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Study of a Single Dose of Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine (SP284) in Japanese Subjects

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ClinicalTrials.gov Identifier: NCT01519713
Recruitment Status : Completed
First Posted : January 27, 2012
Results First Posted : May 28, 2013
Last Update Posted : May 28, 2013
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Meningitis
Meningococcal Meningitis
Meningococcal Infections
Intervention Biological: Meningococcal polysaccharide diphtheria toxoid conjugate
Enrollment 200
Recruitment Details Study participants were enrolled from 20 January through 25 February 2012 in 4 clinic sites in Japan.
Pre-assignment Details A total of 200 subjects who met the inclusion, but no exclusion criteria were enrolled and vaccinated.
Arm/Group Title Adults Menactra® Vaccine Group Adolescents Menactra® Vaccine Group Children Menactra® Vaccine Group
Hide Arm/Group Description Participants aged 18 to 55 years received a single dose of Menactra® vaccine Participants aged 11 to 17 years received a single dose of Menactra® vaccine Participants aged 2 to 10 years received a single dose of Menactra® vaccine
Period Title: Overall Study
Started 194 2 4
Completed 194 2 4
Not Completed 0 0 0
Arm/Group Title Adults Menactra® Vaccine Group Adolescents Menactra® Vaccine Group Children Menactra® Vaccine Group Total
Hide Arm/Group Description Participants aged 18 to 55 years received a single dose of Menactra® vaccine Participants aged 11 to 17 years received a single dose of Menactra® vaccine Participants aged 2 to 10 years received a single dose of Menactra® vaccine Total of all reporting groups
Overall Number of Baseline Participants 194 2 4 200
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 194 participants 2 participants 4 participants 200 participants
<=18 years
0
   0.0%
2
 100.0%
4
 100.0%
6
   3.0%
Between 18 and 65 years
194
 100.0%
0
   0.0%
0
   0.0%
194
  97.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 194 participants 2 participants 4 participants 200 participants
35.6  (11.2) 11.0  (0.0) 4.3  (2.6) 34.7  (12.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 194 participants 2 participants 4 participants 200 participants
Female
97
  50.0%
0
   0.0%
2
  50.0%
99
  49.5%
Male
97
  50.0%
2
 100.0%
2
  50.0%
101
  50.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 194 participants 2 participants 4 participants 200 participants
194 2 4 200
1.Primary Outcome
Title Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:128 Following Vaccination With One Dose of Menactra® Vaccine
Hide Description Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR). Sero protection was defined as SBA-BR titer of ≥ 1:128.
Time Frame 28 Days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined in all enrolled and vaccinated participants, per-protocol population.
Arm/Group Title Adults Menactra® Vaccine Group Adolescents Menactra® Vaccine Group Children Menactra® Vaccine Group
Hide Arm/Group Description:
Participants aged 18 to 55 years received a single dose of Menactra® vaccine
Participants aged 11 to 17 years received a single dose of Menactra® vaccine
Participants aged 2 to 10 years received a single dose of Menactra® vaccine
Overall Number of Participants Analyzed 194 2 4
Measure Type: Number
Unit of Measure: Participants
Serogroup A (N = 194, 2, 4) 177 2 4
Serogroup C (N = 192, 2, 4) 154 2 4
Serogroup Y (N = 192, 2, 4) 180 2 4
Serogroup W-135 (N = 193, 2, 4) 172 2 4
2.Secondary Outcome
Title Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:8 Following Vaccination With One Dose of Menactra® Vaccine
Hide Description Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR).
Time Frame 28 Days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined in all enrolled and vaccinated participants, per-protocol population.
Arm/Group Title Adults Menactra® Vaccine Group Adolescents Menactra® Vaccine Group Children Menactra® Vaccine Group
Hide Arm/Group Description:
Participants aged 18 to 55 years received a single dose of Menactra® vaccine
Participants aged 11 to 17 years received a single dose of Menactra® vaccine
Participants aged 2 to 10 years received a single dose of Menactra® vaccine
Overall Number of Participants Analyzed 194 2 4
Measure Type: Number
Unit of Measure: Participants
Serogroup A (N = 194, 2, 4) 180 2 4
Serogroup C (N = 192, 2, 4) 167 2 4
Serogroup Y (N = 192, 2, 4) 190 2 4
Serogroup W-135 (N = 193, 2, 4) 186 2 4
3.Secondary Outcome
Title Number of Participants With a 4-Fold Rise in Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers on Day 28 From Day 0 Following Vaccination With One Dose of Menactra® Vaccine.
Hide Description Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR).
Time Frame 28 Days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined in all enrolled and vaccinated participants, per-protocol population.
Arm/Group Title Adults Menactra® Vaccine Group Adolescents Menactra® Vaccine Group Children Menactra® Vaccine Group
Hide Arm/Group Description:
Participants aged 18 to 55 years received a single dose of Menactra® vaccine
Participants aged 11 to 17 years received a single dose of Menactra® vaccine
Participants aged 2 to 10 years received a single dose of Menactra® vaccine
Overall Number of Participants Analyzed 194 2 4
Measure Type: Number
Unit of Measure: Participants
Serogroup A (N = 193, 2, 4) 150 2 4
Serogroup C (N = 191, 2, 4) 151 2 3
Serogroup Y (N = 191, 2, 4) 139 1 4
Serogroup W-135 (N = 192, 2, 4) 169 2 4
4.Secondary Outcome
Title Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean Titers Following Vaccination With One Dose of Menactra® Vaccine
Hide Description Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR).
Time Frame Days 0 and 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers of antibodies against meningococcal serogroups A, C, Y and W-135 antigens were determined in all enrolled and vaccinated participants, per-protocol population
Arm/Group Title Adults Menactra® Vaccine Group Adolescents Menactra® Vaccine Group Children Menactra® Vaccine Group
Hide Arm/Group Description:
Participants aged 18 to 55 years received a single dose of Menactra® vaccine
Participants aged 11 to 17 years received a single dose of Menactra® vaccine
Participants aged 2 to 10 years received a single dose of Menactra® vaccine
Overall Number of Participants Analyzed 194 2 4
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Serogroup A (Day 0; N = 193, 2, 4)
26.0
(17.4 to 38.9)
2.0 [1] 
(NA to NA)
2.0 [1] 
(NA to NA)
Serogroup A (Day 28; N = 194, 2, 4)
1202.6
(876.2 to 1650.6)
2896.3
(35.4 to 236766.0)
16384.0
(1804.7 to 148741.4)
Serogroup C (Day 0; N = 193, 2, 4)
5.6
(4.2 to 7.4)
2 [1] 
(NA to NA)
5.7
(0.2 to 154.7)
Serogroup C (Day 28; N = 192, 2, 4)
389.1
(274.4 to 551.8)
2048.0
(0.0 to 91459214176.9)
512.0
(208.0 to 1260.0)
Serogroup Y (Day 0; N = 193, 2, 4)
64.2
(45.1 to 91.5)
181.0
(2.2 to 14797.9)
107.6
(26.9 to 431.2)
Serogroup Y (Day 28; N = 192, 2, 4)
1244.4
(991.3 to 1562.2)
724.1
(0.0 to 395556106.8)
3444.3
(298.5 to 39740.1)
Serogroup W-135 (Day 0; N = 193, 2, 4)
12.8
(9.3 to 17.6)
128.0
(0.0 to 855379.3)
38.1
(1.4 to 1025.1)
Serogroup W-135 (Day 28; N = 193, 2, 4)
995.0
(737.9 to 1341.7)
8192.0
(1.2 to 54744273.9)
9742.0
(2431.7 to 39028.6)
[1]
Data was not computable, variance was zero because all participants had the same value.
5.Secondary Outcome
Title Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean of Individual Titer Ratio Following Vaccination With One Dose of Menactra® Vaccine
Hide Description Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR).
Time Frame 28 Days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titer ratios of antibodies against meningococcal serogroups A, C, Y and W-135 antigens were determined in all enrolled and vaccinated participants, per-protocol population.
Arm/Group Title Adults Menactra® Vaccine Group Adolescents Menactra® Vaccine Group Children Menactra® Vaccine Group
Hide Arm/Group Description:
Participants aged 18 to 55 years received a single dose of Menactra® vaccine
Participants aged 11 to 17 years received a single dose of Menactra® vaccine
Participants aged 2 to 10 years received a single dose of Menactra® vaccine
Overall Number of Participants Analyzed 194 2 4
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Serogroup A (N = 193, 2, 4)
31.9
(21.7 to 46.8)
724.1
(8.9 to 59191.5)
4096.0
(451.2 to 37185.3)
Serogroup C (N = 191, 2, 4)
40.8
(28.3 to 58.9)
512.0
(0.0 to 22864803544.2)
53.8
(1.6 to 1838.6)
Serogroup Y (N = 191, 2, 4)
16.1
(11.6 to 22.2)
4.0
(0.0 to 26730.6)
32.0
(3.5 to 290.5)
Serogroup W-135 (N = 192, 2, 4)
53.6
(38.9 to 73.9)
64.0 [1] 
(NA to NA)
215.3
(3.3 to 13841.7)
[1]
Data was not computable, variance was zero because all participants had the same value.
6.Secondary Outcome
Title Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine
Hide Description

Solicited injection site reactions: Pain, Erythema and Swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.

Grade 3 solicited reactions were defined as: Pain incapacitating (children) and prevents daily activities (adolescents and adults). Fever ≥ 39.0°C; Headache, Malaise and Myalgia, significant, prevents daily activities.

Time Frame Day 0 up to Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Solicited injection site and systemic reactions were assessed in all enrolled and vaccinated participants, Intent-to-treat population.
Arm/Group Title Adults Menactra® Vaccine Group Adolescents Menactra® Vaccine Group Children Menactra® Vaccine Group
Hide Arm/Group Description:
Participants aged 18 to 55 years received a single dose of Menactra® vaccine
Participants aged 11 to 17 years received a single dose of Menactra® vaccine
Participants aged 2 to 10 years received a single dose of Menactra® vaccine
Overall Number of Participants Analyzed 194 2 4
Measure Type: Number
Unit of Measure: Participants
Any injection site Pain 60 0 3
Grade 3 injection site Pain 0 0 0
Any injection site Erythema 5 2 3
Grade 3 injection site Erythema 0 1 0
Any injection site Swelling 2 2 3
Grade 3 injection site Swelling 0 0 0
Any Fever 3 0 0
Grade 3 Fever 0 0 0
Any Headache 22 0 0
Grade 3 Headache 0 0 0
Any Malaise 30 0 0
Grade 3 Malaise 3 0 0
Any Myalgia 48 0 0
Grade 3 Myalgia 1 0 0
Time Frame Adverse events were collected following vaccination on Day 0 up to Day 28 post-vaccination
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adults Menactra® Vaccine Group Adolescents Menactra® Vaccine Group Children Menactra® Vaccine Group
Hide Arm/Group Description Participants aged 18 to 55 years received a single dose of Menactra® vaccine Participants aged 11 to 17 years received a single dose of Menactra® vaccine Participants aged 2 to 10 years received a single dose of Menactra® vaccine
All-Cause Mortality
Adults Menactra® Vaccine Group Adolescents Menactra® Vaccine Group Children Menactra® Vaccine Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Adults Menactra® Vaccine Group Adolescents Menactra® Vaccine Group Children Menactra® Vaccine Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/194 (0.00%)      0/2 (0.00%)      0/4 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
Adults Menactra® Vaccine Group Adolescents Menactra® Vaccine Group Children Menactra® Vaccine Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   63/194 (32.47%)      2/2 (100.00%)      4/4 (100.00%)    
Gastrointestinal disorders       
Dental caries * 1  0/194 (0.00%)  0 1/2 (50.00%)  1 0/4 (0.00%)  0
General disorders       
Injection site pain  1  60/194 (30.93%)  60 0/2 (0.00%)  0 3/4 (75.00%)  3
Injection site erythema  1  5/194 (2.58%)  5 2/2 (100.00%)  2 3/4 (75.00%)  3
Injection site swelling  1  2/194 (1.03%)  2 2/2 (100.00%)  2 3/4 (75.00%)  3
Malaise  1  30/194 (15.46%)  30 0/2 (0.00%)  0 0/4 (0.00%)  0
Infections and infestations       
Nasopharyngitis * 1  15/194 (7.73%)  17 0/2 (0.00%)  0 0/4 (0.00%)  0
Otitis media  1  0/194 (0.00%)  0 0/2 (0.00%)  0 1/4 (25.00%)  1
Musculoskeletal and connective tissue disorders       
Myalgia  1  48/194 (24.74%)  48 0/2 (0.00%)  0 0/4 (0.00%)  0
Indicates events were collected by systematic assessment
*
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.
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
Results Point of Contact
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01519713     History of Changes
Other Study ID Numbers: MTA76 (SFY12080)
U1111-1124-7479 ( Other Identifier: WHO )
First Submitted: January 20, 2012
First Posted: January 27, 2012
Results First Submitted: April 4, 2013
Results First Posted: May 28, 2013
Last Update Posted: May 28, 2013