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Safety and Immunogenicity Study for Use of Menactra® Versus Adacel® in Subjects 11 to 55 Years of Age in South Korea

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ClinicalTrials.gov Identifier: NCT01642589
Recruitment Status : Completed
First Posted : July 17, 2012
Results First Posted : December 3, 2013
Last Update Posted : December 3, 2013
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Conditions Meningitis
Meningococcal Disease
Interventions Biological: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed
Enrollment 300
Recruitment Details The study participants were enrolled from 13 July 2012 to 17 December 2012 in 8 clinic centers in South Korea.
Pre-assignment Details A total of 300 participants that met all inclusion but none of the exclusion criteria were randomized and vaccinated in this study
Arm/Group Title Menactra® Group Tdap - Adacel® Group
Hide Arm/Group Description Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®)
Period Title: Overall Study
Started 200 100
Completed 199 99
Not Completed 1 1
Reason Not Completed
Withdrawal by Subject             1             1
Arm/Group Title Menactra® Group Tdap - Adacel® Group Total
Hide Arm/Group Description Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®) Total of all reporting groups
Overall Number of Baseline Participants 200 100 300
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 200 participants 100 participants 300 participants
<=18 years
100
  50.0%
49
  49.0%
149
  49.7%
Between 18 and 65 years
100
  50.0%
51
  51.0%
151
  50.3%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 200 participants 100 participants 300 participants
24.9  (11.5) 24.2  (10.1) 24.7  (11.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 200 participants 100 participants 300 participants
Female
107
  53.5%
58
  58.0%
165
  55.0%
Male
93
  46.5%
42
  42.0%
135
  45.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 200 participants 100 participants 300 participants
200 100 300
1.Primary Outcome
Title Percentage of Participants With Seroconversion Following Vaccination With Either Menactra® or Adacel® Vaccine
Hide Description

Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were measured using the Serum bactericidal assay using baby rabbit complement (SBA-BR).

Seroconversion was defined as post-vaccination antibody titers of ≥ 4-fold increase from pre-vaccination level.

Time Frame 28 Days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Functional antibody activity for anti meningococcal antibody to serogroups A, C, Y, and W 135 were determined in the Full Analysis Set
Arm/Group Title Menactra® Group Tdap - Adacel® Group
Hide Arm/Group Description:
Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®)
Overall Number of Participants Analyzed 200 100
Measure Type: Number
Unit of Measure: Percentage of participants
Serogroup A 78 9
Serogroup C 88 8
Serogroup Y 75 12
Serogroup W-135 92 8
2.Secondary Outcome
Title Percentage of Participants With Functional Antibody Titers at ≥1:8 Dilution Before and After Menactra® or Adacel® Vaccination
Hide Description Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were measured using the Serum bactericidal assay using baby rabbit complement (SBA-BR) at ≥ 1:8 dilution.
Time Frame Day 0 (pre-vaccination) and 28 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were determined in the Full Analysis Set
Arm/Group Title Menactra® Group Tdap - Adacel® Group
Hide Arm/Group Description:
Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®)
Overall Number of Participants Analyzed 200 100
Measure Type: Number
Unit of Measure: Percentage of participants
Serogroup A (Pre-vaccination) 68 76
Serogroup A (Post-vaccination) 100 78
Serogroup C (Pre-vaccination) 28 19
Serogroup C (Post-vaccination) 93 24
Serogroup Y (Pre vaccination) 75 75
Serogroup Y (Post-vaccination) 99 81
Serogroup W-135 (Pre-vaccination) 50 44
Serogroup W-135 (Post-vaccination) 98 48
3.Secondary Outcome
Title Percentage of Participants With Functional Antibody Titers at ≥1:128 Dilution Before and After Menactra® or Adacel® Vaccination.
Hide Description Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were measured using the Serum bactericidal assay using baby rabbit complement (SBA-BR) at ≥ 1:128 dilution.
Time Frame Day 0 (pre-vaccination) and 28 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Functional antibody activity for anti meningococcal antibody to serogroups A, C, Y, and W 135 were determined in the Full Analysis Set
Arm/Group Title Menactra® Group Tdap - Adacel® Group
Hide Arm/Group Description:
Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®)
Overall Number of Participants Analyzed 200 100
Measure Type: Number
Unit of Measure: Percentage of participants
Serogroup A (Pre-vaccination) 57 64
Serogroup A (Post-vaccination) 99 70
Serogroup C (Pre-vaccination) 25 15
Serogroup C (Post-vaccination) 89 16
Serogroup Y (Pre-vaccination) 52 48
Serogroup Y (Post-vaccination) 96 57
Serogroup W 135 (Pre-vaccination) 22 25
Serogroup W 135 (Post-vaccination) 95 27
4.Secondary Outcome
Title Geometric Mean Titers of Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Antibody Against Serogroups A, C, Y, and W-135 Before and After Menactra® or Adacel® Vaccination
Hide Description Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were measured using the Serum bactericidal assay using baby rabbit complement (SBA-BR).
Time Frame Day 0 (pre-vaccination) and 28 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers for the anti meningococcal antibody to serogroups A, C, Y, and W 135 were determined in the Full Analysis Set
Arm/Group Title Menactra® Group Tdap - Adacel® Group
Hide Arm/Group Description:
Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®)
Overall Number of Participants Analyzed 200 100
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Serogroup A (pre-vaccination)
46.1
(33.7 to 63.2)
75.6
(48.9 to 117)
Serogroup A (post-vaccination)
1121
(949 to 1324)
87.6
(57.1 to 135)
Serogroup C (pre-vaccination)
5.80
(4.50 to 7.46)
4.63
(3.26 to 6.56)
Serogroup C (post-vaccination)
667
(504 to 884)
5.64
(3.82 to 8.32)
Serogroup Y (pre-vaccination)
50.1
(37.7 to 66.6)
47.2
(31.9 to 69.8)
Serogroup Y (post-vaccination)
620
(521 to 738)
66.8
(45.5 to 98.0)
Serogroup W-135 (pre-vaccination)
13.0
(9.83 to 17.1)
11.9
(7.79 to 18.1)
Serogroup W-135 (post-vaccination)
851
(690 to 1050)
14.9
(9.50 to 23.4)
5.Secondary Outcome
Title Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine
Hide Description

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

Grade 3 injection site reactions: Pain - Significant, prevents daily activity; Redness and Swelling - > 100 mm. Grade 3 Systemic reactions: Fever - ≥ 39.0°C; Headache, Malaise, and Myalgia - Significant, prevents daily activity.

Time Frame Day 0 up to Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Solicited injection site and systemic events were assessed in all randomized and vaccinated study participants, Safety Analysis Set
Arm/Group Title Menactra® Group Tdap - Adacel® Group
Hide Arm/Group Description:
Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®)
Overall Number of Participants Analyzed 200 100
Measure Type: Number
Unit of Measure: Participants
Injection Site Pain (199, 99) 64 72
Grade 3 Injection Site Pain (199, 99) 1 2
Injection Site Erythema (199, 99) 5 9
Grade 3 Injection Site Erythema (199, 99) 0 0
Injection Site Swelling (199, 99) 3 6
Grade 3 Injection Site Swelling (199, 99) 0 0
Fever (199, 99) 0 3
Grade 3 Fever (199, 99) 0 0
Headache (199, 99) 37 24
Grade 3 Headache (199, 99) 2 1
Malaise (199, 99) 36 23
Grade 3 Malaise (199, 99) 1 1
Myalgia (199, 99) 51 42
Grade 3 Myalgia (199, 99) 1 1
Time Frame Adverse events data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Menactra® Group Tdap - Adacel® Group
Hide Arm/Group Description Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®)
All-Cause Mortality
Menactra® Group Tdap - Adacel® Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Menactra® Group Tdap - Adacel® Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/200 (0.00%)      0/100 (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%
Menactra® Group Tdap - Adacel® Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   92/200 (46.00%)      76/100 (76.00%)    
General disorders     
Injection Site Pain  1  64/199 (32.16%)  64 72/99 (72.73%)  72
Injection Site Erythema  1  5/199 (2.51%)  5 9/99 (9.09%)  9
Injection Site Swelling  1  3/199 (1.51%)  3 6/99 (6.06%)  6
Malaise  1  36/199 (18.09%)  36 23/99 (23.23%)  23
Musculoskeletal and connective tissue disorders     
Myalgia  1  51/199 (25.63%)  51 42/99 (42.42%)  42
Nervous system disorders     
Headache  1  37/199 (18.59%)  37 24/99 (24.24%)  24
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 14.0
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: NCT01642589     History of Changes
Other Study ID Numbers: MTA52
U1111-1122-2028 ( Other Identifier: WHO )
First Submitted: July 13, 2012
First Posted: July 17, 2012
Results First Submitted: August 29, 2013
Results First Posted: December 3, 2013
Last Update Posted: December 3, 2013