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Safety and Immunogenicity in Dose-Ranging and Formulation-Finding Meningococcal B (MenB) Vaccine Study in 2-month-old Infants

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ClinicalTrials.gov Identifier: NCT00937521
Recruitment Status : Completed
First Posted : July 13, 2009
Results First Posted : March 4, 2015
Last Update Posted : April 7, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Conditions Meningococcal Meningitis
Meningococcal Infections
Interventions Biological: Meningococcal B vaccine
Biological: Control
Biological: Meningococcal B vaccine with antipyretic
Enrollment 1507
Recruitment Details  
Pre-assignment Details  
Arm/Group Title B+OMV (Group I) B+½ OMV (Group II) B+1/4 OMV (Group III) B (Group IV) ½ (B+OMV) (Group V) PH2 B+OMV (Group VI) MenC (Group VII) Par+B+OMV (Group VIII)
Hide Arm/Group Description Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age. Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
Period Title: Overall Study - Prior to Booster Dose
Started 188 190 192 188 191 188 186 184
Premature Withdrawal 3 5 6 1 3 1 5 1
Completed 185 185 186 187 188 187 181 183
Not Completed 3 5 6 1 3 1 5 1
Reason Not Completed
Adverse Event             0             0             2             0             0             0             1             0
Withdrawal by Subject             2             1             3             0             1             0             2             1
Lost to Follow-up             0             0             1             1             0             0             0             0
Inappropriate enrollment             0             4             0             0             2             1             1             0
Protocol Deviation             1             0             0             0             0             0             1             0
Period Title: Booster Phase
Started 155 163 169 170 168 165 165 161
Premature Withdrawal 3 2 5 3 5 5 5 2
Completed 152 161 164 167 163 160 160 159
Not Completed 3 2 5 3 5 5 5 2
Reason Not Completed
Adverse Event             0             0             0             0             0             0             1             0
Withdrawal by Subject             1             0             0             1             0             0             0             2
Lost to Follow-up             2             2             4             2             4             4             3             0
Administrative Reason             0             0             1             0             1             1             0             0
Protocol Deviation             0             0             0             0             0             0             1             0
Arm/Group Title B+OMV (Group I) B+½ OMV (Group II) B+1/4 OMV (Group III) B (Group IV) ½ (B+OMV) (Group V) PH2 B+OMV (Group VI) MenC (Group VII) Par+B+OMV (Group VIII) Total
Hide Arm/Group Description Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age. Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age. Total of all reporting groups
Overall Number of Baseline Participants 188 190 192 188 191 188 186 184 1507
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 188 participants 190 participants 192 participants 188 participants 191 participants 188 participants 186 participants 184 participants 1507 participants
<=18 years
188
 100.0%
190
 100.0%
192
 100.0%
188
 100.0%
191
 100.0%
188
 100.0%
186
 100.0%
184
 100.0%
1507
 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%
>=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%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 188 participants 190 participants 192 participants 188 participants 191 participants 188 participants 186 participants 184 participants 1507 participants
Female
88
  46.8%
91
  47.9%
82
  42.7%
96
  51.1%
79
  41.4%
93
  49.5%
98
  52.7%
72
  39.1%
699
  46.4%
Male
100
  53.2%
99
  52.1%
110
  57.3%
92
  48.9%
112
  58.6%
95
  50.5%
88
  47.3%
112
  60.9%
808
  53.6%
1.Primary Outcome
Title Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination
Hide Description To assess the immunogenicity of seven different formulations of 4CMenB (groups I-VI and VIII) given to healthy infants at 2,3 and 4 months of age as measured by percentages of subjects with serum bactericidal activity (SBA) titer≥1:5 against 44/76-SL, 5/99 and NZ98/254 reference strains, at 1 month after the third vaccination.. The analysis was done on the Per Protocol Primary Population at one month after third injection.
Time Frame At baseline (pre-vaccination) and 30 days after the third vaccination.
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis as per PP population.
Arm/Group Title B+OMV (Group I) B+½ OMV (Group II) B+1/4 OMV (Group III) B (Group IV) ½ (B+OMV) (Group V) PH2 B+OMV (Group VI) MenC (Group VII) Par+B+OMV (Group VIII)
Hide Arm/Group Description:
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
Overall Number of Participants Analyzed 171 174 171 174 172 173 171 169
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of Subjects
44/76SLBaseline(N=166,171,168,170,169,168,168,166)
5
(2 to 9)
2
(0 to 5)
4
(1 to 8)
4
(2 to 8)
4
(2 to 8)
4
(2 to 8)
2
(1 to 6)
3
(1 to 7)
44/76-SL > 3rd(N=170,170,166,166,169,167,165,167)
100
(98 to 100)
99
(97 to 100)
99
(97 to 100)
100
(98 to 100)
99
(97 to 100)
99
(96 to 100)
6
(3 to 11)
100
(98 to 100)
5/99-Baseline (N=162,162,161,161,166,166,161,157)
5
(2 to 9)
3
(1 to 7)
6
(3 to 10)
4
(2 to 9)
8
(5 to 14)
4
(2 to 8)
6
(3 to 10)
4
(1 to 8)
5/99 > 3rd (N=165,167,161,166,165,161,159,160)
99
(97 to 100)
100
(98 to 100)
99
(97 to 100)
100
(98 to 100)
100
(98 to 100)
99
(97 to 100)
3
(1 to 7)
99
(97 to 100)
NZ98/254Baseline(N=170,174,171,174,171,173,171,169
1
(0.015 to 3)
0
(0 to 2)
1
(0.015 to 3)
1
(0.015 to 3)
1
(0 to 4)
1
(0 to 4)
2
(0 to 5)
1
(0.015 to 3)
NZ98/254 > 3rd (N=171,172,169,168,172,169,168,168)
78
(71 to 84)
67
(59 to 74)
56
(48 to 64)
1
(0.015 to 3)
62
(54 to 69)
81
(74 to 87)
2
(0 to 5)
74
(67 to 81)
2.Primary Outcome
Title Number of Subjects With Fever ≥ 38.5 °C (Rectal Temperature) Within 3 Days (Day 1-3) After First Vaccination
Hide Description To assess if any of six different formulations of vaccine groups (Group II to Group VI, Group VIII) reduced the incidence of fever >=38.5C (rectal) occurring within three days (day 1-day3) following first vaccination. The analysis was done on the Safety Population.
Time Frame Day 1 to day 3 after first vaccination.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was done on the Safety Population.
Arm/Group Title B+OMV (Group I) B+½ OMV (Group II) B+1/4 OMV (Group III) B (Group IV) ½ (B+OMV) (Group V) PH2 B+OMV (Group VI) MenC (Group VII) Par+B+OMV (Group VIII)
Hide Arm/Group Description:
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
Overall Number of Participants Analyzed 182 180 186 184 182 180 177 179
Measure Type: Number
Unit of Measure: Subjects
94 91 74 24 60 76 21 46
3.Secondary Outcome
Title Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age)
Hide Description

ToTo assess the immune response of seven different formulations of meningococcal multi-component recombinant, adsorbed vaccine (rMenB+OMV NZ or rMenB (no OMV)) in healthy toddlers as measured by SBA geometric mean titers (GMTs) at:

  1. One month after third vaccination.
  2. One month after booster vaccination (Men B at 12 months of age).
Time Frame At baseline (pre-vaccination), 30 days after the third vaccination, at booster Baseline and at booster vaccination (12 months of age)
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Primary and Booster populations.
Arm/Group Title B+OMV (Group I) B+½ OMV (Group II) B+1/4 OMV (Group III) B (Group IV) ½ (B+OMV) (Group V) PH2 B+OMV (Group VI) MenC (Group VII) Par+B+OMV (Group VIII)
Hide Arm/Group Description:
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
Overall Number of Participants Analyzed 171 174 171 174 172 173 171 169
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
44/76-SL Base(N=166,171,168,170,169,168,168,166)
1.25
(1.14 to 1.37)
1.12
(1.03 to 1.23)
1.2
(1.1 to 1.32)
1.19
(1.08 to 1.3)
1.31
(1.19 to 1.43)
1.2
(1.09 to 1.31)
1.16
(1.09 to 1.25)
1.18
(1.08 to 1.3)
44/76-SL > 3(N=170,170,166,166,169,167,165,167)
101
(90 to 113)
112
(101 to 126)
113
(101 to 126)
62
(56 to 70)
71
(64 to 80)
102
(92 to 114)
1.24
(1.11 to 1.39)
102
(91 to 115)
44/76-SL – Base Boost(N=69,78,74,78,71,71,74,70)
4.94
(3.76 to 6.5)
5.22
(4.03 to 6.76)
5.72
(4.41 to 7.42)
5.44
(4.19 to 7.06)
3.96
(3.02 to 5.18)
3.76
(2.87 to 4.94)
1.15
(1.03 to 1.29)
4.51
(3.43 to 5.95)
44/76-SL > Boost(N=65,73,70,75,76,71,75,63)
120
(95 to 150)
152
(122 to 189)
118
(95 to 146)
53
(43 to 66)
99
(79 to 122)
105
(84 to 131)
12
(10 to 16)
136
(107 to 172)
5/99-Baseline-(N=162,162,161,161,166,166,161,157)
1.18
(1.07 to 1.3)
1.09
(0.99 to 1.2)
1.12
(1.02 to 1.23)
1.13
(1.03 to 1.25)
1.3
(1.18 to 1.43)
1.16
(1.05 to 1.27)
1.21
(1.09 to 1.34)
1.07
(0.97 to 1.18)
5/99 > 3 (N=165,167,161,166,165,161,160)
396
(348 to 450)
503
(442 to 572)
534
(469 to 608)
389
(342 to 443)
316
(278 to 360)
371
(326 to 422)
1.15
(1.03 to 1.29)
455
(399 to 519)
5/99 Base Boost(N=71,76,80,72,77,78,70,71)
69
(53 to 88)
91
(71 to 116)
111
(87 to 141)
74
(57 to 94)
54
(42 to 68)
64
(50 to 81)
1.11
(0.95 to 1.29)
106
(82 to 136)
5/99 > Boost(N=73,77,79,72,76,74,69,76)
1950
(1573 to 2417)
1819
(1478 to 2238)
2238
(1820 to 2751)
730
(590 to 903)
983
(801 to 1205)
1321
(1074 to 1624)
41
(29 to 57)
2182
(1769 to 2691)
NZ98/254-BaselineN=170,174,171,174,171,173,171,169
1.02
(0.99 to 1.06)
1.02
(0.99 to 1.05)
1.03
(1 to 1.06)
1.04
(1 to 1.07)
1.03
(1 to 1.06)
1.04
(1.01 to 1.08)
1.06
(1 to 1.13)
1.02
(0.99 to 1.05)
1month after 3rd vaccN=171,172,169,172,169,169,168
10
(8.59 to 12)
7.81
(6.69 to 9.12)
5.74
(4.92 to 6.71)
1.05
(0.9 to 1.23)
6.66
(5.71 to 7.77)
11
(9.16 to 13)
1.05
(1.01 to 1.1)
8.48
(7.24 to 9.93)
NZ98/254 Bas Bst N=141,155,155,150,150,153,148,143
1.6
(1.43 to 1.8)
1.28
(1.15 to 1.43)
1.23
(1.1 to 1.37)
1.11
(0.99 to 1.24)
1.35
(1.21 to 1.5)
1.41
(1.26 to 1.57)
1.03
(1 to 1.06)
1.48
(1.32 to 1.66)
1month after boosterN=138,152,150,149,152,146,140
20
(16 to 24)
18
(15 to 22)
11
(9.07 to 13)
1.67
(1.38 to 2.03)
14
(12 to 17)
20
(16 to 24)
2.2
(1.89 to 2.57)
20
(17 to 25)
4.Secondary Outcome
Title Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age)
Hide Description To compare the antibody response of meningococcal multi-component recombinant, adsorbed vaccine (formulation I vs. formulation VIII) and of routine infant vaccine given with or without prophylactic administration of paracetamol medication in healthy toddlers.
Time Frame At Baseline (pre-vaccination), at 30 days after the third vaccination, at booster Baseline, at 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
As per PP population.
Arm/Group Title B+OMV (Group I) Par+B+OMV (Group VIII)
Hide Arm/Group Description:
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
Overall Number of Participants Analyzed 171 169
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
44/76-SL Strain - Baseline (N=166,166)
1.25
(1.14 to 1.37)
1.18
(1.08 to 1.3)
44/76-SL > 3rd (N=170,167)
101
(90 to 113)
102
(91 to 115)
44/76-SL Baseline booster (N=69,70)
4.94
(3.76 to 6.5)
4.51
(3.43 to 5.95)
44/76-SL > booster (N=65,63)
120
(95 to 150)
136
(107 to 172)
5/99 Strain - Baseline (N=162,157)
1.18
(1.07 to 1.3)
1.07
(0.97 to 1.18)
5/99 > 3rd (N=165,160)
396
(348 to 450)
455
(399 to 519)
5/99 Baseline booster (N=71,71)
69
(53 to 88)
106
(82 to 136)
5/99 > booser (N=73,76)
1950
(1573 to 2417)
2182
(1769 to 2691)
NZ98/254 Strain-Baseline (N=170,169)
1.02
(0.99 to 1.06)
1.02
(0.99 to 1.05)
NZ98/254 > 3rd (N=171,168)
10
(8.59 to 12)
8.48
(7.24 to 9.93)
NZ98/254 Baseline booster (N=141,143)
1.6
(1.43 to 1.8)
1.48
(1.32 to 1.66)
NZ98/254 > booster (N= 138, 140)
20
(16 to 24)
20
(17 to 25)
5.Secondary Outcome
Title Geometric Mean Ratios, One Month After Primary and Booster Vaccination (Men B at 12 Months of Age)
Hide Description To compare the antibody response between meningococcal multi-component recombinant adsorbed vaccine (formulation I) and routine infant vaccine group along with meningococcal multi-component recombinant adsorbed vaccine with prophylactic administration of paracetamol medication as measured by Geometric Mean Ratios (GMRs).
Time Frame After the third and the booster vaccination.
Hide Outcome Measure Data
Hide Analysis Population Description
As per PP population.
Arm/Group Title B+OMV (Group I) Par+B+OMV (Group VIII)
Hide Arm/Group Description:
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
Overall Number of Participants Analyzed 162 160
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratios
44/76-SL > 3rd (N=157,157)
80
(69 to 93)
84
(72 to 97)
44/76-SL > Booster (N=59,56)
24
(18 to 31)
28
(21 to 36)
5/99 > 3rd (N=152,142)
345
(292 to 408)
417
(350 to 497)
5/99 > Booster (N=68,68)
27
(21 to 35)
20
(16 to 25)
NZ98/254 > 3rd (N=162,160)
9.65
(8.19 to 11)
8.69
(7.36 to 10)
NZ98/254 > Booster (N=129,127)
12
(10 to 15)
14
(11 to 17)
6.Secondary Outcome
Title Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (Pre-fourth Dose)
Hide Description To assess the persistence of bactericidal antibodies at 12 months of age after primary vaccination - three doses of one of the seven different formulations of rMenB+OMV NZ or rMenB (no OMV) (Group I-VI and VIII) and rMenB+OMV NZ with paracetamol medication.
Time Frame 12 months (pre-fourth vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was done on the Per Protocol Booster population.
Arm/Group Title B+OMV (Group I) B+½ OMV (Group II) B+1/4 OMV (Group III) B (Group IV) ½ (B+OMV) (Group V) PH2 B+OMV (Group VI) MenC (Group VII) Par+B+OMV (Group VIII)
Hide Arm/Group Description:
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age..
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age..
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
Overall Number of Participants Analyzed 141 155 155 150 150 153 148 143
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of Subjects
44/76-SL Pre-Boost(N=69,78,74,78,71,71,74,70)
55
(43 to 67)
58
(46 to 69)
66
(54 to 77)
63
(51 to 74)
45
(33 to 57)
44
(32 to 56)
4
(1 to 11)
47
(35 to 59)
5/99 Pre-Boost(N=71,76,80,72,77,78,70,71)
97
(90 to 100)
100
(95 to 100)
100
(95 to 100)
97
(90 to 100)
97
(91 to 100)
99
(93 to 100)
1
(0.036 to 8)
100
(95 to 100)
NZ98/254 Pre-B(N=141,155,155,150,150,153,148,143)
12
(7 to 19)
6
(3 to 11)
5
(2 to 10)
3
(1 to 7)
7
(3 to 12)
8
(4 to 13)
0
(0 to 2)
11
(7 to 18)
7.Secondary Outcome
Title Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (One Month-post Fourth Dose)
Hide Description To assess if any of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (groups I-VI and VIII) induced sufficient immune response when given to healthy toddlers at 12 months of age, as measured by percentage of subjects with SBA titer ≥ 1:5, at 1 month after the fourth vaccination.
Time Frame 1 month after fourth vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was done on the Per Protocol Booster population.
Arm/Group Title B+OMV (Group I) B+½ OMV (Group II) B+1/4 OMV (Group III) B (Group IV) ½ (B+OMV) (Group V) PH2 B+OMV (Group VI) MenC (Group VII) Par+B+OMV (Group VIII)
Hide Arm/Group Description:
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
Overall Number of Participants Analyzed 138 152 150 149 152 146 147 140
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of Subjects
44/76-SL > Booster(N=65,73,70,75,76,71,63)
100
(94 to 100)
100
(95 to 100)
100
(95 to 100)
97
(91 to 100)
100
(95 to 100)
99
(92 to 100)
84
(74 to 91)
100
(94 to 100)
5/99 strain (N=73,77,79,72,76,74,76)
100
(95 to 100)
100
(95 to 100)
100
(95 to 100)
100
(95 to 100)
100
(95 to 100)
100
(95 to 100)
93
(84 to 98)
100
(95 to 100)
NZ98/254 (N=138,152,150,149,152,146,147,140)
89
(83 to 94)
89
(83 to 93)
78
(71 to 84)
18
(12 to 25)
83
(76 to 89)
88
(82 to 93)
24
(18 to 32)
90
(84 to 94)
8.Secondary Outcome
Title Geometric Mean Bactericidal Titers, After Primary and Booster Vaccinations (Men B at 12 Months of Age)
Hide Description To assess the induction of immunological memory of three doses of meningococcal multi-component recombinant, adsorbed vaccine by comparing the serum bactericidal antibodies Geometric Mean Bactericidal Titers (GMTs) response in healthy toddlers administered the fourth dose at 12 months of age to the response in meningococcal B vaccine naive toddlers (Group VII) receiving the first dose of meningococcal multi-component recombinant, adsorbed vaccine at 12 months of age.
Time Frame At 13 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was done on the Per Protocol population.
Arm/Group Title B+OMV (Group I) MenC (Group VII)
Hide Arm/Group Description:
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
Overall Number of Participants Analyzed 138 147
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
44/76-SL > Booster (N=65,75)
120
(95 to 150)
12
(10 to 16)
5/99 > Booster (N=73,69)
1950
(1573 to 2417)
41
(29 to 57)
NZ98/254 > Booster
20
(16 to 24)
2.2
(1.89 to 2.57)
9.Secondary Outcome
Title Percentage of Subjects With hSBA ≥1:5, First Dose of Meningococcal B Vaccine (One Month After Booster)
Hide Description To assess the immune response of first dose of meningococcal multi-component recombinant, adsorbed vaccine given at 12 months of age to toddlers who previously received three doses of MenC-CRM197 vaccine as infants (group VII).
Time Frame 1 month after booster
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was done on the Per Protocol population.
Arm/Group Title MenC (Group VII)
Hide Arm/Group Description:
Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
Overall Number of Participants Analyzed 147
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Subjects
44/76-SL > Booster (N=75)
84
(74 to 91)
5/99 > Booster (N=69)
93
(84 to 98)
NZ98/254 > Booster
24
(18 to 32)
10.Secondary Outcome
Title Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination
Hide Description To assess if any of six different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (Group II to VI, Group VIII) reduced the incidence of fever ≥ 38.5ºC (rectal) occurring within 3 days (day 1-3) following second and third vaccination and 7 days (day 1-7) following each vaccination as compared to rMenB+OMV NZ (Group I).
Time Frame Day 1 through day 7 after second and third vaccination.
Hide Outcome Measure Data
Hide Analysis Population Description
As per safety dataset.
Arm/Group Title B+OMV (Group I) B+½ OMV (Group II) B+1/4 OMV (Group III) B (Group IV) ½ (B+OMV) (Group V) PH2 B+OMV (Group VI) MenC (Group VII) Par+B+OMV (Group VIII)
Hide Arm/Group Description:
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age..
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects in this group received one dose of meningococcal multi-component recombinant, adsorbed vaccine (formulation V)and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age..
Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
Overall Number of Participants Analyzed 182 180 186 184 182 180 177 179
Measure Type: Number
Unit of Measure: Subjects
Second Vaccination (day1-3) 90 82 76 35 74 89 30 33
3rd vac d 1-3(N=181,179,185,183,181,180,177,179) 55 50 36 15 40 53 12 20
First Vaccination (day1-7) 94 91 74 24 60 76 22 46
Second Vaccination (day 1-7) 90 82 77 36 74 90 30 35
3rd vac d 1-7(N=181,179,185,183,181,180,177,179) 55 53 38 16 42 54 14 20
Booster d 1-7(N=155,162,169,168,168,165,164,159) 81 86 64 43 78 68 84 58
11.Secondary Outcome
Title Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination
Hide Description To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting solicited local reactions within 7 days (day 1-7) after each vaccination.
Time Frame Day 1 through day 7 after each vaccination.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the safety population.
Arm/Group Title B+OMV (Group I) B+½ OMV (Group II) B+1/4 OMV (Group III) B (Group IV) ½ (B+OMV) (Group V) PH2 B+OMV (Group VI) MenC (Group VII) Par+B+OMV (Group VIII)
Hide Arm/Group Description:
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
Overall Number of Participants Analyzed 182 180 186 184 182 180 177 179
Measure Type: Number
Unit of Measure: Subjects
Any Local (First Vacc) 163 155 153 123 141 157 127 137
Injection Site Tenderness (First Vacc) 114 116 111 54 97 121 48 79
Injection Site Erythema (First Vacc) 108 99 94 53 77 106 45 73
Injection Site Induration (First Vacc) 101 98 85 48 86 84 25 82
Injection Site Swelling (First Vacc) 58 49 55 24 48 60 15 41
Any Local (Second Vacc) 156 156 155 126 132 156 118 140
Injection Site Tenderness (Second Vacc) 121 116 97 48 88 116 47 85
Injection Site Erythema (Second Vacc) 104 114 114 71 90 104 44 94
Injection Site Induration (Second Vacc) 103 105 97 63 83 94 38 79
Injection Site Swelling (Second Vacc) 64 61 54 34 50 58 21 52
Any Local (3rd N=181,179,185,183,181,180,177,179) 151 147 141 122 130 152 113 128
Injection Site Tenderness (Third Vacc) 102 98 78 47 77 111 42 66
Injection Site Erythema (Third Vacc) 110 106 112 72 94 101 63 91
Injection Site Induration (Third Vacc) 97 92 92 62 79 89 55 80
Injection Site Swelling (Third Vacc) 56 56 46 35 45 58 29 47
Any Local BoostN=155,162,169,168,168,165,162,159 131 132 149 113 127 130 133 121
Injection Site Tenderness (Booster Vacc) 116 107 120 77 106 112 108 92
Injection Site Erythema (Booster Vacc) 90 101 116 67 80 85 93 81
Injection Site Induration (Booster Vacc) 73 83 95 56 66 73 62 60
Injection Site Swelling (Booster Vacc) 55 59 69 31 47 52 39 47
12.Secondary Outcome
Title Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination
Hide Description To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting solicited systemic reactions within 7 days (day 1-7) after each vaccination.
Time Frame Day 1 through day 7 after each vaccination.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the safety population.
Arm/Group Title B+OMV (Group I) B+½ OMV (Group II) B+1/4 OMV (Group III) B (Group IV) ½ (B+OMV) (Group V) PH2 B+OMV (Group VI) MenC (Group VII) Par+B+OMV (Group VIII)
Hide Arm/Group Description:
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
Overall Number of Participants Analyzed 182 180 186 184 182 180 177 179
Measure Type: Number
Unit of Measure: Subjects
Any Systemic (First Vacc) 167 173 175 152 162 171 136 150
Change Eat. Habits (First Vacc) 76 87 84 52 84 90 41 66
Sleepiness (First Vacc) 120 131 119 96 117 119 92 116
Vomiting (First Vacc) 24 18 25 15 22 26 17 22
Diarrhea (First Vacc) 57 55 54 31 41 49 45 41
Irritability (First Vacc) 128 124 128 99 131 131 79 97
Unus Crying (First Vacc) 95 101 105 61 96 108 63 74
Rash (First Vacc) 6 5 5 7 10 10 4 5
Fever ( ≥ 38.5°C ) (First Vacc) 94 91 74 24 60 76 22 46
Antipyr. Med. Used (First Vacc) 102 94 92 37 74 95 32 166
Any Systemic (Second Vacc) 168 158 166 144 156 158 126 147
Change Eat. Habits (Second Vacc) 62 55 58 53 60 80 33 54
Sleepiness (Second Vacc) 105 100 102 85 92 109 75 84
Vomiting (Second Vacc) 18 18 14 15 17 20 14 20
Diarrhea (Second Vacc) 43 41 47 40 39 47 39 40
Irritability (Second Vacc) 130 121 124 94 117 126 82 99
Unus Crying (Second Vacc) 90 90 84 70 83 99 45 71
Rash (Second Vacc) 4 9 4 5 7 4 5 5
Fever ( ≥ 38.5°C ) (Second Vacc) 90 82 77 36 74 90 30 35
Antipyr. Med. Used (Second Vacc) 100 94 83 40 79 105 39 163
Any Syst (3rdN=181,179,185,182,181,180,177,179) 146 131 132 122 141 151 106 127
Change Eat. Habits (Third Vacc) 49 50 42 37 45 60 22 48
Sleepiness (Third Vacc) 75 67 82 64 77 79 52 75
Vomiting (Third Vacc) 8 18 15 12 12 13 11 20
Diarrhea (Third Vacc) 33 29 39 31 34 40 19 32
Irritability (Third Vacc) 115 97 93 74 104 115 76 84
Unus Crying (Third Vacc) 76 82 62 47 69 100 38 47
Rash (Third Vacc) 1 6 4 2 8 10 6 6
Fever ( ≥ 38.5°C ) (Third Vacc) 55 53 38 16 42 54 14 20
Antipyr. Med. Used (Third Vacc) 66 60 51 26 49 63 20 153
Any Syst(BoosterN=155,162,169,169,168,165,164,159) 143 144 139 118 141 142 142 137
Change Eat. Habits (Booster Vacc) 74 77 79 52 70 80 59 66
Sleepiness (Booster Vacc) 76 90 90 63 86 88 85 80
Vomiting (Booster Vacc) 6 11 7 7 10 9 9 20
Diarrhea (Booster Vacc) 30 34 36 43 32 30 26 30
Irritability (Booster Vacc) 116 111 112 86 116 115 117 96
Unus Crying (Booster Vacc) 74 64 69 46 71 82 73 50
Rash (Booster Vacc) 5 5 8 2 8 4 6 5
Fever ( ≥ 38.5°C ) (Booster Vacc) 81 86 64 43 78 68 84 58
Antipyr. Med. Used (Booster Vacc) 84 82 83 42 75 80 92 128
13.Secondary Outcome
Title Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination
Hide Description To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting unsolicited Adverse Events (AEs), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal (throughout the study period) within 7 days (day 1-7) after each vaccination.
Time Frame Day 1 through day 7 after each vaccination.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the safety population.
Arm/Group Title B+OMV (Group I) B+½ OMV (Group II) B+1/4 OMV (Group III) B (Group IV) ½ (B+OMV) (Group V) PH2 B+OMV (Group VI) MenC (Group VII) Par+B+OMV (Group VIII)
Hide Arm/Group Description:
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
Overall Number of Participants Analyzed 184 184 189 187 187 185 184 183
Measure Type: Number
Unit of Measure: Subjects
Any AE (Day 1 to 7) (First Vacc) 55 52 51 33 35 39 27 42
At least Possibly related AE (First Vacc) 48 48 43 30 27 34 22 36
Any SAE (First Vacc) 0 1 0 0 0 1 0 1
Any AE D1-7 2nd N=182,181,186,184,183,180,178,180 55 53 50 41 36 47 28 45
At least Possibly related AE (Second Vaccination) 49 45 45 36 33 41 26 39
Any SAE (Second Vacc) 1 0 1 0 1 0 0 0
Any AE D1-7 3rd N=182,181,186,184,182,180,177,179 40 59 49 35 31 45 35 39
At least Possibly related AE (Third Vacc) 34 52 45 29 23 37 29 36
Any SAE (Third Vacc) 2 0 2 0 1 0 0 0
Any AE D 1-7Boos N=155,163,169,169,168,165,165,161 35 46 56 35 29 30 37 30
At least Possibly related AE (Booster Vacc) 28 41 48 23 23 26 30 25
Any SAE (Booster Vacc) 0 1 2 0 3 0 0 0
14.Secondary Outcome
Title Number of Subjects With Severe Adverse Events and Adverse Events Necessitating a Medical Office or Emergency Room (ER) Visit and/or Resulting in Premature Withdrawal of the Subject From the Study, Throughout the Study Period.
Hide Description To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting Severe Adverse Events (SAEs) and Adverse Events (AEs) necessitating a medical office or Emergency Room (ER) visit and/or resulting in premature withdrawal of the subject from the study, throughout the study period.
Time Frame Overall study period.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the safety population.
Arm/Group Title B+OMV (Group I) B+½ OMV (Group II) B+1/4 OMV (Group III) B (Group IV) ½ (B+OMV) (Group V) PH2 B+OMV (Group VI) MenC (Group VII) Par+B+OMV (Group VIII)
Hide Arm/Group Description:
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
Overall Number of Participants Analyzed 184 184 189 187 187 185 184 183
Measure Type: Number
Unit of Measure: Subjects
AE Leading to Premature Withdrawal-Primary Vacc 0 2 2 0 0 1 2 1
Treatment Emergent SAEs - Primary Vacc 16 20 12 20 13 16 11 15
Tr E SAE Boost (N=155,163,169,169,168,165,165,161) 14 7 12 5 15 9 9 16
15.Secondary Outcome
Title Number of Subjects With Local and Systemic Reactions Within 7 Days (Day 1-7) After Second rMenB+OMV NZ Vaccination in MenC Group
Hide Description To assess the safety and tolerability of two doses of rMenB+OMV NZ vaccine (Group VII) given at 12 and 13 months of age to toddlers who previously received three doses of Menjugate as infants.
Time Frame Day 1 through day 7 at 13 months age.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the safety population.
Arm/Group Title MenC (Group VII)
Hide Arm/Group Description:
Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
Overall Number of Participants Analyzed 156
Measure Type: Number
Unit of Measure: Subjects
Injection Site Tenderness 92
Injection Site Erythema 84
Injection Site Induration 59
Injection Site Swelling 35
Change Eat. Habits (N=155) 43
Sleepiness 57
Vomiting 8
Diarrhea 18
Irritability 75
Unus Crying 37
Rash 4
Fever ( ≥ 38.5°C ) (N=158) 35
Antipyr. Med. Used (N=157) 47
Time Frame All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal were collected during the overall study period.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title B+OMV (Group I) B+½ OMV (Group II) B+1/4 OMV (Group III) B (Group IV) ½ (B+OMV) (Group V) PH2 B+OMV (Group VI) MenC (Group VII) Par+B+OMV (Group VIII) B+OMV (Group I) Booster Phase B+½ OMV (Group II) Booster Phase B+1/4 OMV (Group III) Booster Phase B (Group IV) Booster Phase ½ (B+OMV) (Group V) Booster Phase PH2 B+OMV (Group VI) Booster Phase MenC (Group VII) Booster Phase Par+B+OMV (Group VIII) Booster Phase
Hide Arm/Group Description

Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.

Group defined to be applicable Prior to Booster Phase for AEs reporting.

Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.

Group defined to be applicable Prior to Booster Phase for AEs reporting.

Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.

Group defined to be applicable Prior to Booster Phase for AEs reporting.

Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.

Group defined to be applicable Prior to Booster Phase for AEs reporting..

Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.

Group defined to be applicable Prior to Booster Phase for AEs reporting.

SubjSubjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.

Group defined to be applicable Prior to Booster Phase for AEs reporting.

Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age and one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age. One dose of MenC at 13 months of age.

Group defined to be applicable Prior to Booster Phase for AEs reporting.

Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. Group defined to be applicable Prior to Booster Phase for AEs reporting. Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.

Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine(formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.

Group defined to include Booster Phase.

Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.

Group defined to include Booster Phase.

Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.

Group defined to include Booster Phase.

Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.

Group defined to include Booster Phase.

Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.

Group defined to include Booster Phase.

Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age and one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age. One dose of MenC at 13 months of age.

Group defined to include Booster Phase.

Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. Group defined to include Booster Phase.
All-Cause Mortality
B+OMV (Group I) B+½ OMV (Group II) B+1/4 OMV (Group III) B (Group IV) ½ (B+OMV) (Group V) PH2 B+OMV (Group VI) MenC (Group VII) Par+B+OMV (Group VIII) B+OMV (Group I) Booster Phase B+½ OMV (Group II) Booster Phase B+1/4 OMV (Group III) Booster Phase B (Group IV) Booster Phase ½ (B+OMV) (Group V) Booster Phase PH2 B+OMV (Group VI) Booster Phase MenC (Group VII) Booster Phase Par+B+OMV (Group VIII) Booster Phase
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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
B+OMV (Group I) B+½ OMV (Group II) B+1/4 OMV (Group III) B (Group IV) ½ (B+OMV) (Group V) PH2 B+OMV (Group VI) MenC (Group VII) Par+B+OMV (Group VIII) B+OMV (Group I) Booster Phase B+½ OMV (Group II) Booster Phase B+1/4 OMV (Group III) Booster Phase B (Group IV) Booster Phase ½ (B+OMV) (Group V) Booster Phase PH2 B+OMV (Group VI) Booster Phase MenC (Group VII) Booster Phase Par+B+OMV (Group VIII) Booster Phase
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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   16/184 (8.70%)   20/184 (10.87%)   12/189 (6.35%)   20/187 (10.70%)   13/187 (6.95%)   16/185 (8.65%)   11/184 (5.98%)   15/183 (8.20%)   14/155 (9.03%)   7/163 (4.29%)   12/169 (7.10%)   5/169 (2.96%)   15/168 (8.93%)   9/165 (5.45%)   9/165 (5.45%)   14/161 (8.70%) 
Blood and lymphatic system disorders                                 
Neutropenia * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  1/187 (0.53%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Anaemia * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  1/165 (0.61%)  0/165 (0.00%)  0/161 (0.00%) 
Lymphadenitis * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  1/168 (0.60%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Cardiac disorders                                 
Pulmonary valve stenosis * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  1/185 (0.54%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Congenital, familial and genetic disorders                                 
Congenital megacolon * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  1/187 (0.53%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Cryptorchism * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  1/168 (0.60%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Phimosis * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  1/161 (0.62%) 
Gastrointestinal disorders                                 
Aphthous stomatitis * 1  0/184 (0.00%)  1/184 (0.54%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Enteritis * 1  0/184 (0.00%)  0/184 (0.00%)  1/189 (0.53%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Enterocolitis haemorrhagic * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Gastritis * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  1/185 (0.54%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Gastrooesophageal reflux disease * 1  0/184 (0.00%)  0/184 (0.00%)  1/189 (0.53%)  0/187 (0.00%)  0/187 (0.00%)  1/185 (0.54%)  0/184 (0.00%)  1/183 (0.55%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Inguinal hernia * 1  1/184 (0.54%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  1/155 (0.65%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  1/165 (0.61%)  0/165 (0.00%)  0/161 (0.00%) 
Vomiting * 1  0/184 (0.00%)  1/184 (0.54%)  1/189 (0.53%)  0/187 (0.00%)  1/187 (0.53%)  1/185 (0.54%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Diarrhoea * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  1/168 (0.60%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Intussusception * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  1/168 (0.60%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
General disorders                                 
Pyrexia * 1  1/184 (0.54%)  0/184 (0.00%)  0/189 (0.00%)  1/187 (0.53%)  0/187 (0.00%)  1/185 (0.54%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Injection site erythema * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  1/169 (0.59%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Immune system disorders                                 
Milk allergy * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  1/155 (0.65%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Infections and infestations                                 
Acarodermatitis * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  1/185 (0.54%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Bacterial pyelonephritis * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  1/187 (0.53%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Bronchiolitis * 1  1/184 (0.54%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  1/187 (0.53%)  1/185 (0.54%)  0/184 (0.00%)  0/183 (0.00%)  1/155 (0.65%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  1/168 (0.60%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Bronchitis * 1  3/184 (1.63%)  2/184 (1.09%)  4/189 (2.12%)  4/187 (2.14%)  1/187 (0.53%)  2/185 (1.08%)  2/184 (1.09%)  1/183 (0.55%)  1/155 (0.65%)  1/163 (0.61%)  2/169 (1.18%)  0/169 (0.00%)  4/168 (2.38%)  1/165 (0.61%)  3/165 (1.82%)  2/161 (1.24%) 
Bronchopneumonia * 1  1/184 (0.54%)  0/184 (0.00%)  0/189 (0.00%)  1/187 (0.53%)  0/187 (0.00%)  0/185 (0.00%)  1/184 (0.54%)  2/183 (1.09%)  1/155 (0.65%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  1/168 (0.60%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Corona virus infection * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  1/183 (0.55%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Cytomegalovirus infection * 1  0/184 (0.00%)  1/184 (0.54%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Exanthema subitum * 1  0/184 (0.00%)  0/184 (0.00%)  2/189 (1.06%)  0/187 (0.00%)  1/187 (0.53%)  1/185 (0.54%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  1/161 (0.62%) 
Gastroenteritis * 1  1/184 (0.54%)  2/184 (1.09%)  1/189 (0.53%)  3/187 (1.60%)  1/187 (0.53%)  3/185 (1.62%)  1/184 (0.54%)  1/183 (0.55%)  2/155 (1.29%)  2/163 (1.23%)  1/169 (0.59%)  1/169 (0.59%)  1/168 (0.60%)  5/165 (3.03%)  0/165 (0.00%)  3/161 (1.86%) 
Gastroenteritis rotavirus * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  1/187 (0.53%)  1/187 (0.53%)  1/185 (0.54%)  0/184 (0.00%)  1/183 (0.55%)  0/155 (0.00%)  1/163 (0.61%)  2/169 (1.18%)  0/169 (0.00%)  1/168 (0.60%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Gastroenteritis viral * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  1/187 (0.53%)  1/187 (0.53%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Infection * 1  0/184 (0.00%)  1/184 (0.54%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Laryngitis * 1  0/184 (0.00%)  0/184 (0.00%)  1/189 (0.53%)  1/187 (0.53%)  0/187 (0.00%)  3/185 (1.62%)  0/184 (0.00%)  0/183 (0.00%)  1/155 (0.65%)  0/163 (0.00%)  1/169 (0.59%)  3/169 (1.78%)  2/168 (1.19%)  0/165 (0.00%)  2/165 (1.21%)  1/161 (0.62%) 
Nasopharyngitis * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  1/183 (0.55%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  1/165 (0.61%)  0/165 (0.00%)  1/161 (0.62%) 
Oral candidiasis * 1  0/184 (0.00%)  1/184 (0.54%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  1/184 (0.54%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Oral herpes * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  1/184 (0.54%)  0/183 (0.00%)  1/155 (0.65%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Otitis media acute * 1  0/184 (0.00%)  3/184 (1.63%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  1/184 (0.54%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Pharyngitis * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  1/185 (0.54%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  1/161 (0.62%) 
Pneumonia * 1  0/184 (0.00%)  1/184 (0.54%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  1/185 (0.54%)  1/184 (0.54%)  1/183 (0.55%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Pneumonia respiratory syncytial viral * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  1/187 (0.53%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Pneumonia viral * 1  1/184 (0.54%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Pyelonephritis * 1  0/184 (0.00%)  1/184 (0.54%)  1/189 (0.53%)  1/187 (0.53%)  0/187 (0.00%)  0/185 (0.00%)  2/184 (1.09%)  1/183 (0.55%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Pyelonephritis acute * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  2/187 (1.07%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Respiratory syncytial virus infection * 1  0/184 (0.00%)  0/184 (0.00%)  1/189 (0.53%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  2/183 (1.09%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  1/165 (0.61%)  0/161 (0.00%) 
Rhinitis * 1  1/184 (0.54%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Rhinovirus infection * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  1/183 (0.55%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Sepsis * 1  0/184 (0.00%)  0/184 (0.00%)  1/189 (0.53%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Upper respiratory tract infection * 1  0/184 (0.00%)  1/184 (0.54%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  1/184 (0.54%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Tonsillitis * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  1/187 (0.53%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  1/161 (0.62%) 
Urinary tract infection * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  1/187 (0.53%)  1/187 (0.53%)  1/185 (0.54%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Varicella * 1  1/184 (0.54%)  0/184 (0.00%)  1/189 (0.53%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Viral infection * 1  0/184 (0.00%)  1/184 (0.54%)  0/189 (0.00%)  2/187 (1.07%)  1/187 (0.53%)  0/185 (0.00%)  0/184 (0.00%)  1/183 (0.55%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  1/165 (0.61%)  0/165 (0.00%)  2/161 (1.24%) 
Acute tonsillitis * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  1/168 (0.60%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Bullous impetigo * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  1/168 (0.60%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Cystitis * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  1/169 (0.59%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Device related sepsis * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  1/169 (0.59%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Ear infection * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  1/168 (0.60%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Pharyngotonsillitis * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  1/165 (0.61%)  0/161 (0.00%) 
Renal abscess * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  1/155 (0.65%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Respiratory syncytial virus bronchitis * 1  0/184 (0.00%)  0/184 (0.00%)  1/189 (0.53%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  1/183 (0.55%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  1/165 (0.61%)  0/161 (0.00%) 
Tracheitis * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  1/169 (0.59%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Viral myocarditis * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  1/165 (0.61%)  0/165 (0.00%)  0/161 (0.00%) 
Injury, poisoning and procedural complications                                 
Bone fissure * 1  0/184 (0.00%)  1/184 (0.54%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Concussion * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  1/187 (0.53%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Fall * 1  0/184 (0.00%)  1/184 (0.54%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  2/183 (1.09%)  0/155 (0.00%)  0/163 (0.00%)  2/169 (1.18%)  2/169 (1.18%)  0/168 (0.00%)  1/165 (0.61%)  0/165 (0.00%)  0/161 (0.00%) 
Foreign body aspiration * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  1/185 (0.54%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Foreign body * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  1/168 (0.60%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Head injury * 1  1/184 (0.54%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  1/187 (0.53%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  1/169 (0.59%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Joint dislocation * 1  0/184 (0.00%)  1/184 (0.54%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Road traffic accident * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  1/183 (0.55%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Thermal burn * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  1/155 (0.65%)  0/163 (0.00%)  1/169 (0.59%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  1/165 (0.61%)  0/161 (0.00%) 
Toxicity to various agents * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  1/169 (0.59%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Accidental exposure to product * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  1/155 (0.65%)  0/163 (0.00%)  1/169 (0.59%)  0/169 (0.00%)  1/168 (0.60%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Investigations                                 
Acoustic Stimulation Tests * 1  1/184 (0.54%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Metabolism and nutrition disorders                                 
Decreased appetite * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  1/183 (0.55%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Dehydration * 1  1/184 (0.54%)  0/184 (0.00%)  0/189 (0.00%)  1/187 (0.53%)  1/187 (0.53%)  1/185 (0.54%)  1/184 (0.54%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  1/168 (0.60%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Ketosis * 1  1/184 (0.54%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Weight gain poor * 1  0/184 (0.00%)  1/184 (0.54%)  1/189 (0.53%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                                 
Fibroma * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  1/184 (0.54%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Neoplasm * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  1/161 (0.62%) 
Nervous system disorders                                 
Febrile convulsion * 1  1/184 (0.54%)  1/184 (0.54%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  1/155 (0.65%)  1/163 (0.61%)  0/169 (0.00%)  1/169 (0.59%)  0/168 (0.00%)  1/165 (0.61%)  1/165 (0.61%)  3/161 (1.86%) 
Guillain-Barre syndrome * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  1/184 (0.54%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Hypotonia * 1  0/184 (0.00%)  1/184 (0.54%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  1/183 (0.55%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Myoclonic epilepsy * 1  1/184 (0.54%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Partial seizures * 1  0/184 (0.00%)  1/184 (0.54%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
VIth nerve paralysis * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  1/187 (0.53%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Somnolence * 1  0/184 (0.00%)  1/184 (0.54%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Convulsion * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  1/168 (0.60%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Psychiatric disorders                                 
Affective disorder * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  1/165 (0.61%)  0/165 (0.00%)  1/161 (0.62%) 
Respiratory, thoracic and mediastinal disorders                                 
Asthma * 1  1/184 (0.54%)  0/184 (0.00%)  1/189 (0.53%)  1/187 (0.53%)  1/187 (0.53%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  1/163 (0.61%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Dyspnoea * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  1/187 (0.53%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Respiratory distress * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  1/187 (0.53%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Adenoidal hypertrophy * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  1/163 (0.61%)  0/169 (0.00%)  0/169 (0.00%)  1/168 (0.60%)  0/165 (0.00%)  1/165 (0.61%)  0/161 (0.00%) 
Skin and subcutaneous tissue disorders                                 
Angioedema * 1  0/184 (0.00%)  1/184 (0.54%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Psoriasis * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  1/184 (0.54%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Rash * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  1/184 (0.54%)  0/183 (0.00%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Surgical and medical procedures                                 
Cleft palate repair * 1  0/184 (0.00%)  0/184 (0.00%)  0/189 (0.00%)  0/187 (0.00%)  0/187 (0.00%)  0/185 (0.00%)  0/184 (0.00%)  0/183 (0.00%)  1/155 (0.65%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
B+OMV (Group I) B+½ OMV (Group II) B+1/4 OMV (Group III) B (Group IV) ½ (B+OMV) (Group V) PH2 B+OMV (Group VI) MenC (Group VII) Par+B+OMV (Group VIII) B+OMV (Group I) Booster Phase B+½ OMV (Group II) Booster Phase B+1/4 OMV (Group III) Booster Phase B (Group IV) Booster Phase ½ (B+OMV) (Group V) Booster Phase PH2 B+OMV (Group VI) Booster Phase MenC (Group VII) Booster Phase Par+B+OMV (Group VIII) Booster Phase
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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   181/184 (98.37%)   183/184 (99.46%)   186/189 (98.41%)   183/187 (97.86%)   180/187 (96.26%)   180/185 (97.30%)   175/184 (95.11%)   175/183 (95.63%)   151/155 (97.42%)   159/163 (97.55%)   162/169 (95.86%)   152/169 (89.94%)   154/168 (91.67%)   156/165 (94.55%)   155/165 (93.94%)   150/161 (93.17%) 
Gastrointestinal disorders                                 
Diarrhoea * 1  84/184 (45.65%)  87/184 (47.28%)  80/189 (42.33%)  67/187 (35.83%)  80/187 (42.78%)  81/185 (43.78%)  74/184 (40.22%)  73/183 (39.89%)  31/155 (20.00%)  37/163 (22.70%)  39/169 (23.08%)  47/169 (27.81%)  34/168 (20.24%)  31/165 (18.79%)  40/165 (24.24%)  34/161 (21.12%) 
Vomiting * 1  38/184 (20.65%)  37/184 (20.11%)  42/189 (22.22%)  32/187 (17.11%)  36/187 (19.25%)  43/185 (23.24%)  34/184 (18.48%)  46/183 (25.14%)  6/155 (3.87%)  13/163 (7.98%)  7/169 (4.14%)  7/169 (4.14%)  10/168 (5.95%)  10/165 (6.06%)  15/165 (9.09%)  20/161 (12.42%) 
General disorders                                 
Crying * 1  122/184 (66.30%)  135/184 (73.37%)  137/189 (72.49%)  99/187 (52.94%)  125/187 (66.84%)  141/185 (76.22%)  87/184 (47.28%)  112/183 (61.20%)  74/155 (47.74%)  64/163 (39.26%)  69/169 (40.83%)  46/169 (27.22%)  71/168 (42.26%)  82/165 (49.70%)  85/165 (51.52%)  50/161 (31.06%) 
Injection site erythema * 1  151/184 (82.07%)  150/184 (81.52%)  155/189 (82.01%)  132/187 (70.59%)  131/187 (70.05%)  150/185 (81.08%)  119/184 (64.67%)  132/183 (72.13%)  97/155 (62.58%)  107/163 (65.64%)  120/169 (71.01%)  83/169 (49.11%)  89/168 (52.98%)  96/165 (58.18%)  110/165 (66.67%)  88/161 (54.66%) 
Injection site induration * 1  141/184 (76.63%)  139/184 (75.54%)  141/189 (74.60%)  126/187 (67.38%)  130/187 (69.52%)  130/185 (70.27%)  122/184 (66.30%)  126/183 (68.85%)  81/155 (52.26%)  90/163 (55.21%)  105/169 (62.13%)  71/169 (42.01%)  76/168 (45.24%)  81/165 (49.09%)  97/165 (58.79%)  70/161 (43.48%) 
Injection site pain * 1  150/184 (81.52%)  157/184 (85.33%)  139/189 (73.54%)  101/187 (54.01%)  131/187 (70.05%)  152/185 (82.16%)  105/184 (57.07%)  119/183 (65.03%)  121/155 (78.06%)  110/163 (67.48%)  126/169 (74.56%)  92/169 (54.44%)  111/168 (66.07%)  116/165 (70.30%)  125/165 (75.76%)  97/161 (60.25%) 
Pyrexia * 1  136/184 (73.91%)  127/184 (69.02%)  122/189 (64.55%)  71/187 (37.97%)  114/187 (60.96%)  126/185 (68.11%)  62/184 (33.70%)  78/183 (42.62%)  86/155 (55.48%)  94/163 (57.67%)  70/169 (41.42%)  49/169 (28.99%)  85/168 (50.60%)  72/165 (43.64%)  92/165 (55.76%)  59/161 (36.65%) 
Injection site swelling * 1  97/184 (52.72%)  94/184 (51.09%)  103/189 (54.50%)  80/187 (42.78%)  88/187 (47.06%)  100/185 (54.05%)  75/184 (40.76%)  77/183 (42.08%)  57/155 (36.77%)  63/163 (38.65%)  76/169 (44.97%)  46/169 (27.22%)  53/168 (31.55%)  57/165 (34.55%)  65/165 (39.39%)  50/161 (31.06%) 
Infections and infestations                                 
Bronchitis * 1  34/184 (18.48%)  34/184 (18.48%)  40/189 (21.16%)  31/187 (16.58%)  31/187 (16.58%)  43/185 (23.24%)  34/184 (18.48%)  35/183 (19.13%)  25/155 (16.13%)  18/163 (11.04%)  25/169 (14.79%)  28/169 (16.57%)  28/168 (16.67%)  19/165 (11.52%)  35/165 (21.21%)  17/161 (10.56%) 
Conjunctivitis * 1  14/184 (7.61%)  13/184 (7.07%)  14/189 (7.41%)  13/187 (6.95%)  15/187 (8.02%)  22/185 (11.89%)  10/184 (5.43%)  17/183 (9.29%)  7/155 (4.52%)  7/163 (4.29%)  5/169 (2.96%)  13/169 (7.69%)  8/168 (4.76%)  7/165 (4.24%)  6/165 (3.64%)  10/161 (6.21%) 
Ear infection * 1  10/184 (5.43%)  5/184 (2.72%)  10/189 (5.29%)  6/187 (3.21%)  7/187 (3.74%)  12/185 (6.49%)  9/184 (4.89%)  7/183 (3.83%)  8/155 (5.16%)  4/163 (2.45%)  2/169 (1.18%)  5/169 (2.96%)  9/168 (5.36%)  7/165 (4.24%)  11/165 (6.67%)  4/161 (2.48%) 
Exanthema subitum * 1  9/184 (4.89%)  18/184 (9.78%)  17/189 (8.99%)  17/187 (9.09%)  19/187 (10.16%)  13/185 (7.03%)  20/184 (10.87%)  11/183 (6.01%)  6/155 (3.87%)  7/163 (4.29%)  8/169 (4.73%)  5/169 (2.96%)  5/168 (2.98%)  6/165 (3.64%)  7/165 (4.24%)  10/161 (6.21%) 
Gastroenteritis * 1  10/184 (5.43%)  11/184 (5.98%)  6/189 (3.17%)  9/187 (4.81%)  6/187 (3.21%)  13/185 (7.03%)  7/184 (3.80%)  8/183 (4.37%)  5/155 (3.23%)  4/163 (2.45%)  8/169 (4.73%)  11/169 (6.51%)  12/168 (7.14%)  15/165 (9.09%)  9/165 (5.45%)  7/161 (4.35%) 
Nasopharyngitis * 1  20/184 (10.87%)  22/184 (11.96%)  25/189 (13.23%)  17/187 (9.09%)  19/187 (10.16%)  24/185 (12.97%)  16/184 (8.70%)  19/183 (10.38%)  15/155 (9.68%)  10/163 (6.13%)  18/169 (10.65%)  11/169 (6.51%)  14/168 (8.33%)  15/165 (9.09%)  14/165 (8.48%)  7/161 (4.35%) 
Pharyngitis * 1  21/184 (11.41%)  18/184 (9.78%)  15/189 (7.94%)  21/187 (11.23%)  25/187 (13.37%)  15/185 (8.11%)  18/184 (9.78%)  19/183 (10.38%)  11/155 (7.10%)  16/163 (9.82%)  13/169 (7.69%)  14/169 (8.28%)  22/168 (13.10%)  15/165 (9.09%)  16/165 (9.70%)  15/161 (9.32%) 
Rhinitis * 1  21/184 (11.41%)  14/184 (7.61%)  12/189 (6.35%)  19/187 (10.16%)  21/187 (11.23%)  26/185 (14.05%)  20/184 (10.87%)  12/183 (6.56%)  7/155 (4.52%)  9/163 (5.52%)  8/169 (4.73%)  11/169 (6.51%)  10/168 (5.95%)  8/165 (4.85%)  6/165 (3.64%)  6/161 (3.73%) 
Tonsillitis * 1  6/184 (3.26%)  3/184 (1.63%)  2/189 (1.06%)  12/187 (6.42%)  7/187 (3.74%)  5/185 (2.70%)  5/184 (2.72%)  4/183 (2.19%)  6/155 (3.87%)  10/163 (6.13%)  4/169 (2.37%)  8/169 (4.73%)  5/168 (2.98%)  8/165 (4.85%)  6/165 (3.64%)  9/161 (5.59%) 
Upper respiratory tract infection * 1  13/184 (7.07%)  13/184 (7.07%)  10/189 (5.29%)  10/187 (5.35%)  8/187 (4.28%)  12/185 (6.49%)  9/184 (4.89%)  9/183 (4.92%)  8/155 (5.16%)  7/163 (4.29%)  8/169 (4.73%)  9/169 (5.33%)  7/168 (4.17%)  9/165 (5.45%)  8/165 (4.85%)  5/161 (3.11%) 
Varicella * 1  5/184 (2.72%)  10/184 (5.43%)  2/189 (1.06%)  5/187 (2.67%)  7/187 (3.74%)  5/185 (2.70%)  5/184 (2.72%)  5/183 (2.73%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Viral infection * 1  19/184 (10.33%)  27/184 (14.67%)  23/189 (12.17%)  24/187 (12.83%)  24/187 (12.83%)  17/185 (9.19%)  16/184 (8.70%)  21/183 (11.48%)  12/155 (7.74%)  14/163 (8.59%)  6/169 (3.55%)  16/169 (9.47%)  18/168 (10.71%)  9/165 (5.45%)  12/165 (7.27%)  11/161 (6.83%) 
Nervous system disorders                                 
Somnolence * 1  145/184 (78.80%)  149/184 (80.98%)  146/189 (77.25%)  131/187 (70.05%)  142/187 (75.94%)  143/185 (77.30%)  113/184 (61.41%)  134/183 (73.22%)  76/155 (49.03%)  90/163 (55.21%)  90/169 (53.25%)  63/169 (37.28%)  86/168 (51.19%)  88/165 (53.33%)  100/165 (60.61%)  80/161 (49.69%) 
Psychiatric disorders                                 
Eating disorder * 1  105/184 (57.07%)  106/184 (57.61%)  104/189 (55.03%)  84/187 (44.92%)  112/187 (59.89%)  119/185 (64.32%)  63/184 (34.24%)  93/183 (50.82%)  74/155 (47.74%)  77/163 (47.24%)  79/169 (46.75%)  52/169 (30.77%)  70/168 (41.67%)  80/165 (48.48%)  72/165 (43.64%)  66/161 (40.99%) 
Irritability * 1  157/184 (85.33%)  159/184 (86.41%)  155/189 (82.01%)  139/187 (74.33%)  151/187 (80.75%)  153/185 (82.70%)  121/184 (65.76%)  137/183 (74.86%)  116/155 (74.84%)  111/163 (68.10%)  112/169 (66.27%)  86/169 (50.89%)  116/168 (69.05%)  115/165 (69.70%)  126/165 (76.36%)  96/161 (59.63%) 
Respiratory, thoracic and mediastinal disorders                                 
Cough * 1  22/184 (11.96%)  21/184 (11.41%)  9/189 (4.76%)  19/187 (10.16%)  13/187 (6.95%)  19/185 (10.27%)  12/184 (6.52%)  10/183 (5.46%)  5/155 (3.23%)  12/163 (7.36%)  11/169 (6.51%)  9/169 (5.33%)  11/168 (6.55%)  8/165 (4.85%)  10/165 (6.06%)  7/161 (4.35%) 
Skin and subcutaneous tissue disorders                                 
Dermatitis * 1  10/184 (5.43%)  3/184 (1.63%)  7/189 (3.70%)  0/187 (0.00%)  6/187 (3.21%)  2/185 (1.08%)  13/184 (7.07%)  9/183 (4.92%)  0/155 (0.00%)  0/163 (0.00%)  0/169 (0.00%)  0/169 (0.00%)  0/168 (0.00%)  0/165 (0.00%)  0/165 (0.00%)  0/161 (0.00%) 
Rash * 1  15/184 (8.15%)  18/184 (9.78%)  15/189 (7.94%)  18/187 (9.63%)  24/187 (12.83%)  26/185 (14.05%)  16/184 (8.70%)  19/183 (10.38%)  8/155 (5.16%)  6/163 (3.68%)  11/169 (6.51%)  2/169 (1.18%)  9/168 (5.36%)  6/165 (3.64%)  12/165 (7.27%)  7/161 (4.35%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.1
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.
Results Point of Contact
Name/Title: Novartis Vaccines
Organization: Novartis Vaccines
Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00937521     History of Changes
Other Study ID Numbers: V72P16
2009-010106-11
First Submitted: June 29, 2009
First Posted: July 13, 2009
Results First Submitted: February 13, 2015
Results First Posted: March 4, 2015
Last Update Posted: April 7, 2015