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Trial record 1 of 1 for:    MTA15
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Study of Antibody Responses After a Dose of Tetravalent Meningococcal Diphtheria Conjugate Vaccine in Children

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ClinicalTrials.gov Identifier: NCT00771849
Recruitment Status : Completed
First Posted : October 15, 2008
Results First Posted : April 24, 2009
Last Update Posted : April 14, 2016
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 Meningitis
Meningococcemia
Interventions Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
Biological: Haemophilus Influenzae Type b (Hib) vaccine
Enrollment 103
Recruitment Details Subjects were recruited from August 2003 through March 2004 at 2 clinics in the United Kingdom.
Pre-assignment Details A total of 103 subjects that met the inclusion but none of the exclusion criteria were enrolled, 102 subjects were vaccinated.
Arm/Group Title Menactra® Vaccine Group Hiberix® Vaccine Group
Hide Arm/Group Description Participants received Menactra® Vaccine Participants received Hiberix® Vaccine
Period Title: Overall Study
Started 52 51 [1]
Completed 50 47
Not Completed 2 4
Reason Not Completed
Lost to Follow-up             1             2
Withdrawal by Subject             1             1
Not vaccinated             0             1
[1]
One subject was not vaccinated
Arm/Group Title Menactra® Vaccine Group Hiberix® Vaccine Group Total
Hide Arm/Group Description Participants received Menactra® Vaccine Participants received Hiberix® Vaccine Total of all reporting groups
Overall Number of Baseline Participants 52 51 103
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 51 participants 103 participants
<=18 years
52
 100.0%
51
 100.0%
103
 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:  Months
Number Analyzed 52 participants 51 participants 103 participants
37.0  (8.5) 37.6  (8.3) 37.3  (8.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 51 participants 103 participants
Female
28
  53.8%
22
  43.1%
50
  48.5%
Male
24
  46.2%
29
  56.9%
53
  51.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 52 participants 51 participants 103 participants
52 51 103
1.Primary Outcome
Title Geometric Mean of Antibody Titers (GMTs) as Measured by Serum Bactericidal Assay (SBA) at Baseline (Day 0) and Day 28 Post-vaccination.
Hide Description [Not Specified]
Time Frame Day 0 (before) and 28 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
SBA geometric mean titers for each of the 4 meningococcal serogroups was evaluated in the per-protocol population.
Arm/Group Title Menactra® Vaccine Group Hiberix® Vaccine Group
Hide Arm/Group Description:
Participants received Menactra® Vaccine
Participants received Hiberix® Vaccine
Overall Number of Participants Analyzed 44 36
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Meningococcal Serogroup A - Day 0
136.33
(69.39 to 267.84)
99.66
(47.66 to 208.40)
Meningococcal Serogroup A - Day 28
11404.16
(7383.63 to 17613.96)
199.31
(93.14 to 426.52)
Meningococcal Serogroup C - Day 0
76.11
(36.57 to 158.41)
26.91
(12.49 to 57.97)
Meningococcal Serogroup C - Day 28
12534.67
(8407.56 to 18687.71)
22.63
(10.50 to 48.76)
Meningococcal Serogroup Y - Day 0
236.61
(133.11 to 420.60)
266.05
(151.05 to 468.59)
Meningococcal Serogroup Y - Day 28
4031.98
(2399.10 to 6776.24)
298.63
(155.64 to 572.99)
Meningococcal Serogroup W-135 - Day 0
26.07
(13.30 to 51.13)
24.44
(11.76 to 50.79)
Meningococcal Serogroup W-135 - Day 28
5978.03
(3852.54 to 9276.19)
32
(16.33 to 62.71)
2.Secondary Outcome
Title Participants With a ≥ 4-Fold Rise in Antibody Titers as Measured by Serum Bactericidal Assay (SBA) From Baseline to Day 28 Post-vaccination.
Hide Description [Not Specified]
Time Frame 28 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
SBA titers for each of the 4 meningococcal serogroups was evaluated in the per-protocol population.
Arm/Group Title Menactra® Vaccine Group Hiberix® Vaccine Group
Hide Arm/Group Description:
Participants received Menactra® Vaccine
Participants received Hiberix® Vaccine
Overall Number of Participants Analyzed 44 36
Measure Type: Number
Unit of Measure: Participants
Meningococcal Serogroup A 43 11
Meningococcal Serogroup C 41 2
Meningococcal Serogroup Y 35 1
Meningococcal Serogroup W-135 43 8
Time Frame Adverse events data were collected from the day of vaccination for 28 days post-vaccination.
Adverse Event Reporting Description One participant in the Menactra® vaccine group and 3 participants in the Hiberix® vaccine group that did not complete the study also did not report any unsolicited adverse event.
 
Arm/Group Title Menactra® Vaccine Group Hiberix® Vaccine Group
Hide Arm/Group Description Participants received Menactra® Vaccine Participants received Hiberix® Vaccine
All-Cause Mortality
Menactra® Vaccine Group Hiberix® Vaccine Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Menactra® Vaccine Group Hiberix® Vaccine Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/52 (1.92%)      0/50 (0.00%)    
Nervous system disorders     
Febrile convulsion * 1  1/52 (1.92%)  1 0/50 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 6.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Menactra® Vaccine Group Hiberix® Vaccine Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/52 (28.85%)      22/50 (44.00%)    
Gastrointestinal disorders     
Diarrhoea NOS * 1  2/51 (3.92%)  3/47 (6.38%) 
Pyrexia * 1  1/51 (1.96%)  3/47 (6.38%) 
Infections and infestations     
Gastroenteritis NOS * 1  0/51 (0.00%)  3/47 (6.38%) 
Otitis media NOS * 1  0/51 (0.00%)  3/47 (6.38%) 
Upper respiratory tract infection NOS * 1  10/51 (19.61%)  14/47 (29.79%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  3/51 (5.88%)  3/47 (6.38%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 6.0
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: NCT00771849     History of Changes
Other Study ID Numbers: MTA15
First Submitted: October 13, 2008
First Posted: October 15, 2008
Results First Submitted: March 16, 2009
Results First Posted: April 24, 2009
Last Update Posted: April 14, 2016