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Antibody Persistence and Booster Dose Response in Subjects Who Received Menactra® Three Years Earlier in Study MTA26

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ClinicalTrials.gov Identifier: NCT00700713
Recruitment Status : Completed
First Posted : June 19, 2008
Results First Posted : February 15, 2016
Last Update Posted : February 15, 2016
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
Meningococcemia
Intervention Biological: Meningococcal polysaccharide diphtheria toxoid conjugate
Enrollment 181
Recruitment Details Study participants were enrolled from 17 June 2008 to 01 October 2008 at 13 clinical centers in the United States.
Pre-assignment Details A total of 181 participants who met all inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.
Arm/Group Title One-Dose Menactra Group Two-Dose Menactra Group Menactra-naïve Group
Hide Arm/Group Description Participants received one dose of Menactra® in Study MTA26. Participants received two doses of Menactra® in Study MTA26. Participants had never received Menactra® vaccine.
Period Title: Overall Study
Started 48 66 67
Completed 47 66 65
Not Completed 1 0 2
Reason Not Completed
Protocol Violation             1             0             1
Withdrawal by Subject             0             0             1
Arm/Group Title One-Dose Menactra Group Two-Dose Menactra Group Menactra-naïve Group Total
Hide Arm/Group Description Participants received one dose of Menactra® in Study MTA26. Participants received two doses of Menactra® in Study MTA26 Participants had never received Menactra® vaccine. Total of all reporting groups
Overall Number of Baseline Participants 48 66 67 181
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 66 participants 67 participants 181 participants
<=18 years
48
 100.0%
66
 100.0%
67
 100.0%
181
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 48 participants 66 participants 67 participants 181 participants
57.4  (2.89) 51.6  (1.96) 52.5  (11.8) 53.4  (7.75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 66 participants 67 participants 181 participants
Female
20
  41.7%
38
  57.6%
22
  32.8%
80
  44.2%
Male
28
  58.3%
28
  42.4%
45
  67.2%
101
  55.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 48 participants 66 participants 67 participants 181 participants
48 66 67 181
1.Primary Outcome
Title Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra®
Hide Description Antibody titers to meningococcal serogroups A, C, Y, and W-135 were measured by serum bactericidal assay using human complement (SBA-HC). Bactericidal antibody persistence to meningococcal serogroups was defined as as pre-vaccination titers of ≥1:4 and ≥1:8. Booster response to a single Menactra vaccine dose was defined as antibody titers of ≥1:4 and ≥1:8 30 days post-booster vaccination.
Time Frame Day 0 (pre-vaccination) and Day 30 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Meningococcal serogroups A, C, Y, and W-135 antibody persistence and booster response were assessed in the Per-Protocol Analysis Set.
Arm/Group Title One-Dose Menactra Group Two-Dose Menactra Group Menactra-naïve Group
Hide Arm/Group Description:
Participants received one dose of Menactra® in Study MTA26.
Participants received two doses of Menactra® in Study MTA26.
Participants had never received Menactra® vaccine.
Overall Number of Participants Analyzed 41 63 61
Measure Type: Number
Unit of Measure: Percentage of participants
Serogroup A; Day 0, ≥1:4 (n=41, 63, 61) 70.7 76.2 50.8
Serogroup A; Day 0, ≥1:8 (n=41, 63, 61) 48.8 46.0 18.0
Serogroup A; Day 30, ≥1:4 (n=40, 62, 59) 100.0 100.0 93.2
Serogroup A; Day 30, ≥1:8 (n=40, 62, 59) 100.0 100.0 84.8
Serogroup C; Day 0, ≥1:4 (n=41, 63, 61) 29.3 20.6 9.8
Serogroup C; Day 0, ≥1:8 (n=41, 63, 61) 22.0 12.7 4.9
Serogroup C; Day 30, ≥1:4 (n=41, 63, 59) 100.0 98.4 59.3
Serogroup C; Day 30, ≥1:8 (n=41, 63, 59) 100.0 98.4 54.2
Serogroup Y; Day 0, ≥1:4 (n=41, 63, 61) 31.7 33.3 6.6
Serogroup Y; Day 0, ≥1:8 (n=41, 63, 61) 14.6 14.3 3.3
Serogroup Y; Day 30, ≥1:4 (n=40, 63, 60) 100.0 100.0 81.7
Serogroup Y; Day 30, ≥1:8 (n=40, 63, 60) 100.0 98.4 75.0
Serogroup W-135; Day 0, ≥1:4 (n=41, 63, 61) 43.9 49.2 14.8
Serogroup W-135; Day 0, ≥1:8 (n=41, 63, 61) 29.3 22.2 8.2
Serogroup W-135; Day 30, ≥1:4 (n=40, 63, 60) 100.0 100.0 83.3
Serogroup W-135; Day 30, ≥1:8 (n=40, 63, 60) 100.0 98.4 73.3
2.Other Pre-specified Outcome
Title Geometric Mean Antibody Titers to Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®.
Hide Description Antibody titers to meningococcal serogroups A, C, Y, and W-135 were measured by serum bactericidal assay using human complement (SBA-HC).
Time Frame Day 0 (pre-vaccination) and Day 30 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Meningococcal Serogroups A, C, Y, and W-135 Geometric Mean Titers were assessed in the Per-Protocol Analysis Set.
Arm/Group Title One-Dose Menactra Group Two-Dose Menactra Group Menactra-naïve Group
Hide Arm/Group Description:
Participants received one dose of Menactra® in Study MTA26.
Participants received two doses of Menactra® in Study MTA26.
Participants had never received Menactra® vaccine.
Overall Number of Participants Analyzed 41 63 61
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dilutions)
Serogroup A; Day 0 (N=41, 63, 61)
6.2
(4.4 to 8.8)
7.4
(5.4 to 10.2)
3.5
(2.9 to 4.3)
Serogroup A; Day 30 (N=40, 62, 59)
200.9
(134.2 to 300.6)
234.1
(162.4 to 337.4)
15.6
(11.7 to 20.9)
Serogroup C; Day 0 (N=41, 63, 61)
4.4
(2.6 to 7.3)
2.9
(2.3 to 3.6)
2.2
(2.0 to 2.4)
Serogroup C; Day 30 (N=41, 63, 59)
606.3
(422.1 to 870.9)
397.5
(283.9 to 556.6)
9.5
(6.2 to 14.6)
Serogroup Y; Day 0 (N=41, 63, 61)
3.0
(2.3 to 3.7)
3.1
(2.5 to 3.9)
2.1
(2.0 to 2.3)
Serogroup Y; Day 30 (N=40, 63, 60)
530.1
(374.4 to 750.4)
264.6
(193.6 to 361.7)
13.5
(9.6 to 18.9)
Serogroup W-135; Day 0 (n=41, 63, 61)
4.1
(3.0 to 5.8)
3.7
(3.0 to 4.5)
2.5
(2.1 to 2.9)
Serogroup W-135; Day 30 (N=40, 63, 60)
332.0
(200.1 to 550.8)
256.0
(180.8 to 362.5)
14.9
(10.5 to 21.3)
3.Other Pre-specified Outcome
Title Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®
Hide Description Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Vomiting, Drowsiness, Anorexia, Irritability, Arthralgia, and Diarrhea. Grade 3 Solicited Injection-site: Pain - Incapacitating, unable to perform usual activities; Erythema and Swelling - ≥2.0 in. Grade 3 Solicited systemic: Fever (Temperature) ->39.0˚C (>102.2˚F); Headache - Prevents daily activities; Vomiting - ≥3 episodes per 24 hours; Drowsiness - Disabling, dozing off or falling asleep while engaged in usual activities; Anorexia - Skips ≥3 meals; Irritability - >3 hours duration; Arthralgia - Unwilling to move due to pain; and Diarrhea - ≥ 5 episodes per 24 hours.
Time Frame Day 0 up to Day 7 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.
Arm/Group Title One-Dose Menactra Group Two-Dose Menactra Group Menactra-naïve Group
Hide Arm/Group Description:
Participants received one dose of Menactra® in Study MTA26.
Participants received two doses of Menactra® in Study MTA26.
Participants had never received Menactra® vaccine.
Overall Number of Participants Analyzed 48 66 67
Measure Type: Number
Unit of Measure: Percentage of participants
Injection-site Pain (N=47, 66, 65) 55.3 65.2 63.1
Grade 3 Injection-site Pain (N=47, 66, 65) 2.1 1.5 0.0
Injection-site Erythema (N=47, 66, 65) 23.4 39.4 38.5
Grade 3 Injection-site Erythema (N=47, 66, 65) 6.4 6.1 15.4
Injection-site Swelling (N=47, 66, 65) 19.1 30.3 32.3
Grade 3 Injection-site Swelling (N=47, 66, 65) 8.5 3.0 12.3
Fever (N=47, 66, 65) 12.8 6.1 4.6
Grade 3 Fever (N=47, 66, 65) 0.0 0.0 0.0
Headache (N=47, 66, 65) 8.5 10.6 6.2
Grade 3 Headache (N=47, 66, 65) 2.1 0.0 0.0
Vomiting (N=47, 66, 65) 6.4 1.5 3.1
Grade 3 Vomiting (n=47, 66, 65) 0.0 1.5 1.5
Drowsiness (N=47, 66, 65) 19.1 24.2 10.8
Grade 3 Drowsiness (N=47, 66, 65) 0.0 0.0 0.0
Anorexia (n=47, 66, 65) 4.3 12.1 18.5
Grade 3 Anorexia (N=47, 66, 65) 0.0 0.0 1.5
Irritability (N=47, 66, 65) 19.1 30.3 33.8
Grade 3 Irritability (N=47, 66, 65) 2.1 1.5 4.6
Arthralgia (n=47, 66, 65) 8.5 13.6 16.9
Grade 3 Arthralgia (N=47, 66, 65) 2.1 1.5 0.0
Diarrhea (N=47, 66, 65) 8.5 10.6 9.2
Grade 3 Diarrhea (N=47, 66, 65) 0.0 0.0 0.0
Time Frame Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title One-Dose Menactra Group Two-Dose Menactra Group Menactra-naïve Group
Hide Arm/Group Description Participants received one dose of Menactra® in Study MTA26. Participants received two doses of Menactra® in Study MTA26. Participants had never received Menactra® vaccine.
All-Cause Mortality
One-Dose Menactra Group Two-Dose Menactra Group Menactra-naïve Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
One-Dose Menactra Group Two-Dose Menactra Group Menactra-naïve Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/48 (0.00%)      0/66 (0.00%)      0/67 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
One-Dose Menactra Group Two-Dose Menactra Group Menactra-naïve Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   26/48 (54.17%)      43/66 (65.15%)      41/67 (61.19%)    
Gastrointestinal disorders       
Vomiting  1  3/47 (6.38%)  3 1/66 (1.52%)  1 2/65 (3.08%)  2
Diarrhea  1  4/47 (8.51%)  4 7/66 (10.61%)  7 6/65 (9.23%)  6
General disorders       
Pyrexia * 1  4/48 (8.33%)  4 1/66 (1.52%)  1 4/67 (5.97%)  4
Injection-site Pain  1  26/47 (55.32%)  26 43/66 (65.15%)  43 41/65 (63.08%)  41
Injection-site Erythema  1  11/47 (23.40%)  11 26/66 (39.39%)  26 25/65 (38.46%)  25
Injection-site Swelling  1  9/47 (19.15%)  9 20/66 (30.30%)  20 21/65 (32.31%)  21
Fever  1  6/47 (12.77%)  6 4/66 (6.06%)  4 3/65 (4.62%)  3
Metabolism and nutrition disorders       
Anorexia  1  2/47 (4.26%)  2 8/66 (12.12%)  8 12/65 (18.46%)  12
Musculoskeletal and connective tissue disorders       
Arthralgia  1  4/47 (8.51%)  4 9/66 (13.64%)  9 11/65 (16.92%)  11
Nervous system disorders       
Headache  1  4/47 (8.51%)  4 7/66 (10.61%)  7 4/65 (6.15%)  4
Drowsiness  1  9/47 (19.15%)  9 16/66 (24.24%)  16 7/65 (10.77%)  7
Psychiatric disorders       
Irritability  1  9/47 (19.15%)  9 20/66 (30.30%)  20 22/65 (33.85%)  22
Respiratory, thoracic and mediastinal disorders       
Cough * 1  5/48 (10.42%)  5 4/66 (6.06%)  4 1/67 (1.49%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.0
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: NCT00700713    
Other Study ID Numbers: MTA62
First Submitted: May 7, 2008
First Posted: June 19, 2008
Results First Submitted: January 16, 2016
Results First Posted: February 15, 2016
Last Update Posted: February 15, 2016