Trial Outcomes & Findings for Consistency of Immunogenicity and Non Inferiority of GSK Biologicals' Candidate Malaria Vaccine Lots in Children (NCT NCT01323972)
NCT ID: NCT01323972
Last Updated: 2018-08-17
Results Overview
Antibody titers are presented as geometric mean titers (GMTs) and are measured in titers.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
327 participants
Primary outcome timeframe
One month post-dose 3 (Month 3)
Results posted on
2018-08-17
Participant Flow
Out of the 327 subjects originally enrolled, 7 dropped out of the study before receiving the first vaccination.
Participant milestones
| Measure |
GSK 257049-Lot 1 Group
Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine from the commercial scale lot 1 (formulation 1 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
|
GSK 257049-Lot 2 Group
Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 2 (formulation 2 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
|
GSK 257049-Lot 3 Group
Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 3 (formulation 3 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
|
GSK 257049-Pilot Group
Healthy male or female children aged 5 to 17 received 3 doses of the GSK 257049 vaccine from the pilot scale (pilot formulation of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
81
|
79
|
80
|
80
|
|
Overall Study
COMPLETED
|
79
|
76
|
78
|
79
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
2
|
1
|
Reasons for withdrawal
| Measure |
GSK 257049-Lot 1 Group
Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine from the commercial scale lot 1 (formulation 1 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
|
GSK 257049-Lot 2 Group
Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 2 (formulation 2 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
|
GSK 257049-Lot 3 Group
Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 3 (formulation 3 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
|
GSK 257049-Pilot Group
Healthy male or female children aged 5 to 17 received 3 doses of the GSK 257049 vaccine from the pilot scale (pilot formulation of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
0
|
|
Overall Study
Migrated/moved from study area
|
1
|
2
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
1
|
Baseline Characteristics
Consistency of Immunogenicity and Non Inferiority of GSK Biologicals' Candidate Malaria Vaccine Lots in Children
Baseline characteristics by cohort
| Measure |
GSK 257049-Pilot Group
n=80 Participants
Healthy male or female children aged 5 to 17 received 3 doses of the GSK 257049 vaccine from the pilot scale (pilot formulation of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
|
Total
n=320 Participants
Total of all reporting groups
|
GSK 257049-Lot 1 Group
n=81 Participants
Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine from the commercial scale lot 1 (formulation 1 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
|
GSK 257049-Lot 2 Group
n=79 Participants
Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 2 (formulation 2 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
|
GSK 257049-Lot 3 Group
n=80 Participants
Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 3 (formulation 3 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
|
|---|---|---|---|---|---|
|
Age, Continuous
|
10.2 Months
STANDARD_DEVIATION 3.01 • n=4 Participants
|
10.07 Months
STANDARD_DEVIATION 3.28 • n=21 Participants
|
9.8 Months
STANDARD_DEVIATION 3.35 • n=5 Participants
|
10.2 Months
STANDARD_DEVIATION 3.56 • n=7 Participants
|
10.1 Months
STANDARD_DEVIATION 3.24 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=4 Participants
|
147 Participants
n=21 Participants
|
44 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=4 Participants
|
173 Participants
n=21 Participants
|
37 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African heritage/African American
|
80 Participants
n=4 Participants
|
320 Participants
n=21 Participants
|
81 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One month post-dose 3 (Month 3)Population: The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Antibody titers are presented as geometric mean titers (GMTs) and are measured in titers.
Outcome measures
| Measure |
GSK 257049-Lot 1 Group
n=72 Participants
Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine from the commercial scale lot 1 (formulation 1 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
|
GSK 257049-Lot 2 Group
n=72 Participants
Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 2 (formulation 2 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
|
GSK 257049-Lot 3 Group
n=73 Participants
Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 3 (formulation 3 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
|
GSK 257049-Pooled Group
n=217 Participants
This is a pooled group, made up of GSK 257049-Lot 1 Group, GSK 257049-Lot 2 Group and GSK 257049-Lot 3 Group.
|
GSK 257049-Pilot Group
n=72 Participants
Healthy male or female children aged 5 to 17 received 3 doses of the GSK 257049 vaccine from the pilot scale (pilot formulation of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
|
|---|---|---|---|---|---|
|
Anti-Circumsporozoite (Anti-CS) Antibody Titers
|
319.6 Titers
Interval 268.9 to 379.8
|
241.4 Titers
Interval 207.6 to 280.7
|
302.3 Titers
Interval 259.4 to 352.3
|
285.8 Titers
Interval 260.7 to 313.3
|
271.7 Titers
Interval 228.5 to 323.1
|
SECONDARY outcome
Timeframe: One month post-dose 3 (Month 3)Population: The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).
Outcome measures
| Measure |
GSK 257049-Lot 1 Group
n=72 Participants
Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine from the commercial scale lot 1 (formulation 1 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
|
GSK 257049-Lot 2 Group
n=72 Participants
Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 2 (formulation 2 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
|
GSK 257049-Lot 3 Group
n=73 Participants
Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 3 (formulation 3 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
|
GSK 257049-Pooled Group
n=217 Participants
This is a pooled group, made up of GSK 257049-Lot 1 Group, GSK 257049-Lot 2 Group and GSK 257049-Lot 3 Group.
|
GSK 257049-Pilot Group
n=72 Participants
Healthy male or female children aged 5 to 17 received 3 doses of the GSK 257049 vaccine from the pilot scale (pilot formulation of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
|
|---|---|---|---|---|---|
|
Anti-hepatitis B (Anti-HB) Antibody Concentrations
|
54250.2 mIU/mL
Interval 43293.6 to 67979.7
|
46067.3 mIU/mL
Interval 33919.2 to 62566.2
|
67384.7 mIU/mL
Interval 52271.4 to 86867.7
|
55273.5 mIU/mL
Interval 47508.3 to 64308.0
|
74105.0 mIU/mL
Interval 58613.6 to 93690.7
|
SECONDARY outcome
Timeframe: Over a 7-day (Days 0-6)post-vaccination period after each dose and across dosesPopulation: The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with their symptom sheets filled in, 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 = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.
Outcome measures
| Measure |
GSK 257049-Lot 1 Group
n=81 Participants
Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine from the commercial scale lot 1 (formulation 1 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
|
GSK 257049-Lot 2 Group
n=79 Participants
Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 2 (formulation 2 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
|
GSK 257049-Lot 3 Group
n=80 Participants
Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 3 (formulation 3 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
|
GSK 257049-Pooled Group
n=80 Participants
This is a pooled group, made up of GSK 257049-Lot 1 Group, GSK 257049-Lot 2 Group and GSK 257049-Lot 3 Group.
|
GSK 257049-Pilot Group
Healthy male or female children aged 5 to 17 received 3 doses of the GSK 257049 vaccine from the pilot scale (pilot formulation of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
|
|---|---|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Across Doses
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Across Doses
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Across Doses
|
8 Participants
|
4 Participants
|
4 Participants
|
7 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Across Doses
|
8 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 1
|
16 Participants
|
14 Participants
|
15 Participants
|
13 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Dose 1
|
4 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 1
|
4 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 2
|
7 Participants
|
4 Participants
|
4 Participants
|
8 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Dose 2
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 2
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 3
|
4 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Dose 3
|
3 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 3
|
3 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Across Doses
|
27 Participants
|
20 Participants
|
20 Participants
|
22 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Across Doses
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Over a 7-day (Days 0-6) post-vaccination period after each dose and across dosesPopulation: The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with their symptom sheets filled in, for whom data were available.
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 loss of appetite = not eating at all. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 fever = fever higher than (\>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
GSK 257049-Lot 1 Group
n=81 Participants
Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine from the commercial scale lot 1 (formulation 1 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
|
GSK 257049-Lot 2 Group
n=79 Participants
Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 2 (formulation 2 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
|
GSK 257049-Lot 3 Group
n=80 Participants
Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 3 (formulation 3 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
|
GSK 257049-Pooled Group
n=80 Participants
This is a pooled group, made up of GSK 257049-Lot 1 Group, GSK 257049-Lot 2 Group and GSK 257049-Lot 3 Group.
|
GSK 257049-Pilot Group
Healthy male or female children aged 5 to 17 received 3 doses of the GSK 257049 vaccine from the pilot scale (pilot formulation of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
|
|---|---|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Irritability, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever, Across doses
|
49 Participants
|
41 Participants
|
47 Participants
|
41 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever, Across doses
|
27 Participants
|
19 Participants
|
27 Participants
|
18 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever, Across doses
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness, Across doses
|
6 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness, Across doses
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness, Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Irritability, Across doses
|
12 Participants
|
4 Participants
|
10 Participants
|
9 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Irritability, Across doses
|
5 Participants
|
1 Participants
|
4 Participants
|
5 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability, Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite, Across doses
|
11 Participants
|
7 Participants
|
4 Participants
|
7 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite, Across doses
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite, Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness, Dose 1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Irritability, Dose 1
|
3 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite, Dose 1
|
4 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite, Dose 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever, Dose 1
|
25 Participants
|
23 Participants
|
27 Participants
|
24 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever, Dose 1
|
11 Participants
|
8 Participants
|
11 Participants
|
5 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever, Dose 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness, Dose 2
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness, Dose 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Irritability, Dose 2
|
4 Participants
|
1 Participants
|
4 Participants
|
7 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Irritability, Dose 2
|
2 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite, Dose 2
|
5 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite, Dose 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever, Dose 2
|
28 Participants
|
17 Participants
|
24 Participants
|
20 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever, Dose 2
|
11 Participants
|
7 Participants
|
9 Participants
|
7 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever, Dose 2
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness, Dose 3
|
3 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness, Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness, Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Irritability, Dose 3
|
6 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Irritability, Dose 3
|
3 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability, Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite, Dose 3
|
3 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite, Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite, Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever, Dose 3
|
23 Participants
|
10 Participants
|
21 Participants
|
19 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever, Dose 3
|
15 Participants
|
6 Participants
|
15 Participants
|
10 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever, Dose 3
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Within the 30-day (Days 0-29) post-vaccination periodPopulation: The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
GSK 257049-Lot 1 Group
n=81 Participants
Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine from the commercial scale lot 1 (formulation 1 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
|
GSK 257049-Lot 2 Group
n=79 Participants
Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 2 (formulation 2 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
|
GSK 257049-Lot 3 Group
n=80 Participants
Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 3 (formulation 3 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
|
GSK 257049-Pooled Group
n=80 Participants
This is a pooled group, made up of GSK 257049-Lot 1 Group, GSK 257049-Lot 2 Group and GSK 257049-Lot 3 Group.
|
GSK 257049-Pilot Group
Healthy male or female children aged 5 to 17 received 3 doses of the GSK 257049 vaccine from the pilot scale (pilot formulation of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
|
|---|---|---|---|---|---|
|
Number of Subjects With Unsolicited Adverse Events
|
63 Participants
|
60 Participants
|
70 Participants
|
58 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 8 months post-dose 1Population: The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Outcome measures
| Measure |
GSK 257049-Lot 1 Group
n=81 Participants
Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine from the commercial scale lot 1 (formulation 1 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
|
GSK 257049-Lot 2 Group
n=79 Participants
Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 2 (formulation 2 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
|
GSK 257049-Lot 3 Group
n=80 Participants
Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 3 (formulation 3 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
|
GSK 257049-Pooled Group
n=80 Participants
This is a pooled group, made up of GSK 257049-Lot 1 Group, GSK 257049-Lot 2 Group and GSK 257049-Lot 3 Group.
|
GSK 257049-Pilot Group
Healthy male or female children aged 5 to 17 received 3 doses of the GSK 257049 vaccine from the pilot scale (pilot formulation of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
|
|---|---|---|---|---|---|
|
Number of Subjects With Serious Adverse Events
|
6 Participants
|
5 Participants
|
12 Participants
|
4 Participants
|
—
|
Adverse Events
GSK 257049-Lot 1 Group
Serious events: 6 serious events
Other events: 77 other events
Deaths: 0 deaths
GSK 257049-Lot 2 Group
Serious events: 5 serious events
Other events: 71 other events
Deaths: 0 deaths
GSK 257049-Lot 3 Group
Serious events: 12 serious events
Other events: 71 other events
Deaths: 0 deaths
GSK 257049-Pilot Group
Serious events: 4 serious events
Other events: 67 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GSK 257049-Lot 1 Group
n=81 participants at risk
Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine from the commercial scale lot 1 (formulation 1 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
|
GSK 257049-Lot 2 Group
n=79 participants at risk
Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 2 (formulation 2 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
|
GSK 257049-Lot 3 Group
n=80 participants at risk
Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 3 (formulation 3 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
|
GSK 257049-Pilot Group
n=80 participants at risk
Healthy male or female children aged 5 to 17 received 3 doses of the GSK 257049 vaccine from the pilot scale (pilot formulation of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
|
|---|---|---|---|---|
|
Infections and infestations
Bronchopneumonia
|
4.9%
4/81 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
2.5%
2/79 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
7.5%
6/80 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
1.2%
1/80 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
|
Infections and infestations
Malaria
|
4.9%
4/81 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
5.1%
4/79 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
5.0%
4/80 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
1.2%
1/80 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/81 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
3.8%
3/79 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
3.8%
3/80 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
0.00%
0/80 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
|
Infections and infestations
Sepsis
|
2.5%
2/81 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
1.3%
1/79 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
0.00%
0/80 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
2.5%
2/80 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/81 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
1.3%
1/79 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
2.5%
2/80 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
1.2%
1/80 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
|
Metabolism and nutrition disorders
Malnutrition
|
1.2%
1/81 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
0.00%
0/79 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
0.00%
0/80 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
0.00%
0/80 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
|
Injury, poisoning and procedural complications
Pneumonitis chemical
|
0.00%
0/81 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
0.00%
0/79 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
1.2%
1/80 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
0.00%
0/80 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
Other adverse events
| Measure |
GSK 257049-Lot 1 Group
n=81 participants at risk
Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine from the commercial scale lot 1 (formulation 1 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
|
GSK 257049-Lot 2 Group
n=79 participants at risk
Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 2 (formulation 2 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
|
GSK 257049-Lot 3 Group
n=80 participants at risk
Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 3 (formulation 3 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
|
GSK 257049-Pilot Group
n=80 participants at risk
Healthy male or female children aged 5 to 17 received 3 doses of the GSK 257049 vaccine from the pilot scale (pilot formulation of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2.
|
|---|---|---|---|---|
|
Infections and infestations
Malaria
|
44.4%
36/81 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
44.3%
35/79 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
51.2%
41/80 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
41.2%
33/80 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
|
Infections and infestations
Respiratory tract infection
|
33.3%
27/81 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
29.1%
23/79 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
33.8%
27/80 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
28.7%
23/80 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
|
Infections and infestations
Upper respiratory tract infection
|
22.2%
18/81 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
24.1%
19/79 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
28.7%
23/80 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
20.0%
16/80 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
|
Infections and infestations
Gastroenteritis
|
9.9%
8/81 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
15.2%
12/79 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
8.8%
7/80 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
10.0%
8/80 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
|
Gastrointestinal disorders
Diarrhoea
|
11.1%
9/81 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
3.8%
3/79 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
2.5%
2/80 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
8.8%
7/80 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
|
Infections and infestations
Bronchopneumonia
|
3.7%
3/81 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
3.8%
3/79 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
10.0%
8/80 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
2.5%
2/80 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
|
Gastrointestinal disorders
Enteritis
|
8.6%
7/81 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
6.3%
5/79 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
6.2%
5/80 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
3.8%
3/80 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
|
Infections and infestations
Furuncle
|
4.9%
4/81 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
6.3%
5/79 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
6.2%
5/80 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
7.5%
6/80 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.5%
2/81 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
6.3%
5/79 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
2.5%
2/80 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
1.2%
1/80 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
|
General disorders
Pain
|
33.3%
27/81 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
25.3%
20/79 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
25.0%
20/80 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
27.5%
22/80 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
|
General disorders
Redness
|
9.9%
8/81 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
5.1%
4/79 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
5.0%
4/80 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
8.8%
7/80 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
|
General disorders
Swelling
|
9.9%
8/81 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
7.6%
6/79 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
7.5%
6/80 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
7.5%
6/80 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
|
General disorders
Drowsiness
|
7.4%
6/81 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
3.8%
3/79 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
3.8%
3/80 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
3.8%
3/80 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
|
General disorders
Irritability
|
14.8%
12/81 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
5.1%
4/79 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
12.5%
10/80 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
11.2%
9/80 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
|
General disorders
Loss of appetite
|
13.6%
11/81 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
8.9%
7/79 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
5.0%
4/80 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
8.8%
7/80 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
|
General disorders
Fever (axillary)
|
60.5%
49/81 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
51.9%
41/79 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
58.8%
47/80 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
51.2%
41/80 • Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
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