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Safety, Tolerability and Immunogenicity of Meningococcal B Recombinant Vaccine Administered as Booster Dose at 12, 18 or 24 Months of Age in Toddlers (12-24 Months) Primed With a Three-Dose Immunization Series as Infants in Study V72P12

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ClinicalTrials.gov Identifier: NCT00944034
Recruitment Status : Completed
First Posted : July 22, 2009
Results First Posted : November 10, 2015
Last Update Posted : August 14, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Meningococcal Disease
Meningococcal Meningitis
Interventions Biological: rMenB+OMV NZ with routine vaccinations
Biological: rMenB+OMV NZ
Biological: two doses of rMenB+OMV NZ
Enrollment 1588
Recruitment Details Subjects were enrolled from 6 centres in Belgium, 4 in Czech, 24 in Germany, 5 in Italy, 16 in Spain and 4 in UK who had previously participated in and completed the study V72P12.
Pre-assignment Details All enrolled subjects were included in the trial.
Arm/Group Title B+R246_12 B+R246_18 B+R246_24 B246_12 B246_18 B246_24 B+R234_12 B+R234_18 B+R234_24 B12 14 B18 20 B24 26
Hide Arm/Group Description Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.age Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age. Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age. Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age. Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
Period Title: Overall Study
Started 188 157 152 174 164 143 106 78 73 246 51 56
Completed 183 150 143 170 150 123 102 73 63 236 50 52
Not Completed 5 7 9 4 14 20 4 5 10 10 1 4
Reason Not Completed
Inappropriate enrollment             0             1             0             1             2             1             0             0             1             1             0             0
Withdrawal by Subject             3             2             6             2             5             8             2             2             3             4             0             4
Lost to Follow-up             0             4             2             0             5             7             0             1             5             1             1             0
Death             0             0             1             0             0             0             0             0             0             0             0             0
Protocol Violation             2             0             0             1             2             3             0             1             1             4             0             0
Unable to classify             0             0             0             0             0             1             1             1             0             0             0             0
Administrative reason             0             0             0             0             0             0             1             0             0             0             0             0
Arm/Group Title B+R246_12 B+R246_18 B+R246_24 B246_12 B246_18 B246_24 B+R234_12 B+R234_18 B+R234_24 B12 14 B18 20 B24 26 Total
Hide Arm/Group Description Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age. Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age. Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age. Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age. Total of all reporting groups
Overall Number of Baseline Participants 188 157 152 174 164 143 106 78 73 246 51 56 1588
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 188 participants 157 participants 152 participants 174 participants 164 participants 143 participants 106 participants 78 participants 73 participants 246 participants 51 participants 56 participants 1588 participants
<=18 years
188
 100.0%
157
 100.0%
152
 100.0%
174
 100.0%
164
 100.0%
143
 100.0%
106
 100.0%
78
 100.0%
73
 100.0%
246
 100.0%
51
 100.0%
56
 100.0%
1588
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 188 participants 157 participants 152 participants 174 participants 164 participants 143 participants 106 participants 78 participants 73 participants 246 participants 51 participants 56 participants 1588 participants
12.6  (1.2) 18.1  (0.6) 24  (0.4) 12.7  (0.9) 18.1  (0.5) 24  (0.3) 12.8  (1.4) 18  (0.4) 24  (0.5) 12.6  (1.3) 18  (0.2) 24  (0.2) 17.1  (4.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 188 participants 157 participants 152 participants 174 participants 164 participants 143 participants 106 participants 78 participants 73 participants 246 participants 51 participants 56 participants 1588 participants
Female
78
  41.5%
73
  46.5%
77
  50.7%
81
  46.6%
80
  48.8%
75
  52.4%
62
  58.5%
41
  52.6%
34
  46.6%
115
  46.7%
23
  45.1%
23
  41.1%
762
  48.0%
Male
110
  58.5%
84
  53.5%
75
  49.3%
93
  53.4%
84
  51.2%
68
  47.6%
44
  41.5%
37
  47.4%
39
  53.4%
131
  53.3%
28
  54.9%
33
  58.9%
826
  52.0%
1.Primary Outcome
Title Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects Who Previously Received 3 Doses of rMenB+OMV NZ and Routine Vaccines at 2, 4 and 6 Months of Age.
Hide Description Immunogenicity was assessed in terms of percentage of subjects with serum bactericidal antibody (SBA) titers ≥1:5 (98.3% CI) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99, one month after the fourth (booster) dose of meningococcal B vaccine at 12 or 18 or24 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ and routine vaccines at 2, 4 and 6 months of age.
Time Frame 1 month after booster
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the per-protocol population. This outcome measure was assessed only for the strains H44/76, NZ98/254 and 5/99. As exploratory analyses were performed on the M10713 strain, no endpoints were considered for this strain.
Arm/Group Title B+R246_12 B+R246_18 B+R246_24
Hide Arm/Group Description:
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
Overall Number of Participants Analyzed 162 120 108
Measure Type: Number
Number (98.3% Confidence Interval)
Unit of Measure: percentage of subjects
hSBA≥ 1: 5 (H44/76 strain)(N = 158,116,101)
97
(93 to 99)
100
(96 to 100)
100
(95 to 100)
hSBA≥ 1: 5 (5/99 strain)(N= 156,118,100)
100
(97 to 100)
100
(96 to 100)
100
(95 to 100)
hSBA≥ 1: 5 (NZ 98/254 strain)(N= 159,118,103)
95
(89 to 98)
77
(67 to 86)
84
(74 to 92)
hSBA≥ 1: 5 (M10713 strain)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
In this group exploratory analyses was not performed
2.Secondary Outcome
Title Percentages of Subjects With SBA Titers ≥1:5 After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects Who Previously Received 3 Doses of rMenB+OMV NZ at 2, 4 and 6 Months of Age and Routine Vaccines at 3, 5 and 7 Months of Age.
Hide Description Immunogenicity was assessed in terms of Percentages of Subjects With SBA Titers ≥1:5 (98.3% CI), After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in subjects who previously received 3 doses of rMenB+OMV NZ at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age.
Time Frame 1 month after booster
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on per-protocol population. This outcome measure was assessed only against H44/76, NZ98/254 and 5/99 strains. As exploratory analyses were performed on the M10713 strain, no endpoints were considered for this strain.
Arm/Group Title B246_12 B246_18 B246_24
Hide Arm/Group Description:
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
Overall Number of Participants Analyzed 145 114 98
Measure Type: Number
Number (98.3% Confidence Interval)
Unit of Measure: percentage of subjects
hSBA≥ 1: 5 (H44/76 strain)(N= 138,111,93)
100
(97 to 100)
99
(94 to 100)
100
(95 to 100)
hSBA≥ 1: 5 (5/99 strain)(N= 142,110,92)
100
(97 to 100)
100
(96 to 100)
100
(95 to 100)
hSBA≥ 1: 5 (NZ 98/254 strain)(N= 142,111,95)
96
(90 to 99)
86
(76 to 93)
89
(80 to 96)
hSBA≥ 1: 5 (M10713 strain)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
In this group exploratory analyses was not performed
3.Secondary Outcome
Title Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects Who Previously Received 3 Doses of rMenB+OMV NZ and Routine Vaccines at 2, 3 and 4 Months of Age.
Hide Description Immunogenicity was assessed in terms of percentage of subjects with serum bactericidal antibody (SBA) titers ≥1:5 (98.3% CI) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99, one month after the fourth (booster) dose of meningococcal B vaccine at 12 or 18 or24 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ and routine vaccines at 2, 3 and 4 months of age.
Time Frame 1 month after booster
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the per-protocol population
Arm/Group Title B+R234_12 B+R234_18 B+R234_24
Hide Arm/Group Description:
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
Overall Number of Participants Analyzed 86 58 48
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
hSBA≥ 1: 5 (H44/76 strain)(N= 83,56,48 )
100
(94 to 100)
98
(88 to 100)
100
(91 to 100)
hSBA≥ 1: 5 (5/99 strain)(N= 84,56,46)
100
(94 to 100)
100
(92 to 100)
100
(90 to 100)
hSBA≥ 1: 5 (NZ 98/254 strain)(N= 83,56,48)
97
(89 to 100)
80
(65 to 91)
96
(83 to 100)
hSBA≥ 1: 5 (M10713 strain)(N= 67,50,41)
76
(62 to 87)
74
(57 to 87)
95
(81 to 100)
4.Secondary Outcome
Title Geometric Mean Titers (GMTs) in Subjects One Month After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects at 12 18 or 24 Months of Age Who Previously Received 3 Doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 Months of Age.
Hide Description The serum antibody titers one month after the fourth (booster) dose of meningococcal B vaccine at 12 or 18 or24 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 months of age, are reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.
Time Frame 1 month after booster
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the per-protocol population. For hSBA≥ 1: 5 (H44/76 strain) (N=158 116 101 138 111 93 83 56 48) For hSBA≥ 1: 5 (5/99 strain) (N=156 118 100 142 110 92 84 56 46) For hSBA≥ 1: 5 (NZ 98/254 strain) (N=159 118 103 142 111 95 86 56 48) For hSBA≥ 1: 5 (M10713 strain) (N=0 0 0 0 0 0 67 50 41)
Arm/Group Title B+R246_12 B+R246_18 B+R246_24 B246_12 B246_18 B246_24 B+R234_12 B+R234_18 B+R234_24
Hide Arm/Group Description:
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
Overall Number of Participants Analyzed 162 120 108 145 114 98 86 58 48
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
hSBA≥ 1: 5 (H44/76 strain)
125
(106 to 148)
123
(101 to 149)
108
(88 to 133)
178
(149 to 213)
164
(135 to 200)
152
(122 to 188)
135
(108 to 170)
92
(70 to 121)
128
(95 to 172)
hSBA≥ 1: 5 (5/99 strain)
1276
(1092 to 1491)
2183
(1824 to 2611)
1820
(1497 to 2212)
1713
(1454 to 2020)
2058
(1710 to 2476)
2739
(2233 to 3361)
1558
(1262 to 1923)
1486
(1148 to 1924)
2081
(1564 to 2771)
hSBA≥ 1: 5 (NZ 98/254 strain)
36
(29 to 44)
15
(12 to 19)
17
(14 to 22)
34
(27 to 42)
17
(14 to 22)
19
(15 to 25)
47
(36 to 62)
17
(12 to 24)
33
(23 to 47)
hSBA≥ 1: 5 (M10713 strain)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
12
(8.52 to 17)
15
(10 to 23)
26
(17 to 41)
[1]
In this group exploratory analyses was not performed.
5.Secondary Outcome
Title GMTs in Subjects One Month After the Fourth (Booster) Dose of Meningococcal B Vaccine at 12 Months of Age Previously Vaccinated With 3 Doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 Months of Age and Single Dose of rMenB+OMV NZ Given at Same Age
Hide Description Characterization of immunological memory by serum antibody titers (98.3% CI) one month after the fourth (booster) dose of meningococcal B vaccine at 12 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 months of age and single dose of rMenB+OMV NZ given at same ages, are reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.
Time Frame 1 month after booster
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the per-protocol population
Arm/Group Title B+R246_12 B246_12 B+R234_12 B12 14
Hide Arm/Group Description:
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.
Overall Number of Participants Analyzed 162 145 86 239
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
hSBA≥ 1: 5 (H44/76 strain)(N= 158,138,83,217)
125
(102 to 154)
179
(144 to 223)
137
(104 to 181)
18
(15 to 21)
hSBA≥ 1: 5 (5/99 strain)(N= 156,142,84,216)
1301
(1076 to 1573)
1763
(1441 to 2157)
1607
(1243 to 2077)
49
(42 to 58)
hSBA≥ 1: 5 (NZ 98/254 strain)(N= 159,142,86,220)
37
(29 to 46)
35
(27 to 44)
48
(36 to 65)
3.71
(3.06 to 4.5)
6.Secondary Outcome
Title GMTs in Subjects One Month After the Fourth (Booster) Dose of Meningococcal B Vaccine at 18 and 24months of Age, Previously Vaccinated With 3 Doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 Months of Age and Single Dose of rMenB+OMV NZ Given at Same Age
Hide Description Characterization of immunological memory by serum antibody titers one month after the fourth (booster) dose of meningococcal B vaccine at 18 and 24months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 months of age and single dose of rMenB+OMV NZ given at same ages, are reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.
Time Frame 1 month after booster
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the per-protocol population. For hSBA≥ 1: 5 (H44/76 strain)(N=116 101 111 93 56 48 46 52), hSBA≥ 1: 5 (5/99 strain) (N=118 100 110 92 56 46 48 50), hSBA≥ 1: 5 (NZ 98/254 strain) (N=118 103 111 95 56 48 47 50)
Arm/Group Title B+R246_18 B+R246_24 B246_18 B246_24 B+R234_18 B+R234_24 B18 20 B24 26
Hide Arm/Group Description:
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
Overall Number of Participants Analyzed 120 108 114 98 58 48 47 53
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
hSBA≥ 1: 5 (H44/76 strain)
126
(104 to 154)
110
(89 to 136)
162
(132 to 198)
155
(124 to 193)
93
(70 to 123)
132
(97 to 180)
18
(13 to 25)
14
(10 to 19)
hSBA≥ 1: 5 (5/99 strain)
2195
(1790 to 2691)
1811
(1449 to 2262)
2034
(1648 to 2511)
2735
(2166 to 3455)
1483
(1107 to 1986)
2087
(1508 to 2889)
41
(30 to 56)
30
(22 to 41)
hSBA≥ 1: 5 (NZ 98/254 strain)
16
(12 to 20)
18
(14 to 23)
17
(14 to 22)
20
(15 to 26)
17
(12 to 25)
34
(23 to 49)
2.76
(1.87 to 4.08)
2.1
(1.44 to 3.07)
7.Secondary Outcome
Title Two-dose Catch-up Regimen of rMenB+OMV NZ in Unprimed Toddlers Aged 12, 18 or 24 Months
Hide Description Immunogenicity evaluation of a two-dose catch-up regimen of rMenB+OMV NZ in unprimed toddlers aged 12, 18 or 24 months as measured by serum antibody titers one month after the second vaccination f meningococcal B vaccine at 18 and 24months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.
Time Frame 1 month after second vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the per-protocol population
Arm/Group Title B12 14 B18 20 B24 26
Hide Arm/Group Description:
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
Overall Number of Participants Analyzed 189 44 49
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
hSBA≥ 1: 5 (H44/76 strain)(N= 156,42,45)
188
(164 to 216)
171
(130 to 224)
177
(136 to 231)
hSBA≥ 1: 5 (5/99 strain)(N= 177, 40,46)
635
(548 to 735)
491
(359 to 672)
559
(417 to 749)
hSBA≥ 1: 5 (NZ 98/254 strain)(N = 179,44,45)
40
(35 to 47)
23
(17 to 30)
24
(18 to 32)
hSBA≥ 1: 5 (M10713 strain)(N= 0,34,37)
NA [1] 
(NA to NA)
14
(8.02 to 23)
18
(11 to 29)
[1]
In this group exploratory analyses was not performed.
8.Secondary Outcome
Title Geometric Mean Concentrations Against Vaccine Antigen 287- 953 One Month After Fourth Booster Dose to Previously Primed Toddlers at 12, 18 or 24 Months of Age.
Hide Description Immunogenicity evaluation against vaccine antigen 287-953 one month after fourth booster dose to previously primed toddlers at 12, 18 or 24 months measured by ELISA.
Time Frame 1 month after booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the per-protocol population
Arm/Group Title B+R246_12 B+R246_18 B+R246_24 B246_12 B246_18 B246_24 B+R234_12 B+R234_18 B+R234_24
Hide Arm/Group Description:
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
Overall Number of Participants Analyzed 162 119 108 145 114 98 86 58 48
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
5334
(4670 to 6093)
6395
(5474 to 7470)
6864
(5826 to 8087)
6605
(5733 to 7609)
6418
(5477 to 7520)
8120
(6833 to 9649)
6125
(5110 to 7342)
5952
(4771 to 7426)
6774
(5305 to 8649)
9.Secondary Outcome
Title Geometric Mean Concentrations Against Vaccine Antigen 287- 953 One Month After Booster Given After a Two-dose Catch-up Regimen in Toddlers Starting at 12, 18 or 24 Months of Age.
Hide Description Immunogenicity evaluation against vaccine antigen 287-953 one month after booster given after a two-dose catch-up regimen in toddlers starting at 12, 18 or 24 months of age.one month after fourth booster dose to previously primed toddlers at 12, 18 or 24 months of age measured by ELISA
Time Frame 1 month after booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the per-protocol population
Arm/Group Title B12 14 B18 20 B24 26
Hide Arm/Group Description:
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
Overall Number of Participants Analyzed 177 44 47
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
122
(101 to 147)
121
(84 to 176)
100
(69 to 144)
10.Secondary Outcome
Title Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Fourth Booster Dose of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
Hide Description The safety and tolerability of the 4th booster dose rMenB+OMV NZ vaccine in children (12, 18 or 24 months age) is reported as number of subjects with solicited local and systemic adverse events.
Time Frame From day 1 to day 7 after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the Safety Population.
Arm/Group Title B246_12 B246_18 B246_24
Hide Arm/Group Description:
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
Overall Number of Participants Analyzed 170 153 126
Measure Type: Number
Unit of Measure: participants
Any 156 135 116
Any Local 137 119 113
Injection site Tenderness 104 104 105
Injection site Erythema 117 94 94
Injection site Induration 93 62 73
Injection site Swelling 57 52 50
Any Systemic 134 118 101
ChangeEat.Habits 66 59 51
Sleepiness 63 56 52
Vomiting 8 9 8
Diarrhea 37 23 27
Irritbility 104 91 83
Unusual Crying 52 51 40
Rash 7 3 7
Fever ( >= 38C ) 52 55 28
Any Ohter 59 59 40
Body Temp. <38 C 118 98 98
Medical Attend. Fever 5 5 2
Antipyretic prophylactic 32 28 25
Antipyretic therapeutic 37 39 21
11.Secondary Outcome
Title Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Two-dose Catch-up Regimen of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.
Hide Description The safety and tolerability of the two-dose catch-up regimen of rMenB+OMV NZ vaccine in children (12, 18 or 24 months age) is reported as number of subjects with solicited local and systemic adverse events.
Time Frame day 1 to day 7 after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was done on safety population
Arm/Group Title B12 14 B18 20 B24 26
Hide Arm/Group Description:
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.
Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
Overall Number of Participants Analyzed 239 51 55
Measure Type: Number
Unit of Measure: participants
Injection site Tenderness (vaccination 1) 151 35 47
Injection site Tenderness (vaccination 2) 143 32 42
Injection site Erythema (vaccination 1) 151 32 39
Injection site Erythema (vaccination 2) 148 33 31
Injection site Induration (vaccination 1) 112 20 27
Injection site Induration (vaccination 2) 101 24 22
Injection site Swelling (vaccination 1) 81 15 19
Injection site Swelling (vaccination 2) 72 18 19
Change in Eating habits (vaccination 1) 95 13 25
Change in Eating habits (vaccination 2) 83 19 21
Sleepiness (vaccination 1) 106 21 18
Sleepiness (vaccination 2) 78 16 18
Vomiting (vaccination 1) 19 5 6
Vomiting (vaccination 2) 18 1 4
Diarrhea (vaccination 1) 43 13 20
Diarrhea (vaccination 2) 35 5 7
Irritability (vaccination 1) 156 23 28
Irritability (vaccination 2) 126 27 23
Unusual Crying (vaccination 1) 81 13 15
Unusual Crying (vaccination 2) 67 14 15
Rash (vaccination 1) 13 5 2
Rash (vaccination 2) 10 4 0
Fever ( >= 38C ) (vaccination 1) 83 14 15
Fever ( >= 38C ) (vaccination 2) 74 15 13
Body Temp.<38 C (vaccination 1) 156 37 39
Body Temp.<38 C (vaccination 2) 163 36 39
Medical Attend. Fever (vaccination 1) 9 2 1
Medical Attend. Fever (vaccination 2) 5 1 0
Antipyretic prophylactic (vaccination 1) 49 8 8
Antipyretic prophylactic (vaccination 2) 45 9 11
Antipyretic therapeutic (vaccination 1) 66 9 11
Antipyretic therapeutic (vaccination 2) 54 11 7
Time Frame From day 1 to day 7 after vaccination
Adverse Event Reporting Description Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.
 
Arm/Group Title B+R246_12 B+R246_18 B+R246_24 B246_12 B246_18 B246_24 B+R234_12 B+R234_18 B+R234_24 B12 14 B18 20 B24 26
Hide Arm/Group Description Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age. Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age. Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age. Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
All-Cause Mortality
B+R246_12 B+R246_18 B+R246_24 B246_12 B246_18 B246_24 B+R234_12 B+R234_18 B+R234_24 B12 14 B18 20 B24 26
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
B+R246_12 B+R246_18 B+R246_24 B246_12 B246_18 B246_24 B+R234_12 B+R234_18 B+R234_24 B12 14 B18 20 B24 26
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/185 (2.70%)   3/152 (1.97%)   6/144 (4.17%)   6/170 (3.53%)   7/153 (4.58%)   1/126 (0.79%)   5/104 (4.81%)   5/74 (6.76%)   3/66 (4.55%)   16/239 (6.69%)   0/51 (0.00%)   1/55 (1.82%) 
Congenital, familial and genetic disorders                         
Congenital aural fistula * 1  0/185 (0.00%)  0/152 (0.00%)  0/144 (0.00%)  0/170 (0.00%)  0/153 (0.00%)  0/126 (0.00%)  0/104 (0.00%)  0/74 (0.00%)  0/66 (0.00%)  1/239 (0.42%)  0/51 (0.00%)  0/55 (0.00%) 
Gastrointestinal disorders                         
Coeliac Disease * 1  0/185 (0.00%)  1/152 (0.66%)  0/144 (0.00%)  0/170 (0.00%)  0/153 (0.00%)  0/126 (0.00%)  0/104 (0.00%)  0/74 (0.00%)  0/66 (0.00%)  0/239 (0.00%)  0/51 (0.00%)  0/55 (0.00%) 
Acetonaemic vomiting * 1  0/185 (0.00%)  0/152 (0.00%)  0/144 (0.00%)  0/170 (0.00%)  0/153 (0.00%)  0/126 (0.00%)  0/104 (0.00%)  0/74 (0.00%)  0/66 (0.00%)  1/239 (0.42%)  0/51 (0.00%)  0/55 (0.00%) 
Dysphagia * 1  0/185 (0.00%)  0/152 (0.00%)  0/144 (0.00%)  0/170 (0.00%)  0/153 (0.00%)  0/126 (0.00%)  0/104 (0.00%)  0/74 (0.00%)  0/66 (0.00%)  1/239 (0.42%)  0/51 (0.00%)  0/55 (0.00%) 
Stomatitis * 1  0/185 (0.00%)  0/152 (0.00%)  0/144 (0.00%)  0/170 (0.00%)  0/153 (0.00%)  0/126 (0.00%)  0/104 (0.00%)  1/74 (1.35%)  0/66 (0.00%)  0/239 (0.00%)  0/51 (0.00%)  0/55 (0.00%) 
General disorders                         
Pyrexia * 1  0/185 (0.00%)  0/152 (0.00%)  0/144 (0.00%)  0/170 (0.00%)  0/153 (0.00%)  0/126 (0.00%)  1/104 (0.96%)  0/74 (0.00%)  0/66 (0.00%)  0/239 (0.00%)  0/51 (0.00%)  0/55 (0.00%) 
Infections and infestations                         
Abscess * 1  0/185 (0.00%)  0/152 (0.00%)  0/144 (0.00%)  0/170 (0.00%)  1/153 (0.65%)  0/126 (0.00%)  0/104 (0.00%)  0/74 (0.00%)  0/66 (0.00%)  0/239 (0.00%)  0/51 (0.00%)  0/55 (0.00%) 
Bronchiolitis * 1  0/185 (0.00%)  0/152 (0.00%)  0/144 (0.00%)  0/170 (0.00%)  0/153 (0.00%)  1/126 (0.79%)  0/104 (0.00%)  0/74 (0.00%)  1/66 (1.52%)  0/239 (0.00%)  0/51 (0.00%)  0/55 (0.00%) 
Bronchitis * 1  0/185 (0.00%)  0/152 (0.00%)  0/144 (0.00%)  1/170 (0.59%)  0/153 (0.00%)  0/126 (0.00%)  0/104 (0.00%)  0/74 (0.00%)  0/66 (0.00%)  1/239 (0.42%)  0/51 (0.00%)  0/55 (0.00%) 
Bronchopneumonia * 1  1/185 (0.54%)  0/152 (0.00%)  0/144 (0.00%)  0/170 (0.00%)  0/153 (0.00%)  0/126 (0.00%)  0/104 (0.00%)  0/74 (0.00%)  0/66 (0.00%)  1/239 (0.42%)  0/51 (0.00%)  0/55 (0.00%) 
Ear Infection * 1  1/185 (0.54%)  0/152 (0.00%)  0/144 (0.00%)  0/170 (0.00%)  0/153 (0.00%)  0/126 (0.00%)  0/104 (0.00%)  0/74 (0.00%)  0/66 (0.00%)  0/239 (0.00%)  0/51 (0.00%)  0/55 (0.00%) 
Escherichia urinary tract infection * 1  0/185 (0.00%)  0/152 (0.00%)  0/144 (0.00%)  0/170 (0.00%)  1/153 (0.65%)  0/126 (0.00%)  0/104 (0.00%)  0/74 (0.00%)  0/66 (0.00%)  0/239 (0.00%)  0/51 (0.00%)  0/55 (0.00%) 
Gastroenteritis * 1  0/185 (0.00%)  1/152 (0.66%)  0/144 (0.00%)  0/170 (0.00%)  2/153 (1.31%)  0/126 (0.00%)  0/104 (0.00%)  2/74 (2.70%)  0/66 (0.00%)  2/239 (0.84%)  0/51 (0.00%)  0/55 (0.00%) 
Gastroenteritis Rotavirus * 1  1/185 (0.54%)  1/152 (0.66%)  0/144 (0.00%)  0/170 (0.00%)  0/153 (0.00%)  0/126 (0.00%)  0/104 (0.00%)  0/74 (0.00%)  0/66 (0.00%)  0/239 (0.00%)  0/51 (0.00%)  0/55 (0.00%) 
Laryngitis * 1  0/185 (0.00%)  0/152 (0.00%)  0/144 (0.00%)  0/170 (0.00%)  1/153 (0.65%)  0/126 (0.00%)  0/104 (0.00%)  0/74 (0.00%)  0/66 (0.00%)  0/239 (0.00%)  0/51 (0.00%)  0/55 (0.00%) 
Pharyngitis * 1  0/185 (0.00%)  0/152 (0.00%)  0/144 (0.00%)  1/170 (0.59%)  0/153 (0.00%)  0/126 (0.00%)  0/104 (0.00%)  0/74 (0.00%)  0/66 (0.00%)  0/239 (0.00%)  0/51 (0.00%)  0/55 (0.00%) 
Pneumonia * 1  2/185 (1.08%)  0/152 (0.00%)  1/144 (0.69%)  0/170 (0.00%)  0/153 (0.00%)  0/126 (0.00%)  1/104 (0.96%)  0/74 (0.00%)  0/66 (0.00%)  0/239 (0.00%)  0/51 (0.00%)  0/55 (0.00%) 
Respiratory syncytial virus * 1  1/185 (0.54%)  0/152 (0.00%)  0/144 (0.00%)  0/170 (0.00%)  0/153 (0.00%)  0/126 (0.00%)  0/104 (0.00%)  0/74 (0.00%)  0/66 (0.00%)  0/239 (0.00%)  0/51 (0.00%)  0/55 (0.00%) 
Tonsillitis * 1  1/185 (0.54%)  0/152 (0.00%)  0/144 (0.00%)  0/170 (0.00%)  0/153 (0.00%)  0/126 (0.00%)  0/104 (0.00%)  0/74 (0.00%)  1/66 (1.52%)  0/239 (0.00%)  0/51 (0.00%)  0/55 (0.00%) 
Eczema herpeticum * 1  0/185 (0.00%)  0/152 (0.00%)  0/144 (0.00%)  0/170 (0.00%)  0/153 (0.00%)  0/126 (0.00%)  1/104 (0.96%)  0/74 (0.00%)  0/66 (0.00%)  0/239 (0.00%)  0/51 (0.00%)  0/55 (0.00%) 
Influenza * 1  0/185 (0.00%)  0/152 (0.00%)  0/144 (0.00%)  0/170 (0.00%)  0/153 (0.00%)  0/126 (0.00%)  0/104 (0.00%)  0/74 (0.00%)  0/66 (0.00%)  1/239 (0.42%)  0/51 (0.00%)  0/55 (0.00%) 
Periorbital cellulitis * 1  0/185 (0.00%)  0/152 (0.00%)  0/144 (0.00%)  0/170 (0.00%)  0/153 (0.00%)  0/126 (0.00%)  0/104 (0.00%)  0/74 (0.00%)  0/66 (0.00%)  1/239 (0.42%)  0/51 (0.00%)  0/55 (0.00%) 
Pneumonia respiratory syncytial viral * 1  0/185 (0.00%)  0/152 (0.00%)  0/144 (0.00%)  0/170 (0.00%)  0/153 (0.00%)  0/126 (0.00%)  0/104 (0.00%)  0/74 (0.00%)  0/66 (0.00%)  1/239 (0.42%)  0/51 (0.00%)  0/55 (0.00%) 
Superinfection bacterial * 1  0/185 (0.00%)  0/152 (0.00%)  0/144 (0.00%)  0/170 (0.00%)  0/153 (0.00%)  0/126 (0.00%)  0/104 (0.00%)  0/74 (0.00%)  0/66 (0.00%)  1/239 (0.42%)  0/51 (0.00%)  0/55 (0.00%) 
Upper respiratory tract infection * 1  0/185 (0.00%)  0/152 (0.00%)  0/144 (0.00%)  0/170 (0.00%)  1/153 (0.65%)  0/126 (0.00%)  0/104 (0.00%)  0/74 (0.00%)  0/66 (0.00%)  0/239 (0.00%)  0/51 (0.00%)  0/55 (0.00%) 
Viral infection * 1  0/185 (0.00%)  0/152 (0.00%)  0/144 (0.00%)  1/170 (0.59%)  0/153 (0.00%)  0/126 (0.00%)  0/104 (0.00%)  0/74 (0.00%)  0/66 (0.00%)  0/239 (0.00%)  0/51 (0.00%)  0/55 (0.00%) 
Injury, poisoning and procedural complications                         
Concussion * 1  0/185 (0.00%)  0/152 (0.00%)  0/144 (0.00%)  1/170 (0.59%)  1/153 (0.65%)  0/126 (0.00%)  0/104 (0.00%)  0/74 (0.00%)  0/66 (0.00%)  1/239 (0.42%)  0/51 (0.00%)  1/55 (1.82%) 
Laceration * 1  0/185 (0.00%)  0/152 (0.00%)  1/144 (0.69%)  0/170 (0.00%)  0/153 (0.00%)  0/126 (0.00%)  0/104 (0.00%)  0/74 (0.00%)  0/66 (0.00%)  0/239 (0.00%)  0/51 (0.00%)  0/55 (0.00%) 
Head injury * 1  0/185 (0.00%)  0/152 (0.00%)  0/144 (0.00%)  0/170 (0.00%)  0/153 (0.00%)  0/126 (0.00%)  0/104 (0.00%)  0/74 (0.00%)  1/66 (1.52%)  1/239 (0.42%)  0/51 (0.00%)  0/55 (0.00%) 
Skull fracture * 1  0/185 (0.00%)  0/152 (0.00%)  0/144 (0.00%)  0/170 (0.00%)  0/153 (0.00%)  0/126 (0.00%)  0/104 (0.00%)  0/74 (0.00%)  0/66 (0.00%)  1/239 (0.42%)  0/51 (0.00%)  0/55 (0.00%) 
Autism * 1  0/185 (0.00%)  0/152 (0.00%)  0/144 (0.00%)  0/170 (0.00%)  0/153 (0.00%)  0/126 (0.00%)  0/104 (0.00%)  0/74 (0.00%)  0/66 (0.00%)  1/239 (0.42%)  0/51 (0.00%)  0/55 (0.00%) 
Petit mal Epilepsy * 1  0/185 (0.00%)  0/152 (0.00%)  0/144 (0.00%)  0/170 (0.00%)  0/153 (0.00%)  0/126 (0.00%)  1/104 (0.96%)  0/74 (0.00%)  0/66 (0.00%)  0/239 (0.00%)  0/51 (0.00%)  0/55 (0.00%) 
Accidental exposure to product * 1  0/185 (0.00%)  0/152 (0.00%)  0/144 (0.00%)  0/170 (0.00%)  0/153 (0.00%)  0/126 (0.00%)  0/104 (0.00%)  1/74 (1.35%)  0/66 (0.00%)  0/239 (0.00%)  0/51 (0.00%)  0/55 (0.00%) 
Metabolism and nutrition disorders                         
Dehydration * 1  0/185 (0.00%)  1/152 (0.66%)  0/144 (0.00%)  1/170 (0.59%)  0/153 (0.00%)  0/126 (0.00%)  0/104 (0.00%)  0/74 (0.00%)  0/66 (0.00%)  0/239 (0.00%)  0/51 (0.00%)  0/55 (0.00%) 
Musculoskeletal and connective tissue disorders                         
Arthritis reactive * 1  0/185 (0.00%)  0/152 (0.00%)  0/144 (0.00%)  1/170 (0.59%)  0/153 (0.00%)  0/126 (0.00%)  0/104 (0.00%)  0/74 (0.00%)  0/66 (0.00%)  0/239 (0.00%)  0/51 (0.00%)  0/55 (0.00%) 
Nervous system disorders                         
Convulsion * 1  0/185 (0.00%)  0/152 (0.00%)  1/144 (0.69%)  0/170 (0.00%)  0/153 (0.00%)  0/126 (0.00%)  0/104 (0.00%)  0/74 (0.00%)  0/66 (0.00%)  0/239 (0.00%)  0/51 (0.00%)  0/55 (0.00%) 
Epilepsy * 1  0/185 (0.00%)  0/152 (0.00%)  0/144 (0.00%)  0/170 (0.00%)  0/153 (0.00%)  0/126 (0.00%)  0/104 (0.00%)  0/74 (0.00%)  0/66 (0.00%)  0/239 (0.00%)  0/51 (0.00%)  0/55 (0.00%) 
Febrile convulsion * 1  0/185 (0.00%)  0/152 (0.00%)  2/144 (1.39%)  0/170 (0.00%)  0/153 (0.00%)  0/126 (0.00%)  1/104 (0.96%)  0/74 (0.00%)  1/66 (1.52%)  3/239 (1.26%)  0/51 (0.00%)  0/55 (0.00%) 
Respiratory, thoracic and mediastinal disorders                         
Asthma * 1  0/185 (0.00%)  0/152 (0.00%)  1/144 (0.69%)  0/170 (0.00%)  1/153 (0.65%)  0/126 (0.00%)  0/104 (0.00%)  0/74 (0.00%)  0/66 (0.00%)  0/239 (0.00%)  0/51 (0.00%)  0/55 (0.00%) 
Wheezing * 1  0/185 (0.00%)  0/152 (0.00%)  0/144 (0.00%)  1/170 (0.59%)  0/153 (0.00%)  0/126 (0.00%)  0/104 (0.00%)  0/74 (0.00%)  0/66 (0.00%)  1/239 (0.42%)  0/51 (0.00%)  0/55 (0.00%) 
Pneumonia aspiration * 1  0/185 (0.00%)  0/152 (0.00%)  0/144 (0.00%)  0/170 (0.00%)  0/153 (0.00%)  0/126 (0.00%)  0/104 (0.00%)  0/74 (0.00%)  0/66 (0.00%)  1/239 (0.42%)  0/51 (0.00%)  0/55 (0.00%) 
Adenoidal hypertrophy * 1  0/185 (0.00%)  0/152 (0.00%)  0/144 (0.00%)  0/170 (0.00%)  0/153 (0.00%)  0/126 (0.00%)  0/104 (0.00%)  0/74 (0.00%)  0/66 (0.00%)  1/239 (0.42%)  0/51 (0.00%)  0/55 (0.00%) 
Skin and subcutaneous tissue disorders                         
Rash * 1  0/185 (0.00%)  0/152 (0.00%)  0/144 (0.00%)  1/170 (0.59%)  0/153 (0.00%)  0/126 (0.00%)  0/104 (0.00%)  0/74 (0.00%)  0/66 (0.00%)  0/239 (0.00%)  0/51 (0.00%)  0/55 (0.00%) 
Urticaria * 1  0/185 (0.00%)  0/152 (0.00%)  0/144 (0.00%)  0/170 (0.00%)  0/153 (0.00%)  0/126 (0.00%)  0/104 (0.00%)  1/74 (1.35%)  0/66 (0.00%)  0/239 (0.00%)  0/51 (0.00%)  0/55 (0.00%) 
Social circumstances                         
Walking disability * 1  0/185 (0.00%)  0/152 (0.00%)  0/144 (0.00%)  0/170 (0.00%)  0/153 (0.00%)  0/126 (0.00%)  0/104 (0.00%)  0/74 (0.00%)  0/66 (0.00%)  1/239 (0.42%)  0/51 (0.00%)  0/55 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 17.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
B+R246_12 B+R246_18 B+R246_24 B246_12 B246_18 B246_24 B+R234_12 B+R234_18 B+R234_24 B12 14 B18 20 B24 26
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   180/185 (97.30%)   147/152 (96.71%)   140/144 (97.22%)   163/170 (95.88%)   139/153 (90.85%)   116/126 (92.06%)   102/104 (98.08%)   73/74 (98.65%)   62/66 (93.94%)   230/239 (96.23%)   50/51 (98.04%)   54/55 (98.18%) 
Gastrointestinal disorders                         
Constipation * 1  2/185 (1.08%)  2/152 (1.32%)  1/144 (0.69%)  2/170 (1.18%)  1/153 (0.65%)  1/126 (0.79%)  1/104 (0.96%)  0/74 (0.00%)  0/66 (0.00%)  2/239 (0.84%)  3/51 (5.88%)  2/55 (3.64%) 
Diarrhoea * 1  39/185 (21.08%)  26/152 (17.11%)  32/144 (22.22%)  40/170 (23.53%)  27/153 (17.65%)  27/126 (21.43%)  21/104 (20.19%)  18/74 (24.32%)  13/66 (19.70%)  72/239 (30.13%)  16/51 (31.37%)  21/55 (38.18%) 
Enteritis * 1  5/185 (2.70%)  0/152 (0.00%)  1/144 (0.69%)  2/170 (1.18%)  3/153 (1.96%)  3/126 (2.38%)  2/104 (1.92%)  1/74 (1.35%)  2/66 (3.03%)  4/239 (1.67%)  3/51 (5.88%)  1/55 (1.82%) 
Teething * 1  8/185 (4.32%)  3/152 (1.97%)  1/144 (0.69%)  2/170 (1.18%)  0/153 (0.00%)  0/126 (0.00%)  3/104 (2.88%)  2/74 (2.70%)  0/66 (0.00%)  15/239 (6.28%)  1/51 (1.96%)  0/55 (0.00%) 
Vomiting * 1  15/185 (8.11%)  16/152 (10.53%)  11/144 (7.64%)  13/170 (7.65%)  12/153 (7.84%)  10/126 (7.94%)  15/104 (14.42%)  8/74 (10.81%)  2/66 (3.03%)  41/239 (17.15%)  7/51 (13.73%)  8/55 (14.55%) 
General disorders                         
Crying * 1  56/185 (30.27%)  43/152 (28.29%)  46/144 (31.94%)  52/170 (30.59%)  51/153 (33.33%)  40/126 (31.75%)  41/104 (39.42%)  18/74 (24.32%)  22/66 (33.33%)  105/239 (43.93%)  17/51 (33.33%)  25/55 (45.45%) 
Induration * 1  2/185 (1.08%)  0/152 (0.00%)  2/144 (1.39%)  3/170 (1.76%)  3/153 (1.96%)  4/126 (3.17%)  2/104 (1.92%)  0/74 (0.00%)  0/66 (0.00%)  2/239 (0.84%)  1/51 (1.96%)  4/55 (7.27%) 
Injection site erythema * 1  127/185 (68.65%)  100/152 (65.79%)  109/144 (75.69%)  117/170 (68.82%)  94/153 (61.44%)  94/126 (74.60%)  76/104 (73.08%)  52/74 (70.27%)  49/66 (74.24%)  179/239 (74.90%)  38/51 (74.51%)  41/55 (74.55%) 
Injection site induration * 1  101/185 (54.59%)  74/152 (48.68%)  76/144 (52.78%)  93/170 (54.71%)  62/153 (40.52%)  73/126 (57.94%)  52/104 (50.00%)  41/74 (55.41%)  35/66 (53.03%)  148/239 (61.92%)  27/51 (52.94%)  33/55 (60.00%) 
Injection site pain * 1  107/185 (57.84%)  114/152 (75.00%)  118/144 (81.94%)  104/170 (61.18%)  104/153 (67.97%)  105/126 (83.33%)  70/104 (67.31%)  56/74 (75.68%)  51/66 (77.27%)  187/239 (78.24%)  41/51 (80.39%)  51/55 (92.73%) 
Injection site swelling * 1  73/185 (39.46%)  53/152 (34.87%)  63/144 (43.75%)  57/170 (33.53%)  52/153 (33.99%)  50/126 (39.68%)  32/104 (30.77%)  36/74 (48.65%)  25/66 (37.88%)  107/239 (44.77%)  21/51 (41.18%)  24/55 (43.64%) 
Pyrexia * 1  78/185 (42.16%)  57/152 (37.50%)  50/144 (34.72%)  60/170 (35.29%)  59/153 (38.56%)  32/126 (25.40%)  53/104 (50.96%)  28/74 (37.84%)  27/66 (40.91%)  133/239 (55.65%)  24/51 (47.06%)  22/55 (40.00%) 
Swelling * 1  1/185 (0.54%)  1/152 (0.66%)  2/144 (1.39%)  1/170 (0.59%)  2/153 (1.31%)  2/126 (1.59%)  0/104 (0.00%)  0/74 (0.00%)  0/66 (0.00%)  1/239 (0.42%)  1/51 (1.96%)  3/55 (5.45%) 
Infections and infestations                         
Bronchitis * 1  7/185 (3.78%)  11/152 (7.24%)  5/144 (3.47%)  19/170 (11.18%)  7/153 (4.58%)  5/126 (3.97%)  9/104 (8.65%)  6/74 (8.11%)  4/66 (6.06%)  19/239 (7.95%)  3/51 (5.88%)  9/55 (16.36%) 
Candida nappy rash * 1  0/185 (0.00%)  0/152 (0.00%)  0/144 (0.00%)  0/170 (0.00%)  0/153 (0.00%)  1/126 (0.79%)  1/104 (0.96%)  1/74 (1.35%)  0/66 (0.00%)  2/239 (0.84%)  3/51 (5.88%)  1/55 (1.82%) 
Conjunctivitis * 1  11/185 (5.95%)  11/152 (7.24%)  3/144 (2.08%)  10/170 (5.88%)  10/153 (6.54%)  7/126 (5.56%)  5/104 (4.81%)  1/74 (1.35%)  3/66 (4.55%)  15/239 (6.28%)  4/51 (7.84%)  4/55 (7.27%) 
Ear infection * 1  12/185 (6.49%)  8/152 (5.26%)  6/144 (4.17%)  13/170 (7.65%)  5/153 (3.27%)  6/126 (4.76%)  14/104 (13.46%)  5/74 (6.76%)  3/66 (4.55%)  29/239 (12.13%)  6/51 (11.76%)  4/55 (7.27%) 
Fungal infection * 1  2/185 (1.08%)  0/152 (0.00%)  0/144 (0.00%)  1/170 (0.59%)  0/153 (0.00%)  0/126 (0.00%)  1/104 (0.96%)  0/74 (0.00%)  0/66 (0.00%)  1/239 (0.42%)  1/51 (1.96%)  3/55 (5.45%) 
Gastroenteritis * 1  17/185 (9.19%)  6/152 (3.95%)  4/144 (2.78%)  9/170 (5.29%)  5/153 (3.27%)  7/126 (5.56%)  4/104 (3.85%)  2/74 (2.70%)  0/66 (0.00%)  10/239 (4.18%)  4/51 (7.84%)  2/55 (3.64%) 
Infection * 1  1/185 (0.54%)  0/152 (0.00%)  2/144 (1.39%)  0/170 (0.00%)  3/153 (1.96%)  2/126 (1.59%)  2/104 (1.92%)  1/74 (1.35%)  1/66 (1.52%)  2/239 (0.84%)  3/51 (5.88%)  3/55 (5.45%) 
Influenza * 1  3/185 (1.62%)  4/152 (2.63%)  1/144 (0.69%)  3/170 (1.76%)  2/153 (1.31%)  1/126 (0.79%)  0/104 (0.00%)  2/74 (2.70%)  0/66 (0.00%)  1/239 (0.42%)  1/51 (1.96%)  5/55 (9.09%) 
Lice infestation * 1  0/185 (0.00%)  0/152 (0.00%)  0/144 (0.00%)  1/170 (0.59%)  0/153 (0.00%)  0/126 (0.00%)  0/104 (0.00%)  0/74 (0.00%)  0/66 (0.00%)  0/239 (0.00%)  0/51 (0.00%)  4/55 (7.27%) 
Nasopharyngitis * 1  20/185 (10.81%)  6/152 (3.95%)  12/144 (8.33%)  13/170 (7.65%)  12/153 (7.84%)  4/126 (3.17%)  7/104 (6.73%)  5/74 (6.76%)  2/66 (3.03%)  21/239 (8.79%)  8/51 (15.69%)  7/55 (12.73%) 
Otitis media * 1  3/185 (1.62%)  6/152 (3.95%)  2/144 (1.39%)  6/170 (3.53%)  4/153 (2.61%)  2/126 (1.59%)  3/104 (2.88%)  2/74 (2.70%)  4/66 (6.06%)  11/239 (4.60%)  2/51 (3.92%)  4/55 (7.27%) 
Pharyngitis * 1  7/185 (3.78%)  8/152 (5.26%)  3/144 (2.08%)  5/170 (2.94%)  14/153 (9.15%)  6/126 (4.76%)  5/104 (4.81%)  3/74 (4.05%)  3/66 (4.55%)  16/239 (6.69%)  3/51 (5.88%)  1/55 (1.82%) 
Respiratory tract infection * 1  9/185 (4.86%)  3/152 (1.97%)  2/144 (1.39%)  6/170 (3.53%)  3/153 (1.96%)  3/126 (2.38%)  5/104 (4.81%)  2/74 (2.70%)  2/66 (3.03%)  8/239 (3.35%)  5/51 (9.80%)  6/55 (10.91%) 
Rhinitis * 1  10/185 (5.41%)  5/152 (3.29%)  4/144 (2.78%)  12/170 (7.06%)  4/153 (2.61%)  7/126 (5.56%)  4/104 (3.85%)  3/74 (4.05%)  1/66 (1.52%)  17/239 (7.11%)  2/51 (3.92%)  5/55 (9.09%) 
Scarlet fever * 1  0/185 (0.00%)  1/152 (0.66%)  2/144 (1.39%)  0/170 (0.00%)  2/153 (1.31%)  1/126 (0.79%)  0/104 (0.00%)  0/74 (0.00%)  0/66 (0.00%)  1/239 (0.42%)  3/51 (5.88%)  0/55 (0.00%) 
Tonsillitis * 1  6/185 (3.24%)  9/152 (5.92%)  7/144 (4.86%)  9/170 (5.29%)  6/153 (3.92%)  3/126 (2.38%)  5/104 (4.81%)  3/74 (4.05%)  3/66 (4.55%)  14/239 (5.86%)  2/51 (3.92%)  3/55 (5.45%) 
Upper respiratory tract infection * 1  10/185 (5.41%)  8/152 (5.26%)  0/144 (0.00%)  6/170 (3.53%)  15/153 (9.80%)  5/126 (3.97%)  10/104 (9.62%)  2/74 (2.70%)  0/66 (0.00%)  18/239 (7.53%)  2/51 (3.92%)  5/55 (9.09%) 
Varicella * 1  4/185 (2.16%)  1/152 (0.66%)  2/144 (1.39%)  2/170 (1.18%)  2/153 (1.31%)  7/126 (5.56%)  2/104 (1.92%)  0/74 (0.00%)  5/66 (7.58%)  9/239 (3.77%)  5/51 (9.80%)  1/55 (1.82%) 
Viral infection * 1  12/185 (6.49%)  6/152 (3.95%)  6/144 (4.17%)  7/170 (4.12%)  10/153 (6.54%)  5/126 (3.97%)  5/104 (4.81%)  5/74 (6.76%)  6/66 (9.09%)  21/239 (8.79%)  8/51 (15.69%)  3/55 (5.45%) 
Nervous system disorders                         
Somnolence * 1  72/185 (38.92%)  61/152 (40.13%)  72/144 (50.00%)  63/170 (37.06%)  56/153 (36.60%)  52/126 (41.27%)  50/104 (48.08%)  33/74 (44.59%)  27/66 (40.91%)  129/239 (53.97%)  25/51 (49.02%)  28/55 (50.91%) 
Psychiatric disorders                         
Eating disorder * 1  64/185 (34.59%)  70/152 (46.05%)  68/144 (47.22%)  66/170 (38.82%)  59/153 (38.56%)  51/126 (40.48%)  41/104 (39.42%)  29/74 (39.19%)  28/66 (42.42%)  126/239 (52.72%)  21/51 (41.18%)  34/55 (61.82%) 
Irritability * 1  110/185 (59.46%)  100/152 (65.79%)  92/144 (63.89%)  104/170 (61.18%)  91/153 (59.48%)  83/126 (65.87%)  72/104 (69.23%)  53/74 (71.62%)  44/66 (66.67%)  177/239 (74.06%)  32/51 (62.75%)  35/55 (63.64%) 
Respiratory, thoracic and mediastinal disorders                         
Cough * 1  14/185 (7.57%)  12/152 (7.89%)  5/144 (3.47%)  13/170 (7.65%)  8/153 (5.23%)  7/126 (5.56%)  3/104 (2.88%)  4/74 (5.41%)  2/66 (3.03%)  24/239 (10.04%)  6/51 (11.76%)  8/55 (14.55%) 
Skin and subcutaneous tissue disorders                         
Dermatitis diaper * 1  9/185 (4.86%)  2/152 (1.32%)  2/144 (1.39%)  6/170 (3.53%)  5/153 (3.27%)  0/126 (0.00%)  2/104 (1.92%)  4/74 (5.41%)  0/66 (0.00%)  13/239 (5.44%)  1/51 (1.96%)  2/55 (3.64%) 
Erythema * 1  0/185 (0.00%)  2/152 (1.32%)  1/144 (0.69%)  1/170 (0.59%)  2/153 (1.31%)  2/126 (1.59%)  1/104 (0.96%)  0/74 (0.00%)  1/66 (1.52%)  3/239 (1.26%)  1/51 (1.96%)  3/55 (5.45%) 
Rash * 1  9/185 (4.86%)  9/152 (5.92%)  20/144 (13.89%)  8/170 (4.71%)  5/153 (3.27%)  9/126 (7.14%)  10/104 (9.62%)  7/74 (9.46%)  5/66 (7.58%)  26/239 (10.88%)  8/51 (15.69%)  4/55 (7.27%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 17.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis’ agreement with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publications of the pooled data (i.e., data from all sites) in the clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Posting Director
Organization: Novartis Vaccines
Phone: +39 0577 245863
EMail: anh.phung@novartis.com
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Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00944034     History of Changes
Other Study ID Numbers: V72P12E1
2009-011676-30
First Submitted: July 21, 2009
First Posted: July 22, 2009
Results First Submitted: February 16, 2015
Results First Posted: November 10, 2015
Last Update Posted: August 14, 2017