Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    MTA47
Previous Study | Return to List | Next Study

Immunology and Safety of Menactra® in Children 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: NCT00539032
Recruitment Status : Completed
First Posted : October 3, 2007
Results First Posted : January 24, 2011
Last Update Posted : April 14, 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: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
Enrollment 238
Recruitment Details Participants were enrolled from 30 September to 03 November 2007, at 4 health centers in Saudi Arabia.
Pre-assignment Details A total of 238 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Arm/Group Title Group 1: Menactra® Booster Group Group 2: Menactra® Primary Vaccine (Control) Group
Hide Arm/Group Description Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine. Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine.
Period Title: Overall Study
Started 153 85
Completed 151 84
Not Completed 2 1
Reason Not Completed
Withdrawal by Subject             2             1
Arm/Group Title Group 1: Menactra® Booster Group Group 2: Menactra® Primary Vaccine (Control) Group Total
Hide Arm/Group Description Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine. Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine. Total of all reporting groups
Overall Number of Baseline Participants 153 85 238
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 153 participants 85 participants 238 participants
<=18 years
153
 100.0%
85
 100.0%
238
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 153 participants 85 participants 238 participants
6.12  (0.60) 6.52  (1.22) 6.26  (0.89)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 153 participants 85 participants 238 participants
Female
84
  54.9%
47
  55.3%
131
  55.0%
Male
69
  45.1%
38
  44.7%
107
  45.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Saudi Arabia Number Analyzed 153 participants 85 participants 238 participants
153 85 238
1.Primary Outcome
Title Geometric Mean Titers (GMTs) as Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination.
Hide Description [Not Specified]
Time Frame Day 0 (baseline or pre-vaccination) and Day 28 Post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers by serum bactericidal assay were determined in the per-protocol population.
Arm/Group Title Group 1: Menactra® Booster Group Group 2: Menactra® Primary Vaccine (Control) Group
Hide Arm/Group Description:
Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine.
Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine.
Overall Number of Participants Analyzed 140 81
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Serogroup A: Pre-vaccination
168.9
(117.4 to 243.1)
196.4
(119.0 to 324.0)
Serogroup A: Day 28 Post-vaccination
6991.7
(6107.6 to 8003.8)
8263.3
(6913.1 to 9877.2)
Serogroup C: Pre-vaccination
2.5
(2.2 to 3.0)
4.1
(2.8 to 5.9)
Serogroup C: Day 28 Post-vaccination
167.2
(115.3 to 242.7)
512.0
(334.4 to 761.2)
Serogroup Y: Pre-vaccination
10.2
(6.8 to 15.2)
12.4
(7.1 to 21.6)
Serogroup Y: Day 28 Post-vaccination
2120.2
(1799.0 to 2498.9)
2558.3
(2015.5 to 3247.3)
Serogroup W-135: Pre-vaccination
3.0
(2.4 to 3.8)
2.7
(2.1 to 3.5)
Serogroup W-135: Day 28 Post-vaccination
2387.7
(1950.1 to 2923.5)
2763.2
(2153.9 to 3544.8)
2.Primary Outcome
Title Percentage of Participants With ≥ 4-Fold Rise in Titers for the Menactra® Vaccine Serogroups A, C, Y, and W-135.
Hide Description [Not Specified]
Time Frame Day 28 Post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
4-Fold rise in Menactra® vaccine antibodies were evaluated in the per-protocol population.
Arm/Group Title Group 1: Menactra® Booster Group Group 2: Menactra® Primary Vaccine (Control) Group
Hide Arm/Group Description:
Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine.
Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine.
Overall Number of Participants Analyzed 140 81
Measure Type: Number
Unit of Measure: Percentage of Participants
Serogroup A 94 94
Serogroup C 84 90
Serogroup Y 97 98
Serogroup W-135 99 100
3.Other Pre-specified Outcome
Title Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra®
Hide Description Solicited injection Site reactions: Pain, erythema, and swelling; Solicited systemic reactions: Fever, headache, malaise and myalgia.
Time Frame Days 0-7 Post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat safety population.
Arm/Group Title Group 1: Menactra® Booster Group Group 2: Menactra® Primary Vaccine (Control) Group
Hide Arm/Group Description:
Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine.
Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine.
Overall Number of Participants Analyzed 151 85
Measure Type: Number
Unit of Measure: Participants
Any Solicited Injection Site Reaction 35 19
Any Pain 32 15
Grade 3 Pain (Incapacitating) 1 0
Any Erythema 10 8
Grade 3 Erythema (≥ 5 cm) 0 0
Any Swelling 11 8
Grade 3 Swelling (≥ 5 cm) 0 0
Any Solicited Systemic Reaction 36 16
Any Fever 16 8
Grade 3 Fever (> 39.0 ºC) 1 2
Any Headache 13 5
Grade 3 Headache (Prevents daily activities) 0 0
Any Malaise 18 11
Grade 3 Malaise (Prevents daily activities) 0 0
Any Myalgia 21 10
Grade 3 Myalgia (Prevents daily activities) 0 0
Time Frame Adverse events data were collected from the day of vaccination for up to 28 days post-vaccination
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1: Menactra® Booster Group Group 2: Menactra® Primary Vaccine (Control) Group
Hide Arm/Group Description Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine. Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine.
All-Cause Mortality
Group 1: Menactra® Booster Group Group 2: Menactra® Primary Vaccine (Control) Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Group 1: Menactra® Booster Group Group 2: Menactra® Primary Vaccine (Control) Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/151 (0.66%)      0/85 (0.00%)    
Infections and infestations     
Appendicitis * 1  1/151 (0.66%)  1 0/85 (0.00%)  0
Postoperative wound infections * 1  1/151 (0.66%)  1 0/85 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group 1: Menactra® Booster Group Group 2: Menactra® Primary Vaccine (Control) Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   32/151 (21.19%)      15/85 (17.65%)    
General disorders     
Injection site pain  1  32/151 (21.19%)  32 15/85 (17.65%)  15
Injection site erythema  1  10/151 (6.62%)  10 8/85 (9.41%)  8
Injection site swelling  1  11/151 (7.28%)  11 8/85 (9.41%)  8
Pyrexia  1  16/151 (10.60%)  16 8/85 (9.41%)  8
Malaise  1  18/151 (11.92%)  18 11/85 (12.94%)  11
Myalgia  1  21/151 (13.91%)  21 10/85 (11.76%)  10
Nervous system disorders     
Headache  1  13/151 (8.61%)  13 5/85 (5.88%)  5
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.0
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
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00539032     History of Changes
Other Study ID Numbers: MTA47
First Submitted: October 2, 2007
First Posted: October 3, 2007
Results First Submitted: September 9, 2009
Results First Posted: January 24, 2011
Last Update Posted: April 14, 2016