Trial Outcomes & Findings for Dose Ranging Study of Combined Haemophilus Influenzae Type B-Meningococcal Serogroups CY (Hib-MenCY-TT) Vaccine (NCT NCT00127855)
NCT ID: NCT00127855
Last Updated: 2018-08-27
Results Overview
The cut-off concentration assessed was 1 milligram per milliliter (mg/mL).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
409 participants
Primary outcome timeframe
One month after primary vaccination (Month 5)
Results posted on
2018-08-27
Participant Flow
Of the 409 subjects enrolled, two subjects were determined to be ineligible for enrolment and were actually never vaccinated. Not all subjects that started the primary vaccination course returned for the polysaccharide challenge dose administration.
Participant milestones
| Measure |
MenHibrix Formulation 1 Group
Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 2 Group
Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 3 Group
Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
Menjugate Group
Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
ActHIB Group
Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
|---|---|---|---|---|---|
|
Primary Vaccination Course
STARTED
|
82
|
82
|
80
|
81
|
82
|
|
Primary Vaccination Course
COMPLETED
|
80
|
81
|
78
|
81
|
78
|
|
Primary Vaccination Course
NOT COMPLETED
|
2
|
1
|
2
|
0
|
4
|
|
Polysaccharide Challenge Dose
STARTED
|
80
|
79
|
77
|
81
|
77
|
|
Polysaccharide Challenge Dose
COMPLETED
|
80
|
79
|
77
|
81
|
77
|
|
Polysaccharide Challenge Dose
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
MenHibrix Formulation 1 Group
Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 2 Group
Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 3 Group
Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
Menjugate Group
Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
ActHIB Group
Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
|---|---|---|---|---|---|
|
Primary Vaccination Course
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
|
Primary Vaccination Course
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
1
|
|
Primary Vaccination Course
Lost to Follow-up
|
1
|
1
|
1
|
0
|
2
|
|
Primary Vaccination Course
Other
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Dose Ranging Study of Combined Haemophilus Influenzae Type B-Meningococcal Serogroups CY (Hib-MenCY-TT) Vaccine
Baseline characteristics by cohort
| Measure |
MenHibrix Formulation 1 Group
n=82 Participants
Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 2 Group
n=82 Participants
Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 3 Group
n=80 Participants
Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
Menjugate Group
n=81 Participants
Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
ActHIB Group
n=82 Participants
Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
Total
n=407 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
8.1 Weeks
STANDARD_DEVIATION 1.39 • n=5 Participants
|
8.3 Weeks
STANDARD_DEVIATION 1.46 • n=7 Participants
|
8.2 Weeks
STANDARD_DEVIATION 1.65 • n=5 Participants
|
8.0 Weeks
STANDARD_DEVIATION 1.65 • n=4 Participants
|
8.1 Weeks
STANDARD_DEVIATION 1.43 • n=21 Participants
|
8.1 Weeks
STANDARD_DEVIATION 1.50 • n=10 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
204 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
203 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: One month after primary vaccination (Month 5)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample during the primary vaccination course.
The cut-off concentration assessed was 1 milligram per milliliter (mg/mL).
Outcome measures
| Measure |
MenHibrix Formulation 1 Group
n=74 Participants
Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 2 Group
n=76 Participants
Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 3 Group
n=70 Participants
Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
Menjugate Group
n=74 Participants
Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
ActHIB Group
n=74 Participants
Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
|---|---|---|---|---|---|
|
Number of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 1 Milligram Per Milliliter
|
72 Subjects
|
75 Subjects
|
65 Subjects
|
66 Subjects
|
70 Subjects
|
PRIMARY outcome
Timeframe: One month after primary vaccination (Month 5)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample during the primary vaccination course.
The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.
Outcome measures
| Measure |
MenHibrix Formulation 1 Group
n=69 Participants
Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 2 Group
n=76 Participants
Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 3 Group
n=72 Participants
Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
Menjugate Group
n=74 Participants
Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
ActHIB Group
n=76 Participants
Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
|---|---|---|---|---|---|
|
Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8
|
69 Subjects
|
76 Subjects
|
72 Subjects
|
74 Subjects
|
1 Subjects
|
PRIMARY outcome
Timeframe: One month after primary vaccination (Month 5)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component, for at least one blood sample during the primary vaccination course.
The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.
Outcome measures
| Measure |
MenHibrix Formulation 1 Group
n=67 Participants
Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 2 Group
n=68 Participants
Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 3 Group
n=69 Participants
Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
Menjugate Group
n=68 Participants
Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
ActHIB Group
n=74 Participants
Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
|---|---|---|---|---|---|
|
Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers Greater Than or Equal to 1:8
|
66 Subjects
|
68 Subjects
|
68 Subjects
|
10 Subjects
|
12 Subjects
|
SECONDARY outcome
Timeframe: Prior to vaccination (Day 0), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.
The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.
Outcome measures
| Measure |
MenHibrix Formulation 1 Group
n=69 Participants
Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 2 Group
n=73 Participants
Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 3 Group
n=73 Participants
Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
Menjugate Group
n=79 Participants
Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
ActHIB Group
n=70 Participants
Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
|---|---|---|---|---|---|
|
Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8
Day 0 (N= 68; 66; 63; 66; 70)
|
2 Subjects
|
6 Subjects
|
2 Subjects
|
3 Subjects
|
1 Subjects
|
|
Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8
Month 10 (N= 69; 71; 73; 74; 68)
|
67 Subjects
|
70 Subjects
|
70 Subjects
|
67 Subjects
|
6 Subjects
|
|
Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8
Month 11 (N= 69; 73; 71; 79; 66)
|
69 Subjects
|
73 Subjects
|
71 Subjects
|
77 Subjects
|
18 Subjects
|
SECONDARY outcome
Timeframe: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.
Titers were presented as geometric mean titers (GMTs) expressed as the reciprocal of the dilution resulting in 50 percent inhibition.
Outcome measures
| Measure |
MenHibrix Formulation 1 Group
n=69 Participants
Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 2 Group
n=76 Participants
Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 3 Group
n=73 Participants
Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
Menjugate Group
n=79 Participants
Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
ActHIB Group
n=76 Participants
Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
|---|---|---|---|---|---|
|
Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers
Month 10 (N= 69; 71; 73; 74; 68)
|
260.5 Titer
Interval 190.7 to 355.8
|
214.2 Titer
Interval 163.5 to 280.7
|
199.8 Titer
Interval 143.8 to 277.6
|
170.8 Titer
Interval 113.2 to 257.7
|
4.9 Titer
Interval 4.2 to 5.7
|
|
Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers
Day 0 (N= 68; 66; 63; 66; 70)
|
4.3 Titer
Interval 3.9 to 4.7
|
5.2 Titer
Interval 4.1 to 6.6
|
4.2 Titer
Interval 3.9 to 4.6
|
4.2 Titer
Interval 4.0 to 4.5
|
4.1 Titer
Interval 3.9 to 4.4
|
|
Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers
Month 5 (N= 69; 76; 72; 74; 76)
|
1293.1 Titer
Interval 1027.7 to 1627.1
|
1065.6 Titer
Interval 858.8 to 1322.3
|
968.4 Titer
Interval 770.8 to 1216.6
|
1931.9 Titer
Interval 1541.2 to 2421.6
|
4.2 Titer
Interval 3.8 to 4.5
|
|
Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers
Month 11 (N= 69; 73; 71; 79; 66)
|
1985.5 Titer
Interval 1542.6 to 2555.8
|
919.5 Titer
Interval 692.3 to 1221.2
|
1530.4 Titer
Interval 1119.6 to 2091.8
|
774.8 Titer
Interval 536.7 to 1118.5
|
9.0 Titer
Interval 6.4 to 12.8
|
SECONDARY outcome
Timeframe: Prior to vaccination (Day 0), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.
The cut-off titer assessed was a dilution of 1:8. Titers were expressed as the reciprocal of the dilution resulting in 50 percent inhibition.
Outcome measures
| Measure |
MenHibrix Formulation 1 Group
n=69 Participants
Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 2 Group
n=71 Participants
Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 3 Group
n=70 Participants
Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
Menjugate Group
n=77 Participants
Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
ActHIB Group
n=71 Participants
Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
|---|---|---|---|---|---|
|
Number of Subjects With rSBA-MenY Titers Greater Than or Equal to 1:8
Day 0 (N= 68; 65; 58; 63; 66)
|
4 Subjects
|
7 Subjects
|
5 Subjects
|
9 Subjects
|
4 Subjects
|
|
Number of Subjects With rSBA-MenY Titers Greater Than or Equal to 1:8
Month 10 (N= 69; 69; 70; 71; 68)
|
61 Subjects
|
55 Subjects
|
60 Subjects
|
17 Subjects
|
22 Subjects
|
|
Number of Subjects With rSBA-MenY Titers Greater Than or Equal to 1:8
Month 11 (N= 68; 71; 70; 77; 71)
|
68 Subjects
|
71 Subjects
|
69 Subjects
|
32 Subjects
|
38 Subjects
|
SECONDARY outcome
Timeframe: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.
Titers were presented as geometric mean titers (GMTs) expressed as the reciprocal of the dilution resulting in 50 percent inhibition.
Outcome measures
| Measure |
MenHibrix Formulation 1 Group
n=69 Participants
Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 2 Group
n=71 Participants
Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 3 Group
n=70 Participants
Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
Menjugate Group
n=77 Participants
Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
ActHIB Group
n=74 Participants
Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
|---|---|---|---|---|---|
|
Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers
Day 0 (N= 68; 65; 58; 63; 66)
|
4.6 Titer
Interval 4.0 to 5.4
|
5.6 Titer
Interval 4.3 to 7.2
|
5.1 Titer
Interval 4.1 to 6.3
|
6.3 Titer
Interval 4.7 to 8.4
|
4.9 Titer
Interval 4.0 to 5.9
|
|
Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers
Month 11 (N= 68; 71; 70; 77; 71)
|
1838.0 Titer
Interval 1427.9 to 2366.0
|
1539.8 Titer
Interval 1165.4 to 2034.5
|
1653.8 Titer
Interval 1202.5 to 2274.4
|
18.8 Titer
Interval 12.1 to 29.4
|
32.0 Titer
Interval 19.7 to 52.0
|
|
Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers
Month 5 (N= 67; 68; 69; 68; 74)
|
843.5 Titer
Interval 640.1 to 1111.7
|
1020.0 Titer
Interval 790.0 to 1316.8
|
741.8 Titer
Interval 538.0 to 1022.9
|
6.9 Titer
Interval 5.0 to 9.5
|
7.3 Titer
Interval 5.2 to 10.1
|
|
Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup Y (MenY) Titers
Month 10 (N= 69; 69; 70; 71; 68)
|
114.5 Titer
Interval 78.6 to 167.0
|
139.6 Titer
Interval 86.8 to 224.7
|
129.9 Titer
Interval 87.1 to 193.7
|
10.0 Titer
Interval 6.7 to 15.0
|
13.4 Titer
Interval 8.6 to 20.9
|
SECONDARY outcome
Timeframe: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.
The cut-off concentration assessed was 30 micrograms per milliliter (µg/mL).
Outcome measures
| Measure |
MenHibrix Formulation 1 Group
n=71 Participants
Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 2 Group
n=70 Participants
Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 3 Group
n=71 Participants
Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
Menjugate Group
n=76 Participants
Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
ActHIB Group
n=71 Participants
Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
|---|---|---|---|---|---|
|
Number of Subjects With Anti-polysaccharide C (PSC) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)
Day 0 (N= 54; 54; 49; 56; 56)
|
5 Subjects
|
5 Subjects
|
6 Subjects
|
5 Subjects
|
4 Subjects
|
|
Number of Subjects With Anti-polysaccharide C (PSC) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)
Month 5 (N= 63; 65; 61; 62; 63)
|
63 Subjects
|
65 Subjects
|
61 Subjects
|
62 Subjects
|
1 Subjects
|
|
Number of Subjects With Anti-polysaccharide C (PSC) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)
Month 11 (N= 71; 70; 71; 76; 71)
|
71 Subjects
|
70 Subjects
|
71 Subjects
|
76 Subjects
|
69 Subjects
|
|
Number of Subjects With Anti-polysaccharide C (PSC) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)
Month 10 (N= 63; 68; 61; 74; 67)
|
63 Subjects
|
68 Subjects
|
61 Subjects
|
74 Subjects
|
1 Subjects
|
SECONDARY outcome
Timeframe: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.
Titers are presented as Geometric Mean Titers (GMTs) expressed as micrograms per milliliter (µg/mL).
Outcome measures
| Measure |
MenHibrix Formulation 1 Group
n=71 Participants
Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 2 Group
n=70 Participants
Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 3 Group
n=71 Participants
Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
Menjugate Group
n=76 Participants
Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
ActHIB Group
n=71 Participants
Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
|---|---|---|---|---|---|
|
Anti-polysaccharide C (PSC) Antibody Concentration
Day 0 (N= 54; 54; 49; 56; 56)
|
0.17 microgram per milliliter (µg/mL)
Interval 0.15 to 0.2
|
0.17 microgram per milliliter (µg/mL)
Interval 0.15 to 0.18
|
0.17 microgram per milliliter (µg/mL)
Interval 0.15 to 0.19
|
0.17 microgram per milliliter (µg/mL)
Interval 0.15 to 0.2
|
0.17 microgram per milliliter (µg/mL)
Interval 0.15 to 0.19
|
|
Anti-polysaccharide C (PSC) Antibody Concentration
Month 5 (N= 63; 65; 61; 62; 63)
|
12.02 microgram per milliliter (µg/mL)
Interval 9.9 to 14.59
|
12.09 microgram per milliliter (µg/mL)
Interval 10.59 to 13.81
|
9.95 microgram per milliliter (µg/mL)
Interval 8.34 to 11.87
|
15.36 microgram per milliliter (µg/mL)
Interval 12.67 to 18.62
|
0.15 microgram per milliliter (µg/mL)
Interval 0.15 to 0.16
|
|
Anti-polysaccharide C (PSC) Antibody Concentration
Month 10 (N= 63; 68; 61; 74; 67)
|
3.11 microgram per milliliter (µg/mL)
Interval 2.52 to 3.85
|
3.10 microgram per milliliter (µg/mL)
Interval 2.64 to 3.64
|
2.74 microgram per milliliter (µg/mL)
Interval 2.29 to 3.27
|
2.87 microgram per milliliter (µg/mL)
Interval 2.23 to 3.71
|
0.15 microgram per milliliter (µg/mL)
Interval 0.15 to 0.16
|
|
Anti-polysaccharide C (PSC) Antibody Concentration
Month 11 (N= 71; 70; 71; 76; 71)
|
11.47 microgram per milliliter (µg/mL)
Interval 9.25 to 14.22
|
7.94 microgram per milliliter (µg/mL)
Interval 6.42 to 9.81
|
10.96 microgram per milliliter (µg/mL)
Interval 8.63 to 13.91
|
7.56 microgram per milliliter (µg/mL)
Interval 6.17 to 9.26
|
1.49 microgram per milliliter (µg/mL)
Interval 1.23 to 1.81
|
SECONDARY outcome
Timeframe: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.
The cut-off concentration assessed was 30 micrograms per milliliter (µg/mL).
Outcome measures
| Measure |
MenHibrix Formulation 1 Group
n=70 Participants
Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 2 Group
n=71 Participants
Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 3 Group
n=72 Participants
Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
Menjugate Group
n=77 Participants
Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
ActHIB Group
n=71 Participants
Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
|---|---|---|---|---|---|
|
Number of Subjects With Anti-polysaccharide Y (PSY) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)
Month 5 (N= 67; 70; 72; 66; 69)
|
67 Subjects
|
70 Subjects
|
72 Subjects
|
2 Subjects
|
0 Subjects
|
|
Number of Subjects With Anti-polysaccharide Y (PSY) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)
Month 10 (N= 70; 69; 71; 76; 67)
|
70 Subjects
|
69 Subjects
|
70 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Anti-polysaccharide Y (PSY) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)
Month 11 (N= 69; 71; 71; 77; 71)
|
69 Subjects
|
71 Subjects
|
71 Subjects
|
70 Subjects
|
64 Subjects
|
|
Number of Subjects With Anti-polysaccharide Y (PSY) Antibody Concentration Greater Than or Equal to 30 Micrograms Per Milliliter (µg/mL)
Day 0 (N= 51; 51; 47; 56; 54)
|
3 Subjects
|
4 Subjects
|
3 Subjects
|
7 Subjects
|
7 Subjects
|
SECONDARY outcome
Timeframe: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.
Titers are presented as Geometric Mean Titers (GMTs) expressed as micrograms per milliliter (µg/mL).
Outcome measures
| Measure |
MenHibrix Formulation 1 Group
n=70 Participants
Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 2 Group
n=71 Participants
Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 3 Group
n=72 Participants
Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
Menjugate Group
n=77 Participants
Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
ActHIB Group
n=71 Participants
Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
|---|---|---|---|---|---|
|
Anti-polysaccharide Y (PSY) Antibody Concentration
Day 0 (N= 51; 51; 47; 56; 54)
|
0.17 Microgram per milliliter (µg/mL)
Interval 0.15 to 0.19
|
0.18 Microgram per milliliter (µg/mL)
Interval 0.15 to 0.23
|
0.17 Microgram per milliliter (µg/mL)
Interval 0.15 to 0.19
|
0.20 Microgram per milliliter (µg/mL)
Interval 0.16 to 0.26
|
0.19 Microgram per milliliter (µg/mL)
Interval 0.16 to 0.23
|
|
Anti-polysaccharide Y (PSY) Antibody Concentration
Month 10 (N= 70; 69; 71; 76; 67)
|
5.26 Microgram per milliliter (µg/mL)
Interval 4.2 to 6.6
|
5.20 Microgram per milliliter (µg/mL)
Interval 4.17 to 6.49
|
4.10 Microgram per milliliter (µg/mL)
Interval 3.22 to 5.23
|
0.15 Microgram per milliliter (µg/mL)
Interval 0.15 to 0.15
|
0.15 Microgram per milliliter (µg/mL)
Interval 0.15 to 0.16
|
|
Anti-polysaccharide Y (PSY) Antibody Concentration
Month 5 (N= 67; 70; 72; 66; 69)
|
19.22 Microgram per milliliter (µg/mL)
Interval 15.42 to 23.95
|
19.09 Microgram per milliliter (µg/mL)
Interval 15.44 to 23.59
|
15.83 Microgram per milliliter (µg/mL)
Interval 12.64 to 19.82
|
0.16 Microgram per milliliter (µg/mL)
Interval 0.15 to 0.17
|
0.15 Microgram per milliliter (µg/mL)
Interval 0.15 to 0.15
|
|
Anti-polysaccharide Y (PSY) Antibody Concentration
Month 11 (N= 69; 71; 71; 77; 71)
|
47.95 Microgram per milliliter (µg/mL)
Interval 39.8 to 57.77
|
37.15 Microgram per milliliter (µg/mL)
Interval 29.16 to 47.32
|
51.12 Microgram per milliliter (µg/mL)
Interval 38.71 to 67.52
|
1.37 Microgram per milliliter (µg/mL)
Interval 1.05 to 1.79
|
1.33 Microgram per milliliter (µg/mL)
Interval 1.02 to 1.72
|
SECONDARY outcome
Timeframe: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.
The cut-off concentrations assessed were 0.15 micrograms per milliliter (µg/mL) and 1 µg/mL.
Outcome measures
| Measure |
MenHibrix Formulation 1 Group
n=74 Participants
Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 2 Group
n=76 Participants
Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 3 Group
n=73 Participants
Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
Menjugate Group
n=79 Participants
Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
ActHIB Group
n=74 Participants
Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
|---|---|---|---|---|---|
|
Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values
Month 5 ≥ 0.15 µg/mL (N= 74; 76; 70; 74; 74)
|
74 Subjects
|
76 Subjects
|
70 Subjects
|
73 Subjects
|
74 Subjects
|
|
Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values
Month 11 ≥ 1 µg/mL (N= 68; 73; 71; 79; 72)
|
67 Subjects
|
69 Subjects
|
65 Subjects
|
57 Subjects
|
58 Subjects
|
|
Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values
Day 0 ≥ 0.15 µg/mL (N= 68; 70; 67; 67; 73)
|
29 Subjects
|
37 Subjects
|
41 Subjects
|
32 Subjects
|
37 Subjects
|
|
Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values
Month 10 ≥ 0.15 µg/mL (N= 70; 72; 73; 76; 70)
|
70 Subjects
|
71 Subjects
|
72 Subjects
|
71 Subjects
|
68 Subjects
|
|
Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values
Month 11 ≥ 0.15 µg/mL (N= 68; 73; 71; 79; 72)
|
68 Subjects
|
72 Subjects
|
71 Subjects
|
78 Subjects
|
71 Subjects
|
|
Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values
Day 0 ≥ 1 µg/mL (N= 68; 70; 67; 67; 73)
|
7 Subjects
|
10 Subjects
|
6 Subjects
|
6 Subjects
|
8 Subjects
|
|
Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values
Month 5 ≥ 1 µg/mL (N= 74; 76; 70; 74; 74)
|
72 Subjects
|
75 Subjects
|
65 Subjects
|
66 Subjects
|
70 Subjects
|
|
Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values
Month 10 ≥ 1 µg/mL (N= 70; 72; 73; 76; 70)
|
46 Subjects
|
42 Subjects
|
36 Subjects
|
39 Subjects
|
41 Subjects
|
SECONDARY outcome
Timeframe: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5), before administration of the polysaccharide challenge dose (Month 10) and one month after administration of the polysaccharide challenge dose (Month 11)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10/Month 11 data.
Concentrations are presented as GMCs and expressed as µg/mL.
Outcome measures
| Measure |
MenHibrix Formulation 1 Group
n=74 Participants
Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 2 Group
n=76 Participants
Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 3 Group
n=73 Participants
Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
Menjugate Group
n=79 Participants
Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
ActHIB Group
n=74 Participants
Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
|---|---|---|---|---|---|
|
Anti-PRP Antibody Concentration
Day 0 (N= 68; 70; 67; 67; 73)
|
0.152 Microgram per milliliter (µg/mL)
Interval 0.12 to 0.194
|
0.224 Microgram per milliliter (µg/mL)
Interval 0.164 to 0.305
|
0.214 Microgram per milliliter (µg/mL)
Interval 0.166 to 0.276
|
0.172 Microgram per milliliter (µg/mL)
Interval 0.132 to 0.223
|
0.201 Microgram per milliliter (µg/mL)
Interval 0.153 to 0.265
|
|
Anti-PRP Antibody Concentration
Month 5 (N= 74; 76; 70; 74; 74)
|
6.441 Microgram per milliliter (µg/mL)
Interval 5.315 to 7.805
|
7.324 Microgram per milliliter (µg/mL)
Interval 5.877 to 9.127
|
5.577 Microgram per milliliter (µg/mL)
Interval 4.375 to 7.11
|
4.465 Microgram per milliliter (µg/mL)
Interval 3.399 to 5.865
|
5.714 Microgram per milliliter (µg/mL)
Interval 4.538 to 7.195
|
|
Anti-PRP Antibody Concentration
Month 10 (N= 70; 72; 73; 76; 70)
|
1.386 Microgram per milliliter (µg/mL)
Interval 1.134 to 1.693
|
1.383 Microgram per milliliter (µg/mL)
Interval 1.092 to 1.751
|
1.148 Microgram per milliliter (µg/mL)
Interval 0.914 to 1.441
|
0.949 Microgram per milliliter (µg/mL)
Interval 0.728 to 1.238
|
1.141 Microgram per milliliter (µg/mL)
Interval 0.868 to 1.501
|
|
Anti-PRP Antibody Concentration
Month 11 (N= 68; 73; 71; 79; 72)
|
8.653 Microgram per milliliter (µg/mL)
Interval 6.701 to 11.173
|
6.750 Microgram per milliliter (µg/mL)
Interval 5.002 to 9.107
|
5.112 Microgram per milliliter (µg/mL)
Interval 3.878 to 6.739
|
2.512 Microgram per milliliter (µg/mL)
Interval 1.837 to 3.435
|
3.283 Microgram per milliliter (µg/mL)
Interval 2.38 to 4.529
|
SECONDARY outcome
Timeframe: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.
Seroprotection is defined as anti-diphtheria toxoid antibody concentration greater than or equal to 0.1 International Units per Milliliter (IU/mL).
Outcome measures
| Measure |
MenHibrix Formulation 1 Group
n=78 Participants
Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 2 Group
n=78 Participants
Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 3 Group
n=75 Participants
Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
Menjugate Group
n=80 Participants
Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
ActHIB Group
n=76 Participants
Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
|---|---|---|---|---|---|
|
Number of Subjects Seroprotected for Anti-diphtheria Antibodies
Month 10 (N= 78; 78; 75; 80; 75)
|
76 Subjects
|
75 Subjects
|
72 Subjects
|
74 Subjects
|
75 Subjects
|
|
Number of Subjects Seroprotected for Anti-diphtheria Antibodies
Day 0 (N= 68; 70; 65; 69; 74)
|
26 Subjects
|
28 Subjects
|
28 Subjects
|
26 Subjects
|
29 Subjects
|
|
Number of Subjects Seroprotected for Anti-diphtheria Antibodies
Month 5 (N= 74; 76; 74; 77; 76)
|
74 Subjects
|
76 Subjects
|
74 Subjects
|
77 Subjects
|
76 Subjects
|
SECONDARY outcome
Timeframe: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.
Concentrations are presented as GMCs and expressed as International Units per Milliliter (IU/mL).
Outcome measures
| Measure |
MenHibrix Formulation 1 Group
n=78 Participants
Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 2 Group
n=78 Participants
Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 3 Group
n=75 Participants
Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
Menjugate Group
n=80 Participants
Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
ActHIB Group
n=76 Participants
Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
|---|---|---|---|---|---|
|
Anti-diphtheria Antibody Concentrations
Day 0 (N= 68; 70; 65; 69; 74)
|
0.090 International Units per Milliliter
Interval 0.074 to 0.11
|
0.098 International Units per Milliliter
Interval 0.077 to 0.123
|
0.101 International Units per Milliliter
Interval 0.08 to 0.127
|
0.090 International Units per Milliliter
Interval 0.074 to 0.11
|
0.093 International Units per Milliliter
Interval 0.074 to 0.117
|
|
Anti-diphtheria Antibody Concentrations
Month 5 (N= 74; 76; 74; 77; 76)
|
1.721 International Units per Milliliter
Interval 1.48 to 2.003
|
1.797 International Units per Milliliter
Interval 1.508 to 2.141
|
2.000 International Units per Milliliter
Interval 1.706 to 2.346
|
1.845 International Units per Milliliter
Interval 1.598 to 2.13
|
1.970 International Units per Milliliter
Interval 1.76 to 2.206
|
|
Anti-diphtheria Antibody Concentrations
Month 10 (N= 78; 78; 75; 80; 75)
|
0.513 International Units per Milliliter
Interval 0.423 to 0.622
|
0.505 International Units per Milliliter
Interval 0.41 to 0.621
|
0.519 International Units per Milliliter
Interval 0.423 to 0.638
|
0.405 International Units per Milliliter
Interval 0.33 to 0.497
|
0.543 International Units per Milliliter
Interval 0.467 to 0.631
|
SECONDARY outcome
Timeframe: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.
Seroprotection is defined as anti-tetanus toxoid antibody concentration greater than or equal to 0.1 International Units per Milliliter (IU/mL).
Outcome measures
| Measure |
MenHibrix Formulation 1 Group
n=78 Participants
Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 2 Group
n=78 Participants
Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 3 Group
n=75 Participants
Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
Menjugate Group
n=80 Participants
Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
ActHIB Group
n=76 Participants
Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
|---|---|---|---|---|---|
|
Number of Subjects Seroprotected for Anti-tetanus Antibodies
Day 0 (N= 62; 64; 60; 60; 68)
|
54 Subjects
|
58 Subjects
|
57 Subjects
|
57 Subjects
|
62 Subjects
|
|
Number of Subjects Seroprotected for Anti-tetanus Antibodies
Month 5 (N= 74; 76; 74; 77; 76)
|
74 Subjects
|
76 Subjects
|
74 Subjects
|
77 Subjects
|
76 Subjects
|
|
Number of Subjects Seroprotected for Anti-tetanus Antibodies
Month 10 (N= 78; 78; 75; 80; 75)
|
78 Subjects
|
78 Subjects
|
74 Subjects
|
78 Subjects
|
75 Subjects
|
SECONDARY outcome
Timeframe: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.
Concentrations are presented as GMCs and expressed as International Units per Milliliter (IU/mL).
Outcome measures
| Measure |
MenHibrix Formulation 1 Group
n=78 Participants
Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 2 Group
n=78 Participants
Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 3 Group
n=75 Participants
Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
Menjugate Group
n=80 Participants
Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
ActHIB Group
n=76 Participants
Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
|---|---|---|---|---|---|
|
Anti-tetanus Antibody Concentrations
Day 0 (N= 62; 64; 60; 60; 68)
|
0.460 International Units per Milliliter
Interval 0.343 to 0.617
|
0.470 International Units per Milliliter
Interval 0.364 to 0.608
|
0.501 International Units per Milliliter
Interval 0.386 to 0.651
|
0.562 International Units per Milliliter
Interval 0.435 to 0.727
|
0.533 International Units per Milliliter
Interval 0.403 to 0.705
|
|
Anti-tetanus Antibody Concentrations
Month 5 (N= 74; 76; 74; 77; 76)
|
3.301 International Units per Milliliter
Interval 2.909 to 3.747
|
3.816 International Units per Milliliter
Interval 3.34 to 4.36
|
3.366 International Units per Milliliter
Interval 2.974 to 3.81
|
1.877 International Units per Milliliter
Interval 1.603 to 2.197
|
2.033 International Units per Milliliter
Interval 1.773 to 2.33
|
|
Anti-tetanus Antibody Concentrations
Month 10 (N= 78; 78; 75; 80; 75)
|
1.114 International Units per Milliliter
Interval 0.967 to 1.283
|
1.307 International Units per Milliliter
Interval 1.119 to 1.528
|
1.062 International Units per Milliliter
Interval 0.905 to 1.246
|
0.603 International Units per Milliliter
Interval 0.5 to 0.728
|
0.756 International Units per Milliliter
Interval 0.633 to 0.902
|
SECONDARY outcome
Timeframe: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.
Seropositivity is defined as anti-FHA antibody concentration greater than or equal to 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).
Outcome measures
| Measure |
MenHibrix Formulation 1 Group
n=78 Participants
Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 2 Group
n=78 Participants
Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 3 Group
n=75 Participants
Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
Menjugate Group
n=79 Participants
Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
ActHIB Group
n=76 Participants
Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
|---|---|---|---|---|---|
|
Number of Subjects Seroseropositive for Anti-filamentus Haemagglutinin (FHA) Antibodies
Day 0 (N= 64; 69; 65; 67; 70)
|
34 Subjects
|
28 Subjects
|
38 Subjects
|
44 Subjects
|
31 Subjects
|
|
Number of Subjects Seroseropositive for Anti-filamentus Haemagglutinin (FHA) Antibodies
Month 5 (N= 74; 76; 74; 77; 76)
|
74 Subjects
|
76 Subjects
|
74 Subjects
|
77 Subjects
|
76 Subjects
|
|
Number of Subjects Seroseropositive for Anti-filamentus Haemagglutinin (FHA) Antibodies
Month 10 (N= 78; 78; 75; 79; 75)
|
77 Subjects
|
77 Subjects
|
72 Subjects
|
79 Subjects
|
75 Subjects
|
SECONDARY outcome
Timeframe: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10 data.
Concentrations are presented as GMCs and expressed as Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).
Outcome measures
| Measure |
MenHibrix Formulation 1 Group
n=77 Participants
Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 2 Group
n=77 Participants
Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 3 Group
n=74 Participants
Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
Menjugate Group
n=79 Participants
Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
ActHIB Group
n=76 Participants
Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
|---|---|---|---|---|---|
|
Anti- FHA Antibody Concentrations
Day 0 (N= 64; 69; 65; 67; 70)
|
5.1 ELISA Units per Milliliter (EL.U/mL)
Interval 4.2 to 6.2
|
4.6 ELISA Units per Milliliter (EL.U/mL)
Interval 3.7 to 5.7
|
5.8 ELISA Units per Milliliter (EL.U/mL)
Interval 4.8 to 7.1
|
7.4 ELISA Units per Milliliter (EL.U/mL)
Interval 5.8 to 9.5
|
4.8 ELISA Units per Milliliter (EL.U/mL)
Interval 3.9 to 5.9
|
|
Anti- FHA Antibody Concentrations
Month 5 (N= 74; 76; 74; 77; 76)
|
137.2 ELISA Units per Milliliter (EL.U/mL)
Interval 116.4 to 161.7
|
141.5 ELISA Units per Milliliter (EL.U/mL)
Interval 122.1 to 163.9
|
136.2 ELISA Units per Milliliter (EL.U/mL)
Interval 118.0 to 157.2
|
132.1 ELISA Units per Milliliter (EL.U/mL)
Interval 114.1 to 153.0
|
146.7 ELISA Units per Milliliter (EL.U/mL)
Interval 124.8 to 172.4
|
|
Anti- FHA Antibody Concentrations
Month 10 (N= 78; 78; 75; 79; 75)
|
49.4 ELISA Units per Milliliter (EL.U/mL)
Interval 40.6 to 60.0
|
50.9 ELISA Units per Milliliter (EL.U/mL)
Interval 41.4 to 62.6
|
44.3 ELISA Units per Milliliter (EL.U/mL)
Interval 35.7 to 55.0
|
39.9 ELISA Units per Milliliter (EL.U/mL)
Interval 33.9 to 47.0
|
50.2 ELISA Units per Milliliter (EL.U/mL)
Interval 41.6 to 60.6
|
SECONDARY outcome
Timeframe: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.
Seropositivity is defined as anti-PRN antibody concentration greater than or equal to 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).
Outcome measures
| Measure |
MenHibrix Formulation 1 Group
n=78 Participants
Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 2 Group
n=78 Participants
Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 3 Group
n=75 Participants
Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
Menjugate Group
n=80 Participants
Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
ActHIB Group
n=76 Participants
Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
|---|---|---|---|---|---|
|
Number of Subjects Seroseropositive for Anti-pertactin (PRN) Antibodies
Day 0 (N= 67; 63; 67; 68; 71)
|
20 Subjects
|
26 Subjects
|
25 Subjects
|
30 Subjects
|
26 Subjects
|
|
Number of Subjects Seroseropositive for Anti-pertactin (PRN) Antibodies
Month 5 (N= 74; 76; 74; 77; 76)
|
74 Subjects
|
76 Subjects
|
74 Subjects
|
76 Subjects
|
76 Subjects
|
|
Number of Subjects Seroseropositive for Anti-pertactin (PRN) Antibodies
Month 10 (N= 78; 78; 75; 80; 75)
|
76 Subjects
|
75 Subjects
|
71 Subjects
|
73 Subjects
|
74 Subjects
|
SECONDARY outcome
Timeframe: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10 data.
Concentrations are presented as GMCs and expressed as Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).
Outcome measures
| Measure |
MenHibrix Formulation 1 Group
n=78 Participants
Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 2 Group
n=78 Participants
Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 3 Group
n=75 Participants
Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
Menjugate Group
n=80 Participants
Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
ActHIB Group
n=76 Participants
Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
|---|---|---|---|---|---|
|
Anti-PRN Antibody Concentrations
Month 5 (N= 74; 76; 74; 77; 76)
|
128.3 ELISA Units per Milliliter (EL.U/mL)
Interval 107.4 to 153.1
|
120.7 ELISA Units per Milliliter (EL.U/mL)
Interval 98.6 to 147.7
|
106.2 ELISA Units per Milliliter (EL.U/mL)
Interval 89.3 to 126.3
|
112.9 ELISA Units per Milliliter (EL.U/mL)
Interval 91.6 to 139.1
|
137.8 ELISA Units per Milliliter (EL.U/mL)
Interval 118.2 to 160.7
|
|
Anti-PRN Antibody Concentrations
Day 0 (N= 67; 63; 67; 68; 71)
|
3.9 ELISA Units per Milliliter (EL.U/mL)
Interval 3.2 to 4.7
|
4.7 ELISA Units per Milliliter (EL.U/mL)
Interval 3.7 to 5.8
|
4.6 ELISA Units per Milliliter (EL.U/mL)
Interval 3.7 to 5.7
|
5.3 ELISA Units per Milliliter (EL.U/mL)
Interval 4.1 to 6.8
|
4.4 ELISA Units per Milliliter (EL.U/mL)
Interval 3.6 to 5.4
|
|
Anti-PRN Antibody Concentrations
Month 10 (N= 78; 78; 75; 80; 75)
|
36.2 ELISA Units per Milliliter (EL.U/mL)
Interval 29.5 to 44.3
|
31.8 ELISA Units per Milliliter (EL.U/mL)
Interval 25.2 to 40.0
|
27.3 ELISA Units per Milliliter (EL.U/mL)
Interval 22.1 to 33.8
|
27.2 ELISA Units per Milliliter (EL.U/mL)
Interval 21.5 to 34.4
|
35.8 ELISA Units per Milliliter (EL.U/mL)
Interval 29.7 to 43.1
|
SECONDARY outcome
Timeframe: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.
Seropositivity is defined as anti-PT antibody concentration greater than or equal to 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).
Outcome measures
| Measure |
MenHibrix Formulation 1 Group
n=77 Participants
Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 2 Group
n=76 Participants
Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 3 Group
n=74 Participants
Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
Menjugate Group
n=78 Participants
Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
ActHIB Group
n=76 Participants
Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
|---|---|---|---|---|---|
|
Number of Subjects Seroseropositive for Anti-pertussis Toxoid (PT) Antibodies
Month 5 (N= 74; 76; 74; 77; 76)
|
74 Subjects
|
76 Subjects
|
74 Subjects
|
77 Subjects
|
76 Subjects
|
|
Number of Subjects Seroseropositive for Anti-pertussis Toxoid (PT) Antibodies
Month 10 (N= 77; 76; 73; 78; 75)
|
71 Subjects
|
66 Subjects
|
62 Subjects
|
61 Subjects
|
63 Subjects
|
|
Number of Subjects Seroseropositive for Anti-pertussis Toxoid (PT) Antibodies
Day 0 (N= 65; 66; 65; 63; 74)
|
5 Subjects
|
6 Subjects
|
5 Subjects
|
11 Subjects
|
3 Subjects
|
SECONDARY outcome
Timeframe: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10 data.
Concentrations are presented as GMCs and expressed as Enzyme-Linked Immunosorbent Assay (ELISA) Units per Milliliter (EL.U/mL).
Outcome measures
| Measure |
MenHibrix Formulation 1 Group
n=77 Participants
Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 2 Group
n=76 Participants
Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 3 Group
n=74 Participants
Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
Menjugate Group
n=78 Participants
Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
ActHIB Group
n=76 Participants
Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
|---|---|---|---|---|---|
|
Anti- PT Antibody Concentrations
Month 10 (N= 77; 76; 73; 78; 75)
|
11.6 ELISA Units per Milliliter (EL.U/mL)
Interval 10.0 to 13.6
|
11.6 ELISA Units per Milliliter (EL.U/mL)
Interval 9.6 to 14.0
|
9.9 ELISA Units per Milliliter (EL.U/mL)
Interval 8.2 to 12.1
|
8.2 ELISA Units per Milliliter (EL.U/mL)
Interval 6.8 to 9.8
|
9.8 ELISA Units per Milliliter (EL.U/mL)
Interval 8.1 to 11.9
|
|
Anti- PT Antibody Concentrations
Day 0 (N= 65; 66; 65; 63; 74)
|
2.7 ELISA Units per Milliliter (EL.U/mL)
Interval 2.5 to 2.9
|
2.7 ELISA Units per Milliliter (EL.U/mL)
Interval 2.5 to 2.9
|
2.8 ELISA Units per Milliliter (EL.U/mL)
Interval 2.5 to 3.1
|
3.1 ELISA Units per Milliliter (EL.U/mL)
Interval 2.7 to 3.5
|
2.7 ELISA Units per Milliliter (EL.U/mL)
Interval 2.4 to 2.9
|
|
Anti- PT Antibody Concentrations
Month 5 (N= 74; 76; 74; 77; 76)
|
55.1 ELISA Units per Milliliter (EL.U/mL)
Interval 48.4 to 62.8
|
55.2 ELISA Units per Milliliter (EL.U/mL)
Interval 47.9 to 63.6
|
53.7 ELISA Units per Milliliter (EL.U/mL)
Interval 46.1 to 62.5
|
49.7 ELISA Units per Milliliter (EL.U/mL)
Interval 43.2 to 57.2
|
54.8 ELISA Units per Milliliter (EL.U/mL)
Interval 47.3 to 63.5
|
SECONDARY outcome
Timeframe: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.
Seroprotection is defined as anti-HBs antibody concentration greater than or equal to 10 Milli-International Units per Milliliter (mIU/mL).
Outcome measures
| Measure |
MenHibrix Formulation 1 Group
n=74 Participants
Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 2 Group
n=74 Participants
Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 3 Group
n=74 Participants
Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
Menjugate Group
n=76 Participants
Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
ActHIB Group
n=75 Participants
Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
|---|---|---|---|---|---|
|
Number of Subjects Seroprotected for Anti-hepatitis B (HBs) Antibodies
Day 0 (N= 57; 55; 56; 52; 57)
|
15 Subjects
|
16 Subjects
|
12 Subjects
|
14 Subjects
|
22 Subjects
|
|
Number of Subjects Seroprotected for Anti-hepatitis B (HBs) Antibodies
Month 5 (N= 72; 74; 74; 76; 75)
|
71 Subjects
|
74 Subjects
|
74 Subjects
|
76 Subjects
|
74 Subjects
|
|
Number of Subjects Seroprotected for Anti-hepatitis B (HBs) Antibodies
Month 10 (N= 74; 70; 70; 75; 69)
|
72 Subjects
|
68 Subjects
|
68 Subjects
|
72 Subjects
|
68 Subjects
|
SECONDARY outcome
Timeframe: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10 data.
Concentrations are presented as GMCs and expressed as Milli-International Units per Milliliter (mIU/mL).
Outcome measures
| Measure |
MenHibrix Formulation 1 Group
n=74 Participants
Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 2 Group
n=74 Participants
Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 3 Group
n=74 Participants
Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
Menjugate Group
n=76 Participants
Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
ActHIB Group
n=75 Participants
Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
|---|---|---|---|---|---|
|
Anti- HBs Antibody Concentrations
Day 0 (N= 57; 55; 56; 52; 57)
|
13.7 Milli-International Units per Milliliter
Interval 8.1 to 23.1
|
12.2 Milli-International Units per Milliliter
Interval 7.8 to 19.2
|
10.0 Milli-International Units per Milliliter
Interval 6.9 to 14.5
|
10.1 Milli-International Units per Milliliter
Interval 7.1 to 14.4
|
18.8 Milli-International Units per Milliliter
Interval 11.1 to 32.0
|
|
Anti- HBs Antibody Concentrations
Month 5 (N= 72; 74; 74; 76; 75)
|
1769.2 Milli-International Units per Milliliter
Interval 1276.4 to 2452.2
|
1840.7 Milli-International Units per Milliliter
Interval 1467.3 to 2309.0
|
1652.6 Milli-International Units per Milliliter
Interval 1301.2 to 2098.8
|
1752.2 Milli-International Units per Milliliter
Interval 1373.3 to 2235.6
|
1609.7 Milli-International Units per Milliliter
Interval 1191.1 to 2175.5
|
|
Anti- HBs Antibody Concentrations
Month 10 (N= 74; 70; 70; 75; 69)
|
452.3 Milli-International Units per Milliliter
Interval 311.6 to 656.6
|
490.5 Milli-International Units per Milliliter
Interval 346.6 to 694.1
|
452.9 Milli-International Units per Milliliter
Interval 329.7 to 622.3
|
390.5 Milli-International Units per Milliliter
Interval 278.4 to 547.8
|
534.9 Milli-International Units per Milliliter
Interval 378.7 to 755.7
|
SECONDARY outcome
Timeframe: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.
Seroprotection is defined as anti-polio antibody titer greater than or equal to 1:8 dilution.
Outcome measures
| Measure |
MenHibrix Formulation 1 Group
n=71 Participants
Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 2 Group
n=70 Participants
Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 3 Group
n=70 Participants
Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
Menjugate Group
n=76 Participants
Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
ActHIB Group
n=67 Participants
Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
|---|---|---|---|---|---|
|
Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies
Polio-2 Day 0 (N= 56; 59; 50; 55; 52)
|
42 Subjects
|
40 Subjects
|
36 Subjects
|
44 Subjects
|
43 Subjects
|
|
Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies
Polio-2 Month 5 (N= 59; 66; 64; 66; 64)
|
59 Subjects
|
66 Subjects
|
64 Subjects
|
66 Subjects
|
63 Subjects
|
|
Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies
Polio-2 Month 10 (N= 71; 70; 69; 75; 67)
|
70 Subjects
|
66 Subjects
|
65 Subjects
|
71 Subjects
|
64 Subjects
|
|
Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies
Polio-3 Day 0 (N= 56; 59; 50; 56; 52)
|
20 Subjects
|
20 Subjects
|
24 Subjects
|
22 Subjects
|
21 Subjects
|
|
Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies
Polio-3 Month 5 (N= 62; 68; 66; 66; 65)
|
62 Subjects
|
68 Subjects
|
65 Subjects
|
65 Subjects
|
65 Subjects
|
|
Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies
Polio-3 Month 10 (N= 71; 70; 69; 76; 67)
|
71 Subjects
|
69 Subjects
|
67 Subjects
|
75 Subjects
|
65 Subjects
|
|
Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies
Polio-1 Day 0 (N= 56; 58; 50; 56; 52)
|
45 Subjects
|
50 Subjects
|
44 Subjects
|
49 Subjects
|
45 Subjects
|
|
Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies
Polio-1 Month 5 (N= 62; 68; 66; 66; 65)
|
62 Subjects
|
68 Subjects
|
66 Subjects
|
66 Subjects
|
65 Subjects
|
|
Number of Subjects Seroprotected for Anti-poliovirus Types 1, 2 and 3 Antibodies
Polio-1 Month 10 (N= 71; 69; 70; 76; 66)
|
70 Subjects
|
65 Subjects
|
69 Subjects
|
76 Subjects
|
65 Subjects
|
SECONDARY outcome
Timeframe: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10 data.
Titers are presented as GMTs and expressed in terms of the 50 % inhibitory dilution.
Outcome measures
| Measure |
MenHibrix Formulation 1 Group
n=71 Participants
Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 2 Group
n=70 Participants
Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 3 Group
n=70 Participants
Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
Menjugate Group
n=76 Participants
Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
ActHIB Group
n=67 Participants
Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
|---|---|---|---|---|---|
|
Anti-poliovirus Types 1, 2 and 3 Antibody Titers
Polio-2 Month 10 (N= 71; 70; 69; 75; 67)
|
139.8 Titer
Interval 104.1 to 187.8
|
94.1 Titer
Interval 67.5 to 131.3
|
110.1 Titer
Interval 77.0 to 157.4
|
89.6 Titer
Interval 63.4 to 126.7
|
88.3 Titer
Interval 61.6 to 126.5
|
|
Anti-poliovirus Types 1, 2 and 3 Antibody Titers
Polio-1 Day 0 (N= 56; 58; 50; 56; 52)
|
36.7 Titer
Interval 24.6 to 54.8
|
33.3 Titer
Interval 23.2 to 47.6
|
32.9 Titer
Interval 21.7 to 49.7
|
52.3 Titer
Interval 34.9 to 78.2
|
36.6 Titer
Interval 24.6 to 54.3
|
|
Anti-poliovirus Types 1, 2 and 3 Antibody Titers
Polio-1 Month 5 (N= 62; 68; 66; 66; 65)
|
669.6 Titer
Interval 507.5 to 883.4
|
476.8 Titer
Interval 364.0 to 624.4
|
574.7 Titer
Interval 436.2 to 757.1
|
454.0 Titer
Interval 337.5 to 610.7
|
517.6 Titer
Interval 396.9 to 674.9
|
|
Anti-poliovirus Types 1, 2 and 3 Antibody Titers
Polio-1 Month 10 (N= 71; 69; 70; 76; 66)
|
175.8 Titer
Interval 129.3 to 239.1
|
120.6 Titer
Interval 83.8 to 173.7
|
162.4 Titer
Interval 120.2 to 219.4
|
116.4 Titer
Interval 86.6 to 156.5
|
166.4 Titer
Interval 124.7 to 222.2
|
|
Anti-poliovirus Types 1, 2 and 3 Antibody Titers
Polio-2 Day 0 (N= 56; 59; 50; 55; 52)
|
14.9 Titer
Interval 11.2 to 19.9
|
13.8 Titer
Interval 10.3 to 18.3
|
15.9 Titer
Interval 11.4 to 22.1
|
17.2 Titer
Interval 12.8 to 23.3
|
17.1 Titer
Interval 12.7 to 23.0
|
|
Anti-poliovirus Types 1, 2 and 3 Antibody Titers
Polio-2 Month 5 (N= 59; 66; 64; 66; 64)
|
533.8 Titer
Interval 393.3 to 724.4
|
369.8 Titer
Interval 273.4 to 500.0
|
408.0 Titer
Interval 297.6 to 559.4
|
348.9 Titer
Interval 265.3 to 458.8
|
368.0 Titer
Interval 264.0 to 512.9
|
|
Anti-poliovirus Types 1, 2 and 3 Antibody Titers
Polio-3 Day 0 (N= 56; 59; 50; 56; 52)
|
6.4 Titer
Interval 5.3 to 7.8
|
6.6 Titer
Interval 5.2 to 8.3
|
7.9 Titer
Interval 6.2 to 10.1
|
7.7 Titer
Interval 5.8 to 10.1
|
8.0 Titer
Interval 6.1 to 10.5
|
|
Anti-poliovirus Types 1, 2 and 3 Antibody Titers
Polio-3 Month 5 (N= 62; 68; 66; 66; 65)
|
1266.3 Titer
Interval 992.1 to 1616.2
|
1034.8 Titer
Interval 778.8 to 1374.8
|
1062.2 Titer
Interval 809.2 to 1394.2
|
1084.9 Titer
Interval 804.2 to 1463.7
|
945.5 Titer
Interval 695.9 to 1284.5
|
|
Anti-poliovirus Types 1, 2 and 3 Antibody Titers
Polio-3 Month 10 (N= 71; 70; 69; 76; 67)
|
348.4 Titer
Interval 260.0 to 466.9
|
263.8 Titer
Interval 194.2 to 358.3
|
250.9 Titer
Interval 184.1 to 342.1
|
264.0 Titer
Interval 192.1 to 362.9
|
203.9 Titer
Interval 139.6 to 297.8
|
SECONDARY outcome
Timeframe: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for safety, including all vaccinated subjects who had not received a vaccine not specified or forbidden in the protocol, for the Month 10 data.
Pneumococcal antibodies assessed included anti-4, anti-6B, anti-9V, anti-14, anti-18C, anti-19F and anti-23F antibodies. The cut-off values assessed were 0.05 and 0.2 micrograms per milliliter (µg/mL).
Outcome measures
| Measure |
MenHibrix Formulation 1 Group
n=73 Participants
Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 2 Group
n=71 Participants
Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 3 Group
n=72 Participants
Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
Menjugate Group
n=77 Participants
Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
ActHIB Group
n=67 Participants
Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
|---|---|---|---|---|---|
|
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values
Anti-4 ≥ 0.2 µg/mL Day 0 (N=44;43;39;51;46)
|
3 Subjects
|
1 Subjects
|
3 Subjects
|
1 Subjects
|
2 Subjects
|
|
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values
Anti-4 ≥ 0.2 µg/mL Month 5 (N=69;70;69;58;66)
|
69 Subjects
|
70 Subjects
|
69 Subjects
|
1 Subjects
|
66 Subjects
|
|
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values
Anti-4 ≥ 0.05 µg/mL Day 0 (N=44;43;39;51;46)
|
10 Subjects
|
9 Subjects
|
10 Subjects
|
11 Subjects
|
10 Subjects
|
|
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values
Anti-4 ≥ 0.05 µg/mL Month 10 (N=70;68;66;69;64)
|
70 Subjects
|
68 Subjects
|
65 Subjects
|
1 Subjects
|
64 Subjects
|
|
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values
Anti-6B ≥ 0.05 µg/mL Day 0 (N=44;41;39;49;49)
|
18 Subjects
|
21 Subjects
|
20 Subjects
|
25 Subjects
|
23 Subjects
|
|
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values
Anti-6B ≥ 0.05 µg/mL Month 5 (N=68;70;69;63;65)
|
65 Subjects
|
69 Subjects
|
61 Subjects
|
3 Subjects
|
60 Subjects
|
|
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values
Anti-6B ≥ 0.05 µg/mL Month 10 (N=69;63;62;71;62)
|
62 Subjects
|
57 Subjects
|
55 Subjects
|
2 Subjects
|
55 Subjects
|
|
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values
Anti-9V ≥ 0.05 µg/mL Day 0 (N=46;42;40;52;48)
|
19 Subjects
|
22 Subjects
|
23 Subjects
|
23 Subjects
|
18 Subjects
|
|
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values
Anti-9V ≥ 0.05 µg/mL Month 5 (N=68;71;71;62;67)
|
68 Subjects
|
70 Subjects
|
71 Subjects
|
3 Subjects
|
66 Subjects
|
|
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values
Anti-9V ≥ 0.05 µg/mL Month 10 (N=60;60;56;63;56)
|
60 Subjects
|
58 Subjects
|
56 Subjects
|
5 Subjects
|
56 Subjects
|
|
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values
Anti-14 ≥ 0.05 µg/mL Day 0 (N=31;33;31;41;43)
|
29 Subjects
|
25 Subjects
|
26 Subjects
|
37 Subjects
|
39 Subjects
|
|
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values
Anti-14 ≥ 0.05 µg/mL Month 5 (N=65;65;68;49;65)
|
65 Subjects
|
65 Subjects
|
68 Subjects
|
24 Subjects
|
65 Subjects
|
|
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values
Anti-14 ≥ 0.05 µg/mL Month 10 (N=68;67;64;69;61)
|
67 Subjects
|
67 Subjects
|
63 Subjects
|
13 Subjects
|
61 Subjects
|
|
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values
Anti-18C ≥ 0.05 µg/mL Day 0 (N=40;40;37;47;47)
|
20 Subjects
|
19 Subjects
|
21 Subjects
|
23 Subjects
|
25 Subjects
|
|
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values
Anti-18C ≥ 0.05 µg/mL Month 10 (N=48;52;51;53;46)
|
47 Subjects
|
52 Subjects
|
51 Subjects
|
0 Subjects
|
45 Subjects
|
|
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values
Anti-19F ≥ 0.05 µg/mL Day 0 (N=42;42;36;50;45))
|
28 Subjects
|
28 Subjects
|
25 Subjects
|
37 Subjects
|
28 Subjects
|
|
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values
Anti-19F ≥ 0.05 µg/mL Month 5 (N=65;67;66;56;65)
|
65 Subjects
|
66 Subjects
|
66 Subjects
|
7 Subjects
|
65 Subjects
|
|
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values
Anti-19F ≥ 0.05 µg/mL Month 10 (N=73;71;65;77;63)
|
73 Subjects
|
68 Subjects
|
65 Subjects
|
14 Subjects
|
61 Subjects
|
|
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values
Anti-23F ≥ 0.05 µg/mL Day 0 (N=41;43;38;48;48)
|
17 Subjects
|
14 Subjects
|
15 Subjects
|
19 Subjects
|
22 Subjects
|
|
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values
Anti-23F ≥ 0.05 µg/mL Month 5 (N=66;68;70;59;66)
|
65 Subjects
|
66 Subjects
|
67 Subjects
|
3 Subjects
|
63 Subjects
|
|
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values
Anti-6B ≥ 0.2 µg/mL Day 0 (N=44;41;39;49;49)
|
6 Subjects
|
11 Subjects
|
7 Subjects
|
9 Subjects
|
8 Subjects
|
|
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values
Anti-6B ≥ 0.2 µg/mL Month 5 (N=68;70;69;63;65)
|
58 Subjects
|
64 Subjects
|
56 Subjects
|
1 Subjects
|
56 Subjects
|
|
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values
Anti-6B ≥ 0.2 µg/mL Month 10 (N=69;63;62;71;62)
|
45 Subjects
|
41 Subjects
|
49 Subjects
|
0 Subjects
|
42 Subjects
|
|
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values
Anti-9V ≥ 0.2 µg/mL Day 0 (N=46;42;40;52;48)
|
9 Subjects
|
6 Subjects
|
8 Subjects
|
10 Subjects
|
8 Subjects
|
|
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values
Anti-14 ≥ 0.2 µg/mL Month 5 (N=65;65;68;49;65)
|
64 Subjects
|
65 Subjects
|
68 Subjects
|
7 Subjects
|
64 Subjects
|
|
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values
Anti-18C ≥ 0.2 µg/mL Month 10 (N=48;52;51;53;46)
|
47 Subjects
|
50 Subjects
|
50 Subjects
|
0 Subjects
|
42 Subjects
|
|
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values
Anti-19F ≥ 0.2 µg/mL Day 0 (N=42;42;36;50;45)
|
14 Subjects
|
18 Subjects
|
16 Subjects
|
22 Subjects
|
15 Subjects
|
|
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values
Anti-19F ≥ 0.2 µg/mL Month 5 (N=65;67;66;56;65)
|
65 Subjects
|
66 Subjects
|
66 Subjects
|
2 Subjects
|
63 Subjects
|
|
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values
Anti-19F ≥ 0.2 µg/mL Month 10 (N=73;71;65;77;63)
|
54 Subjects
|
51 Subjects
|
55 Subjects
|
8 Subjects
|
45 Subjects
|
|
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values
Anti-23F ≥ 0.2 µg/mL Day 0 (N=41;43;38;48;48)
|
5 Subjects
|
6 Subjects
|
7 Subjects
|
9 Subjects
|
8 Subjects
|
|
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values
Anti-23F ≥ 0.2 µg/mL Month 5 (N=66;68;70;59;66)
|
64 Subjects
|
64 Subjects
|
67 Subjects
|
0 Subjects
|
62 Subjects
|
|
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values
Anti-23F ≥ 0.2 µg/mL Month 10 (N=73;69;63;75;65)
|
66 Subjects
|
56 Subjects
|
53 Subjects
|
0 Subjects
|
52 Subjects
|
|
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values
Anti-23F ≥ 0.05 µg/mL Month 10 (N=73;69;63;75;65)
|
71 Subjects
|
67 Subjects
|
59 Subjects
|
0 Subjects
|
63 Subjects
|
|
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values
Anti-4 ≥ 0.2 µg/mL Month 10 (N=70;68;66;69;64)
|
65 Subjects
|
60 Subjects
|
61 Subjects
|
1 Subjects
|
53 Subjects
|
|
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values
Anti-9V ≥ 0.2 µg/mL Month 5 (N=68;71;71;62;67)
|
68 Subjects
|
69 Subjects
|
71 Subjects
|
1 Subjects
|
66 Subjects
|
|
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values
Anti-9V ≥ 0.2 µg/mL Month 10 (N=60;60;56;63;56)
|
55 Subjects
|
54 Subjects
|
55 Subjects
|
2 Subjects
|
56 Subjects
|
|
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values
Anti-14 ≥ 0.2 µg/mL Day 0 (N=31;33;31;41;43)
|
20 Subjects
|
18 Subjects
|
16 Subjects
|
28 Subjects
|
30 Subjects
|
|
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values
Anti-14 ≥ 0.2 µg/mL Month 10 (N=68;67;64;69;61)
|
64 Subjects
|
65 Subjects
|
63 Subjects
|
5 Subjects
|
60 Subjects
|
|
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values
Anti-18C ≥ 0.2 µg/mL Day 0 (N=40;40;37;47;47)
|
10 Subjects
|
6 Subjects
|
8 Subjects
|
6 Subjects
|
10 Subjects
|
|
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values
Anti-18C ≥ 0.2 µg/mL Month 5 (N=67;71;72;65;67)
|
66 Subjects
|
70 Subjects
|
72 Subjects
|
2 Subjects
|
65 Subjects
|
|
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values
Anti-4 ≥ 0.05 µg/mL Month 5 (N=69;70;69;58;66)
|
69 Subjects
|
70 Subjects
|
69 Subjects
|
2 Subjects
|
66 Subjects
|
|
Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to Pre-defined Cut-off Values
Anti-18C ≥ 0.05 µg/mL Month 5 (N=67;71;72;65;67)
|
66 Subjects
|
71 Subjects
|
72 Subjects
|
5 Subjects
|
66 Subjects
|
SECONDARY outcome
Timeframe: Prior to vaccination (Day 0), one month after the 3-dose primary vaccination course (Month 5) and before administration of the polysaccharide challenge dose (Month 10)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity for Day 0/Month5 data and on the Booster ATP cohort for immunogenicity for the Month 10 data.
Pneumococcal antibodies assessed included anti-4, anti-6B, anti-9V, anti-14, anti-18C, anti-19F and anti-23F antibodies. Concentrations are presented as GMCs and expressed as micrograms per milliliter (µg/mL).
Outcome measures
| Measure |
MenHibrix Formulation 1 Group
n=73 Participants
Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 2 Group
n=71 Participants
Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 3 Group
n=72 Participants
Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
Menjugate Group
n=77 Participants
Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
ActHIB Group
n=67 Participants
Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
|---|---|---|---|---|---|
|
Anti-pneumococcal Antibody Concentrations
Anti-4 Month 5 (N= 69; 70; 69; 58; 66)
|
2.101 Micrograms per milliliter (µg/mL)
Interval 1.78 to 2.48
|
2.049 Micrograms per milliliter (µg/mL)
Interval 1.718 to 2.442
|
2.023 Micrograms per milliliter (µg/mL)
Interval 1.729 to 2.366
|
0.027 Micrograms per milliliter (µg/mL)
Interval 0.024 to 0.03
|
2.062 Micrograms per milliliter (µg/mL)
Interval 1.787 to 2.38
|
|
Anti-pneumococcal Antibody Concentrations
Anti-4 Day 0 (N= 44; 43; 39; 51; 46)
|
0.036 Micrograms per milliliter (µg/mL)
Interval 0.029 to 0.046
|
0.035 Micrograms per milliliter (µg/mL)
Interval 0.028 to 0.043
|
0.040 Micrograms per milliliter (µg/mL)
Interval 0.03 to 0.053
|
0.034 Micrograms per milliliter (µg/mL)
Interval 0.028 to 0.04
|
0.036 Micrograms per milliliter (µg/mL)
Interval 0.029 to 0.046
|
|
Anti-pneumococcal Antibody Concentrations
Anti-4 Month 10 (N= 70; 68; 66; 69; 64)
|
0.495 Micrograms per milliliter (µg/mL)
Interval 0.407 to 0.603
|
0.528 Micrograms per milliliter (µg/mL)
Interval 0.431 to 0.646
|
0.508 Micrograms per milliliter (µg/mL)
Interval 0.414 to 0.623
|
0.026 Micrograms per milliliter (µg/mL)
Interval 0.024 to 0.027
|
0.450 Micrograms per milliliter (µg/mL)
Interval 0.372 to 0.544
|
|
Anti-pneumococcal Antibody Concentrations
Anti-6B Day 0 (N= 44; 41; 39; 49; 49)
|
0.055 Micrograms per milliliter (µg/mL)
Interval 0.039 to 0.078
|
0.080 Micrograms per milliliter (µg/mL)
Interval 0.052 to 0.123
|
0.067 Micrograms per milliliter (µg/mL)
Interval 0.046 to 0.099
|
0.070 Micrograms per milliliter (µg/mL)
Interval 0.049 to 0.101
|
0.067 Micrograms per milliliter (µg/mL)
Interval 0.045 to 0.099
|
|
Anti-pneumococcal Antibody Concentrations
Anti-6B Month 5 (N= 68; 70; 69; 63; 65)
|
1.060 Micrograms per milliliter (µg/mL)
Interval 0.744 to 1.511
|
1.079 Micrograms per milliliter (µg/mL)
Interval 0.808 to 1.442
|
0.834 Micrograms per milliliter (µg/mL)
Interval 0.567 to 1.225
|
0.027 Micrograms per milliliter (µg/mL)
Interval 0.025 to 0.03
|
0.879 Micrograms per milliliter (µg/mL)
Interval 0.604 to 1.278
|
|
Anti-pneumococcal Antibody Concentrations
Anti-6B Month 10 (N= 69; 63; 62; 71; 62)
|
0.307 Micrograms per milliliter (µg/mL)
Interval 0.223 to 0.424
|
0.307 Micrograms per milliliter (µg/mL)
Interval 0.223 to 0.423
|
0.292 Micrograms per milliliter (µg/mL)
Interval 0.215 to 0.398
|
0.026 Micrograms per milliliter (µg/mL)
Interval 0.025 to 0.027
|
0.308 Micrograms per milliliter (µg/mL)
Interval 0.22 to 0.43
|
|
Anti-pneumococcal Antibody Concentrations
Anti-9V Month 5 (N= 68; 71; 71; 62; 67)
|
3.102 Micrograms per milliliter (µg/mL)
Interval 2.563 to 3.754
|
2.363 Micrograms per milliliter (µg/mL)
Interval 1.822 to 3.066
|
2.823 Micrograms per milliliter (µg/mL)
Interval 2.376 to 3.354
|
0.028 Micrograms per milliliter (µg/mL)
Interval 0.024 to 0.033
|
2.651 Micrograms per milliliter (µg/mL)
Interval 2.079 to 3.38
|
|
Anti-pneumococcal Antibody Concentrations
Anti-9V Month 10 (N= 60; 60; 56; 63; 56)
|
0.818 Micrograms per milliliter (µg/mL)
Interval 0.656 to 1.02
|
0.721 Micrograms per milliliter (µg/mL)
Interval 0.555 to 0.937
|
0.933 Micrograms per milliliter (µg/mL)
Interval 0.758 to 1.147
|
0.030 Micrograms per milliliter (µg/mL)
Interval 0.025 to 0.035
|
0.881 Micrograms per milliliter (µg/mL)
Interval 0.742 to 1.045
|
|
Anti-pneumococcal Antibody Concentrations
Anti-14 Day 0 (N= 31; 33; 31; 41; 43)
|
0.367 Micrograms per milliliter (µg/mL)
Interval 0.203 to 0.664
|
0.227 Micrograms per milliliter (µg/mL)
Interval 0.121 to 0.427
|
0.258 Micrograms per milliliter (µg/mL)
Interval 0.143 to 0.467
|
0.394 Micrograms per milliliter (µg/mL)
Interval 0.253 to 0.612
|
0.388 Micrograms per milliliter (µg/mL)
Interval 0.247 to 0.609
|
|
Anti-pneumococcal Antibody Concentrations
Anti-14 Month 5 (N= 65; 65; 68; 49; 65)
|
4.095 Micrograms per milliliter (µg/mL)
Interval 3.037 to 5.52
|
5.592 Micrograms per milliliter (µg/mL)
Interval 4.238 to 7.378
|
4.309 Micrograms per milliliter (µg/mL)
Interval 3.306 to 5.616
|
0.062 Micrograms per milliliter (µg/mL)
Interval 0.043 to 0.09
|
4.372 Micrograms per milliliter (µg/mL)
Interval 3.211 to 5.954
|
|
Anti-pneumococcal Antibody Concentrations
Anti-14 Month 10 (N= 68; 67; 64; 69; 61)
|
2.362 Micrograms per milliliter (µg/mL)
Interval 1.786 to 3.124
|
2.767 Micrograms per milliliter (µg/mL)
Interval 2.149 to 3.563
|
2.549 Micrograms per milliliter (µg/mL)
Interval 1.968 to 3.304
|
0.039 Micrograms per milliliter (µg/mL)
Interval 0.03 to 0.051
|
2.379 Micrograms per milliliter (µg/mL)
Interval 1.807 to 3.132
|
|
Anti-pneumococcal Antibody Concentrations
Anti-18C Day 0 (N= 40; 40; 37; 47; 47)
|
0.073 Micrograms per milliliter (µg/mL)
Interval 0.049 to 0.109
|
0.063 Micrograms per milliliter (µg/mL)
Interval 0.045 to 0.09
|
0.075 Micrograms per milliliter (µg/mL)
Interval 0.05 to 0.111
|
0.063 Micrograms per milliliter (µg/mL)
Interval 0.045 to 0.09
|
0.078 Micrograms per milliliter (µg/mL)
Interval 0.054 to 0.112
|
|
Anti-pneumococcal Antibody Concentrations
Anti-18C Month 5 (N= 67; 71; 72; 65; 67)
|
3.518 Micrograms per milliliter (µg/mL)
Interval 2.748 to 4.504
|
2.969 Micrograms per milliliter (µg/mL)
Interval 2.464 to 3.578
|
2.936 Micrograms per milliliter (µg/mL)
Interval 2.44 to 3.533
|
0.029 Micrograms per milliliter (µg/mL)
Interval 0.025 to 0.035
|
3.326 Micrograms per milliliter (µg/mL)
Interval 2.557 to 4.327
|
|
Anti-pneumococcal Antibody Concentrations
Anti-18C Month 10 (N= 48; 52; 51; 53; 46)
|
0.775 Micrograms per milliliter (µg/mL)
Interval 0.601 to 1.0
|
0.742 Micrograms per milliliter (µg/mL)
Interval 0.607 to 0.907
|
0.708 Micrograms per milliliter (µg/mL)
Interval 0.577 to 0.867
|
0.025 Micrograms per milliliter (µg/mL)
Interval 0.025 to 0.025
|
0.668 Micrograms per milliliter (µg/mL)
Interval 0.503 to 0.887
|
|
Anti-pneumococcal Antibody Concentrations
Anti-19F Day 0 (N= 42; 42; 36; 50; 45)
|
0.124 Micrograms per milliliter (µg/mL)
Interval 0.076 to 0.202
|
0.126 Micrograms per milliliter (µg/mL)
Interval 0.083 to 0.19
|
0.129 Micrograms per milliliter (µg/mL)
Interval 0.08 to 0.206
|
0.135 Micrograms per milliliter (µg/mL)
Interval 0.092 to 0.198
|
0.115 Micrograms per milliliter (µg/mL)
Interval 0.073 to 0.18
|
|
Anti-pneumococcal Antibody Concentrations
Anti-19F Month 5 (N= 65; 67; 66; 56; 65)
|
2.303 Micrograms per milliliter (µg/mL)
Interval 1.889 to 2.806
|
1.846 Micrograms per milliliter (µg/mL)
Interval 1.444 to 2.36
|
2.061 Micrograms per milliliter (µg/mL)
Interval 1.719 to 2.472
|
0.030 Micrograms per milliliter (µg/mL)
Interval 0.026 to 0.035
|
1.881 Micrograms per milliliter (µg/mL)
Interval 1.508 to 2.346
|
|
Anti-pneumococcal Antibody Concentrations
Anti-19F Month 10 (N= 73; 71; 65; 77; 63)
|
0.413 Micrograms per milliliter (µg/mL)
Interval 0.32 to 0.532
|
0.335 Micrograms per milliliter (µg/mL)
Interval 0.252 to 0.443
|
0.397 Micrograms per milliliter (µg/mL)
Interval 0.307 to 0.512
|
0.042 Micrograms per milliliter (µg/mL)
Interval 0.031 to 0.056
|
0.339 Micrograms per milliliter (µg/mL)
Interval 0.252 to 0.456
|
|
Anti-pneumococcal Antibody Concentrations
Anti-23F Day 0 (N= 41; 43; 38; 48; 48)
|
0.053 Micrograms per milliliter (µg/mL)
Interval 0.038 to 0.075
|
0.045 Micrograms per milliliter (µg/mL)
Interval 0.033 to 0.062
|
0.062 Micrograms per milliliter (µg/mL)
Interval 0.04 to 0.096
|
0.060 Micrograms per milliliter (µg/mL)
Interval 0.041 to 0.086
|
0.065 Micrograms per milliliter (µg/mL)
Interval 0.044 to 0.098
|
|
Anti-pneumococcal Antibody Concentrations
Anti-23F Month 5 (N= 66; 68; 70; 59; 66)
|
2.581 Micrograms per milliliter (µg/mL)
Interval 1.97 to 3.381
|
2.112 Micrograms per milliliter (µg/mL)
Interval 1.544 to 2.891
|
2.098 Micrograms per milliliter (µg/mL)
Interval 1.551 to 2.838
|
0.027 Micrograms per milliliter (µg/mL)
Interval 0.025 to 0.029
|
1.988 Micrograms per milliliter (µg/mL)
Interval 1.426 to 2.772
|
|
Anti-pneumococcal Antibody Concentrations
Anti-23F Month 10 (N= 73; 69; 63; 75; 65)
|
0.783 Micrograms per milliliter (µg/mL)
Interval 0.595 to 1.032
|
0.642 Micrograms per milliliter (µg/mL)
Interval 0.474 to 0.87
|
0.644 Micrograms per milliliter (µg/mL)
Interval 0.469 to 0.885
|
0.025 Micrograms per milliliter (µg/mL)
Interval 0.025 to 0.025
|
0.578 Micrograms per milliliter (µg/mL)
Interval 0.426 to 0.785
|
|
Anti-pneumococcal Antibody Concentrations
Anti-9V Day 0 (N= 46; 42; 40; 52; 48)
|
0.058 Micrograms per milliliter (µg/mL)
Interval 0.04 to 0.085
|
0.065 Micrograms per milliliter (µg/mL)
Interval 0.044 to 0.096
|
0.079 Micrograms per milliliter (µg/mL)
Interval 0.051 to 0.121
|
0.059 Micrograms per milliliter (µg/mL)
Interval 0.043 to 0.08
|
0.055 Micrograms per milliliter (µg/mL)
Interval 0.039 to 0.077
|
SECONDARY outcome
Timeframe: During the 8-Day (Day 0-7) follow-up period after any vaccine dose during the primary vaccination coursePopulation: The analysis was performed on the Total Vaccinated Cohort, on subjects having completed the symptom sheet.
Solicited local symptoms assessed include pain, redness and swelling at the injection site. Solicited general symptoms assessed include drowsiness, irritability, loss of appetite and fever (rectal temperature greater than or equal to 38 degrees Celcius).
Outcome measures
| Measure |
MenHibrix Formulation 1 Group
n=81 Participants
Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 2 Group
n=82 Participants
Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 3 Group
n=79 Participants
Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
Menjugate Group
n=81 Participants
Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
ActHIB Group
n=82 Participants
Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
|---|---|---|---|---|---|
|
Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course
Irritability
|
76 Subjects
|
79 Subjects
|
76 Subjects
|
80 Subjects
|
80 Subjects
|
|
Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course
Loss of appetite
|
57 Subjects
|
56 Subjects
|
49 Subjects
|
47 Subjects
|
58 Subjects
|
|
Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course
Fever
|
65 Subjects
|
64 Subjects
|
64 Subjects
|
64 Subjects
|
70 Subjects
|
|
Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course
Pain
|
54 Subjects
|
50 Subjects
|
53 Subjects
|
66 Subjects
|
60 Subjects
|
|
Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course
Redness
|
67 Subjects
|
67 Subjects
|
64 Subjects
|
75 Subjects
|
69 Subjects
|
|
Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course
Swelling
|
53 Subjects
|
64 Subjects
|
56 Subjects
|
60 Subjects
|
58 Subjects
|
|
Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Course
Drowsiness
|
65 Subjects
|
72 Subjects
|
58 Subjects
|
70 Subjects
|
67 Subjects
|
SECONDARY outcome
Timeframe: During the 8-Day (Day 0-7) follow-up period after the polysaccharide challenge dosePopulation: The analysis was performed on the Booster Total Vaccinated Cohort, on subjects having completed the symptom sheet.
Solicited local symptoms assessed include pain, redness and swelling at the injection site. Solicited general symptoms assessed include drowsiness, irritability, loss of appetite and fever (rectal temperature greater than or equal to 38 degrees Celcius).
Outcome measures
| Measure |
MenHibrix Formulation 1 Group
n=80 Participants
Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 2 Group
n=79 Participants
Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 3 Group
n=77 Participants
Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
Menjugate Group
n=81 Participants
Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
ActHIB Group
n=77 Participants
Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
|---|---|---|---|---|---|
|
Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose
Pain
|
19 Subjects
|
15 Subjects
|
18 Subjects
|
17 Subjects
|
16 Subjects
|
|
Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose
Redness
|
39 Subjects
|
27 Subjects
|
27 Subjects
|
44 Subjects
|
29 Subjects
|
|
Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose
Swelling
|
15 Subjects
|
15 Subjects
|
13 Subjects
|
15 Subjects
|
12 Subjects
|
|
Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose
Drowsiness
|
26 Subjects
|
25 Subjects
|
17 Subjects
|
26 Subjects
|
18 Subjects
|
|
Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose
Irritability
|
48 Subjects
|
48 Subjects
|
45 Subjects
|
46 Subjects
|
49 Subjects
|
|
Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose
Loss of appetite
|
26 Subjects
|
27 Subjects
|
25 Subjects
|
24 Subjects
|
23 Subjects
|
|
Number of Subjects Reporting Solicited Local and General Symptoms After Administration of the Polysaccharide Challenge Dose
Fever
|
29 Subjects
|
20 Subjects
|
27 Subjects
|
36 Subjects
|
34 Subjects
|
SECONDARY outcome
Timeframe: During the 31-Day (Day 0-30) follow-up period after any vaccine dose during the primary vaccination coursePopulation: The analysis was performed on the Total Vaccinated Cohort.
Unsolicited adverse event covers any adverse event 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.
Outcome measures
| Measure |
MenHibrix Formulation 1 Group
n=82 Participants
Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 2 Group
n=82 Participants
Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 3 Group
n=80 Participants
Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
Menjugate Group
n=81 Participants
Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
ActHIB Group
n=82 Participants
Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
|---|---|---|---|---|---|
|
Number of Subjects Reporting Unsolicited Adverse Events During the Primary Vaccination Course
|
64 Subjects
|
68 Subjects
|
56 Subjects
|
58 Subjects
|
68 Subjects
|
SECONDARY outcome
Timeframe: During the 31-Day (Day 0-30) follow-up period after administration of the polysaccharide challenge dosePopulation: The analysis was performed on the Booster Total Vaccinated Cohort.
Unsolicited adverse event covers any adverse event 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.
Outcome measures
| Measure |
MenHibrix Formulation 1 Group
n=80 Participants
Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 2 Group
n=79 Participants
Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 3 Group
n=77 Participants
Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
Menjugate Group
n=81 Participants
Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
ActHIB Group
n=77 Participants
Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
|---|---|---|---|---|---|
|
Number of Subjects Reporting Unsolicited Adverse Events After Administration of the Polysaccharide Challenge Dose
|
39 Subjects
|
46 Subjects
|
47 Subjects
|
50 Subjects
|
52 Subjects
|
SECONDARY outcome
Timeframe: Up to one month after the 3-dose primary vaccination course (Month 5)Population: The analysis was performed on the Total Vaccinated Cohort.
Serious adverse events cover all medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Outcome measures
| Measure |
MenHibrix Formulation 1 Group
n=82 Participants
Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 2 Group
n=82 Participants
Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 3 Group
n=80 Participants
Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
Menjugate Group
n=81 Participants
Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
ActHIB Group
n=82 Participants
Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
|---|---|---|---|---|---|
|
Number of Subjects Reporting Serious Adverse Events During the Primary Vaccination Course
|
5 Subjects
|
5 Subjects
|
2 Subjects
|
4 Subjects
|
6 Subjects
|
SECONDARY outcome
Timeframe: Up to one month following administration of the polysaccharide challenge dose (Month 11)Population: The analysis was performed on the Booster Total Vaccinated Cohort.
Serious adverse events cover all medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Outcome measures
| Measure |
MenHibrix Formulation 1 Group
n=80 Participants
Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 2 Group
n=79 Participants
Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 3 Group
n=77 Participants
Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
Menjugate Group
n=81 Participants
Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
ActHIB Group
n=77 Participants
Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
|---|---|---|---|---|---|
|
Number of Subjects Reporting Serious Adverse Events After Administration of the Polysaccharide Challenge Dose
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
2 Subjects
|
Adverse Events
MenHibrix Formulation 1 Group
Serious events: 5 serious events
Other events: 81 other events
Deaths: 0 deaths
MenHibrix Formulation 2 Group
Serious events: 5 serious events
Other events: 81 other events
Deaths: 0 deaths
MenHibrix Formulation 3 Group
Serious events: 2 serious events
Other events: 77 other events
Deaths: 0 deaths
Menjugate Group
Serious events: 4 serious events
Other events: 81 other events
Deaths: 0 deaths
ActHIB Group
Serious events: 6 serious events
Other events: 82 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MenHibrix Formulation 1 Group
n=82 participants at risk
Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 2 Group
n=82 participants at risk
Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 3 Group
n=80 participants at risk
Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
Menjugate Group
n=81 participants at risk
Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
ActHIB Group
n=82 participants at risk
Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
|---|---|---|---|---|---|
|
Reproductive system and breast disorders
Balanitis
|
0.00%
0/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/80 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/81 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
1.2%
1/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/80 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/79 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/77 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/81 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
1.3%
1/77 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/80 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
1.2%
1/81 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
|
Infections and infestations
Croup infectious
|
0.00%
0/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
1.2%
1/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/80 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/81 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/80 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
1.2%
1/81 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/80 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/81 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
1.2%
1/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
|
Infections and infestations
Gastroenteritis
|
1.2%
1/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/80 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/81 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
|
Infections and infestations
Gastroenteritis viral
|
2.4%
2/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/80 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
1.2%
1/81 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
1.2%
1/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/80 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/81 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
|
Infections and infestations
Influenza
|
0.00%
0/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
1.2%
1/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/80 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/81 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
|
Infections and infestations
Lobar pneumonia
|
1.2%
1/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/80 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/81 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
|
Immune system disorders
Milk allergy
|
0.00%
0/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
1.2%
1/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/80 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/81 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/80 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/79 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/77 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/81 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
1.3%
1/77 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
|
Pregnancy, puerperium and perinatal conditions
Sudden infant death syndrome
|
0.00%
0/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
1.2%
1/80 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/81 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/80 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
1.2%
1/81 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
Other adverse events
| Measure |
MenHibrix Formulation 1 Group
n=82 participants at risk
Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 2 Group
n=82 participants at risk
Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
MenHibrix Formulation 3 Group
n=80 participants at risk
Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
Menjugate Group
n=81 participants at risk
Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
ActHIB Group
n=82 participants at risk
Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
|
|---|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
15.0%
12/80 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
12.7%
10/79 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
18.2%
14/77 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
21.0%
17/81 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
14.3%
11/77 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
|
General disorders
Injection site bruising
|
14.6%
12/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
14.6%
12/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
18.8%
15/80 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
19.8%
16/81 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
13.4%
11/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
|
Psychiatric disorders
Irritability
|
6.2%
5/80 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
7.6%
6/79 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
10.4%
8/77 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
7.4%
6/81 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
7.8%
6/77 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
7.3%
6/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
11.0%
9/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
5.0%
4/80 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
12.3%
10/81 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
7.3%
6/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
4/80 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
5.1%
4/79 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
3.9%
3/77 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
3.7%
3/81 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
6.5%
5/77 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.3%
6/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
12.2%
10/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
7.5%
6/80 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
8.6%
7/81 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
4.9%
4/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
|
General disorders
Pyrexia
|
2.5%
2/80 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
5.1%
4/79 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
13.0%
10/77 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
3.7%
3/81 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
7.8%
6/77 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
|
Gastrointestinal disorders
Teething
|
2.5%
2/80 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
6.3%
5/79 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
5.2%
4/77 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
7.4%
6/81 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
9.1%
7/77 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.5%
2/80 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
7.6%
6/79 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
3.9%
3/77 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
3.7%
3/81 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
3.9%
3/77 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.8%
8/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
2.4%
2/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
8.8%
7/80 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
3.7%
3/81 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
2.4%
2/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
|
Gastrointestinal disorders
Gingival pain
|
1.2%
1/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
3.7%
3/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
3.8%
3/80 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
6.2%
5/81 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
2.4%
2/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
|
Infections and infestations
Bronchiolitis
|
3.7%
3/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
4.9%
4/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
3.8%
3/80 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/81 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
6.1%
5/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
3.7%
3/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
5.0%
4/80 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
3.7%
3/81 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
4.9%
4/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
7.3%
6/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
2.5%
2/80 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/81 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
4.9%
4/82 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
|
General disorders
Injection site haemorrhage
|
8.8%
7/80 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
11.4%
9/79 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
3.9%
3/77 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
8.6%
7/81 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
9.1%
7/77 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorhea
|
5.0%
4/80 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
7.6%
6/79 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
6.5%
5/77 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
8.6%
7/81 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
6.5%
5/77 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
|
Infections and infestations
Otitis media
|
6.2%
5/80 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
3.8%
3/79 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
3.9%
3/77 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
1.2%
1/81 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
3.9%
3/77 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
|
Gastrointestinal disorders
Diarrhea
|
5.0%
4/80 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/79 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
2.6%
2/77 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
6.2%
5/81 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/77 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/80 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
1.3%
1/79 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
5.2%
4/77 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/81 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
0.00%
0/77 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/80 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
1.3%
1/79 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
1.3%
1/77 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
1.2%
1/81 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
5.2%
4/77 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
|
General disorders
Pain at the injection site
|
23.8%
19/80 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
19.0%
15/79 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
23.4%
18/77 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
21.0%
17/81 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
20.8%
16/77 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
|
General disorders
Redness at the injection site
|
48.8%
39/80 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
34.2%
27/79 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
35.1%
27/77 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
54.3%
44/81 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
37.7%
29/77 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
|
General disorders
Swelling at the injection site
|
18.8%
15/80 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
19.0%
15/79 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
16.9%
13/77 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
18.5%
15/81 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
15.6%
12/77 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
|
General disorders
Drowsiness
|
32.5%
26/80 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
31.6%
25/79 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
22.1%
17/77 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
32.1%
26/81 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
23.4%
18/77 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
|
General disorders
Irritability
|
60.0%
48/80 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
60.8%
48/79 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
58.4%
45/77 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
56.8%
46/81 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
63.6%
49/77 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
|
General disorders
Loss of appetite
|
32.5%
26/80 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
34.2%
27/79 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
32.5%
25/77 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
29.6%
24/81 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
29.9%
23/77 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
|
General disorders
Fever
|
36.2%
29/80 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
25.3%
20/79 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
35.1%
27/77 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
44.4%
36/81 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
44.2%
34/77 • SAEs: Up to 1 month following primary vaccination and challenge dose; Non-systematically assessed other AEs: Up to 31 days following primary vaccination and challenge dose; Systematically assessed other AEs: During 8-day follow-up after each dose.
The number at risk for systematically assessed symptoms comprises only those subjects who had returned the symptom sheet.
|
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