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Evaluation of Meningococcal Immune Response Among Children Who Previously Received MenACWY Conjugate Vaccine

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ClinicalTrials.gov Identifier: NCT01148017
Recruitment Status : Completed
First Posted : June 22, 2010
Results First Posted : May 14, 2014
Last Update Posted : August 14, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Meningococcal Meningitis
Intervention Biological: Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine
Enrollment 433
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ACWY - 4 ACWY - 2 Naïve - 40 Naïve - 60
Hide Arm/Group Description Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age. Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age. Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM. Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
Period Title: Overall Study
Started 214 121 53 45
Completed 134 87 53 45
Not Completed 80 34 0 0
Reason Not Completed
Withdrawal by Subject             31             14             0             0
Lost to Follow-up             23             10             0             0
Inappropriate enrollment             1             0             0             0
Administrative reason             22             9             0             0
Unable to classify             3             1             0             0
Arm/Group Title ACWY - 4 ACWY - 2 Naïve - 40 Naïve - 60 Total
Hide Arm/Group Description Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age. Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age. Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM. Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM. Total of all reporting groups
Overall Number of Baseline Participants 214 121 53 45 433
Hide Baseline Analysis Population Description
Analysis was done on the all enrolled population, ie, all subjects who had signed an informed consent, undergone screening procedures, and were enrolled.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 214 participants 121 participants 53 participants 45 participants 433 participants
40 months enrollment (N=210, 119, 53, 382) 39.2  (1.8) 39.3  (1.7) 38.7  (1.8) NA [1]   (NA) 39.2  (1.8)
60 months enrollment (N=136, 89, 45, 270) 59.7  (2.2) 59.6  (2.4) NA [2]   (NA) 60  (1.7) 59.7  (2.2)
[1]
Subjects in this group were enrolled at 60 months of age.
[2]
Subjects in this group were enrolled at 40 months of age.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 214 participants 121 participants 53 participants 45 participants 433 participants
Female
97
  45.3%
55
  45.5%
29
  54.7%
26
  57.8%
207
  47.8%
Male
117
  54.7%
66
  54.5%
24
  45.3%
19
  42.2%
226
  52.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 214 participants 121 participants 53 participants 45 participants 433 participants
214 121 53 45 433
1.Primary Outcome
Title Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 1:8 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y
Hide Description The persistence of the antibody response in subjects of 40 months of age, previously vaccinated with MenACWY-CRM in the parent study, and baseline antibody levels in age-matched naive subjects, is measured by the percentage of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:8 directed against N. meningitidis serogroups A, C, W-135, and Y.
Time Frame Visit 9 (continuation from the parent study), 40-month visit.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the Per Protocol Set 40-month persistence (PPS 40-month persistence), ie, all subjects in the enrolled population who provided an evaluable serum sample at the 40-months of age visit and had no major protocol deviation.
Arm/Group Title ACWY - 4 ACWY - 2 Naïve - 40
Hide Arm/Group Description:
Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.
Overall Number of Participants Analyzed 206 117 51
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
Men A
10
(6 to 15)
35
(26 to 44)
2
(0.05 to 10)
Men C (N=206, 116, 51)
34
(28 to 41)
51
(41 to 60)
12
(4 to 24)
Men W-135 (N=204, 115, 51)
76
(70 to 82)
83
(74 to 89)
47
(33 to 62)
Men Y (N=205, 116, 51)
67
(60 to 73)
71
(62 to 79)
22
(11 to 35)
2.Primary Outcome
Title Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 1:8 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y
Hide Description The persistence of the antibody response in subjects of 60 months of age previously vaccinated with MenACWY-CRM in the parent study, and baseline antibody levels in age-matched naive subjects, is measured by the percentages of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:8 directed against N. meningitidis serogroups A, C, W-135, and Y.
Time Frame Visit 10, 60 months of age
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the Per Protocol Set 60-Month persistence (PPS 60-Month persistence), ie, all subjects in the enrolled population who provided an evaluable serum sample at the 60-month of age visit and had no major protocol deviation.
Arm/Group Title ACWY - 4 ACWY - 2 Naïve - 60
Hide Arm/Group Description:
Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
Overall Number of Participants Analyzed 123 80 45
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
Men A
6
(2 to 11)
25
(16 to 36)
2
(0.056 to 12)
Men C
27
(19 to 36)
43
(32 to 54)
22
(11 to 37)
Men W-135 (N=121, 78, 45)
69
(60 to 77)
74
(63 to 84)
40
(26 to 56)
Men Y (N=122, 80, 44)
56
(46 to 65)
69
(57 to 79)
25
(13 to 40)
3.Secondary Outcome
Title Percentages of Subjects With hSBA Titers ≥ 1:4 Against N Meningitidis Serogroups A, C, W-135, and Y in Subjects of 40 Months of Age
Hide Description The persistence of the antibody response in subjects of 40 months of age previously vaccinated with MenACWY-CRM in the parent study, and baseline antibody levels in age-matched naive subjects, is measured by the percentage of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:4 directed against N. meningitidis serogroups A, C, W-135, and Y.
Time Frame Visit 9, 40 months of age.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the PPS 40-month persistence.
Arm/Group Title ACWY - 4 ACWY - 2 Naïve - 40
Hide Arm/Group Description:
Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.
Overall Number of Participants Analyzed 206 117 51
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
Men A
13
(9 to 18)
40
(31 to 50)
2
(0.05 to 10)
Men C (N=206, 116, 51)
43
(36 to 50)
61
(52 to 70)
16
(7 to 29)
Men W-135 (N=204, 115, 51)
81
(75 to 86)
88
(80 to 93)
49
(35 to 63)
Men Y (N=205, 116, 51)
76
(69 to 81)
80
(72 to 87)
24
(13 to 37)
4.Secondary Outcome
Title Percentages of Subjects With hSBA Titers ≥ 1:4 Against N Meningitidis Serogroups A, C, W-135, and Y Subjects of 60 Months of Age
Hide Description The persistence of the antibody response in subjects of 60 months of age previously vaccinated with MenACWY-CRM in the parent study, and baseline antibody levels in age-matched naive subjects, is measured by the percentage of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:4 directed against N. meningitidis serogroups A, C, W-135, and Y.
Time Frame Visit 10, 60 months of age.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the PPS 60-Month persistence.
Arm/Group Title ACWY - 4 ACWY - 2 Naïve - 60
Hide Arm/Group Description:
Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
Overall Number of Participants Analyzed 123 80 45
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
Men A
9
(5 to 15)
33
(22 to 44)
2
(0.056 to 12)
Men C
46
(37 to 55)
60
(48 to 71)
33
(20 to 49)
Men W-135 (N=121, 78, 45)
74
(66 to 82)
83
(73 to 91)
42
(28 to 58)
Men Y (N=122, 80, 44)
65
(56 to 73)
74
(63 to 83)
25
(13 to 40)
5.Secondary Outcome
Title hSBA Geometric Mean Titers (GMTs) Directed Against N. Meningitidis Serogroups A, C, W-135, and Y in Subjects of 40 Months of Age
Hide Description The persistence of the antibody response in children of 40 months of age previously vaccinated with MenACWY-CRM in study V59P14 (NCT00474526), and baseline antibody levels in age-matched naive subjects, is measured by the hSBA GMTs directed against N meningitidis serogroups A, C, W-135, and Y.
Time Frame Visit 9 (continuation from the parent study), 40-months of age.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the PPS 40-month persistence.
Arm/Group Title ACWY - 4 ACWY - 2 Naïve - 40
Hide Arm/Group Description:
Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.
Overall Number of Participants Analyzed 206 117 51
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Men A
2.54
(2.23 to 2.9)
4.81
(4.06 to 5.69)
2.02
(1.57 to 2.61)
Men C (N=206, 116, 51)
6.14
(4.98 to 7.59)
9.24
(7.05 to 12)
2.52
(1.68 to 3.78)
Men W-135 (N=204, 115, 51)
26
(21 to 32)
29
(22 to 39)
8.25
(5.47 to 12)
Men Y (N=205, 116, 51)
16
(13 to 20)
18
(14 to 24)
3.69
(2.44 to 5.57)
6.Secondary Outcome
Title hSBA GMTs Directed Against N Meningitidis Serogroups A, C, W-135, and Y in Subjects of 60 Months of Age
Hide Description The persistence of the antibody response in children of 60 months of age previously vaccinated with MenACWY-CRM in study V59P14 (NCT00474526), and baseline antibody levels in age-matched naive subjects is measured by the hSBA GMTs directed against N meningitidis serogroups A, C, W-135, and Y.
Time Frame Visit 10, 60 months of age.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the PPS 60-Month persistence.
Arm/Group Title ACWY - 4 ACWY - 2 Naïve - 60
Hide Arm/Group Description:
Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
Overall Number of Participants Analyzed 123 80 45
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Men A
2.27
(1.95 to 2.63)
3.74
(3.12 to 4.48)
2.14
(1.68 to 2.74)
Men C
5.17
(3.96 to 6.75)
9.26
(6.71 to 13)
3.87
(2.5 to 5.98)
Men W-135 (N=121, 78, 45)
17
(13 to 22)
20
(14 to 28)
6.63
(4.25 to 10)
Men Y (N=122, 80, 44)
11
(8.1 to 14)
14
(9.94 to 19)
4.1
(2.61 to 6.45)
7.Secondary Outcome
Title Percentages of Subjects With hSBA Titers ≥ 1:8, and ≥ 1:4 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y, at 1 Month Post-vaccination
Hide Description The antibody response to one booster dose of MenACWY-CRM in children of 60 months of age who had previously received at least one dose of MenACWY-CRM in the parent study compared to the antibody response to one dose of MenACWY-CRM in meningococcal vaccine-naïve subjects, is measured by the percentage of subjects with hSBA titers ≥ 1:8 and ≥1:4 directed against N. meningitidis serogroups A, C, W-135, and Y, at 1 month post-vaccination.
Time Frame Visit 11, 1 month after vaccination.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the PPS-Immunogenicity after one dose of MenACWY-CRM (PPS Post-MenACWY-CRM), ie, all subjects in the enrolled population who correctly received the vaccine, provided at least one evaluable serum sample at the relevant time points and whose assay result was available for at least one serogroup with no major protocol deviation.
Arm/Group Title ACWY - 4 ACWY - 2 Naïve - 60
Hide Arm/Group Description:
Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
Overall Number of Participants Analyzed 116 76 45
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
Men A (≥1:8)
97
(91 to 99)
97
(91 to 100)
87
(73 to 95)
Men C (≥1:8; N=115, 75, 45)
96
(90 to 99)
99
(93 to 100)
84
(71 to 94)
Men W-135 (≥1:8; N=104, 70, 44)
100
(97 to 100)
100
(95 to 100)
89
(75 to 96)
Men Y (≥1:8; N=111, 74, 44)
100
(97 to 100)
100
(95 to 100)
73
(57 to 85)
Men A (≥1:4)
97
(91 to 99)
97
(91 to 100)
89
(76 to 96)
Men C (≥1:4; N=115, 75, 45)
97
(93 to 99)
100
(95 to 100)
87
(73 to 95)
Men W-135 (≥1:4; N=104, 70, 44)
100
(97 to 100)
100
(95 to 100)
91
(78 to 97)
Men Y (≥1:4; N=111, 74, 44)
100
(97 to 100)
100
(95 to 100)
80
(65 to 90)
8.Secondary Outcome
Title Percentage of Subjects With Seroresponse at 1 Month Post-vaccination
Hide Description

The antibody response to one booster dose of MenACWY-CRM in children of 60 months of age who had previously received at least one dose of MenACWY-CRM in the parent study, compared to the antibody response to one dose of MenACWY-CRM in meningococcal vaccine-naïve subjects, is measured by the percentage of subjects with seroresponse at 1 month post-vaccination.

Seroresponse is defined as hSBA ≥ 1:8 for subjects with pre-vaccination hSBA titer ≤1:4, and as at least a four-fold rise in hSBA for subjects with pre-vaccination hSBA titer ≥ 1:4.

Time Frame Visit 11, 1 month after vaccination.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the PPS Post-MenACWY-CRM.
Arm/Group Title ACWY - 4 ACWY - 2 Naïve - 60
Hide Arm/Group Description:
Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
Overall Number of Participants Analyzed 116 76 45
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
Men A
97
(91 to 99)
96
(89 to 99)
87
(73 to 95)
Men C (N=115, 75, 45)
87
(79 to 93)
87
(77 to 93)
73
(58 to 85)
Men W-135 (N=104, 70, 44)
99
(95 to 100)
100
(95 to 100)
57
(41 to 72)
Men Y (N=111, 74, 44)
98
(94 to 100)
99
(93 to 100)
52
(37 to 68)
9.Secondary Outcome
Title Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity
Hide Description

Number of subjects reporting solicited local and systemic Adverse Events (AEs) and other indicators of reactogenicity after receiving study vaccination.

Note: solicited AEs were not recorded for naive subjects at 40 months of age, but only SAEs and medically attended AEs.

Time Frame From day 1 to 7 after vaccination.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the Solicited Safety Set (from 6 hours to day 7), ie, all subjects who received a vaccination at 60 months and provided postvaccination solicited safety data.
Arm/Group Title ACWY - 4 ACWY - 2 Naïve - 60
Hide Arm/Group Description:
Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
Overall Number of Participants Analyzed 129 83 49
Measure Type: Number
Unit of Measure: Subjects
Any local 67 44 29
Injection site pain 54 33 24
Injection site erythema 26 20 13
Injection site induration 18 14 10
Any systemic 45 26 23
Change in eating habits 14 5 4
Sleepiness 20 9 7
Irritability 24 14 8
Vomiting 4 0 3
Diarrhea 7 1 1
Arthralgia 2 4 0
Headache 6 6 2
Rash 4 2 3
Fever 4 2 2
Any other 18 11 7
Stayed home due to reaction 5 0 0
Use of analgesics/antipyretics 18 11 7
10.Secondary Outcome
Title Number of Subjects Reporting Unsolicited AEs and SAEs
Hide Description Number of subjects reporting unsolicited AEs, serious adverse events (SAEs) and medically attended AEs after receiving study vaccination.
Time Frame Day 1 to 7 after vaccination for any unsolicited AEs, day 1 to study termination for SAEs and medically attended AEs (for the naive-40 group), day 8 to study termination for SAEs and medically attended AEs (for the other groups).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the Post MenACWY at 60 months safety set ie, all subjects who received a vaccination at 60 months and were assessed for postvaccination safety, and on the Post MenACWY at 40 Months Safety Set, ie, the Naive subjects enrolled at 40 months of age who received vaccination at 40 months and were assessed for post vaccination safety.
Arm/Group Title ACWY - 4 ACWY - 2 Naïve - 40 Naïve - 60
Hide Arm/Group Description:
Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.
Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
Overall Number of Participants Analyzed 132 87 11 50
Measure Type: Number
Unit of Measure: Number of subjects
Any unsolicited AE 7 8 NA [1]  12
Medically attended AEs 0 0 27 0
Any SAE 0 0 0 0
[1]
Unsolicited AEs were not recorded for this group.
Time Frame Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Adverse Event Reporting Description Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
 
Arm/Group Title ACWY - 4 ACWY - 2 Naïve - 40 Naïve - 60
Hide Arm/Group Description Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age. Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age. Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM. Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
All-Cause Mortality
ACWY - 4 ACWY - 2 Naïve - 40 Naïve - 60
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ACWY - 4 ACWY - 2 Naïve - 40 Naïve - 60
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/132 (0.00%)   0/87 (0.00%)   0/11 (0.00%)   0/50 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ACWY - 4 ACWY - 2 Naïve - 40 Naïve - 60
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   86/132 (65.15%)   57/87 (65.52%)   3/11 (27.27%)   39/50 (78.00%) 
Eye disorders         
Conjunctivitis * 1  0/132 (0.00%)  1/87 (1.15%)  0/11 (0.00%)  4/50 (8.00%) 
Gastrointestinal disorders         
Diarrhoea  1  7/132 (5.30%)  2/87 (2.30%)  0/11 (0.00%)  1/50 (2.00%) 
Vomiting  1  4/132 (3.03%)  0/87 (0.00%)  0/11 (0.00%)  3/50 (6.00%) 
General disorders         
Injection site erythema  1  26/132 (19.70%)  22/87 (25.29%)  0/11 (0.00%)  13/50 (26.00%) 
Injection site induration  1  21/132 (15.91%)  15/87 (17.24%)  0/11 (0.00%)  11/50 (22.00%) 
Injection site pain  1  59/132 (44.70%)  37/87 (42.53%)  0/11 (0.00%)  24/50 (48.00%) 
Irritability  1  24/132 (18.18%)  14/87 (16.09%)  0/11 (0.00%)  9/50 (18.00%) 
Infections and infestations         
Otitis media acute * 1  1/132 (0.76%)  0/87 (0.00%)  1/11 (9.09%)  0/50 (0.00%) 
Upper respiratory tract infection * 1  0/132 (0.00%)  0/87 (0.00%)  1/11 (9.09%)  2/50 (4.00%) 
Viral pharyngitis * 1  0/132 (0.00%)  0/87 (0.00%)  1/11 (9.09%)  0/50 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  2/132 (1.52%)  4/87 (4.60%)  1/11 (9.09%)  1/50 (2.00%) 
Nervous system disorders         
Headache  1  6/132 (4.55%)  7/87 (8.05%)  0/11 (0.00%)  2/50 (4.00%) 
Somnolence  1  21/132 (15.91%)  9/87 (10.34%)  0/11 (0.00%)  7/50 (14.00%) 
Psychiatric disorders         
Eating disorders  1  14/132 (10.61%)  5/87 (5.75%)  0/11 (0.00%)  4/50 (8.00%) 
Skin and subcutaneous tissue disorders         
Ingrown nail * 1  0/132 (0.00%)  0/87 (0.00%)  1/11 (9.09%)  0/50 (0.00%) 
Rash * 1  4/132 (3.03%)  2/87 (2.30%)  0/11 (0.00%)  3/50 (6.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
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
Name/Title: Posting Director
Organization: Novartis Vaccines
Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01148017     History of Changes
Other Study ID Numbers: V59P14E1
First Submitted: June 16, 2010
First Posted: June 22, 2010
Results First Submitted: April 15, 2014
Results First Posted: May 14, 2014
Last Update Posted: August 14, 2017