Study of Antibody Responses After a Dose of Tetravalent Meningococcal Diphtheria Conjugate Vaccine in Children
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00771849
First received: October 13, 2008
Last updated: April 23, 2010
Last verified: April 2010
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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 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 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
More Information
Additional Information:
Related Info 
Related Info 
Publications:
| Responsible Party: | Medical Monitor, Sanofi Pasteur Inc. |
| 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: | April 23, 2010 |
| 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 May 16, 2013