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Trial record 1 of 1 for:    MTA16
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Antibody Responses Following Meningococcal Tetravalent (A, C, Y, and W-135) Conjugate Vaccination in Healthy Adults

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ClinicalTrials.gov Identifier: NCT00772629
Recruitment Status : Terminated (See detailed description for termination reason)
First Posted : October 15, 2008
Results First Posted : April 27, 2009
Last Update Posted : February 14, 2014
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: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
Enrollment 18
Recruitment Details Participants were recruited from 26 January to 29 April 2004 at 2 Medical clinics in the United Kingdom
Pre-assignment Details Eighteen (18) participants that met the inclusion and exclusion criteria were enrolled. One whom no baseline blood sample could be obtained at Visit 1 was not vaccinated and withdrew from the study.
Arm/Group Title Meningococcal Vaccine-naive Group Meningococcal Vaccine-primed Group
Hide Arm/Group Description Participants have never received any meningococcal vaccine in the past Participants who previously received unconjugated polysaccharide vaccine (either bivalent A and C or tetravalent A, C, Y, and W 135
Period Title: Overall Study
Started 17 1
Completed 16 1
Not Completed 1 0
Reason Not Completed
Subject was not vaccinated             1             0
Arm/Group Title Meningococcal Vaccine-naive Group Meningococcal Vaccine-primed Group Total
Hide Arm/Group Description Participants have never received any meningococcal vaccine in the past Participants who previously received unconjugated polysaccharide vaccine (either bivalent A and C or tetravalent A, C, Y, and W 135 Total of all reporting groups
Overall Number of Baseline Participants 17 1 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 1 participants 18 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
17
 100.0%
1
 100.0%
18
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 1 participants 18 participants
35.8  (10.20) 43.0  (0) 36.2  (10.03)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 1 participants 18 participants
Female
13
  76.5%
0
   0.0%
13
  72.2%
Male
4
  23.5%
1
 100.0%
5
  27.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 17 participants 1 participants 18 participants
17 1 18
1.Primary Outcome
Title Participants With a ≥ 4-fold Rise in Antibody Titers as Measured by Serum Bactericidal Assay (SBA) From Day 0 to Day 28.
Hide Description Number of participants with a minimum of 4 fold rise in Antibody Titers as Measured SBA to each vaccine meningococcal serogroups from Baseline to Day 28.
Time Frame Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
SBA-BR to each of the 4 meningococcal serogroups in the vaccine was evaluated in the per-protocol population.
Arm/Group Title Meningococcal Vaccine-naive Group Meningococcal Vaccine-primed Group
Hide Arm/Group Description:
Participants have never received any meningococcal vaccine in the past
Participants who previously received unconjugated polysaccharide vaccine (either bivalent A and C or tetravalent A, C, Y, and W 135
Overall Number of Participants Analyzed 16 1
Measure Type: Number
Unit of Measure: Participants
Meningococcal serogroup A 14 0
Meningococcal serogroup C 11 0
Meningococcal serogroup Y 14 1
Meningococcal serogroup W-135 15 0
Time Frame Adverse events data were collected from the day of vaccination for 42 days post-vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Meningococcal Vaccine-naive Group Meningococcal Vaccine-primed Group
Hide Arm/Group Description Participants have never received any meningococcal vaccine in the past Participants who previously received unconjugated polysaccharide vaccine (either bivalent A and C or tetravalent A, C, Y, and W 135
All-Cause Mortality
Meningococcal Vaccine-naive Group Meningococcal Vaccine-primed Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Meningococcal Vaccine-naive Group Meningococcal Vaccine-primed Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Meningococcal Vaccine-naive Group Meningococcal Vaccine-primed Group
Affected / at Risk (%) Affected / at Risk (%)
Total   8/16 (50.00%)   0/1 (0.00%) 
General disorders     
Chest pain * 1  1/16 (6.25%)  0/1 (0.00%) 
Infections and infestations     
Cellulitis * 1  1/16 (6.25%)  0/1 (0.00%) 
Nasopharyngitis * 1  1/16 (6.25%)  0/1 (0.00%) 
Tinea pedis * 1  1/16 (6.25%)  0/1 (0.00%) 
Upper respiratory tract infection NOS * 1  1/16 (6.25%)  0/1 (0.00%) 
Viral infection NOS * 1  1/16 (6.25%)  0/1 (0.00%) 
Nervous system disorders     
Headache * 1  2/16 (12.50%)  0/1 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma NOS * 1  1/16 (6.25%)  0/1 (0.00%) 
Skin and subcutaneous tissue disorders     
Paronychia * 1  1/16 (6.25%)  0/1 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 6.0
Enrollment was terminated before the planned sample size was achieved because the principal investigator and the Sponsor decided that sufficient sera had been obtained to meet the secondary objective of the study.
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: NCT00772629     History of Changes
Other Study ID Numbers: MTA16
First Submitted: October 13, 2008
First Posted: October 15, 2008
Results First Submitted: March 16, 2009
Results First Posted: April 27, 2009
Last Update Posted: February 14, 2014