7)
|
4 Participants
|
10 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
BUN, Within (baseline) - Within (Month 7)
|
47 Participants
|
51 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
BUN, Within (baseline) - Above (Month 7)
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
BUN, Above (baseline) - Below (Month 7)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
BUN, Above (baseline) - Within (Month 7)
|
6 Participants
|
6 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
BUN, Above (baseline) - Above (Month 7)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
ALAT, Unknown (baseline) - Below (Month 7)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
ALAT, Unknown (baseline) - Within (Month 7)
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
ALAT, Unknown (baseline) - Above (Month 7)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
ALAT, Below (baseline) - Above (Month 7)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
ALAT, Within (baseline) - Below (Month 7)
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
ALAT, Within (baseline) - Within (Month 7)
|
64 Participants
|
60 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
ALAT, Above (baseline) - Below (Month 7)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
ALAT, Above (baseline) - Within (Month 7)
|
3 Participants
|
7 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
BAS, Unknown (baseline) - Within (Month 7)
|
1 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
BAS, Unknown (baseline) - Above (Month 7)
|
0 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
BAS, Within (baseline) - Within (Month 7)
|
72 Participants
|
67 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
BAS, Within (baseline) - Above (Month 7)
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
BAS, Above (baseline) - Within (Month 7)
|
—
|
2 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
BAS, Above (baseline) - Above (Month 7)
|
—
|
2 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
CREA, Unknown (baseline) - Below (Month 7)
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
CREA, Below (baseline) - Above (Month 7)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
CREA, Within (baseline) - Below (Month 7)
|
8 Participants
|
9 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
CREA, Within (baseline) - Within (Month 7)
|
34 Participants
|
36 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
EOS, Unknown (baseline) - Above (Month 7)
|
0 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
HGB, Above (baseline) - Within (Month 7)
|
3 Participants
|
5 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
EOS, Below (baseline) - Below (Month 7)
|
0 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
EOS, Below (baseline) - Within (Month 7)
|
1 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
EOS, Within (baseline) - Below (Month 7)
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
EOS, Within (baseline) - Within (Month 7)
|
42 Participants
|
38 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
EOS, Within (baseline) - Above (Month 7)
|
9 Participants
|
10 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
EOS, Above (baseline) - Below (Month 7)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
EOS, Above (baseline) - Within (Month 7)
|
3 Participants
|
10 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
EOS, Above (baseline) - Above (Month 7)
|
18 Participants
|
13 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
RBC, Unknown (baseline) - Below (Month 7)
|
0 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
RBC, Unknown (baseline) - Within (Month 7)
|
1 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
RBC, Unknown (baseline) - Above (Month 7)
|
0 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
RBC, Below (baseline) - Below (Month 7)
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
RBC, Below (baseline) - Within (Month 7)
|
4 Participants
|
3 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
RBC, Below (baseline) - Above (Month 7)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
RBC, Within (baseline) - Below (Month 7)
|
4 Participants
|
4 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
RBC, Within (baseline) - Within (Month 7)
|
63 Participants
|
61 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
RBC, Within (baseline) - Above (Month 7)
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
RBC, Above (baseline) - Below (Month 7)
|
—
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
RBC, Above (baseline) - Within (Month 7)
|
—
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
RBC, Above (baseline) - Above (Month 7)
|
—
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
HCT, Unknown (baseline) - Below (Month 7)
|
0 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
HCT, Unknown (baseline) - Within (Month 7)
|
0 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
HCT, Unknown (baseline) - Above (Month 7)
|
1 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
HCT, Below (baseline) - Below (Month 7)
|
15 Participants
|
15 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
HCT, Below (baseline) - Within (Month 7)
|
11 Participants
|
9 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
HCT, Below (baseline) - Above (Month 7)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
HCT, Within (baseline) - Below (Month 7)
|
2 Participants
|
4 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
HCT, Within (baseline) - Within (Month 7)
|
41 Participants
|
40 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
HCT, Within (baseline) - Above (Month 7)
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
HCT, Above (baseline) - Below (Month 7)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
HCT, Above (baseline) - Within (Month 7)
|
3 Participants
|
4 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
HCT, Above (baseline) - Above (Month 7)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
HGB, Unknown (baseline) - Below (Month 7)
|
0 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
HGB, Unknown (baseline) - Within (Month 7)
|
0 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
HGB, Unknown (baseline) - Above (Month 7)
|
1 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
HGB, Below (baseline) - Below (Month 7)
|
10 Participants
|
7 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
HGB, Above (baseline) - Below (Month 7)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
HGB, Below (baseline) - Within (Month 7)
|
11 Participants
|
7 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
HGB, Below (baseline) - Above (Month 7)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
HGB, Within (baseline) - Below (Month 7)
|
1 Participants
|
7 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
HGB, Within (baseline) - Within (Month 7)
|
40 Participants
|
44 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
HGB, Within (baseline) - Above (Month 7)
|
6 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
HGB, Above (baseline) - Above (Month 7)
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
WBC, Unknown (baseline) - Below (Month 7)
|
0 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
WBC, Unknown (baseline) - Within (Month 7)
|
1 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
WBC, Unknown (baseline) - Above (Month 7)
|
0 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
WBC, Below (baseline) - Below (Month 7)
|
3 Participants
|
4 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
WBC, Below (baseline) - Within (Month 7)
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
WBC, Below (baseline) - Above (Month 7)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
WBC, Within (baseline) - Below (Month 7)
|
1 Participants
|
7 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
WBC, Within (baseline) - Within (Month 7)
|
59 Participants
|
48 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
WBC, Within (baseline) - Above (Month 7)
|
3 Participants
|
3 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
WBC, Above (baseline) - Below (Month 7)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
WBC, Above (baseline) - Within (Month 7)
|
3 Participants
|
5 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
WBC, Above (baseline) - Above (Month 7)
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
LYM, Unknown (baseline) - Below (Month 7)
|
0 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
LYM, Unknown (baseline) - Within (Month 7)
|
1 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
LYM, Unknown (baseline) - Above (Month 7)
|
0 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
LYM, Below (baseline) - Below (Month 7)
|
5 Participants
|
6 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
LYM, Below (baseline) - Within (Month 7)
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
LYM, Below (baseline) - Above (Month 7)
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
LYM, Within (baseline) - Below (Month 7)
|
6 Participants
|
5 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
LYM, Within (baseline) - Within (Month 7)
|
37 Participants
|
36 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
LYM, Within (baseline) - Above (Month 7)
|
6 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
LYM, Above (baseline) - Below (Month 7)
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
LYM, Above (baseline) - Within (Month 7)
|
10 Participants
|
8 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
LYM, Above (baseline) - Above (Month 7)
|
6 Participants
|
11 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
MONO, Unknown (baseline) - Below (Month 7)
|
1 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
MONO, Unknown (baseline) - Within (Month 7)
|
0 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
MONO, Unknown (baseline) - Above (Month 7)
|
0 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
MONO, Below (baseline) - Below (Month 7)
|
2 Participants
|
4 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
MONO, Below (baseline) - Within (Month 7)
|
6 Participants
|
4 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
MONO, Below (baseline) - Above (Month 7)
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
MONO, Within (baseline) - Below (Month 7)
|
4 Participants
|
3 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
MONO, Within (baseline) - Within (Month 7)
|
49 Participants
|
51 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
MONO, Within (baseline) - Above (Month 7)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
MONO, Above (baseline) - Below (Month 7)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
MONO, Above (baseline) - Within (Month 7)
|
11 Participants
|
7 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
MONO, Above (baseline) - Above (Month 7)
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
NEU, Unknown (baseline) - Below (Month 7)
|
0 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
NEU, Unknown (baseline) - Within (Month 7)
|
1 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
NEU, Unknown (baseline) - Above (Month 7)
|
0 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
NEU, Below (baseline) - Below (Month 7)
|
5 Participants
|
10 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
NEU, Below (baseline) - Within (Month 7)
|
10 Participants
|
10 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
NEU, Below (baseline) - Above (Month 7)
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
NEU, Within (baseline) - Below (Month 7)
|
4 Participants
|
4 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
NEU, Within (baseline) - Within (Month 7)
|
43 Participants
|
35 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
NEU, Within (baseline) - Above (Month 7)
|
6 Participants
|
6 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
NEU, Above (baseline) - Below (Month 7)
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
NEU, Above (baseline) - Within (Month 7)
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
NEU, Above (baseline) - Above (Month 7)
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
PLA, Unknown (baseline) - Below (Month 7)
|
0 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
PLA, Unknown (baseline) - Within (Month 7)
|
2 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
PLA, Unknown (baseline) - Above (Month 7)
|
0 Participants
|
—
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
PLA, Below (baseline) - Below (Month 7)
|
—
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
PLA, Below (baseline) - Within (Month 7)
|
—
|
2 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
PLA, Below (baseline) - Above (Month 7)
|
—
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
PLA, Within (baseline) - Below (Month 7)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
PLA, Within (baseline) - Within (Month 7)
|
56 Participants
|
53 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
PLA, Within (baseline) - Above (Month 7)
|
4 Participants
|
2 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
PLA, Above (baseline) - Below (Month 7)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
PLA, Above (baseline) - Within (Month 7)
|
7 Participants
|
8 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
PLA, Above (baseline) - Above (Month 7)
|
5 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
Cervarix Group
n=74 Participants
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.
|
Priorix + Infanrix Group
n=74 Participants
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.
|
|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs) From Day 0 up to Month 7
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 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)Population: 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.
The number of subjects with AEs and SAEs leading to premature discontinuation of the study was assessed.
Outcome measures
| Measure |
Cervarix Group
n=74 Participants
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.
|
Priorix + Infanrix Group
n=74 Participants
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.
|
|---|---|---|
|
Number of Subjects With AEs and SAEs Leading to Withdrawal From Day 0 up to Month 7
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
Cervarix Group
n=74 Participants
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.
|
Priorix + Infanrix Group
n=74 Participants
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.
|
|---|---|---|
|
Number of Subjects With Potential Immune-mediated Diseases (pIMDs) From Day 0 up to Month 7
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
Cervarix Group
n=74 Participants
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.
|
Priorix + Infanrix Group
n=74 Participants
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.
|
|---|---|---|
|
Number of Subjects With Medically Significant Conditions (MSCs) From Day 0 up to Month 7
|
37 Participants
|
28 Participants
|
PRIMARY outcome
Timeframe: At Month 7 (i.e. 30 days after the vaccination at Month 6)Population: 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.
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.
Outcome measures
| Measure |
Cervarix Group
n=64 Participants
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.
|
Priorix + Infanrix Group
n=44 Participants
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.
|
|---|---|---|
|
Number of Seroconverted Subjects for HPV-16 and HPV-18 Antigens at Month 7
Anti-HPV-16
|
64 Participants
|
1 Participants
|
|
Number of Seroconverted Subjects for HPV-16 and HPV-18 Antigens at Month 7
Anti-HPV-18
|
62 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: At Month 7 (i.e. 30 days after the vaccination at Month 6)Population: 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.
Antibody concentrations were assessed by ELISA and expressed as geometric mean concentrations (GMCs) in EU/mL.
Outcome measures
| Measure |
Cervarix Group
n=64 Participants
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.
|
Priorix + Infanrix Group
n=44 Participants
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.
|
|---|---|---|
|
Anti-HPV-16/18 Antibody Concentrations at Month 7
Anti-HPV-16
|
20080.0 EU/mL
Interval 16831.8 to 23954.9
|
10.4 EU/mL
Interval 8.7 to 12.5
|
|
Anti-HPV-16/18 Antibody Concentrations at Month 7
Anti-HPV-18
|
10621.8 EU/mL
Interval 8865.3 to 12726.3
|
9.6 EU/mL
Interval 8.4 to 11.1
|
SECONDARY outcome
Timeframe: At Month 7, Month 12 (for both groups) and at Month 18, Month 24 and Month 36 (only for Cervarix Group)Population: 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.
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.
Outcome measures
| Measure |
Cervarix Group
n=67 Participants
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.
|
Priorix + Infanrix Group
n=49 Participants
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.
|
|---|---|---|
|
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)
Anti-HPV-16, Month 7
|
64 Participants
|
1 Participants
|
|
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)
Anti-HPV-16, Month 12
|
65 Participants
|
1 Participants
|
|
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)
Anti-HPV-16, Month 18
|
66 Participants
|
—
|
|
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)
Anti-HPV-16, Month 24
|
67 Participants
|
—
|
|
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)
Anti-HPV-16, Month 36
|
67 Participants
|
—
|
|
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)
Anti-HPV-18, Month 7
|
62 Participants
|
1 Participants
|
|
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)
Anti-HPV-18, Month 12
|
63 Participants
|
0 Participants
|
|
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)
Anti-HPV-18, Month 18
|
64 Participants
|
—
|
|
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)
Anti-HPV-18, Month 24
|
65 Participants
|
—
|
|
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)
Anti-HPV-18, Month 36
|
65 Participants
|
—
|
SECONDARY outcome
Timeframe: At Month 7, Month 12 (for both groups) and at Month 18, Month 24 and Month 36 (only for Cervarix Group)Population: 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.
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.
Outcome measures
| Measure |
Cervarix Group
n=67 Participants
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.
|
Priorix + Infanrix Group
n=49 Participants
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.
|
|---|---|---|
|
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)
Anti-HPV-16, Month 7
|
20080.0 EU/mL
Interval 16831.8 to 23954.9
|
10.4 EU/mL
Interval 8.7 to 12.5
|
|
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)
Anti-HPV-16, Month 12
|
3246.5 EU/mL
Interval 2617.4 to 4026.8
|
9.7 EU/mL
Interval 9.3 to 10.2
|
|
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)
Anti-HPV-16, Month 18
|
2800.5 EU/mL
Interval 2325.8 to 3372.0
|
—
|
|
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)
Anti-HPV-16, Month 24
|
1951.9 EU/mL
Interval 1553.7 to 2452.2
|
—
|
|
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)
Anti-HPV-16, Month 36
|
1680.6 EU/mL
Interval 1384.2 to 2040.4
|
—
|
|
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)
Anti-HPV-18, Month 7
|
10621.8 EU/mL
Interval 8865.3 to 12726.3
|
9.6 EU/mL
Interval 8.4 to 11.1
|
|
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)
Anti-HPV-18, Month 12
|
1216.6 EU/mL
Interval 953.1 to 1553.0
|
9.0 EU/mL
Interval 9.0 to 9.0
|
|
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)
Anti-HPV-18, Month 18
|
802.9 EU/mL
Interval 632.4 to 1019.5
|
—
|
|
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)
Anti-HPV-18, Month 24
|
766.6 EU/mL
Interval 603.3 to 974.2
|
—
|
|
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)
Anti-HPV-18, Month 36
|
536.4 EU/mL
Interval 420.6 to 684.0
|
—
|
SECONDARY outcome
Timeframe: At Day 0 and Day 42 (i.e. 42 days after the vaccination at Day 0)Population: 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.
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.
Outcome measures
| Measure |
Cervarix Group
n=68 Participants
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.
|
Priorix + Infanrix Group
n=58 Participants
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.
|
|---|---|---|
|
Number of Seropositive Subjects for Measles Antigen
Anti-measles, Day 0
|
65 Participants
|
50 Participants
|
|
Number of Seropositive Subjects for Measles Antigen
Anti-measles, Day 42
|
67 Participants
|
58 Participants
|
SECONDARY outcome
Timeframe: At Day 0 and Day 42 (i.e. 42 days after the vaccination at Day 0)Population: 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.
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.
Outcome measures
| Measure |
Cervarix Group
n=68 Participants
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.
|
Priorix + Infanrix Group
n=58 Participants
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.
|
|---|---|---|
|
Anti-measles Antibody Concentrations
Anti-measles, Day 0
|
1029.8 mIU/mL
Interval 852.8 to 1243.6
|
694.8 mIU/mL
Interval 524.0 to 921.3
|
|
Anti-measles Antibody Concentrations
Anti-measles, Day 42
|
897.1 mIU/mL
Interval 748.8 to 1074.8
|
2512.3 mIU/mL
Interval 2140.3 to 2949.0
|
SECONDARY outcome
Timeframe: At Day 0 and Day 42 (i.e. 42 days after the vaccination at Day 0)Population: 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.
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.
Outcome measures
| Measure |
Cervarix Group
n=68 Participants
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.
|
Priorix + Infanrix Group
n=58 Participants
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.
|
|---|---|---|
|
Number of Seropositive Subjects for Mumps Antigen
Anti-mumps, Day 0
|
64 Participants
|
50 Participants
|
|
Number of Seropositive Subjects for Mumps Antigen
Anti-mumps, Day 42
|
66 Participants
|
57 Participants
|
SECONDARY outcome
Timeframe: At Day 0 and Day 42 (i.e. 42 days after the vaccination at Day 0)Population: 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.
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.
Outcome measures
| Measure |
Cervarix Group
n=68 Participants
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.
|
Priorix + Infanrix Group
n=58 Participants
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.
|
|---|---|---|
|
Anti-mumps Antibody Concentrations
Anti-mumps, Day 0
|
3613.7 U/mL
Interval 2742.1 to 4762.4
|
2142.6 U/mL
Interval 1492.7 to 3075.5
|
|
Anti-mumps Antibody Concentrations
Anti-mumps, Day 42
|
3594.1 U/mL
Interval 2749.1 to 4698.8
|
7001.1 U/mL
Interval 5414.9 to 9052.1
|
SECONDARY outcome
Timeframe: At Day 0 and Day 42 (i.e. 42 days after the vaccination at Day 0)Population: 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.
A seropositive subject was defined as a subject whose anti-rubella antibody titer was ≥ 4 IU/mL, as assessed by ELISA.
Outcome measures
| Measure |
Cervarix Group
n=68 Participants
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.
|
Priorix + Infanrix Group
n=58 Participants
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.
|
|---|---|---|
|
Number of Seropositive Subjects for Rubella Antigen
Anti-rubella, Day 42
|
68 Participants
|
58 Participants
|
|
Number of Seropositive Subjects for Rubella Antigen
Anti-rubella, Day 0
|
66 Participants
|
53 Participants
|
SECONDARY outcome
Timeframe: At Day 0 and Day 42 (i.e. 42 days after the vaccination at Day 0)Population: 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.
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.
Outcome measures
| Measure |
Cervarix Group
n=68 Participants
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.
|
Priorix + Infanrix Group
n=58 Participants
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.
|
|---|---|---|
|
Anti-rubella Antibody Concentrations
Anti-rubella, Day 0
|
82.0 IU/mL
Interval 69.4 to 96.8
|
48.9 IU/mL
Interval 36.3 to 65.9
|
|
Anti-rubella Antibody Concentrations
Anti-rubella, Day 42
|
79.3 IU/mL
Interval 67.3 to 93.6
|
124.2 IU/mL
Interval 107.0 to 144.2
|
SECONDARY outcome
Timeframe: At Month 7 (i.e. 30 days after the vaccination at Month 6)Population: 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.
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.
Outcome measures
| Measure |
Cervarix Group
n=65 Participants
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.
|
Priorix + Infanrix Group
n=47 Participants
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.
|
|---|---|---|
|
Number of Seroprotected Subjects Against Diphtheria and Tetanus Antigens
Anti-D
|
45 Participants
|
47 Participants
|
|
Number of Seroprotected Subjects Against Diphtheria and Tetanus Antigens
Anti-T
|
60 Participants
|
47 Participants
|
SECONDARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
Cervarix Group
n=74 Participants
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.
|
Priorix + Infanrix Group
n=74 Participants
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.
|
|---|---|---|
|
Number of Subjects With pIMDs From Day 0 up to Month 12
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
Cervarix Group
n=74 Participants
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.
|
Priorix + Infanrix Group
n=74 Participants
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.
|
|---|---|---|
|
Number of Subjects With MSCs From Day 0 up to Month 12
|
38 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
Cervarix Group
n=74 Participants
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.
|
Priorix + Infanrix Group
n=74 Participants
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.
|
|---|---|---|
|
Number of Subjects With SAEs From Day 0 up to Month 12
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
Cervarix Group
n=74 Participants
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.
|
Priorix + Infanrix Group
n=74 Participants
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.
|
|---|---|---|
|
Number of Subjects With SAEs Related to the Investigational Products or Any Fatal SAE
Related SAE(s)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With SAEs Related to the Investigational Products or Any Fatal SAE
Fatal SAE(s)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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)Population: 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.
The number of subjects with AEs and SAEs leading to premature discontinuation of study was assessed.
Outcome measures
| Measure |
Cervarix Group
n=74 Participants
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.
|
Priorix + Infanrix Group
n=74 Participants
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.
|
|---|---|---|
|
Number of Subjects With AEs/SAEs Leading to Withdrawal Throughout the Study Period
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the 43-day period (i.e. from the day of vaccination up to 42 subsequent days) following the vaccination at Day 0Population: 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.
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.
Outcome measures
| Measure |
Cervarix Group
n=74 Participants
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.
|
Priorix + Infanrix Group
n=74 Participants
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.
|
|---|---|---|
|
Number of Subjects Reporting the Intake of Concomitant Medication During the 43-day Period Following the Vaccination at Day 0
Any medication
|
45 Participants
|
36 Participants
|
|
Number of Subjects Reporting the Intake of Concomitant Medication During the 43-day Period Following the Vaccination at Day 0
Any antipyretic
|
29 Participants
|
24 Participants
|
|
Number of Subjects Reporting the Intake of Concomitant Medication During the 43-day Period Following the Vaccination at Day 0
Prophylactic antipyretic
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting the Intake of Concomitant Medication During the 43-day Period Following the Vaccination at Day 0
Any antibiotic
|
18 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: During the 30-day period (i.e. from the day of vaccination up to 29 subsequent days) following the vaccination at Month 6Population: 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.
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.
Outcome measures
| Measure |
Cervarix Group
n=74 Participants
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.
|
Priorix + Infanrix Group
n=71 Participants
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.
|
|---|---|---|
|
Number of Subjects Reporting the Intake of Concomitant Medication During the 30-day Period Following the Vaccination at Month 6
Any medication
|
19 Participants
|
23 Participants
|
|
Number of Subjects Reporting the Intake of Concomitant Medication During the 30-day Period Following the Vaccination at Month 6
Any antipyretic
|
10 Participants
|
8 Participants
|
|
Number of Subjects Reporting the Intake of Concomitant Medication During the 30-day Period Following the Vaccination at Month 6
Prophylactic antipyretic
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting the Intake of Concomitant Medication During the 30-day Period Following the Vaccination at Month 6
Any antibiotic
|
6 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: From Day 0 up to Month 6 (i.e. from first vaccination at Day 0 up to the second vaccination at Month 6)Population: 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.
The percentage of subjects who received the specified total number of doses (dose 1, dose 2, any dose) is reported.
Outcome measures
| Measure |
Cervarix Group
n=74 Participants
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.
|
Priorix + Infanrix Group
n=74 Participants
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.
|
|---|---|---|
|
Percentage of Subjects Completing the Vaccination Schedule in Both Groups
Subjects receiving at least 1 dose
|
100 Percentage of subjects
|
100 Percentage of subjects
|
|
Percentage of Subjects Completing the Vaccination Schedule in Both Groups
Subjects receiving only 1 dose
|
0 Percentage of subjects
|
4.1 Percentage of subjects
|
|
Percentage of Subjects Completing the Vaccination Schedule in Both Groups
Subjects receiving 2 doses
|
100 Percentage of subjects
|
95.9 Percentage of subjects
|
SECONDARY outcome
Timeframe: During the 43-day period (i.e. from the day of vaccination up to 42 subsequent days) following the vaccination at Day 0Population: 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.
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.
Outcome measures
| Measure |
Cervarix Group
n=74 Participants
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.
|
Priorix + Infanrix Group
n=74 Participants
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.
|
|---|---|---|
|
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
Any Fever
|
30 Participants
|
27 Participants
|
|
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
Grade 3 Fever
|
7 Participants
|
2 Participants
|
|
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
Related Fever
|
6 Participants
|
7 Participants
|
|
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
Any Measles/Rubella-like rash
|
1 Participants
|
1 Participants
|
|
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
Grade 3 Measles/Rubella-like rash
|
0 Participants
|
0 Participants
|
|
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
Related Measles/Rubella-like rash
|
1 Participants
|
1 Participants
|
|
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
Any Parotid gland swelling
|
0 Participants
|
0 Participants
|
|
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
Grade 3 Parotid gland swelling
|
0 Participants
|
0 Participants
|
|
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
Related Parotid gland swelling
|
0 Participants
|
0 Participants
|
|
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
Any Signs of meningism
|
0 Participants
|
1 Participants
|
|
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
Grade 3 Signs of meningism
|
0 Participants
|
0 Participants
|
|
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
Related Signs of meningism
|
0 Participants
|
1 Participants
|
Adverse Events
Cervarix Group
Serious events: 1 serious events
Other events: 70 other events
Deaths: 0 deaths
Priorix + Infanrix Group
Serious events: 2 serious events
Other events: 65 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cervarix Group
n=74 participants at risk
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.
|
Priorix + Infanrix Group
n=74 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Abscess limb
|
0.00%
0/74 • 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.
|
1.4%
1/74 • Number of events 1 • 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.
|
|
Infections and infestations
Gastroenteritis
|
1.4%
1/74 • Number of events 1 • 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.
|
1.4%
1/74 • Number of events 1 • 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.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/74 • 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.
|
1.4%
1/74 • Number of events 1 • 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.
|
Other adverse events
| Measure |
Cervarix Group
n=74 participants at risk
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.
|
Priorix + Infanrix Group
n=74 participants at risk
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.
|
|---|---|---|
|
General disorders
Pain
|
73.0%
54/74 • Number of events 88 • 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.
|
54.1%
40/74 • Number of events 51 • 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.
|
|
General disorders
Swelling
|
25.7%
19/74 • Number of events 22 • 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.
|
24.3%
18/74 • Number of events 21 • 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.
|
|
General disorders
Fatigue
|
20.3%
15/74 • Number of events 17 • 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.
|
13.5%
10/74 • Number of events 14 • 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.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.4%
1/74 • Number of events 1 • 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.
|
1.4%
1/74 • Number of events 1 • 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.
|
|
Infections and infestations
Acarodermatitis
|
2.7%
2/74 • Number of events 2 • 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.
|
0.00%
0/74 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
|
4.1%
3/74 • Number of events 3 • 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.
|
0.00%
0/74 • 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.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/74 • 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.
|
1.4%
1/74 • Number of events 1 • 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.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/74 • 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.
|
1.4%
1/74 • Number of events 1 • 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.
|
|
Gastrointestinal disorders
Anal fissure
|
1.4%
1/74 • Number of events 1 • 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.
|
0.00%
0/74 • 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.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.6%
13/74 • Number of events 15 • 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.
|
14.9%
11/74 • Number of events 16 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.7%
2/74 • Number of events 2 • 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.
|
4.1%
3/74 • Number of events 3 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis
|
0.00%
0/74 • 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.
|
1.4%
1/74 • Number of events 1 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
1.4%
1/74 • Number of events 1 • 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.
|
0.00%
0/74 • 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.
|
|
Infections and infestations
Bronchitis
|
1.4%
1/74 • Number of events 1 • 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.
|
0.00%
0/74 • 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.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
1.4%
1/74 • Number of events 1 • 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.
|
0.00%
0/74 • 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.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
1.4%
1/74 • Number of events 1 • 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.
|
0.00%
0/74 • 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.
|
|
Infections and infestations
Conjunctivitis
|
1.4%
1/74 • Number of events 1 • 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.
|
0.00%
0/74 • 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.
|
|
Eye disorders
Conjunctivitis allergic
|
1.4%
1/74 • Number of events 1 • 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.
|
0.00%
0/74 • 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.
|
|
Gastrointestinal disorders
Constipation
|
1.4%
1/74 • Number of events 1 • 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.
|
0.00%
0/74 • 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.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/74 • 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.
|
1.4%
1/74 • Number of events 1 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.7%
2/74 • Number of events 3 • 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.
|
1.4%
1/74 • Number of events 1 • 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.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
28.4%
21/74 • Number of events 24 • 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.
|
17.6%
13/74 • Number of events 15 • 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.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
4.1%
3/74 • Number of events 4 • 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.
|
1.4%
1/74 • Number of events 1 • 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.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
1.4%
1/74 • Number of events 1 • 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.
|
0.00%
0/74 • 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.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/74 • 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.
|
2.7%
2/74 • Number of events 2 • 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.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/74 • 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.
|
1.4%
1/74 • Number of events 1 • 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.
|
|
Infections and infestations
Ear infection
|
0.00%
0/74 • 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.
|
1.4%
1/74 • Number of events 1 • 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.
|
|
Ear and labyrinth disorders
Ear pain
|
1.4%
1/74 • Number of events 1 • 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.
|
0.00%
0/74 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/74 • 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.
|
1.4%
1/74 • Number of events 1 • 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.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
24.3%
18/74 • Number of events 22 • 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.
|
24.3%
18/74 • Number of events 19 • 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.
|
|
Eye disorders
Eye allergy
|
1.4%
1/74 • Number of events 1 • 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.
|
0.00%
0/74 • 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.
|
|
Gastrointestinal disorders
Food poisoning
|
1.4%
1/74 • Number of events 1 • 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.
|
0.00%
0/74 • 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.
|
|
Infections and infestations
Gastroenteritis
|
6.8%
5/74 • Number of events 5 • 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.
|
9.5%
7/74 • Number of events 7 • 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.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
14.9%
11/74 • Number of events 11 • 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.
|
21.6%
16/74 • Number of events 21 • 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.
|
|
Infections and infestations
Giardiasis
|
1.4%
1/74 • Number of events 1 • 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.
|
0.00%
0/74 • 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.
|
|
Infections and infestations
Gingival abscess
|
0.00%
0/74 • 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.
|
1.4%
1/74 • Number of events 1 • 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.
|
|
Injury, poisoning and procedural complications
Head injury
|
1.4%
1/74 • Number of events 1 • 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.
|
1.4%
1/74 • Number of events 1 • 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.
|
|
Nervous system disorders
Headache
|
24.3%
18/74 • Number of events 25 • 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.
|
33.8%
25/74 • Number of events 35 • 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.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/74 • 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.
|
1.4%
1/74 • Number of events 1 • 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.
|
|
Infections and infestations
Impetigo
|
4.1%
3/74 • Number of events 3 • 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.
|
0.00%
0/74 • 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.
|
|
Infections and infestations
Infection parasitic
|
1.4%
1/74 • Number of events 1 • 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.
|
2.7%
2/74 • Number of events 2 • 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.
|
|
Infections and infestations
Influenza
|
1.4%
1/74 • Number of events 1 • 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.
|
0.00%
0/74 • 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.
|
|
General disorders
Influenza like illness
|
0.00%
0/74 • 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.
|
1.4%
1/74 • Number of events 1 • 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.
|
|
Psychiatric disorders
Irritability
|
29.7%
22/74 • Number of events 31 • 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.
|
25.7%
19/74 • Number of events 24 • 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.
|
|
Infections and infestations
Lice infestation
|
0.00%
0/74 • 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.
|
1.4%
1/74 • Number of events 1 • 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.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/74 • 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.
|
1.4%
1/74 • Number of events 1 • 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.
|
|
Nervous system disorders
Meningism
|
0.00%
0/74 • 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.
|
1.4%
1/74 • Number of events 1 • 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.
|
|
Injury, poisoning and procedural complications
Mouth injury
|
1.4%
1/74 • Number of events 1 • 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.
|
0.00%
0/74 • 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.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
1.4%
1/74 • Number of events 1 • 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.
|
0.00%
0/74 • 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.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
28.4%
21/74 • Number of events 26 • 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.
|
18.9%
14/74 • Number of events 20 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.4%
1/74 • Number of events 1 • 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.
|
0.00%
0/74 • 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.
|
|
Infections and infestations
Nasopharyngitis
|
32.4%
24/74 • Number of events 28 • 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.
|
36.5%
27/74 • Number of events 33 • 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.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/74 • 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.
|
1.4%
1/74 • Number of events 1 • 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.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.4%
1/74 • Number of events 1 • 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.
|
0.00%
0/74 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/74 • 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.
|
1.4%
1/74 • Number of events 1 • 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.
|
|
Infections and infestations
Otitis externa
|
1.4%
1/74 • Number of events 1 • 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.
|
0.00%
0/74 • 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.
|
|
Infections and infestations
Otitis media
|
0.00%
0/74 • 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.
|
1.4%
1/74 • Number of events 1 • 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.
|
|
Infections and infestations
Otitis media acute
|
2.7%
2/74 • Number of events 2 • 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.
|
1.4%
1/74 • Number of events 1 • 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.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.4%
1/74 • Number of events 1 • 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.
|
1.4%
1/74 • Number of events 1 • 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.
|
|
Infections and infestations
Pharyngitis
|
8.1%
6/74 • Number of events 6 • 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.
|
5.4%
4/74 • Number of events 4 • 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.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/74 • 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.
|
1.4%
1/74 • Number of events 1 • 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.
|
|
Infections and infestations
Pyoderma
|
0.00%
0/74 • 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.
|
1.4%
1/74 • Number of events 1 • 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.
|
|
General disorders
Pyrexia
|
48.6%
36/74 • Number of events 39 • 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.
|
44.6%
33/74 • Number of events 39 • 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.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.1%
6/74 • Number of events 6 • 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.
|
6.8%
5/74 • Number of events 5 • 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.
|
|
Skin and subcutaneous tissue disorders
Rash morbilliform
|
1.4%
1/74 • Number of events 1 • 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.
|
1.4%
1/74 • Number of events 1 • 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.
|
|
Infections and infestations
Rhinitis
|
1.4%
1/74 • Number of events 1 • 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.
|
2.7%
2/74 • Number of events 2 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
1.4%
1/74 • Number of events 2 • 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.
|
1.4%
1/74 • Number of events 1 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/74 • 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.
|
1.4%
1/74 • Number of events 1 • 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.
|
|
Infections and infestations
Sinusitis
|
5.4%
4/74 • Number of events 4 • 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.
|
0.00%
0/74 • 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.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/74 • 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.
|
1.4%
1/74 • Number of events 1 • 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.
|
|
Nervous system disorders
Somnolence
|
21.6%
16/74 • Number of events 23 • 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.
|
20.3%
15/74 • Number of events 16 • 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.
|
|
Injury, poisoning and procedural complications
Stab wound
|
0.00%
0/74 • 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.
|
1.4%
1/74 • Number of events 1 • 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.
|
|
Infections and infestations
Tinea pedis
|
1.4%
1/74 • Number of events 1 • 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.
|
0.00%
0/74 • 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.
|
|
Infections and infestations
Tooth abscess
|
2.7%
2/74 • Number of events 2 • 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.
|
1.4%
1/74 • Number of events 1 • 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.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/74 • 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.
|
1.4%
1/74 • Number of events 1 • 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.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
13.5%
10/74 • Number of events 10 • 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.
|
9.5%
7/74 • Number of events 7 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Vasomotor rhinitis
|
1.4%
1/74 • Number of events 1 • 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.
|
1.4%
1/74 • Number of events 1 • 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.
|
|
Infections and infestations
Viral infection
|
2.7%
2/74 • Number of events 2 • 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.
|
2.7%
2/74 • Number of events 3 • 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.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/74 • 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.
|
1.4%
1/74 • Number of events 1 • 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.
|
|
Infections and infestations
Vulvovaginitis
|
1.4%
1/74 • Number of events 1 • 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.
|
1.4%
1/74 • Number of events 1 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER