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

October 13, 2008
January 20, 2014
August 2003
March 2004   (final data collection date for primary outcome measure)
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 ]
  • Immunogenicity: To provide information concerning the immune response of a tetravalent meningococcal diphtheria conjugate vaccine. [ Time Frame: 28 days post vaccination ] [ Designated as safety issue: No ]
  • Safety: To provide information concerning the safety after administration of a tetravalent meningococcal diphtheria conjugate vaccine. [ Time Frame: 28 days post-vaccination ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00771849 on ClinicalTrials.gov Archive Site
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 ]
Not Provided
Not Provided
Not Provided
 
Study of Antibody Responses After a Dose of Tetravalent Meningococcal Diphtheria Conjugate Vaccine in Children
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Meningitis
  • Meningococcemia
  • Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
    0.5 mL, Intramuscular
    Other Name: Menactra®
  • Biological: Haemophilus Influenzae Type b (Hib) vaccine
    0.5 mL, Intramuscular
    Other Name: Hiberix®
  • Experimental: Menactra® Vaccine Group
    Participants receiving the tetravalent (A, C, Y, and W 135) meningococcal diphtheria toxoid conjugate vaccine
    Intervention: Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
  • Active Comparator: Hiberix® Vaccine Group
    Participants receiving Haemophilus Influenzae Type b (Hib) vaccine
    Intervention: Biological: Haemophilus Influenzae Type b (Hib) vaccine
El Bashir H, Heath PT, Papa T, Ruggeberg JU, Johnson N, Sinha R, Balfour G, Booy R. Antibody responses to meningococcal (groups A, C, Y and W135) polysaccharide diphtheria toxoid conjugate vaccine in children who previously received meningococcal C conjugate vaccine. Vaccine. 2006 Mar 24;24(14):2544-9. Epub 2005 Dec 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
103
May 2004
March 2004   (final data collection date for primary outcome measure)

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.
Both
2 Years to 4 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00771849
MTA15
No
Sanofi ( Sanofi Pasteur, a Sanofi Company )
Sanofi Pasteur, a Sanofi Company
Not Provided
Study Director: Medical Monitor Sanofi Pasteur Inc.
Sanofi
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP