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Trial record 1 of 1 for:    MTA89
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Immunogenicity and Safety of Two-Dose Series of Menactra® in Japanese Healthy Adult Subjects

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ClinicalTrials.gov Identifier: NCT02591290
Recruitment Status : Completed
First Posted : October 29, 2015
Results First Posted : November 6, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Meningitis
Meningococcal Meningitis
Meningococcal Infections
Intervention Biological: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate
Enrollment 60
Recruitment Details Participants were enrolled from 20 October 2015 through 18 December 2015 at a single center in Japan.
Pre-assignment Details A total of 60 participants were enrolled in the study.
Arm/Group Title Menactra® Vaccine
Hide Arm/Group Description Participants received 2 doses of 0.5 mL Menactra® Vaccine, intramuscularly, with 8-week interval.
Period Title: Overall Study
Started 60
Vaccinated Dose 1 60
Vaccinated Dose 2 58
Completed 58
Not Completed 2
Reason Not Completed
Withdrawal by Subject             2
Arm/Group Title Menactra® Vaccine
Hide Arm/Group Description Participants received 2 doses of 0.5 mL Menactra® Vaccine, intramuscularly, with 8-week interval.
Overall Number of Baseline Participants 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants
38.6  (9.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
Female
28
  46.7%
Male
32
  53.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 60 participants
60
1.Primary Outcome
Title Number of Participants With Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers >=1:128
Hide Description Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by Serum Bactericidal Assay using Baby Rabbit complement (SBA-BR).
Time Frame Day 0 (pre-vaccination), Day 28 post-vaccination 1, Day 28 post-vaccination 2
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol (PP) analysis set included all participants who received 2 study vaccinations and provided the valid blood samples of pre-vaccination and post-1st and post-2nd vaccination.
Arm/Group Title Menactra® Vaccine
Hide Arm/Group Description:
Participants received 2 doses of 0.5 mL Menactra® Vaccine, intramuscularly, with 8-week interval.
Overall Number of Participants Analyzed 56
Measure Type: Count of Participants
Unit of Measure: Participants
Serogroup A (Pre-Vaccination)
43
  76.8%
Serogroup A (Day 28 post-vaccination 1)
56
 100.0%
Serogroup A (Day 28 post-vaccination 2)
56
 100.0%
Serogroup C (Pre-Vaccination)
15
  26.8%
Serogroup C (Day 28 post-vaccination 1)
47
  83.9%
Serogroup C (Day 28 post-vaccination 2)
52
  92.9%
Serogroup Y (Pre-Vaccination)
28
  50.0%
Serogroup Y (Day 28 post-vaccination 1)
54
  96.4%
Serogroup Y (Day 28 post-vaccination 2)
53
  94.6%
Serogroup W-135 (Pre-Vaccination)
15
  26.8%
Serogroup W-135 (Day 28 post-vaccination 1)
51
  91.1%
Serogroup W-135 (Day 28 post-vaccination 2)
53
  94.6%
2.Other Pre-specified Outcome
Title Number of Participants With >=4-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers Following Vaccination
Hide Description Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR in the serum specimens. Number of participants with >=4-fold rise in each meningococcal serogroups antibody titer at Day 28 post-vaccination 1 and at Day 28 post-vaccination 2 were reported.
Time Frame Day 28 post-vaccination 1, Day 28 post-vaccination 2
Hide Outcome Measure Data
Hide Analysis Population Description
PP analysis set included all participants who received 2 study vaccinations and provided the valid blood samples of pre-vaccination and post-1st and post-2nd vaccination.
Arm/Group Title Menactra® Vaccine
Hide Arm/Group Description:
Participants received 2 doses of 0.5 mL Menactra® Vaccine, intramuscularly, with 8-week interval.
Overall Number of Participants Analyzed 56
Measure Type: Count of Participants
Unit of Measure: Participants
Serogroup A (Day 28 post-vaccination 1)
40
  71.4%
Serogroup A (Day 28 post-vaccination 2)
39
  69.6%
Serogroup C (Day 28 post-vaccination 1)
46
  82.1%
Serogroup C (Day 28 post-vaccination 2)
47
  83.9%
Serogroup Y (Day 28 post-vaccination 1)
43
  76.8%
Serogroup Y (Day 28 post-vaccination 2)
48
  85.7%
Serogroup W-135 (Day 28 post-vaccination 1)
52
  92.9%
Serogroup W-135 (Day 28 post-vaccination 2)
55
  98.2%
3.Other Pre-specified Outcome
Title Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination
Hide Description Solicited injection (Inj.) site reactions: Pain (Grade 1: no interference with activity, Grade 2: some interference, Grade 3: significant interference), erythema and swelling (Grade 1: >=25 to <=50 mm; Grade 2: >=51 to <=100 mm; Grade 3: >100 mm); Solicited systemic reactions: Fever (Grade 1: >=37.5 degree Celsius to <=38.4 degree Celsius, Grade 2: >=38.5 degree Celsius to <=38.9 degree Celsius, Grade 3: >=39.0 degree Celsius), headache, malaise and myalgia (Grade 1: no interference with activity, Grade 2: some interference, Grade 3: significant interference). Number of participants with any of the Grade 1, 2 or 3 solicited injection-site and systemic reactions and Grade 3 solicited injection-site and systemic reactions were reported.
Time Frame Within 7 days post-vaccination 1, Within 7 days post-vaccination 2
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study vaccine.
Arm/Group Title Menactra® Vaccine
Hide Arm/Group Description:
Participants received 2 doses of 0.5 mL Menactra® Vaccine, intramuscularly, with 8-week interval.
Overall Number of Participants Analyzed 60
Measure Type: Count of Participants
Unit of Measure: Participants
Any Inj. site pain (post-vaccination 1) Number Analyzed 60 participants
18
  30.0%
Grade 3 Inj site pain (post-vaccination 1) Number Analyzed 60 participants
0
   0.0%
Any Inj site pain (post-vaccination 2) Number Analyzed 58 participants
17
  29.3%
Grade 3 Inj site pain (post-vaccination 2) Number Analyzed 58 participants
0
   0.0%
Any Erythema (post-vaccination 1) Number Analyzed 60 participants
0
   0.0%
Grade 3 Erythema (post-vaccination 1) Number Analyzed 60 participants
0
   0.0%
Any Erythema (post-vaccination 2) Number Analyzed 58 participants
0
   0.0%
Grade 3 Erythema (post-vaccination 2) Number Analyzed 58 participants
0
   0.0%
Any Swelling (post-vaccination 1) Number Analyzed 60 participants
0
   0.0%
Grade 3 Swelling (post-vaccination 1) Number Analyzed 60 participants
0
   0.0%
Any Swelling (post-vaccination 2) Number Analyzed 58 participants
0
   0.0%
Grade 3 Swelling (post-vaccination 2) Number Analyzed 58 participants
0
   0.0%
Any Fever (post-vaccination 1) Number Analyzed 60 participants
1
   1.7%
Grade 3 Fever (post-vaccination 1) Number Analyzed 60 participants
0
   0.0%
Any Fever (post-vaccination 2) Number Analyzed 58 participants
1
   1.7%
Grade 3 Fever (post-vaccination 2) Number Analyzed 58 participants
0
   0.0%
Any Headache (post-vaccination 1) Number Analyzed 60 participants
5
   8.3%
Grade 3 Headache (post-vaccination 1) Number Analyzed 60 participants
0
   0.0%
Any Headache (post-vaccination 2) Number Analyzed 58 participants
5
   8.6%
Grade 3 Headache (post-vaccination 2) Number Analyzed 58 participants
0
   0.0%
Any Malaise (post-vaccination 1) Number Analyzed 60 participants
9
  15.0%
Grade 3 Malaise (post-vaccination 1) Number Analyzed 60 participants
0
   0.0%
Any Malaise (post-vaccination 2) Number Analyzed 58 participants
3
   5.2%
Grade 3 Malaise (post-vaccination 2) Number Analyzed 58 participants
0
   0.0%
Any Myalgia (post-vaccination 1) Number Analyzed 60 participants
12
  20.0%
Grade 3 Myalgia (post-vaccination 1) Number Analyzed 60 participants
0
   0.0%
Any Myalgia (post-vaccination 2) Number Analyzed 58 participants
11
  19.0%
Grade 3 Myalgia (post-vaccination 2) Number Analyzed 58 participants
0
   0.0%
Time Frame Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 98 days at the longest.
Adverse Event Reporting Description

A solicited reaction is an AE that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF.

An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.

 
Arm/Group Title Menactra® Vaccine
Hide Arm/Group Description Participants received 2 doses of 0.5 mL Menactra® Vaccine, intramuscularly, with 8-week interval.
All-Cause Mortality
Menactra® Vaccine
Affected / at Risk (%)
Total   0/60 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Menactra® Vaccine
Affected / at Risk (%)
Total   0/60 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Menactra® Vaccine
Affected / at Risk (%)
Total   32/60 (53.33%) 
General disorders   
Injection site pain  1  25/60 (41.67%) 
Malaise  1  10/60 (16.67%) 
Musculoskeletal and connective tissue disorders   
Myalgia  1  18/60 (30.00%) 
Nervous system disorders   
Headache  1  7/60 (11.67%) 
1
Term from vocabulary, MedDRA 18.1
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
EMail: RegistryContactUs@sanofipasteur.com
Layout table for additonal information
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT02591290     History of Changes
Other Study ID Numbers: EFC14375/MTA89
U1111-1174-4291 ( Other Identifier: WHO )
First Submitted: October 27, 2015
First Posted: October 29, 2015
Results First Submitted: October 5, 2017
Results First Posted: November 6, 2017
Last Update Posted: November 6, 2017