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Trial record 1 of 1 for:    MTA40
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Immunogenicity and Safety of Menactra® Vaccine in Adolescents in Saudi Arabia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00444951
Recruitment Status : Completed
First Posted : March 8, 2007
Results First Posted : March 4, 2011
Last Update Posted : July 14, 2015
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Neisseria Meningitidis
Meningococcal Infections
Interventions Biological: Menactra®: Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine
Biological: Mencevax®: Group A, C, W135 and Y polysaccharide meningococcal vaccine
Enrollment 450
Recruitment Details Participants were enrolled from 17 February 2007, to 01 July 2007, in 7 clinic centers in Saudi Arabia.
Pre-assignment Details A total of 450 participants who met the inclusion and exclusion criteria were enrolled, and 446 were vaccinated.
Arm/Group Title Menactra® Group Mencevax® Group Control Group
Hide Arm/Group Description Participants have received previously a dose of an A, C, Y, W-135 vaccine and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, received a booster dose of Menactra® (Meningococcal [serogroups A, C, Y, W-135] polysaccharide diphtheria toxoid conjugate) vaccine. Participants who had previously been given 1 dose of quadrivalent (A, C, Y, W-135) and at least 1 dose of bivalent (A, C) meningococcal polysaccharide vaccine received a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine. Participants who had not previously been given any meningococcal vaccine received 1 dose of Menactra®, meningococcal (serogroups A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine.
Period Title: Overall Study
Started 145 142 163
Completed 140 136 160
Not Completed 5 6 3
Reason Not Completed
Lost to Follow-up             1             1             0
Withdrawal by Subject             4             5             3
Arm/Group Title Menactra® Group Mencevax® Group Control Group Total
Hide Arm/Group Description Participants have received previously a dose of an A, C, Y, W-135 vaccine and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, received a booster dose of Menactra® (Meningococcal [serogroups A, C, Y, W-135] polysaccharide diphtheria toxoid conjugate) vaccine. Participants who had previously been given 1 dose of quadrivalent (A, C, Y, W-135) and at least 1 dose of bivalent (A, C) meningococcal polysaccharide vaccine received a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine. Participants who had not previously been given any meningococcal vaccine received 1 dose of Menactra®, meningococcal (serogroups A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine. Total of all reporting groups
Overall Number of Baseline Participants 145 142 163 450
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 145 participants 142 participants 163 participants 450 participants
<=18 years
110
  75.9%
115
  81.0%
134
  82.2%
359
  79.8%
Between 18 and 65 years
35
  24.1%
27
  19.0%
29
  17.8%
91
  20.2%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 145 participants 142 participants 163 participants 450 participants
17.90  (1.20) 17.77  (1.15) 17.85  (1.15) 17.84  (1.16)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 145 participants 142 participants 163 participants 450 participants
Female
78
  53.8%
78
  54.9%
53
  32.5%
209
  46.4%
Male
67
  46.2%
64
  45.1%
110
  67.5%
241
  53.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Saudi Arabia Number Analyzed 145 participants 142 participants 163 participants 450 participants
145 142 163 450
1.Primary Outcome
Title Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination
Hide Description [Not Specified]
Time Frame Baseline (Day 0) and Day 28 after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers were evaluated in participants who received vaccine injection (full analysis set population).
Arm/Group Title Menactra® Group Mencevax® Group Control Group
Hide Arm/Group Description:
Participants have received previously a dose of an A, C, Y, W-135 vaccine and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, received a booster dose of Menactra® (Meningococcal [serogroups A, C, Y, W-135] polysaccharide diphtheria toxoid conjugate) vaccine.
Participants who had previously been given 1 dose of quadrivalent (A, C, Y, W-135) and at least 1 dose of bivalent (A, C) meningococcal polysaccharide vaccine received a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine.
Participants who had not previously been given any meningococcal vaccine received 1 dose of Menactra®, meningococcal (serogroups A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine.
Overall Number of Participants Analyzed 144 141 161
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dil)
Serogroup A (Baseline)
651.5
(496.4 to 854.9)
889.7
(699.5 to 1131.5)
441.1
(327.8 to 593.4)
Serogroup A (Day 28)
4116.3
(3468.7 to 4884.9)
3833.4
(3308.4 to 4441.7)
6351.6
(5508.3 to 7324.0)
Serogroup C (Baseline)
14.7
(9.9 to 22.0)
15.8
(10.4 to 23.8)
16.8
(11.1 to 25.4)
Serogroup C (Day 28)
288.3
(190.2 to 437.0)
158.6
(99.7 to 252.0)
993.4
(714.5 to 1381.2)
Serogroup Y (Baseline)
78.8
(49.7 to 125.0)
73.4
(44.7 to 120.7)
16.8
(11.1 to 25.3)
Serogroup Y (Day 28)
2770.1
(2197.0 to 3492.6)
1936.3
(1425.7 to 2629.8)
4204.6
(3458.2 to 5112.0)
Serogroup W-135 (Baseline)
18.5
(11.8 to 29.0)
24.5
(15.2 to 39.6)
8.1
(5.6 to 11.8)
Serogroup W-135 (Day 28)
2435.5
(1714.7 to 3459.3)
1455.7
(958.1 to 2211.7)
6926.7
(5647.9 to 8495.1)
2.Secondary Outcome
Title Percentage of Participants With At Least a 4-Fold Rise in Titers Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Post-Menatcra® Vaccination
Hide Description [Not Specified]
Time Frame Baseline (Day 0) and Day 28 After Vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
4-Fold rise titers were determined in the per-protocol population.
Arm/Group Title Menactra® Group Mencevax® Group Control Group
Hide Arm/Group Description:
Participants have received previously a dose of an A, C, Y, W-135 vaccine and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, received a booster dose of Menactra® (Meningococcal [serogroups A, C, Y, W-135] polysaccharide diphtheria toxoid conjugate) vaccine.
Participants who had previously been given 1 dose of quadrivalent (A, C, Y, W-135) and at least 1 dose of bivalent (A, C) meningococcal polysaccharide vaccine received a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine.
Participants who had not previously been given any meningococcal vaccine received 1 dose of Menactra®, meningococcal (serogroups A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine.
Overall Number of Participants Analyzed 140 136 160
Measure Type: Number
Unit of Measure: Percentage of Participants
Serogroup A 66 62 86
Serogroup C 71 57 81
Serogroup Y 80 69 96
Serogroup W-135 84 72 96
3.Secondary Outcome
Title Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination
Hide Description [Not Specified]
Time Frame Day 0 to Day 7 Post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis was on all vaccinated participants, intend-to-treat population (Safety analysis set)
Arm/Group Title Menactra® Group Mencevax® Group Control Group
Hide Arm/Group Description:
Participants have received previously a dose of an A, C, Y, W-135 vaccine and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, received a booster dose of Menactra® (Meningococcal [serogroups A, C, Y, W-135] polysaccharide diphtheria toxoid conjugate) vaccine.
Participants who had previously been given 1 dose of quadrivalent (A, C, Y, W-135) and at least 1 dose of bivalent (A, C) meningococcal polysaccharide vaccine received a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine.
Participants who had not previously been given any meningococcal vaccine received 1 dose of Menactra®, meningococcal (serogroups A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine.
Overall Number of Participants Analyzed 144 141 160
Measure Type: Number
Unit of Measure: Participants
Any Solicited Injection Site Reaction 88 71 98
Any Injection Site Pain 85 66 95
Grade 3 Injection Site Pain (Incapacitating) 10 3 9
Any Injection Site Erythema 39 34 42
Grade 3 Injection Site Erythema (≥ 5 cm) 0 1 2
Any Injection Site Swelling 46 29 34
Grade 3 Injection Site Swelling (≥ 5 cm) 0 0 4
Any Solicited Systemic Reaction 87 86 90
Any Fever 25 17 16
Grade 3 Fever (> 39.0 ºC) 3 1 0
Any Headache 66 64 60
Grade 3 Headache (Prevents daily activities) 8 6 8
Any Malaise 61 55 61
Grade 3 Malaise (Prevents daily activities) 8 7 6
Any Myalgia 60 55 72
Grade 3 Myalgia (Prevents daily activities) 10 8 10
Time Frame Adverse event data were collected from Day 0 to 1 month post-vaccination
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Menactra® Group Mencevax® Group Control Group
Hide Arm/Group Description Participants have received previously a dose of an A, C, Y, W-135 vaccine and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, received a booster dose of Menactra® (Meningococcal [serogroups A, C, Y, W-135] polysaccharide diphtheria toxoid conjugate) vaccine. Participants who had previously been given 1 dose of quadrivalent (A, C, Y, W-135) and at least 1 dose of bivalent (A, C) meningococcal polysaccharide vaccine received a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine. Participants who had not previously been given any meningococcal vaccine received 1 dose of Menactra®, meningococcal (serogroups A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine.
All-Cause Mortality
Menactra® Group Mencevax® Group Control Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Menactra® Group Mencevax® Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/144 (0.69%)      0/141 (0.00%)      0/160 (0.00%)    
Infections and infestations       
Perianal abcess * 1  1/144 (0.69%)  1 0/141 (0.00%)  0 0/160 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.0%
Menactra® Group Mencevax® Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   85/144 (59.03%)      66/141 (46.81%)      95/160 (59.38%)    
Gastrointestinal disorders       
Malaise † 1  61/142 (42.96%)  61 55/138 (39.86%)  55 61/158 (38.61%)  61
General disorders       
Injection site pain † 1  85/142 (59.86%)  85 66/138 (47.83%)  66 95/158 (60.13%)  95
Injection site erythema † 1  39/142 (27.46%)  39 34/138 (24.64%)  34 42/158 (26.58%)  42
Injection site swelling † 1  46/142 (32.39%)  46 29/138 (21.01%)  29 34/158 (21.52%)  34
Fever † 1  25/142 (17.61%)  25 17/138 (12.32%)  17 16/158 (10.13%)  16
Musculoskeletal and connective tissue disorders       
Myalgia † 1  60/142 (42.25%)  60 55/138 (39.86%)  55 72/158 (45.57%)  72
Nervous system disorders       
Headache † 1  66/142 (46.48%)  66 64/138 (46.38%)  64 60/158 (37.97%)  60
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
[Not Specified]
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
Publications:
Layout table for additonal information
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00444951    
Other Study ID Numbers: MTA40
First Submitted: March 7, 2007
First Posted: March 8, 2007
Results First Submitted: February 9, 2011
Results First Posted: March 4, 2011
Last Update Posted: July 14, 2015