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Safety, Tolerability and Immunogenicity of Two Different Formulations of Meningococcal B Recombinant Vaccine, When Administered to Healthy Infants

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ClinicalTrials.gov Identifier: NCT00433914
Recruitment Status : Completed
First Posted : February 12, 2007
Results First Posted : March 6, 2015
Last Update Posted : March 6, 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
Condition Meningococcal Disease
Interventions Biological: rMenB
Biological: rMenB+OMV
Enrollment 60
Recruitment Details Subjects were enrolled at one study center in the United Kingdom (UK).
Pre-assignment Details All enrolled subjects were included in the trial.
Arm/Group Title rMenB rMenB+OMV
Hide Arm/Group Description 6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age. 6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
Period Title: Overall Study
Started 30 30
Completed 30 27
Not Completed 0 3
Reason Not Completed
Withdrawal by Subject             0             2
Lost to Follow-up             0             1
Arm/Group Title rMenB rMenB+OMV Total
Hide Arm/Group Description 6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age. 6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age. Total of all reporting groups
Overall Number of Baseline Participants 30 30 60
Hide Baseline Analysis Population Description
Analysis was performed on all enrolled subjects.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 30 participants 30 participants 60 participants
7.0  (0.8) 7.1  (0.7) 7.1  (0.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Female
14
  46.7%
18
  60.0%
32
  53.3%
Male
16
  53.3%
12
  40.0%
28
  46.7%
1.Primary Outcome
Title Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ
Hide Description Immunogenicity was measured as the percentage of subjects who achieved bactericidal titers ≥1:4 against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), evaluated using serum bactericidal assay, before vaccination (baseline) and one month after second vaccination (2 months later after vaccination at 6-8 months of age) and third vaccination (at 12 months of age).
Time Frame Baseline and one month after second and third vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the per protocol (PP) population set, i.e. all subjects in the enrolled population who received all the relevant doses of vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violation as defined prior to analysis.
Arm/Group Title rMenB rMenB+OMV
Hide Arm/Group Description:
6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
Overall Number of Participants Analyzed 25 24
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
Strain 44/76-SL - Baseline
8
(1 to 26)
29
(13 to 51)
Strain 44/76-SL - Post-2nd Vaccination (N=25,23)
100
(86 to 100)
100
(85 to 100)
Strain 44/76-SL - Post-3rd Vaccination (N=24,24)
100
(86 to 100)
100
(86 to 100)
Strain 5/99 - Baseline
0
(0 to 14)
0
(0 to 14)
Strain 5/99 - Post-2nd Vaccination (N=25,23)
100
(86 to 100)
100
(85 to 100)
Strain 5/99 - Post-3rd Vaccination (N=24,24)
100
(86 to 100)
100
(86 to 100)
Strain NZ98/254 - Baseline
0
(0 to 14)
0
(0 to 14)
Strain NZ98/254 - Post-2nd Vaccination (N=24,22)
4
(0 to 21)
95
(77 to 100)
Strain NZ98/254 - Post-3rd Vaccination (N=22,24)
9
(1 to 29)
96
(79 to 100)
Strain UK P1.7-2,4 - Baseline (N=24,21)
0
(0 to 14)
0
(0 to 16)
Strain UKP1.7-2,4 - Post-2nd Vaccination (N=23,19)
0
(0 to 15)
100
(82 to 100)
Strain UKP1.7-2,4 - Post-3rd Vaccination (N=21,22)
5
(0 to 24)
100
(85 to 100)
Strain GB101 - Baseline (N=24,21)
0
(0 to 14)
10
(1 to 30)
Strain GB101 - Post-2nd Vaccination (N=22,21)
23
(8 to 45)
67
(43 to 85)
Strain GB101 - Post-3rd Vaccination (N=22,22)
27
(11 to 50)
73
(50 to 89)
Strain GB355 - Baseline (N=12,11)
0
(0 to 26)
0
(0 to 28)
Strain GB355 - Post-2nd Vaccination (N=11,14)
0
(0 to 28)
7
(0 to 34)
Strain GB355 - Post-3rd Vaccination (N=12,11)
0
(0 to 26)
18
(2 to 52)
Strain GB364 - Baseline (N=22,17)
9
(1 to 29)
12
(1 to 36)
Strain GB364 - Post-2nd Vaccination (N=19,16)
95
(74 to 100)
88
(62 to 98)
Strain GB364 - Post-3rd Vaccination (N=17,19)
88
(64 to 99)
95
(74 to 100)
2.Primary Outcome
Title Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ
Hide Description Immunogenicity was measured as the percentage of subjects who achieved bactericidal titers ≥1:8 against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), before vaccination (baseline) and one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).
Time Frame Baseline and one month after second and third vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the per protocol (PP) population set.
Arm/Group Title rMenB rMenB+OMV
Hide Arm/Group Description:
6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
Overall Number of Participants Analyzed 25 24
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
Strain 44/76-SL - Baseline
0
(0 to 14)
4
(0 to 21)
Strain 44/76-SL - Post-2nd Vaccination (N=25,23)
96
(80 to 100)
100
(85 to 100)
Strain 44/76-SL - Post-3rd Vaccination (N=24,24)
100
(86 to 100)
100
(86 to 100)
Strain 5/99 - Baseline
0
(0 to 14)
0
(0 to 14)
Strain 5/99 - Post-2nd Vaccination (N=25,23)
100
(86 to 100)
100
(85 to 100)
Strain 5/99 - Post-3rd Vaccination (N=24,24)
100
(86 to 100)
100
(86 to 100)
Strain NZ98/254 - Baseline
0
(0 to 14)
0
(0 to 14)
Strain NZ98/254 - Post-2nd Vaccination (N=24,22)
0
(0 to 14)
91
(71 to 99)
Strain NZ98/254 - Post-3rd Vaccination (N=22,24)
5
(0 to 23)
96
(79 to 100)
Strain UK P1.7-2,4 - Baseline (N=24,21)
0
(0 to 14)
0
(0 to 16)
Strain UKP1.7-2,4 - Post-2nd Vaccination (N=23,19)
0
(0 to 15)
84
(60 to 97)
Strain UKP1.7-2,4 - Post-3rd Vaccination (N=21,22)
0
(0 to 16)
95
(77 to 100)
Strain GB101 - Baseline (N=24,21)
0
(0 to 14)
10
(1 to 30)
Strain GB101 - Post-2nd Vaccination (N=22,21)
9
(1 to 29)
33
(15 to 57)
Strain GB101 - Post-3rd Vaccination (N=22,22)
14
(3 to 35)
45
(24 to 68)
Strain GB355 - Baseline (N=12,11)
0
(0 to 26)
0
(0 to 28)
Strain GB355 - Post-2nd Vaccination (N=11,14)
0
(0 to 28)
0
(0 to 23)
Strain GB355 - Post-3rd Vaccination (N=12,11)
0
(0 to 26)
0
(0 to 28)
Strain GB364 - Baseline (N=22,17)
0
(0 to 15)
0
(0 to 20)
Strain GB364 - Post-2nd Vaccination (N=19,16)
74
(49 to 91)
69
(41 to 89)
Strain GB364 - Post-3rd Vaccination (N=17,19)
71
(44 to 90)
84
(60 to 97)
3.Secondary Outcome
Title Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ
Hide Description Immunogenicity was measured as the percentage of subjects who achieved a four-fold increase in bactericidal titers against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).
Time Frame One month after second and third vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the per protocol (PP) population set.
Arm/Group Title rMenB rMenB+OMV
Hide Arm/Group Description:
6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
Overall Number of Participants Analyzed 25 24
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
Strain 44/76-SL - Post-2nd Vaccination (N=25,23)
96
(80 to 100)
100
(85 to 100)
Strain 44/76-SL - Post-3rd Vaccination (N=24,24)
100
(86 to 100)
100
(86 to 100)
Strain 5/99 - Post-2nd Vaccination (N=25,23)
100
(86 to 100)
100
(85 to 100)
Strain 5/99 - Post-3rd Vaccination
100
(86 to 100)
100
(86 to 100)
Strain NZ98/254 - Post-2nd Vaccination (N=24,22)
0
(0 to 14)
91
(71 to 99)
Strain NZ98/254 - Post-3rd Vaccination (N=22,24)
5
(0 to 23)
96
(79 to 100)
Strain UKP1.7-2,4 - Post-2nd Vaccination (N=22,17)
0
(0 to 15)
88
(64 to 99)
Strain UKP1.7-2,4 - Post-3rd Vaccination (N=20,20)
0
(0 to 17)
95
(75 to 100)
Strain GB101 - Post-2nd Vaccination (N=21,18)
10
(1 to 30)
22
(6 to 48)
Strain GB101 - Post-3rd Vaccination (N=21,19)
14
(3 to 36)
32
(13 to 57)
Strain GB355 - Post-2nd Vaccination (N=5,7)
0
(0 to 52)
0
(0 to 41)
Strain GB355 - Post-3rd Vaccination (N=7,6)
0
(0 to 41)
0
(0 to 46)
Strain GB364 - Post-2nd Vaccination (N=17,14)
76
(50 to 93)
64
(35 to 87)
Strain GB364 - Post-3rd Vaccination (N=15,15)
80
(52 to 96)
80
(52 to 96)
287-953proteinantigen-Post-2ndVaccination(N=25,23)
100
(86 to 100)
100
(85 to 100)
287-953proteinantigen-Post-3rdVaccination(N=24,25)
100
(86 to 100)
100
(86 to 100)
4.Secondary Outcome
Title Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ
Hide Description The immune response was measured as the geometric mean bactericidal titers directed against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), before vaccination (baseline) and one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).
Time Frame Baseline and one month after second and third vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the per protocol (PP) population set.
Arm/Group Title rMenB rMenB+OMV
Hide Arm/Group Description:
6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
Overall Number of Participants Analyzed 25 24
Geometric Mean (95% Confidence Interval)
Unit of Measure: Geometric mean titers
Strain 44/76-SL - Baseline
1.16
(0.89 to 1.52)
1.70
(1.29 to 2.24)
Strain 44/76-SL - Post-2nd Vaccination (N=25,23)
94
(66 to 134)
250
(173 to 361)
Strain 44/76-SL - Post-3rd Vaccination (N=24,24)
109
(79 to 153)
189
(136 to 263)
Strain 5/99 - Baseline
1.00
(0.94 to 1.07)
1.05
(0.98 to 1.12)
Strain 5/99 - Post-2nd Vaccination (N=25,23)
710
(532 to 947)
534
(395 to 721)
Strain 5/99 - Post-3rd Vaccination (N=24,24)
1202
(929 to 1555)
906
(700 to 1172)
Strain NZ98/254 - Baseline
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Strain NZ98/254 - Post-2nd Vaccination (N=24,22)
1.06
(0.82 to 1.38)
27
(21 to 36)
Strain NZ98/254 - Post-3rd Vaccination (N=22,24)
1.21
(0.86 to 1.72)
44
(32 to 62)
Strain UK P1.7-2,4 - Baseline (N=24,21)
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Strain UKP1.7-2,4 - Post-2nd Vaccination (N=23,19)
1.00
(0.75 to 1.34)
17
(12 to 24)
Strain UKP1.7-2,4 - Post-3rd Vaccination (N=21,22)
1.07
(0.72 to 1.58)
34
(23 to 50)
Strain GB101 - Baseline (N=24,21)
1.12
(0.81 to 1.56)
1.49
(1.05 to 2.11)
Strain GB101 - Post-2nd Vaccination (N=22,21)
1.82
(1.14 to 2.90)
4.56
(2.83 to 7.35)
Strain GB101 - Post-3rd Vaccination (N=22,22)
2.20
(1.14 to 4.23)
9.36
(4.87 to 18)
Strain GB355 - Baseline (N=12,11)
1.00
(1.00 to 1.00)
1.00
(1.00 to 1.00)
Strain GB355 - Post-2nd Vaccination (N=11,14)
1.00
(0.83 to 1.21)
1.16
(0.98 to 1.37)
Strain GB355 - Post-3rd Vaccination (N=12,11)
1.06
(0.82 to 1.36)
1.46
(1.12 to 1.90)
Strain GB364 - Baseline (N=22,17)
1.46
(1.19 to 1.79)
1.50
(1.19 to 1.90)
Strain GB364 - Post-2nd Vaccination (N=19,16)
11
(6.39 to 19)
12
(6.75 to 23)
Strain GB364 - Post-3rd Vaccination (N=17,19)
12
(6.17 to 22)
21
(11 to 37)
5.Secondary Outcome
Title Geometric Mean ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ
Hide Description The immune response was measured as the geometric mean concentrations (GMCs) against the meningococcal antigen 287-953, evaluated using enzyme-linked immunosorbent assay (ELISA), before vaccination (baseline) and one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).
Time Frame Baseline and one month after second and third vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the per protocol (PP) population set.
Arm/Group Title rMenB rMenB+OMV
Hide Arm/Group Description:
6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
Overall Number of Participants Analyzed 25 25
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
Antigen 287-953 - Baseline
24
(21 to 28)
21
(18 to 24)
Antigen 287-953 - Post-2nd Vaccination (N=25,23)
1759
(1331 to 2324)
2912
(2178 to 3894)
Antigen 287-953 - Post-3rd Vaccination (N=24,25)
2298
(1778 to 2970)
3521
(2739 to 4527)
6.Secondary Outcome
Title Percentage of Subjects With Four-fold Rise in ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ
Hide Description Immunogenicity was measured as the percentage of subjects who achieved a four-fold increase in ELISA geometric mean concentrations against meningococcal 287-953 antigen, one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).
Time Frame One month after second and third vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the per protocol (PP) population set.
Arm/Group Title rMenB rMenB+OMV
Hide Arm/Group Description:
6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
Overall Number of Participants Analyzed 25 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
Antigen 287-953 - Post-2nd Vaccination (N=25,23)
100
(86 to 100)
100
(85 to 100)
Antigen 287-953 - Post-3rd Vaccination (N=24,25)
100
(86 to 100)
100
(86 to 100)
7.Secondary Outcome
Title Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ
Hide Description Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 through day 7 after each vaccination of rMenB vaccine with and without OMV-NZ administered at 6-8 months (vaccination 1), 2 months later (vaccination 2) and at 12 months (vaccination 3).
Time Frame Day 1 through day 7 after each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the safety set, i.e. all subjects in the exposed population who provided post-baseline safety data.
Arm/Group Title rMenB rMenB+OMV
Hide Arm/Group Description:
6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
Overall Number of Participants Analyzed 30 30
Measure Type: Number
Unit of Measure: Number of subjects
Local reactions 29 29
Tenderness - Vaccination 1 4 9
Tenderness - Vaccination 2 (N=30,28) 5 11
Tenderness - Vaccination 3 (N=30,27) 12 10
Erythema - Vaccination 1 26 26
Erythema - Vaccination 2 (N=30,28) 22 25
Erythema - Vaccination 3 (N=30,27) 24 26
Induration - Vaccination 1 15 18
Induration - Vaccination 2 (N=30,28) 12 16
Induration - Vaccination 3 (N=30,27) 15 18
Swelling - Vaccination 1 4 11
Swelling - Vaccination 2 (N=30,28) 9 10
Swelling - Vaccination 3 (N=30,27) 11 9
Systemic reactions 22 28
Change in eating habits - Vaccination 1 (N=30,29) 6 8
Change in eating habits - Vaccination 2 (N=30,27) 1 7
Change in eating habits - Vaccination 3 (N=30,27) 8 5
Sleepiness - Vaccination 1 7 11
Sleepiness - Vaccination 2 (N=30,28) 7 8
Sleepiness - Vaccination 3 (N=30,27) 7 4
Vomiting - Vaccination 1 6 4
Vomiting - Vaccination 2 (N=30,28) 1 3
Vomiting - Vaccination 3 (N=30,27) 6 2
Diarrhea - Vaccination 1 2 5
Diarrhea - Vaccination 2 (N=30,28) 4 1
Diarrhea - Vaccination 3 (N=30,27) 5 5
Unusual crying - Vaccination 1 2 3
Unusual crying - Vaccination 2 (N=30,28) 2 2
Unusual crying - Vaccination 3 (N=30,27) 4 7
Irritability - Vaccination 1 14 14
Irritability - Vaccination 2 (N=30,28) 10 17
Irritability - Vaccination 3 (N=30,28) 13 18
Rash - Vaccination 1 3 3
Rash - Vaccination 2 (N=30,28) 5 4
Rash - Vaccination 3 (N=30,27) 5 4
Fever (≥38 °C) - Vaccination 1 1 3
Fever (≥38 °C) - Vaccination 2 (N=30,28) 2 3
Fever (≥38 °C) - Vaccination 3 (N=30,27) 4 1
Analg/Antipyr medications used - Vaccination 1 10 18
Analg/Antipyr medications used - Vaccination 2 12 17
Analg/Antipyr medications used - Vaccination 3 15 16
Time Frame Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title rMenB rMenB+OMV
Hide Arm/Group Description 6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age. 6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
All-Cause Mortality
rMenB rMenB+OMV
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
rMenB rMenB+OMV
Affected / at Risk (%) Affected / at Risk (%)
Total   5/30 (16.67%)   1/30 (3.33%) 
Infections and infestations     
Cellulitis * 1  1/30 (3.33%)  0/30 (0.00%) 
Croup infectious * 1  1/30 (3.33%)  0/30 (0.00%) 
Gastroenteritis * 1  1/30 (3.33%)  0/30 (0.00%) 
Localised infection * 1  1/30 (3.33%)  0/30 (0.00%) 
Nervous system disorders     
Febrile convulsion * 1  0/30 (0.00%)  1/30 (3.33%) 
Respiratory, thoracic and mediastinal disorders     
Wheezing * 1  1/30 (3.33%)  0/30 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (17.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
rMenB rMenB+OMV
Affected / at Risk (%) Affected / at Risk (%)
Total   30/30 (100.00%)   30/30 (100.00%) 
Gastrointestinal disorders     
Diarrhoea * 1  16/30 (53.33%)  13/30 (43.33%) 
Teething * 1  11/30 (36.67%)  13/30 (43.33%) 
Vomiting * 1  16/30 (53.33%)  10/30 (33.33%) 
General disorders     
Induration * 1  1/30 (3.33%)  4/30 (13.33%) 
Injection site erythema * 1  28/30 (93.33%)  28/30 (93.33%) 
Injection site swelling * 1  14/30 (46.67%)  17/30 (56.67%) 
Pyrexia * 1  7/30 (23.33%)  6/30 (20.00%) 
Swelling * 1  0/30 (0.00%)  3/30 (10.00%) 
Crying * 1  5/30 (16.67%)  10/30 (33.33%) 
Injection site pain * 1  13/30 (43.33%)  18/30 (60.00%) 
vaccination site erythema * 1  2/30 (6.67%)  0/30 (0.00%) 
Injection site induration * 1  20/30 (66.67%)  26/30 (86.67%) 
Infections and infestations     
Conjunctivitis * 1  1/30 (3.33%)  5/30 (16.67%) 
Gastroenteritis * 1  0/30 (0.00%)  4/30 (13.33%) 
Lower respiratory tract infection * 1  2/30 (6.67%)  3/30 (10.00%) 
Nasopharyngitis * 1  1/30 (3.33%)  3/30 (10.00%) 
Otitis media * 1  2/30 (6.67%)  1/30 (3.33%) 
Rhinitis * 1  5/30 (16.67%)  3/30 (10.00%) 
Tonsilitis * 1  1/30 (3.33%)  2/30 (6.67%) 
Upper respiratory tract infection * 1  0/30 (0.00%)  2/30 (6.67%) 
Varicella * 1  2/30 (6.67%)  0/30 (0.00%) 
Viral rash * 1  2/30 (6.67%)  2/30 (6.67%) 
Viral upper respiratory tract infection * 1  4/30 (13.33%)  0/30 (0.00%) 
Nervous system disorders     
Somnolence * 1  14/30 (46.67%)  16/30 (53.33%) 
Psychiatric disorders     
Irritability * 1  18/30 (60.00%)  25/30 (83.33%) 
Eating disorder * 1  13/30 (43.33%)  14/30 (46.67%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  3/30 (10.00%)  6/30 (20.00%) 
Rhinorrhoea * 1  2/30 (6.67%)  1/30 (3.33%) 
Skin and subcutaneous tissue disorders     
Eczema * 1  1/30 (3.33%)  2/30 (6.67%) 
Erythema * 1  1/30 (3.33%)  4/30 (13.33%) 
Rash * 1  8/30 (26.67%)  9/30 (30.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (17.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
Layout table for Results Point of Contact information
Name/Title: Posting Director
Organization: Novartis Vaccines and Diagnostics
EMail: RegistryContactVaccinesUS@novartis.com
Layout table for additonal information
Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00433914     History of Changes
Other Study ID Numbers: V72P9
Eudract Number: 2006-005589-38
First Submitted: February 9, 2007
First Posted: February 12, 2007
Results First Submitted: February 18, 2015
Results First Posted: March 6, 2015
Last Update Posted: March 6, 2015