Trial Outcomes & Findings for Immunogenicity and Safety of Meningococcal Vaccine GSK134612 Given as 1 or 2 Doses to Healthy 9-12 Months Old Toddlers. (NCT NCT00471081)
NCT ID: NCT00471081
Last Updated: 2019-06-25
Results Overview
The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
385 participants
Primary outcome timeframe
One month after the last dose (at Month 4)
Results posted on
2019-06-25
Participant Flow
A total of 196 subjects were enrolled and randomized in the GSK 134612 1 dose Group at the study start but 36 subjects were not vaccinated, due to the 3-month period between enrollment and vaccination.
The majority of subjects withdrawn in the active Phase were still contacted for the safety follow-up, therefore the subjects listed as withdrawn were not necessarily the same individuals in the two phases (Active Phase and Extended Safety Follow-Up).
Participant milestones
| Measure |
GSK 134612 1 Dose Group
Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 vaccine at 12 months of age, administered intramuscularly in the left thigh.
|
GSK 134612 2 Doses Group
Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 at 9 months of age and another dose at 12 months of age, administered intramuscularly in the left thigh.
|
|---|---|---|
|
Active Phase
STARTED
|
160
|
189
|
|
Active Phase
COMPLETED
|
158
|
176
|
|
Active Phase
NOT COMPLETED
|
2
|
13
|
|
Extended Safety Follow-Up
STARTED
|
160
|
189
|
|
Extended Safety Follow-Up
COMPLETED
|
158
|
176
|
|
Extended Safety Follow-Up
NOT COMPLETED
|
2
|
13
|
Reasons for withdrawal
| Measure |
GSK 134612 1 Dose Group
Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 vaccine at 12 months of age, administered intramuscularly in the left thigh.
|
GSK 134612 2 Doses Group
Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 at 9 months of age and another dose at 12 months of age, administered intramuscularly in the left thigh.
|
|---|---|---|
|
Active Phase
Protocol Violation
|
1
|
1
|
|
Active Phase
Withdrawal by Subject
|
0
|
3
|
|
Active Phase
Lost to Follow-up
|
0
|
1
|
|
Active Phase
Lost health plan/insurance
|
1
|
8
|
|
Extended Safety Follow-Up
Withdrawal by Subject
|
1
|
4
|
|
Extended Safety Follow-Up
Lost to Follow-up
|
1
|
8
|
|
Extended Safety Follow-Up
Missing confirmed
|
0
|
1
|
Baseline Characteristics
Immunogenicity and Safety of Meningococcal Vaccine GSK134612 Given as 1 or 2 Doses to Healthy 9-12 Months Old Toddlers.
Baseline characteristics by cohort
| Measure |
GSK 134612 1 Dose Group
n=160 Participants
Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 vaccine at 12 months of age, administered intramuscularly in the left thigh.
|
GSK 134612 2 Doses Group
n=189 Participants
Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 at 9 months of age and another dose at 12 months of age, administered intramuscularly in the left thigh.
|
Total
n=349 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
9 Months
STANDARD_DEVIATION 0.08 • n=5 Participants
|
9 Months
STANDARD_DEVIATION 0.0 • n=7 Participants
|
9 Months
STANDARD_DEVIATION 0.05 • n=5 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
178 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
83 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
171 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One month after the last dose (at Month 4)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8.
Outcome measures
| Measure |
GSK 134612 1 Dose Group
n=132 Participants
Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 vaccine at 12 months of age, administered intramuscularly in the left thigh.
|
GSK 134612 2 Doses Group
n=146 Participants
Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 at 9 months of age and another dose at 12 months of age, administered intramuscularly in the left thigh.
|
|---|---|---|
|
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value
hSBA-MenA
|
105 Participants
|
122 Participants
|
|
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value
hSBA-MenC
|
123 Participants
|
137 Participants
|
|
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value
hSBA-MenW-135
|
60 Participants
|
142 Participants
|
|
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value
hSBA-MenY
|
74 Participants
|
145 Participants
|
SECONDARY outcome
Timeframe: One month after the first dose (at Month 1)Population: This analysis was performed on subjects who have received the Month 0 vaccination in the GSK 134612 2 doses Group from the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8.
Outcome measures
| Measure |
GSK 134612 1 Dose Group
n=131 Participants
Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 vaccine at 12 months of age, administered intramuscularly in the left thigh.
|
GSK 134612 2 Doses Group
Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 at 9 months of age and another dose at 12 months of age, administered intramuscularly in the left thigh.
|
|---|---|---|
|
Number of Subjects With Serum Bactericidal Assay Using hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value
hSBA-MenA
|
81 Participants
|
—
|
|
Number of Subjects With Serum Bactericidal Assay Using hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value
hSBA-MenC
|
115 Participants
|
—
|
|
Number of Subjects With Serum Bactericidal Assay Using hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value
hSBA-MenW-135
|
22 Participants
|
—
|
|
Number of Subjects With Serum Bactericidal Assay Using hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value
hSBA-MenY
|
49 Participants
|
—
|
SECONDARY outcome
Timeframe: At Month 1 (for GSK 134612 2 doses Group only) and Month 4Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. Month 1 data are not available for the GSK 134612 1 dose Group (only vaccinated at Month 3).
The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.
Outcome measures
| Measure |
GSK 134612 1 Dose Group
n=132 Participants
Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 vaccine at 12 months of age, administered intramuscularly in the left thigh.
|
GSK 134612 2 Doses Group
n=146 Participants
Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 at 9 months of age and another dose at 12 months of age, administered intramuscularly in the left thigh.
|
|---|---|---|
|
Number of Subjects With Serum Bactericidal Assay Using hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value
hSBA-MenA, Month 1
|
—
|
90 Participants
|
|
Number of Subjects With Serum Bactericidal Assay Using hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value
hSBA-MenA, Month 4
|
115 Participants
|
122 Participants
|
|
Number of Subjects With Serum Bactericidal Assay Using hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value
hSBA-MenC, Month 1
|
—
|
115 Participants
|
|
Number of Subjects With Serum Bactericidal Assay Using hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value
hSBA-MenC, Month 4
|
123 Participants
|
137 Participants
|
|
Number of Subjects With Serum Bactericidal Assay Using hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value
hSBA-MenW-135, Month 1
|
—
|
24 Participants
|
|
Number of Subjects With Serum Bactericidal Assay Using hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value
hSBA-MenW-135, Month 4
|
63 Participants
|
142 Participants
|
|
Number of Subjects With Serum Bactericidal Assay Using hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value
hSBA-MenY, Month 1
|
—
|
52 Participants
|
|
Number of Subjects With Serum Bactericidal Assay Using hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value
hSBA-MenY, Month 4
|
79 Participants
|
145 Participants
|
SECONDARY outcome
Timeframe: At Month 1 (for GSK 134612 2 doses Group only) and Month 4Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. Month 1 data are not available for the GSK 134612 1 dose Group (only vaccinated at Month 3).
Antibody titers were presented as geometric mean titers (GMTs).
Outcome measures
| Measure |
GSK 134612 1 Dose Group
n=132 Participants
Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 vaccine at 12 months of age, administered intramuscularly in the left thigh.
|
GSK 134612 2 Doses Group
n=146 Participants
Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 at 9 months of age and another dose at 12 months of age, administered intramuscularly in the left thigh.
|
|---|---|---|
|
hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers
hSBA-MenA, Month 1
|
—
|
13.6 Titers
Interval 10.5 to 17.7
|
|
hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers
hSBA-MenA, Month 4
|
24.9 Titers
Interval 19.5 to 31.9
|
50.8 Titers
Interval 39.6 to 65.1
|
|
hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers
hSBA-MenC, Month 1
|
—
|
83.7 Titers
Interval 63.8 to 110.0
|
|
hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers
hSBA-MenC, Month 4
|
161.5 Titers
Interval 126.3 to 206.5
|
1105.5 Titers
Interval 906.2 to 1348.6
|
|
hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers
hSBA-MenW-135, Month 1
|
—
|
3.5 Titers
Interval 2.8 to 4.3
|
|
hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers
hSBA-MenW-135, Month 4
|
11.6 Titers
Interval 8.2 to 16.4
|
1062.9 Titers
Interval 878.4 to 1286.3
|
|
hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers
hSBA-MenY, Month 1
|
—
|
7.0 Titers
Interval 5.2 to 9.5
|
|
hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers
hSBA-MenY, Month 4
|
15.7 Titers
Interval 11.1 to 22.1
|
475.2 Titers
Interval 392.2 to 575.9
|
SECONDARY outcome
Timeframe: At Month 1 (for GSK 134612 2 doses Group only) and Month 4Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. Month 1 data are not available for the GSK 134612 1 dose Group (only vaccinated at Month 3).
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8.
Outcome measures
| Measure |
GSK 134612 1 Dose Group
n=51 Participants
Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 vaccine at 12 months of age, administered intramuscularly in the left thigh.
|
GSK 134612 2 Doses Group
n=51 Participants
Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 at 9 months of age and another dose at 12 months of age, administered intramuscularly in the left thigh.
|
|---|---|---|
|
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value
rSBA-MenA, Month 1
|
—
|
41 Participants
|
|
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value
rSBA-MenA, Month 4
|
51 Participants
|
47 Participants
|
|
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value
rSBA-MenC, Month 1
|
—
|
42 Participants
|
|
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value
rSBA-MenC, Month 4
|
51 Participants
|
51 Participants
|
|
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value
rSBA-MenW-135, Month 1
|
—
|
43 Participants
|
|
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value
rSBA-MenW-135, Month 4
|
51 Participants
|
50 Participants
|
|
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value
rSBA-MenY, Month 1
|
—
|
42 Participants
|
|
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value
rSBA-MenY, Month 4
|
50 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: At Month 1 (GSK 134612 2 doses Group only) and Month 4Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. Month 1 data are not available for the GSK 134612 1 dose Group (only vaccinated at Month 3).
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:128.
Outcome measures
| Measure |
GSK 134612 1 Dose Group
n=51 Participants
Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 vaccine at 12 months of age, administered intramuscularly in the left thigh.
|
GSK 134612 2 Doses Group
n=51 Participants
Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 at 9 months of age and another dose at 12 months of age, administered intramuscularly in the left thigh.
|
|---|---|---|
|
Number of Subjects With Serum Bactericidal Assay Using rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to the Cut-off Value
rSBA-MenA, Month 1
|
—
|
41 Participants
|
|
Number of Subjects With Serum Bactericidal Assay Using rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to the Cut-off Value
rSBA-MenA, Month 4
|
50 Participants
|
47 Participants
|
|
Number of Subjects With Serum Bactericidal Assay Using rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to the Cut-off Value
rSBA-MenC, Month 1
|
—
|
35 Participants
|
|
Number of Subjects With Serum Bactericidal Assay Using rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to the Cut-off Value
rSBA-MenC, Month 4
|
44 Participants
|
50 Participants
|
|
Number of Subjects With Serum Bactericidal Assay Using rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to the Cut-off Value
rSBA-MenW-135, Month 1
|
—
|
43 Participants
|
|
Number of Subjects With Serum Bactericidal Assay Using rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to the Cut-off Value
rSBA-MenW-135, Month 4
|
51 Participants
|
50 Participants
|
|
Number of Subjects With Serum Bactericidal Assay Using rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to the Cut-off Value
rSBA-MenY, Month 1
|
—
|
42 Participants
|
|
Number of Subjects With Serum Bactericidal Assay Using rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to the Cut-off Value
rSBA-MenY, Month 4
|
49 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: At Month 1 (GSK 134612 2 doses Group only) and Month 4Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. Month 1 data are not available for the GSK 134612 1 dose Group (only vaccinated at Month 3).
Antibody titers were presented as geometric mean titers (GMTs).
Outcome measures
| Measure |
GSK 134612 1 Dose Group
n=51 Participants
Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 vaccine at 12 months of age, administered intramuscularly in the left thigh.
|
GSK 134612 2 Doses Group
n=51 Participants
Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 at 9 months of age and another dose at 12 months of age, administered intramuscularly in the left thigh.
|
|---|---|---|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers
rSBA-MenA, Month 1
|
—
|
1092.6 Titers
Interval 839.0 to 1422.9
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers
rSBA-MenA, Month 4
|
1911.5 Titers
Interval 1390.1 to 2628.5
|
1179.1 Titers
Interval 931.0 to 1493.3
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers
rSBA-MenC, Month 1
|
—
|
229.3 Titers
Interval 165.4 to 317.9
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers
rSBA-MenC, Month 4
|
456.3 Titers
Interval 336.2 to 619.4
|
1484.4 Titers
Interval 1110.3 to 1984.6
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers
rSBA-MenW-135, Month 1
|
—
|
1412.3 Titers
Interval 1029.7 to 1936.9
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers
rSBA-MenW-135, Month 4
|
3069.9 Titers
Interval 2246.9 to 4194.4
|
1771.6 Titers
Interval 1363.0 to 2302.7
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers
rSBA-MenY, Month 1
|
—
|
817.1 Titers
Interval 671.0 to 995.1
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers
rSBA-MenY, Month 4
|
1521.0 Titers
Interval 1100.8 to 2101.7
|
1125.9 Titers
Interval 938.7 to 1350.3
|
SECONDARY outcome
Timeframe: At Month 1 (GSK 134612 2 doses Group only) and Month 4Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. Month 1 data are not available for the GSK 134612 1 dose Group (only vaccinated at Month 3).
The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL).
Outcome measures
| Measure |
GSK 134612 1 Dose Group
n=60 Participants
Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 vaccine at 12 months of age, administered intramuscularly in the left thigh.
|
GSK 134612 2 Doses Group
n=66 Participants
Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 at 9 months of age and another dose at 12 months of age, administered intramuscularly in the left thigh.
|
|---|---|---|
|
Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value
Anti-PSA, Month 1
|
—
|
35 Participants
|
|
Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value
Anti-PSA, Month 4
|
26 Participants
|
29 Participants
|
|
Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value
Anti-PSC, Month 1
|
—
|
66 Participants
|
|
Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value
Anti-PSC, Month 4
|
60 Participants
|
56 Participants
|
|
Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value
Anti-PSW-135, Month 1
|
—
|
31 Participants
|
|
Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value
Anti-PSW-135, Month 4
|
30 Participants
|
54 Participants
|
|
Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value
Anti-PSY, Month 1
|
—
|
25 Participants
|
|
Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value
Anti-PSY, Month 4
|
36 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: At Month 1 (GSK 134612 s doses Group only) and Month 4Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. Month 1 data are not available for the GSK 134612 1 dose Group (only vaccinated at Month 3).
The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 2.0 micrograms per milliliter (μg/mL).
Outcome measures
| Measure |
GSK 134612 1 Dose Group
n=60 Participants
Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 vaccine at 12 months of age, administered intramuscularly in the left thigh.
|
GSK 134612 2 Doses Group
n=66 Participants
Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 at 9 months of age and another dose at 12 months of age, administered intramuscularly in the left thigh.
|
|---|---|---|
|
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Greater Than or Equal to the Cut-off Value
Anti-PSA, Month 1
|
—
|
35 Participants
|
|
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Greater Than or Equal to the Cut-off Value
Anti-PSA, Month 4
|
26 Participants
|
27 Participants
|
|
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Greater Than or Equal to the Cut-off Value
Anti-PSC, Month 1
|
—
|
65 Participants
|
|
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Greater Than or Equal to the Cut-off Value
Anti-PSC, Month 4
|
59 Participants
|
40 Participants
|
|
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Greater Than or Equal to the Cut-off Value
Anti-PSW-135, Month 1
|
—
|
26 Participants
|
|
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Greater Than or Equal to the Cut-off Value
Anti-PSW-135, Month 4
|
29 Participants
|
53 Participants
|
|
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Greater Than or Equal to the Cut-off Value
Anti-PSY, Month 1
|
—
|
16 Participants
|
|
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Greater Than or Equal to the Cut-off Value
Anti-PSY, Month 4
|
33 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: At Month 1 (GSK 134612 2 doses Group only) and Month 4Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. Month 1 data are not available for the GSK 134612 1 dose Group (only vaccinated at Month 3).
Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).
Outcome measures
| Measure |
GSK 134612 1 Dose Group
n=60 Participants
Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 vaccine at 12 months of age, administered intramuscularly in the left thigh.
|
GSK 134612 2 Doses Group
n=66 Participants
Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 at 9 months of age and another dose at 12 months of age, administered intramuscularly in the left thigh.
|
|---|---|---|
|
Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations
Anti-PSA, Month 1
|
—
|
12.39 μg/mL
Interval 9.31 to 16.48
|
|
Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations
Anti-PSA, Month 4
|
35.92 μg/mL
Interval 25.68 to 50.23
|
5.59 μg/mL
Interval 4.2 to 7.44
|
|
Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations
Anti-PSC, Month 1
|
—
|
8.15 μg/mL
Interval 7.05 to 9.42
|
|
Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations
Anti-PSC, Month 4
|
10.91 μg/mL
Interval 9.26 to 12.86
|
3.42 μg/mL
Interval 2.85 to 4.09
|
|
Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations
Anti-PSW-135, Month 1
|
—
|
4.42 μg/mL
Interval 3.2 to 6.11
|
|
Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations
Anti-PSW-135, Month 4
|
7.37 μg/mL
Interval 4.89 to 11.12
|
13.47 μg/mL
Interval 10.99 to 16.51
|
|
Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations
Anti-PSY, Month 1
|
—
|
3.40 μg/mL
Interval 2.17 to 5.33
|
|
Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations
Anti-PSY, Month 4
|
8.19 μg/mL
Interval 5.71 to 11.73
|
12.43 μg/mL
Interval 9.95 to 15.53
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) and 8-day (Days 0-7) periods following each vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had the symptoms sheet filled in and for whom data were available. Post-Dose 2 data are not available for the GSK 134612 1 dose Group (received a single vaccination).
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 30 millimeters (mm) of injection site.
Outcome measures
| Measure |
GSK 134612 1 Dose Group
n=156 Participants
Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 vaccine at 12 months of age, administered intramuscularly in the left thigh.
|
GSK 134612 2 Doses Group
n=182 Participants
Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 at 9 months of age and another dose at 12 months of age, administered intramuscularly in the left thigh.
|
|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 2, Days 0-7
|
—
|
19 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 1, Days 0-3
|
34 Participants
|
54 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 1, Days 0-3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Dose 1, Days 0-3
|
28 Participants
|
49 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Dose 1, Days 0-3
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 1, Days 0-3
|
13 Participants
|
27 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 1, Days 0-3
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 2, Days 0-3
|
—
|
42 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 2, Days 0-3
|
—
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Dose 2, Days 0-3
|
—
|
37 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Dose 2, Days 0-3
|
—
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 2, Days 0-3
|
—
|
19 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 2, Days 0-3
|
—
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 1, Days 0-7
|
35 Participants
|
54 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 1, Days 0-7
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Dose 1, Days 0-7
|
28 Participants
|
49 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Dose 1, Days 0-7
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 1, Days 0-7
|
13 Participants
|
27 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 1, Days 0-7
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 2, Days 0-7
|
—
|
42 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 2, Days 0-7
|
—
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Dose 2, Days 0-7
|
—
|
37 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Dose 2, Days 0-7
|
—
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 2, Days 0-7
|
—
|
0 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) and 8-day (Days 0-7) periods following each vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had the symptoms sheet filled in and for whom data were available. Post-Dose 2 data are not available for the GSK 134612 1 dose Group (received a single vaccination).
Assessed solicited general symptoms were drowsiness, fever \[defined as axillary, oral, tympanic or rectal temperature equal to or above (≥) 38 degrees Celsius (°C)\], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever higher than (\>) 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
GSK 134612 1 Dose Group
n=157 Participants
Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 vaccine at 12 months of age, administered intramuscularly in the left thigh.
|
GSK 134612 2 Doses Group
n=184 Participants
Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 at 9 months of age and another dose at 12 months of age, administered intramuscularly in the left thigh.
|
|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness, Dose 1, Days 0-3
|
42 Participants
|
63 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness, Dose 1, Days 0-3
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness, Dose 1, Days 0-3
|
32 Participants
|
51 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever, Dose 1, Days 0-3
|
12 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever, Dose 1, Days 0-3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever, Dose 1, Days 0-3
|
7 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Irritability, Dose 1, Days 0-3
|
63 Participants
|
101 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability, Dose 1, Days 0-3
|
2 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Irritability, Dose 1, Days 0-3
|
48 Participants
|
87 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite, Dose 1, Days 0-3
|
34 Participants
|
42 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite, Dose 1, Days 0-3
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite, Dose 1, Days 0-3
|
19 Participants
|
31 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness, Dose 2, Days 0-3
|
—
|
47 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness, Dose 2, Days 0-3
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness, Dose 2, Days 0-3
|
—
|
36 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever, Dose 2, Days 0-3
|
—
|
11 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever, Dose 2, Days 0-3
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever, Dose 2, Days 0-3
|
—
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Irritability, Dose 2, Days 0-3
|
—
|
77 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability, Dose 2, Days 0-3
|
—
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Irritability, Dose 2, Days 0-3
|
—
|
59 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite, Dose 2, Days 0-3
|
—
|
46 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite, Dose 2, Days 0-3
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite, Dose 2, Days 0-3
|
—
|
32 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness, Dose 1, Days 0-7
|
52 Participants
|
70 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness, Dose 1, Days 0-7
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness, Dose 1, Days 0-7
|
37 Participants
|
53 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever, Dose 1, Days 0-7
|
17 Participants
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever, Dose 1, Days 0-7
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever, Dose 1, Days 0-7
|
7 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Irritability, Dose 1, Days 0-7
|
69 Participants
|
103 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability, Dose 1, Days 0-7
|
4 Participants
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Irritability, Dose 1, Days 0-7
|
48 Participants
|
87 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite, Dose 1, Days 0-7
|
42 Participants
|
48 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite, Dose 1, Days 0-7
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite, Dose 1, Days 0-7
|
22 Participants
|
33 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness, Dose 2, Days 0-7
|
—
|
52 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness, Dose 2, Days 0-7
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness, Dose 2, Days 0-7
|
—
|
39 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever, Dose 2, Days 0-7
|
—
|
16 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever, Dose 2, Days 0-7
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever, Dose 2, Days 0-7
|
—
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Irritability, Dose 2, Days 0-7
|
—
|
84 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability, Dose 2, Days 0-7
|
—
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Irritability, Dose 2, Days 0-7
|
—
|
62 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite, Dose 2, Days 0-7
|
—
|
51 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite, Dose 2, Days 0-7
|
—
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite, Dose 2, Days 0-7
|
—
|
32 Participants
|
SECONDARY outcome
Timeframe: Up to 1 month post-vaccinationPopulation: The analysis was 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 134612 1 Dose Group
n=160 Participants
Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 vaccine at 12 months of age, administered intramuscularly in the left thigh.
|
GSK 134612 2 Doses Group
n=189 Participants
Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 at 9 months of age and another dose at 12 months of age, administered intramuscularly in the left thigh.
|
|---|---|---|
|
Number of Subjects With Any Unsolicited Adverse Events (AEs)
|
87 Participants
|
140 Participants
|
SECONDARY outcome
Timeframe: Up to study end (Month 9)Population: The analysis was 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 134612 1 Dose Group
n=160 Participants
Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 vaccine at 12 months of age, administered intramuscularly in the left thigh.
|
GSK 134612 2 Doses Group
n=189 Participants
Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 at 9 months of age and another dose at 12 months of age, administered intramuscularly in the left thigh.
|
|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
5 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to study end (Month 9)Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Outcome measures
| Measure |
GSK 134612 1 Dose Group
n=160 Participants
Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 vaccine at 12 months of age, administered intramuscularly in the left thigh.
|
GSK 134612 2 Doses Group
n=189 Participants
Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 at 9 months of age and another dose at 12 months of age, administered intramuscularly in the left thigh.
|
|---|---|---|
|
Number of Subjects With New Onset Chronic Ilnesses (NOCI)
|
19 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: Up to study end (Month 9)Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
Rash assessed included hives, idiopathic thrombocytopenic purpura and petechiae.
Outcome measures
| Measure |
GSK 134612 1 Dose Group
n=160 Participants
Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 vaccine at 12 months of age, administered intramuscularly in the left thigh.
|
GSK 134612 2 Doses Group
n=189 Participants
Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 at 9 months of age and another dose at 12 months of age, administered intramuscularly in the left thigh.
|
|---|---|---|
|
Number of Subjects Reporting Rash
|
16 Participants
|
61 Participants
|
SECONDARY outcome
Timeframe: Up to study end (Month 9)Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
Among AEs prompting emergency room visits were: infections, injuries, skin diseases and respiratory diseases.
Outcome measures
| Measure |
GSK 134612 1 Dose Group
n=160 Participants
Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 vaccine at 12 months of age, administered intramuscularly in the left thigh.
|
GSK 134612 2 Doses Group
n=189 Participants
Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 at 9 months of age and another dose at 12 months of age, administered intramuscularly in the left thigh.
|
|---|---|---|
|
Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits
|
17 Participants
|
32 Participants
|
Adverse Events
GSK 134612 1 Dose Group
Serious events: 5 serious events
Other events: 124 other events
Deaths: 0 deaths
GSK 134612 2 Doses Group
Serious events: 2 serious events
Other events: 172 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GSK 134612 1 Dose Group
n=160 participants at risk
Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 vaccine at 12 months of age, administered intramuscularly in the left thigh.
|
GSK 134612 2 Doses Group
n=189 participants at risk
Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 at 9 months of age and another dose at 12 months of age, administered intramuscularly in the left thigh.
|
|---|---|---|
|
Metabolism and nutrition disorders
Dehydration
|
0.62%
1/160 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
0.53%
1/189 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
|
Infections and infestations
Otitis media
|
0.62%
1/160 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
0.53%
1/189 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
|
Infections and infestations
Pneumonia
|
0.62%
1/160 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
0.53%
1/189 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.62%
1/160 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
0.00%
0/189 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
|
Infections and infestations
Bronchiolitis
|
0.62%
1/160 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
0.00%
0/189 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
|
Nervous system disorders
Febrile convulsion
|
0.62%
1/160 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
0.00%
0/189 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
|
Infections and infestations
Gastroenteritis
|
0.62%
1/160 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
0.00%
0/189 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.62%
1/160 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
0.00%
0/189 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/160 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
0.53%
1/189 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.00%
0/160 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
0.53%
1/189 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
Other adverse events
| Measure |
GSK 134612 1 Dose Group
n=160 participants at risk
Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 vaccine at 12 months of age, administered intramuscularly in the left thigh.
|
GSK 134612 2 Doses Group
n=189 participants at risk
Healthy male or female subjects of 9 months of age at the time of enrollment received 1 dose of GSK 134612 at 9 months of age and another dose at 12 months of age, administered intramuscularly in the left thigh.
|
|---|---|---|
|
Infections and infestations
Bronchiolitis
|
0.62%
1/160 • Number of events 1 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
5.3%
10/189 • Number of events 10 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
26.2%
42/160 • Number of events 42 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
43.9%
83/189 • Number of events 99 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
0.62%
1/160 • Number of events 1 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
6.3%
12/189 • Number of events 13 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
|
Gastrointestinal disorders
Diarrhoea
|
3.8%
6/160 • Number of events 6 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
11.1%
21/189 • Number of events 22 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
17.5%
28/160 • Number of events 28 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
32.8%
62/189 • Number of events 88 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
|
Psychiatric disorders
Irritability
|
43.1%
69/160 • Number of events 69 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
67.2%
127/189 • Number of events 191 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.4%
7/160 • Number of events 7 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
5.8%
11/189 • Number of events 12 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
|
Infections and infestations
Otitis media
|
11.2%
18/160 • Number of events 19 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
19.6%
37/189 • Number of events 39 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
|
General disorders
Pain
|
21.9%
35/160 • Number of events 35 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
36.5%
69/189 • Number of events 96 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
|
General disorders
Pyrexia
|
16.9%
27/160 • Number of events 27 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
31.2%
59/189 • Number of events 70 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.5%
4/160 • Number of events 4 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
6.9%
13/189 • Number of events 13 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.0%
8/160 • Number of events 8 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
4.2%
8/189 • Number of events 8 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
|
Nervous system disorders
Somnolence
|
32.5%
52/160 • Number of events 52 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
49.2%
93/189 • Number of events 122 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
|
General disorders
Swelling
|
8.1%
13/160 • Number of events 13 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
20.1%
38/189 • Number of events 46 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
|
Gastrointestinal disorders
Teething
|
6.2%
10/160 • Number of events 11 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
9.5%
18/189 • Number of events 18 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
|
Infections and infestations
Upper respiratory tract infection
|
8.8%
14/160 • Number of events 14 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
19.6%
37/189 • Number of events 43 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
|
Infections and infestations
Viral infection
|
1.9%
3/160 • Number of events 3 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
5.8%
11/189 • Number of events 11 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
|
Gastrointestinal disorders
Vomiting
|
3.8%
6/160 • Number of events 6 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
8.5%
16/189 • Number of events 16 • Solicited local/general symptoms: during the 8-day (Days 0-7) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period, SAEs: during the entire study period (from Month 0 up to Month 9).
|
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