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Trial record 3 of 43 for:    Vaccine | Studies With Results | Interventional Studies | Saline | Phase 3

A Multi-center, Observer-blind, Placebo-controlled, Randomized Study to Evaluate the Immunogenicity and Safety of MenACWY in Adolescents and Adults in Korea

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ClinicalTrials.gov Identifier: NCT01274897
Recruitment Status : Completed
First Posted : January 12, 2011
Results First Posted : October 16, 2012
Last Update Posted : October 16, 2012
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Meningococcal Disease
Meningococcal Meningitis
Interventions Biological: Novartis MenACWY-CRM
Biological: Saline Placebo
Enrollment 450
Recruitment Details Participants were enrolled at 8 centres in the Korea.
Pre-assignment Details All enrolled subjects were included in the trial.
Arm/Group Title MenACWY-CRM Placebo
Hide Arm/Group Description Subjects received one dose of MenACWY-CRM conjugate vaccine. Subjects received the saline placebo.
Period Title: Overall Study
Started 297 153
Completed 297 153
Not Completed 0 0
Arm/Group Title MenACWY-CRM Placebo Total
Hide Arm/Group Description Subjects received one dose of MenACWY-CRM conjugate vaccine. Subjects received the saline placebo. Total of all reporting groups
Overall Number of Baseline Participants 297 153 450
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Age, Years Number Analyzed 297 participants 153 participants 450 participants
19.6  (9.2) 19.3  (8.9) 19.5  (9.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 297 participants 153 participants 450 participants
Female
139
  46.8%
77
  50.3%
216
  48.0%
Male
158
  53.2%
76
  49.7%
234
  52.0%
1.Primary Outcome
Title Percentages of Subjects With Seroresponse, Directed Against Neisseria Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination.
Hide Description

Immunogenicity was measured as the percentage of subjects with hSBA response and associated 95% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y by serum bactericidal assay using human complement, human serum bactericidal assay (hSBA), at day 29 (28 days after MenACWY-CRM vaccination).

Seroresponse is defined as:

  1. for subjects with a pre-vaccination hSBA titer < 1:4, a postvaccination hSBA titer ≥ 1:8.
  2. for subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the pre-vaccination titer.
Time Frame day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on per protocol (PP) population i.e. the subjects who received the vaccine correctly and provided evaluable serum samples at the relevant time points.
Arm/Group Title MenACWY-CRM Placebo
Hide Arm/Group Description:
Subjects received one dose of MenACWY-CRM conjugate vaccine.
Subjects received the saline placebo.
Overall Number of Participants Analyzed 296 152
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
Serogroup A (N=295,152)
76
(71 to 81)
1
(0 to 5)
Serogroup C (N=293,150)
86
(82 to 90)
1
(0 to 5)
Serogroup W (N=293,151)
28
(23 to 33)
4
(1 to 8)
Serogroup Y (N=294,152)
69
(63 to 74)
2
(0 to 6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MenACWY-CRM
Comments The null hypothesis associated with the primary immunogenicity objective is that for at least one of the four serogroups, the percentage of subjects with hSBA seroresponse at 29 days postvaccination is < 50%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments The immune response considered sufficient if for serogroup A the lower limit of the two-sided 95% Clopper-Pearson confidence interval (CI) of the percentage of subjects with hSBA seroresponse is ≥50%.
Method Clopper and Pearson
Comments [Not Specified]
Method of Estimation Estimation Parameter Lower limit of the two-sided 95% CI
Estimated Value 71
Confidence Interval (2-Sided) 95%
71 to 81
Estimation Comments For serogroup A.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MenACWY-CRM
Comments The null hypothesis associated with the primary immunogenicity objective is that for at least one of the four serogroups, the percentage of subjects with hSBA seroresponse at 29 days postvaccination is < 50%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments The immune response was considered sufficient if for serogroup C, the lower limit of the two-sided 95% CI of the percentage of subjects with hSBA seroresponse was ≥50%.
Method Clopper and Pearson
Comments [Not Specified]
Method of Estimation Estimation Parameter Lower limit of the two-sided 95% CI
Estimated Value 82
Confidence Interval (2-Sided) 95%
82 to 90
Estimation Comments For the serogroup C
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MenACWY-CRM
Comments The null hypothesis associated with the primary immunogenicity objective is that for at least one of the four serogroups, the percentage of subjects with hSBA seroresponse at 29 days postvaccination is < 50%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments The immune response was considered sufficient if for serogroup W, the lower limit of the two-sided 95% CI of the percentage of subjects with hSBA seroresponse was ≥50%.
Method Clopper and Pearson
Comments [Not Specified]
Method of Estimation Estimation Parameter Lower limit of the two-sided 95% CI
Estimated Value 23
Confidence Interval (2-Sided) 95%
23 to 33
Estimation Comments For the serogroup W
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MenACWY-CRM
Comments The null hypothesis associated with the primary immunogenicity objective is that for at least one of the four serogroups, the percentage of subjects with hSBA seroresponse at 29 days postvaccination is < 50%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments The immune response was considered sufficient if for serogroup Y, the lower limit of the two-sided 95% CI of the percentage of subjects with hSBA seroresponse was ≥50%.
Method Clopper and Pearson
Comments [Not Specified]
Method of Estimation Estimation Parameter Lower limit of the two-sided 95% CI
Estimated Value 63
Confidence Interval (2-Sided) 95%
63 to 74
Estimation Comments For serogroup Y
2.Secondary Outcome
Title Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination.
Hide Description Immunogenicity was assessed as hSBA GMTs and associated 95% CI, measured against N. meningitidis serogroups A, C, W and Y, before the vaccination (baseline, day 1) and at day 29 (28 days after MenACWY-CRM vaccination).
Time Frame day 1 and day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on PP population.
Arm/Group Title MenACWY-CRM Placebo
Hide Arm/Group Description:
Subjects received one dose of MenACWY-CRM conjugate vaccine.
Subjects received the saline placebo.
Overall Number of Participants Analyzed 296 152
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Serogroup A at Day 1 (N=295,152)
2.7
(2.47 to 2.95)
2.86
(2.53 to 3.24)
Serogroup A at Day 29 (N=295,152)
48
(39 to 57)
3
(2.31 to 3.88)
Serogroup C at Day 1 (N=293,150)
7.82
(6.76 to 9.05)
5.94
(4.85 to 7.27)
Serogroup C at Day 29 (N=293,150)
231
(198 to 269)
6.04
(4.89 to 7.47)
Serogroup W at Day 1 (N=293,151)
51
(44 to 61)
48
(38 to 60)
Serogroup W at Day 29 (N=293,151)
147
(125 to 171)
47
(38 to 58)
Serogroup Y at Day 1 (N=294,152)
9.01
(7.64 to 11)
8.82
(7.02 to 11)
Serogroup Y at Day 29 (N=294,152)
107
(89 to 128)
8.4
(6.54 to 11)
3.Secondary Outcome
Title Percentages of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination.
Hide Description Immunogenicity was measured as the percentage of subjects with hSBA titer ≥1:8 and associated 95% CI, at baseline before vaccination (day 1) and at day 29 (28 days after MenACWY-CRM vaccination).
Time Frame day 1 and day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on PP population.
Arm/Group Title MenACWY-CRM Placebo
Hide Arm/Group Description:
Subjects received one dose of MenACWY-CRM conjugate vaccine.
Subjects received the saline placebo.
Overall Number of Participants Analyzed 296 152
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
Serogroup A at Day 1 (N=295,152)
13
(9 to 17)
15
(10 to 22)
Serogroup A at Day 29 (N=295,152)
79
(74 to 84)
16
(10 to 23)
Serogroup C at Day 1 (N=293,150)
49
(44 to 55)
39
(31 to 47)
Serogroup C at Day 29 (N=293,150)
99
(97 to 100)
37
(30 to 46)
Serogroup W at Day 1 (N=293,151)
89
(85 to 92)
87
(80 to 92)
Serogroup W at Day 29 (N=293,151)
98
(96 to 99)
88
(82 to 93)
Serogroup Y at Day 1 (N=294,152)
54
(48 to 60)
53
(44 to 61)
Serogroup Y at Day 29 (N=294,152)
94
(91 to 97)
51
(42 to 59)
4.Secondary Outcome
Title Number of Subjects Who Reported Local and Systemic Reactogenicity During 7 Days After MenACWY-CRM Vaccination
Hide Description [Not Specified]
Time Frame during 7 days of vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on safety population i.e. the subjects in the exposed population who provided post-baseline safety data.
Arm/Group Title MenACWY-CRM Placebo
Hide Arm/Group Description:
Subjects received one dose of MenACWY-CRM conjugate vaccine.
Subjects received the saline placebo.
Overall Number of Participants Analyzed 297 153
Measure Type: Number
Unit of Measure: Subjects
Injection site pain 69 12
Injection site erythema 30 3
Injection site induration 30 0
Chills 17 7
Nausea 22 10
Myalgia 45 13
Arthralgia 6 4
Headache 39 25
Rash 1 0
Fever (≥38°C) 3 1
Axillary temperature (<38.0°C) 294 152
Stayed home 9 2
Used analgesic or antipyretic medicines 7 3
Time Frame Throughout the study period (29 days)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MenACWY-CRM Placebo
Hide Arm/Group Description Subjects received one dose of MenACWY-CRM conjugate vaccine. Subjects received the saline placebo.
All-Cause Mortality
MenACWY-CRM Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
MenACWY-CRM Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/297 (0.00%)      0/153 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MenACWY-CRM Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   117/297 (39.39%)      50/153 (32.68%)    
Gastrointestinal disorders     
Nausea  1  22/297 (7.41%)  22 10/153 (6.54%)  10
General disorders     
Chills  1  17/297 (5.72%)  17 7/153 (4.58%)  7
Injection site erythema  1  30/297 (10.10%)  30 3/153 (1.96%)  3
Injection site induration  1  30/297 (10.10%)  30 0/153 (0.00%)  0
Injection site pain  1  69/297 (23.23%)  69 12/153 (7.84%)  12
Malaise  1  21/297 (7.07%)  21 9/153 (5.88%)  9
Musculoskeletal and connective tissue disorders     
Myalgia  1  46/297 (15.49%)  46 13/153 (8.50%)  13
Nervous system disorders     
Headache  1  39/297 (13.13%)  39 25/153 (16.34%)  25
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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
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: NCT01274897    
Other Study ID Numbers: V59_39
First Submitted: January 9, 2011
First Posted: January 12, 2011
Results First Submitted: March 13, 2012
Results First Posted: October 16, 2012
Last Update Posted: October 16, 2012