Study of Antibody Responses After a Dose of Tetravalent Meningococcal Diphtheria Conjugate Vaccine in Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00771849
First received: October 13, 2008
Last updated: January 20, 2014
Last verified: January 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 103
Study Start Date: August 2003
Study Completion Date: May 2004
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

  Eligibility

Ages Eligible for Study:   2 Years to 4 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00771849

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

Additional Information:
Publications:
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00771849     History of Changes
Other Study ID Numbers: MTA15
Study First Received: October 13, 2008
Results First Received: March 16, 2009
Last Updated: January 20, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Sanofi:
Meningitis
Meningococcemia
Neisseria meningitidis

Additional relevant MeSH terms:
Diphtheria
Meningitis
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 17, 2014