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Study of a Single Dose of Menactra® Vaccine 4-6 Years After Prior Menactra Vaccine

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ClinicalTrials.gov Identifier: NCT01442675
Recruitment Status : Completed
First Posted : September 28, 2011
Results First Posted : November 18, 2014
Last Update Posted : November 18, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Meningitis
Meningococcal Infection
Intervention Biological: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate: Menactra®
Enrollment 834
Recruitment Details The study participants were enrolled from 26 September 2011 through 21 December 2011 at 15 clinic centers in the United States.
Pre-assignment Details A total of 834 participants who met all of the inclusion and none of the exclusion criteria were randomized; 831 were vaccinated in this study.
Arm/Group Title Menactra® Vaccine Group
Hide Arm/Group Description Participants <56 years of age who received Menactra vaccine 4-6 years previously at age ≥11 years received a single dose of Menactra vaccine in this study.
Period Title: Overall Study
Started 834
Safety Analysis Set 831 [1]
Per-Protocol Analysis Set 781 [2]
Completed 822
Not Completed 12
Reason Not Completed
Protocol Violation             6
Lost to Follow-up             2
Withdrawal by Subject             4
[1]
Safety Analysis Set are subjects who received study vaccine and for whom safety data were available.
[2]
The Per-Protocol Analysis Set are subjects with no pre-defined protocol deviations.
Arm/Group Title Menactra® Vaccine Group
Hide Arm/Group Description Participants <56 years of age who received Menactra vaccine 4-6 years previously at age ≥11 years received a single dose of Menactra in this study.
Overall Number of Baseline Participants 834
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 834 participants
<=18 years
592
  71.0%
Between 18 and 65 years
242
  29.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Age Continuous Number Analyzed 834 participants
17.8  (3.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 834 participants
Female
434
  52.0%
Male
400
  48.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 834 participants
834
1.Primary Outcome
Title Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®
Hide Description Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC)
Time Frame Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
SBA-HC antibody titers were assessed in the Per-protocol Analysis Set.
Arm/Group Title Menactra® Vaccine Group
Hide Arm/Group Description:
Participants <56 years of age who received Menactra vaccine 4-6 years previously at age ≥11 years received a single dose of Menactra in this study.
Overall Number of Participants Analyzed 781
Measure Type: Number
Unit of Measure: Participants
Serogroup A 776
Serogroup C 778
Serogroup Y 779
Serogroup W-135 780
2.Secondary Outcome
Title Number of Participants Achieving Antibody Titers ≥1:4 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Hide Description

Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC).

Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.

Time Frame Day 0 (pre-vaccination), Day 6 and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
SBA-HC antibody titers were assessed in the Per-protocol Analysis Set. Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.
Arm/Group Title Menactra® Vaccine Group
Hide Arm/Group Description:
Participants <56 years of age who received Menactra 4-6 years previously at age ≥11 years received a single dose of Menactra vaccine
Overall Number of Participants Analyzed 781
Measure Type: Number
Unit of Measure: Participants
Serogroup A (Day 0 pre-vaccination; N=781) 675
Serogroup A (Day 6 post-vaccination; N=112) 110
Serogroup A (Day 28 post-vaccination; N=781) 781
Serogroup C (Day 0 pre-vaccination; N=781) 443
Serogroup C (Day 6 post-vaccination; N=112) 112
Serogroup C (Day 28 post-vaccination; N=781) 780
Serogroup Y (Day 0 pre-vaccination; N=781) 389
Serogroup Y (Day 6 post-vaccination; N=112) 111
Serogroup Y (Day 28 post-vaccination; N=781) 780
Serogroup W-135 (Day 0 pre-vaccination; N=781) 604
Serogroup W-135 (Day 6 post-vaccination; N=112) 111
Serogroup W-135 (Day 28 post-vaccination; N=781) 780
3.Secondary Outcome
Title Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Hide Description

Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC).

Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.

Time Frame Day 0 (pre-vaccination), Day 6 and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
SBA-HC antibody titers were assessed in the Per-protocol Analysis Set. Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.
Arm/Group Title Menactra® Vaccine Group
Hide Arm/Group Description:
Participants <56 years of age who received Menactra 4-6 years previously at age ≥11 years received a single dose of Menactra vaccine
Overall Number of Participants Analyzed 781
Measure Type: Number
Unit of Measure: Participants
Serogroup A (Day 0 pre-vaccination; N=781) 504
Serogroup A (Day 6 post-vaccination; N=112) 110
Serogroup A (Day 28 post-vaccination; N=781) 776
Serogroup C (Day 0 pre-vaccination; N=781) 345
Serogroup C (Day 6 post-vaccination; N=112) 111
Serogroup C (Day 28 post-vaccination; N=781) 778
Serogroup Y (Day 0 pre-vaccination; N=781) 302
Serogroup Y (Day 6 post-vaccination; N=112) 111
Serogroup Y (Day 28 post-vaccination; N=781) 779
Serogroup W-135 (Day 0 pre-vaccination; N=781) 535
Serogroup W-135 (Day 6 post-vaccination; N=112) 111
Serogroup W-135 (Day 28 post-vaccination; N=781) 780
4.Secondary Outcome
Title Number of Participants Achieving At Least Four-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®
Hide Description Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC). Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.
Time Frame Day 6 and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
SBA-HC antibody titers were assessed in the Per-protocol Analysis Set. Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.
Arm/Group Title Menactra® Vaccine Group
Hide Arm/Group Description:
Participants <56 years of age who received Menactra 4-6 years previously at age ≥11 years received a single dose of Menactra vaccine
Overall Number of Participants Analyzed 781
Measure Type: Number
Unit of Measure: Participants
Serogroup A (Day 6 post-vaccination; N=112) 97
Serogroup A (Day 28 post-vaccination; N=781) 742
Serogroup C (Day 6 post-vaccination; N=112) 102
Serogroup C (Day 28 post-vaccination; N=781) 744
Serogroup Y (Day 6 post-vaccination; N=112) 106
Serogroup Y (Day 28 post-vaccination; N=781) 758
Serogroup W-135 (Day 6 post-vaccination; N=112) 103
Serogroup W-135 (Day 28 post-vaccination; N=781) 750
5.Secondary Outcome
Title Geometric Mean Antibody Titers Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Hide Description Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC). Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.
Time Frame Day 0 (pre-vaccination), Day 6 and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers (GMTs) were assessed in the Per-protocol Analysis Set. Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC GMTs at this time point.
Arm/Group Title Menactra® Vaccine Group
Hide Arm/Group Description:
Participants <56 years of age who received Menactra 4-6 years previously at age ≥11 years received a single dose of Menactra vaccine
Overall Number of Participants Analyzed 781
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Serogroup A (Day 0 pre-vaccination; N=781)
8.9
(8.3 to 9.6)
Serogroup A (Day 6 post-vaccination; N=112)
227.6
(166.4 to 311.3)
Serogroup A (Day 28 post-vaccination; N=781)
421.2
(378.8 to 468.3)
Serogroup C (Day 0 pre-vaccination; N=781)
8.8
(7.8 to 10.0)
Serogroup C (Day 6 post-vaccination; N=112)
639.8
(457.4 to 895.0)
Serogroup C (Day 28 post-vaccination; N=781)
1135
(1013.0 to 1271.8)
Serogroup Y (Day 0 pre-vaccination; N=781)
6.2
(5.6 to 6.9)
Serogroup Y (Day 6 post-vaccination; N=112)
655.8
(474.8 to 905.9)
Serogroup Y (Day 28 post-vaccination; N=781)
1303.6
(1183.1 to 1436.4)
Serogroup W-135 (Day 0 pre-vaccination; N=781)
13.8
(12.4 to 15.3)
Serogroup W-135 (Day 6 post-vaccination; N=112)
702
(508.0 to 970.2)
Serogroup W-135 (Day 28 post-vaccination; N=781)
1271.6
(1145.3 to 1411.8)
6.Secondary Outcome
Title Geometric Mean Antibody Titer Ratios Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®
Hide Description Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC). Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.
Time Frame Day 6 and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers ratios (GMTRs) were assessed in the Per-protocol Analysis Set. Serum samples were also collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC GMTRs at this time point.
Arm/Group Title Menactra® Vaccine Group
Hide Arm/Group Description:
Participants <56 years of age who received Menactra 4-6 years previously at age ≥11 years received a single dose of Menactra vaccine
Overall Number of Participants Analyzed 781
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers ratio
Serogroup A (Day 6 post-vaccination; N=112)
30.5
(21.8 to 42.5)
Serogroup A (Day 28 post-vaccination; N=781)
47.2
(42.3 to 52.7)
Serogroup C (Day 6 post-vaccination; N=112)
64
(42.7 to 95.9)
Serogroup C (Day 28 post-vaccination; N=781)
128.3
(112.0 to 147.0)
Serogroup Y (Day 6 post-vaccination; N=112)
121.1
(84.5 to 173.5)
Serogroup Y (Day 28 post-vaccination; N=781)
209.1
(184.4 to 237.1)
Serogroup W-135 (Day 6 post-vaccination; N=112)
45.5
(31.0 to 67.0)
Serogroup W-135 (Day 28 post-vaccination; N=781)
92.4
(81.1 to 105.4)
7.Secondary Outcome
Title Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®
Hide Description Solicited injection-site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 injection-site reactions: Pain - Significant, prevents daily activity; Erythema and Swelling - >100 mm. Grade 3 systemic reactions: Fever - ≥40˚C or ≥104˚F; Headache, Malaise, Myalgia, and Shivering - Significant, prevents daily activity.
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 Menactra® Vaccine Group
Hide Arm/Group Description:
Participants <56 years of age who received Menactra 4-6 years previously at age ≥11 years received a single dose of Menactra vaccine
Overall Number of Participants Analyzed 831
Measure Type: Number
Unit of Measure: Participants
Injection-site Pain (N=821) 494
Grade 3 Injection-site Pain (N=821) 20
Injection-site Erythema (N=821) 10
Grade 3 Injection-site Erythema (N=821) 0
Injection-site Swelling (N=821) 14
Grade 3 Injection-site Swelling (N=821) 0
Fever (N=817) 6
Grade 3 Fever (N=817) 0
Headache (N=822) 317
Grade 3 Headache (N=822) 22
Malaise (N=822) 242
Grade 3 Malaise (N=822) 23
Myalgia (N=822) 352
Grade 3 Myalgia (N=822) 19
Shivering (N=822) 102
Grade 3 Shivering (N=822) 6
Time Frame Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
Adverse Event Reporting Description The solicited injection site and systemic reactions were recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
 
Arm/Group Title Menactra® Vaccine Group
Hide Arm/Group Description Participants <56 years of age who received Menactra 4-6 years previously at age >= 11 years received a single dose of Menactra vaccine
All-Cause Mortality
Menactra® Vaccine Group
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Menactra® Vaccine Group
Affected / at Risk (%) # Events
Total   11/831 (1.32%)    
Infections and infestations   
Bronchitis * 1  1/831 (0.12%)  1
Appendicitis * 1  1/831 (0.12%)  1
Serratia infection * 1  1/831 (0.12%)  1
Injury, poisoning and procedural complications   
Injury * 1  1/831 (0.12%)  1
Wound Dehiscence * 1  1/831 (0.12%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Benign hydatidiform mole * 1  1/831 (0.12%)  1
Psychiatric disorders   
Affective disorder * 1  1/831 (0.12%)  1
Depression * 1  1/831 (0.12%)  1
Suicidal ideation * 2  2/831 (0.24%)  2
Renal and urinary disorders   
Post streptococcal glomerulonephritis * 2  1/831 (0.12%)  1
Respiratory, thoracic and mediastinal disorders   
Pulmonary embolism * 2  1/831 (0.12%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.0
2
Term from vocabulary, MedDRA version 14.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
Menactra® Vaccine Group
Affected / at Risk (%) # Events
Total   494/831 (59.45%)    
General disorders   
Injection site Pain  1  494/821 (60.17%)  494
Malaise  1  242/822 (29.44%)  242
Shivering  1  102/822 (12.41%)  102
Musculoskeletal and connective tissue disorders   
Myalgia  1  352/822 (42.82%)  352
Nervous system disorders   
Headache  1  317/822 (38.56%)  317
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 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: NCT01442675    
Other Study ID Numbers: MTA77
U1111-1117-7012 ( Other Identifier: WHO )
First Submitted: September 26, 2011
First Posted: September 28, 2011
Results First Submitted: November 11, 2014
Results First Posted: November 18, 2014
Last Update Posted: November 18, 2014