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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 Description
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Brief Summary:

The study investigated safety profile and the antibody responses to an experimental tetravalent meningococcal diphtheria conjugate vaccine (Menactra®) in children who have received a monovalent meningococcal C conjugate vaccine at least one year previously.

Primary objective:

To describe and compare the Serum Bactericidal Assay (SBA) antibody response for serogroup C in participants receiving Menactra® to the serogroup C antibody response in a control group of participants receiving a licensed Haemophilus Influenzae Type b (Hib) conjugate vaccine 28 days following vaccination.


Condition or disease Intervention/treatment Phase
Meningitis Meningococcemia Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Biological: Haemophilus Influenzae Type b (Hib) vaccine Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Antibody Responses for Serogroup C After One Dose of an Experimental Tetravalent (A, C, Y, and W-135) Meningococcal Diphtheria Toxoid Conjugate Vaccine Versus a Non-meningococcal Control Vaccine in Children Who Have Previously Received a Monovalent Meningococcal C Conjugate Vaccine
Study Start Date : August 2003
Actual Primary Completion Date : March 2004
Actual Study Completion Date : May 2004

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Menactra® Vaccine Group
Participants receiving the tetravalent (A, C, Y, and W 135) meningococcal diphtheria toxoid conjugate vaccine
 Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
Other Name: Menactra®
Active Comparator: Hiberix® Vaccine Group
Participants receiving Haemophilus Influenzae Type b (Hib) vaccine
 Biological: Haemophilus Influenzae Type b (Hib) vaccine
0.5 mL, Intramuscular
Other Name: Hiberix®


Outcome Measures
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Primary Outcome Measures :
  1. Geometric Mean of Antibody Titers (GMTs) as Measured by Serum Bactericidal Assay (SBA) at Baseline (Day 0) and Day 28 Post-vaccination. [ Time Frame: Day 0 (before) and 28 days post-vaccination ]

Secondary Outcome Measures :
  1. Participants With a ≥ 4-Fold Rise in Antibody Titers as Measured by Serum Bactericidal Assay (SBA) From Baseline to Day 28 Post-vaccination. [ Time Frame: 28 days post-vaccination ]

Eligibility Criteria
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Ages Eligible for Study:   2 Years to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria :

  • Participant is healthy, as determined by medical history and physical examination.
  • Participant is 2 years to < 5 years of age at the time of vaccination.
  • At least one year from primary vaccination with a monovalent meningococcal C conjugate vaccine has elapsed.
  • Parent/Guardian has signed an Ethics Committee-approved informed consent form. A culturally appropriate translation will be used for non-English speaking participants where required.

Exclusion Criteria :

  • Serious chronic disease (i.e. cardiac, renal, neurologic, metabolic, rheumatologic, etc.)
  • Known or suspected impairment of immunologic function
  • Acute medical illness with or without fever within the last 72 hours or an axillary temperature ≥ 37.5ºC at the time of inclusion
  • History of documented invasive meningococcal disease
  • Administration of immune globulin, other blood products within the last three months, injected or oral corticosteroids or other immunomodulatory therapy within six weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting < 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrolment
  • Antibiotic therapy within the 72 hours prior to vaccination or 72 hours prior to drawing any blood sample
  • Received any vaccine in the 28-day period prior to enrolment, or scheduled to receive any vaccine during enrolment in the trial
  • Received a meningococcal C conjugate vaccine within one year prior to enrolment
  • Suspected or known hypersensitivity to any of the vaccine components
  • Unavailable for the entire study period or unable to attend the scheduled visits or to comply with the study procedures
  • Enrolled in another clinical trial
  • Any condition, which, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00771849


Locations
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United Kingdom
London, United Kingdom, E1 1BB
London, United Kingdom, SW17 ORE
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Medical Monitor Sanofi Pasteur Inc.
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00771849    
Other Study ID Numbers: MTA15
First Posted: October 15, 2008    Key Record Dates
Results First Posted: April 24, 2009
Last Update Posted: April 14, 2016
Last Verified: April 2016
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Meningitis
Meningococcemia
Neisseria meningitidis
Additional relevant MeSH terms:
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Diphtheria
Meningitis
Neuroinflammatory Diseases
Nervous System Diseases
Corynebacterium Infections
 Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections