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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Meningitis, Meningococcemia

Intervention / Treatment
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* Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
* Biological: Haemophilus Influenzae Type b (Hib) vaccine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Menactra® Vaccine Group<br>Participants receiving the tetravalent (A, C, Y, and W 135) meningococcal diphtheria toxoid conjugate vaccine | Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate<br>* 0.5 mL, Intramuscular<br>* Other names: Menactra®;|
| Active Comparator: Hiberix® Vaccine Group<br>Participants receiving Haemophilus Influenzae Type b (Hib) vaccine | Biological: Haemophilus Influenzae Type b (Hib) vaccine<br>* 0.5 mL, Intramuscular<br>* Other names: Hiberix®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean of Antibody Titers (GMTs) as Measured by Serum Bactericidal Assay (SBA) at Baseline (Day 0) and Day 28 Post-vaccination. |  | Day 0 (before) and 28 days post-vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants With a ≥ 4-Fold Rise in Antibody Titers as Measured by Serum Bactericidal Assay (SBA) From Baseline to Day 28 Post-vaccination. |  | 28 days post-vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Meningitis, Meningococcemia, Neisseria meningitidis