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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Meningitis
Central Nervous System Diseases
Central Nervous System Infections
Nervous System Diseases

ClinicalTrials.gov processed this record on November 25, 2014