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Antibody Persistence and Response to Re-vaccination With Either Menactra® or Menomune® 3 Years After Initial Vaccination

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ClinicalTrials.gov Identifier: NCT01239043
Recruitment Status : Completed
First Posted : November 11, 2010
Results First Posted : June 19, 2012
Last Update Posted : June 25, 2012
Sponsor:
Information provided by (Responsible Party):
Sanofi

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
Interventions Biological: Menomune®: A, C, Y, W 135 Meningococcal Polysaccharide
Biological: Menactra®: Meningococcal (A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate
Enrollment 139
Recruitment Details Participants were enrolled from 08 November 2010 to 16 December 2010 at 6 US clinical centers.
Pre-assignment Details A total of 139 participants who met the inclusion, but no exclusion criteria were enrolled and vaccinated.
Arm/Group Title Menomune® Vaccine Group Menactra® Vaccine Group
Hide Arm/Group Description All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial. All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
Period Title: Overall Study
Started 36 [1] 103
Completed 34 102
Not Completed 2 1
Reason Not Completed
Protocol Violation             2             1
[1]
For safety analysis number includes 1 participant randomized to Menactra who received Menomune.
Arm/Group Title Menomune® Vaccine Group Menactra® Vaccine Group Total
Hide Arm/Group Description All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial. All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial. Total of all reporting groups
Overall Number of Baseline Participants 36 103 139
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 103 participants 139 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
  22.2%
28
  27.2%
36
  25.9%
>=65 years
28
  77.8%
75
  72.8%
103
  74.1%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants 103 participants 139 participants
71.8  (7.2) 71.1  (6.8) 71.3  (6.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 103 participants 139 participants
Female
20
  55.6%
57
  55.3%
77
  55.4%
Male
16
  44.4%
46
  44.7%
62
  44.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 36 participants 103 participants 139 participants
36 103 139
1.Primary Outcome
Title Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine
Hide Description

Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia.

Grade 3 reactions were defined as: Pain, headache, malaise, and myalgia - significant, prevents daily activity; Erythema and swelling - > 100 mm; Fever, temperature of ≥ 39.0ºC or ≥ 102.1ºF.

Time Frame Day 0 to Day 7 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Solicited reactions were assessed in all subjects who received at a dose of study vaccine, according to the vaccine actually received (Safety Analysis Population).
Arm/Group Title Menomune® Vaccine Group Menactra® Vaccine Group
Hide Arm/Group Description:
All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
Overall Number of Participants Analyzed 34 103
Measure Type: Number
Unit of Measure: Participants
Any Pain 8 33
Grade 3 Pain 0 1
Any Erythema 9 0
Grade 3 Erythema 0 0
Any Swelling 1 2
Grade 3 Swelling 0 0
Any Fever 0 0
Grade 3 Fever 0 0
Any Headache 8 16
Grade 3 Headache 1 1
Any Malaise 3 8
Grade 3 Malaise 0 0
Any Myalgia 6 22
Grade 3 Myalgia 1 1
2.Other Pre-specified Outcome
Title Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine
Hide Description Geometric mean titers (GMTs) of antibodies to serogroups A, C, Y, and W-135 were measured by serum bactericidal assay with human complement (SBA-HC).
Time Frame Day 0 (pre-vaccination) and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
GMTs were assessed in participants who met all inclusion, but no exclusion criteria; received assigned study vaccine; and had serology samples with valid test results (Per-Protocol Population).
Arm/Group Title Menomune® Vaccine Group Menactra® Vaccine Group
Hide Arm/Group Description:
All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
Overall Number of Participants Analyzed 32 99
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Serogroup A Pre-vaccination (N = 32, 99)
7.2
(4.4 to 11.8)
10.1
(7.6 to 13.3)
Serogroup A Post-vaccination (N = 31, 99)
15.6
(9.2 to 26.5)
87.1
(62.0 to 122.3)
Serogroup C Pre-vaccination (N = 32, 99)
9.9
(5.5 to 18.0)
6.6
(4.9 to 8.9)
Serogroup C Post-vaccination (N = 32, 99)
14.4
(7.4 to 27.8)
93.4
(63.0 to 138.5)
Serogroup Y Pre-vaccination (N = 32, 99)
7.2
(4.1 to 12.6)
6.2
(4.4 to 8.7)
Serogroup Y Post-vaccination (N = 31, 99)
11.4
(6.2 to 21.1)
96.1
(62.1 to 148.5)
Serogroup W-135 Pre-vaccination (N = 32, 99)
4.1
(2.9 to 5.7)
7.6
(5.6 to 10.4)
Serogroup W-135 Post-vaccination (N = 31, 99)
6.4
(4.4 to 9.3)
80.1
(55.0 to 116.5)
3.Other Pre-specified Outcome
Title Summary of Participants Antibody Titers for Each of the Vaccine Serogroups Before and 28 Days After Vaccination With Either Menomune or Menactra Vaccine.
Hide Description Titers of antibodies to serogroups A, C, Y, and W-135 for each participant were measured by serum bactericidal assay with human complement (SBA-HC).
Time Frame Day 0 (pre-vaccination) and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Antibody titers were assessed in participants who met all inclusion, but no exclusion criteria; received assigned study vaccine; and had serology samples with valid test results (Per-Protocol Population).
Arm/Group Title Menomune® Vaccine Group Menactra® Vaccine Group
Hide Arm/Group Description:
All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
Overall Number of Participants Analyzed 32 99
Measure Type: Number
Unit of Measure: Participants
Serogroup A ≥ 1:4 Pre-vaccination (N = 32, 99) 23 79
Serogroup A ≥ 1:8 Pre-vaccination (N = 32, 99) 14 57
Serogroup A ≥ 1:4 Post-vaccination (N = 31, 99) 28 97
Serogroup A ≥ 1:8 Post-vaccination (N = 31, 99) 24 92
Serogroup C ≥1:4 Pre-vaccination (N = 32, 99) 20 55
Serogroup C ≥ 1:8 Pre-vaccination (N = 32, 99) 17 41
Serogroup C ≥1:4 Post-vaccination (N = 32, 99) 24 95
Serogroup C ≥ 1:8 Post-vaccination (N = 32, 99) 18 90
Serogroup Y ≥ 1:4 Pre-vaccination (N = 32, 99) 15 43
Serogroup Y ≥ 1:8 Pre-vaccination (N = 32, 99) 14 34
Serogroup Y ≥1:4 Post-vaccination (N = 31, 99) 19 89
Serogroup Y≥1:8 Post -vaccination (N = 31, 99) 18 87
Serogroup W-135 ≥1:4 Pre-vaccination (N = 32, 99) 15 59
Serogroup W-135 ≥1:8 Pre-vaccination (N = 32, 99) 12 44
Serogroup W-135 ≥1:4 Post-accination (N = 31, 99) 25 95
Serogroup W-135 ≥1:8 Post-vaccination (N = 31, 99) 14 92
4.Other Pre-specified Outcome
Title Number of Participants Who Achieved a Four-Fold Rise in Bactericidal Antibody Titers From Baseline Following Vaccination With Either Menomune or Menactra Vaccine.
Hide Description Titers of antibodies to serogroups A, C, Y, and W-135 were measured by serum bactericidal assay with human complement (SBA-HC).
Time Frame Day 0 (pre-vaccination) and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Antibody titers were assessed in participants who met all inclusion, but no exclusion criteria; received assigned study vaccine; and had serology samples with valid test results (Per-Protocol Population).
Arm/Group Title Menomune® Vaccine Group Menactra® Vaccine Group
Hide Arm/Group Description:
All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
Overall Number of Participants Analyzed 32 99
Measure Type: Number
Unit of Measure: Participants
Serogroup A (N = 31, 99) 8 70
Serogroup C (N = 32, 99) 5 77
Serogroup Y (N = 31, 99) 4 75
Serogroup W-135 (N = 31, 99) 2 73
5.Other Pre-specified Outcome
Title Geometric Mean Titers of Individual Antibodies to Vaccine Antigens Following Vaccination With Either Menomune or Menactra Vaccine (SBA-BR)
Hide Description Geometric mean titers (GMTs) of antibodies to serogroups A, C, Y, and W-135 were measured by serum bactericidal assay with baby rabbit complement (SBA-BR).
Time Frame Day 0 (pre-vaccination) and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
GMTs were assessed in participants who met all inclusion, but no exclusion criteria; received assigned study vaccine; and had serology samples with valid test results (Per-Protocol Population).
Arm/Group Title Menomune® Vaccine Group Menactra® Vaccine Group
Hide Arm/Group Description:
All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
Overall Number of Participants Analyzed 32 99
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Serogroup A Pre-vaccination (N = 32, 99)
22.1
(9.5 to 51.6)
20.2
(12.8 to 31.7)
Serogroup A Post -vccination (N = 31, 98)
119.7
(45.9 to 312.3)
396.9
(266.8 to 590.5)
Serogroup C Pre-vaccination (N = 32, 99)
39.7
(16.2 to 97.6)
35
(22.1 to 55.6)
Serogroup C Post-vaccination (N = 31, 98)
109.5
(40.2 to 298.0)
698.9
(450.4 to 1084.7)
Serogroup Y Pre-vaccination (N = 32, 99)
71.3
(36.1 to 140.9)
70.6
(46.6 to 106.8)
Serogroup Y Post-vaccination (N = 31, 99)
200.2
(98.8 to 405.4)
556.9
(370.6 to 836.8)
Serogroup W-135 Pre-vaccination (N = 32, 99)
74.5
(37.5 to 147.9)
79
(52.4 to 118.9)
Serogroup W-135 Post-vaccination (N = 31, 98)
214.1
(101.6 to 451.2)
534.2
(351.7 to 811.4)
6.Other Pre-specified Outcome
Title Number of Participants With Antibody Titers at ≥ 1:8 for Each of the Vaccine Serogroups Before and After Vaccination With Either Menomune or Menactra Vaccine
Hide Description Titers of antibodies to vaccine serogroups A, C, Y, and W-135 were measured by serum bactericidal assay with baby rabbit complement (SBA-BR).
Time Frame Day 0 (pre-vaccination) and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Antibody titers were assessed in participants who met all inclusion, but no exclusion criteria; received assigned study vaccine and serology samples with valid test results (Per-Protocol Population).
Arm/Group Title Menomune® Vaccine Group Menactra® Vaccine Group
Hide Arm/Group Description:
All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
Overall Number of Participants Analyzed 32 99
Measure Type: Number
Unit of Measure: Participants
Serogroup A Pre-vaccination (N = 32, 99) 12 35
Serogroup A Post-vaccination (N = 31, 98) 21 87
Serogroup C Pre-vaccination (N = 32, 99) 17 53
Serogroup C Post-vaccination (N = 31, 98) 20 91
Serogroup Y Pre-vaccination (N = 32, 99) 26 75
Serogroup Y Post-vaccination (N = 31, 99) 29 94
Serogroup W-135 Pre-vaccination (N = 32, 99) 25 75
Serogroup W-135 Post-vaccination (N = 31, 98) 27 91
7.Other Pre-specified Outcome
Title Number of Participants Who Achieved a Four-Fold Rise in Bactericidal Antibody Titers From Baseline After Vaccination With Either Menomune or Menactra Vaccine
Hide Description Titers of antibodies to serogroups A, C, Y, and W-135 were measured by serum bactericidal assay with baby rabbit complement (SBA-BR).
Time Frame Day 0 (pre-vaccination) and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Antibody titers were assessed in participants who met all inclusion, but no exclusion criteria; received assigned study vaccine; and had serology samples with valid test results (Per-Protocol Population).
Arm/Group Title Menomune® Vaccine Group Menactra® Vaccine Group
Hide Arm/Group Description:
All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
Overall Number of Participants Analyzed 31 99
Measure Type: Number
Unit of Measure: Participants
Serogroup A (N = 31, 98) 12 69
Serogroup C (N = 31, 98) 10 78
Serogroup Y (N = 31, 99) 17 60
Serogroup W-135 (N = 31, 98) 13 67
Time Frame Adverse events data were collected from vaccination on Day 0 through Day 28 post-vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Menomune® Vaccine Group Menactra® Vaccine Group
Hide Arm/Group Description All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial. All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
All-Cause Mortality
Menomune® Vaccine Group Menactra® Vaccine Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Menomune® Vaccine Group Menactra® Vaccine Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/36 (0.00%)      0/103 (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%
Menomune® Vaccine Group Menactra® Vaccine Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/36 (25.00%)      33/103 (32.04%)    
General disorders     
Injection Site Pain  1  8/34 (23.53%)  8 33/103 (32.04%)  33
Injection Site Erythema  1  9/34 (26.47%)  9 0/103 (0.00%)  0
Malaise  1  3/34 (8.82%)  3 8/103 (7.77%)  8
Infections and infestations     
Upper Respiratory Tract Infection * 1  3/36 (8.33%)  3 1/103 (0.97%)  1
Injury, poisoning and procedural complications     
Muscle Strain * 1  2/36 (5.56%)  2 0/103 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Myalgia  1  6/34 (17.65%)  6 22/103 (21.36%)  22
Nervous system disorders     
Headache  1  8/34 (23.53%)  8 16/103 (15.53%)  16
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.1
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
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
ClinicalTrials.gov Identifier: NCT01239043     History of Changes
Other Study ID Numbers: MTA75
U1111-1115-6685 ( Other Identifier: WHO )
First Submitted: November 8, 2010
First Posted: November 11, 2010
Results First Submitted: May 14, 2012
Results First Posted: June 19, 2012
Last Update Posted: June 25, 2012