Study of Menactra® in Children Aged 4 to 6 Years When Administered Concomitantly With a Fifth Dose of DAPTACEL®

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the immunogenicity and safety of the concomitant administration of Menactra® vaccine and DAPTACEL® vaccine. The main objectives are: Immunogenicity: To evaluate the antibody responses to both vaccines when Menactra vaccine is given concomitantly with DAPTACEL® compared to when either vaccine is given alone. Safety: To evaluate the rate of local and systemic reactions when DAPTACEL® and Menactra vaccines are administered concomitantly compared to when each vaccine is given alone.

Official Title
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Immunogenicity and Safety of Meningococcal (Serogroups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) in Children Aged 4 to 6 Years in the US When Administered Concomitantly With a Fifth Dose Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed.

Conditions
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Meningococcal Meningitis, Tetanus, Diphtheria, Pertussis, Poliomyelitis

Intervention / Treatment
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* Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine
* Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine
* Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy, as determined by medical history and physical examination. Aged 4 to < 7 years at the time of study vaccination on Day 0. Informed consent form that has been approved by the Institutional Review Board (IRB) and signed/dated by the parent or legal guardian. Previous documented vaccination history of 4th dose diphtheria, tetanus and acellular pertussis (DTaP) series. Exclusion Criteria: Serious chronic disease (e.g. cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric, hematologic) Known or suspected impairment of immunologic function Acute medical illness with or without fever within the last 72 hours or temperature ≥ 100.4°F (≥ 38°C) at the time of enrollment History of documented invasive meningococcal disease or previous meningococcal vaccination Received a 5th dose vaccination with any tetanus, diphtheria or pertussis vaccine, or 4th dose of IPV prior to this study. Received either immune globulin or other blood products within the last 3 months; or received injected or oral corticosteroids, or other immunomodulator therapy, within 6 weeks of the study vaccines. Individuals on a tapering dose schedule of oral steroids lasting < 7 days and individuals (e.g., asthmatics) on a short schedule of oral steroids lasting 3 to 4 days may be included in the trial as long as they have not received more than one course within the last 2 weeks prior to enrollment. Received oral or injected antibiotic therapy within the 72 hours prior to any blood draw. Suspected or known hypersensitivity to any of the study vaccine components, history of serious or life-threatening reaction to the trial vaccines or a vaccine containing the same substances. Thrombocytopenia or a bleeding disorder contraindicating IM vaccination. 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. Diagnosed with any condition, which, in the opinion of the physician investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine. Received any other vaccine 30 days prior to the first study vaccination or scheduled to receive any vaccination during the course of the study. Personal or family history of Guillain-Barré Syndrome (GBS).

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 7 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: Group 1<br>DAPTACEL® + IPOL on Day 0 and Menactra on Day 30 | Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine<br>* 0.5 mL IM of each vaccine. (DAPTACEL® + IPOL on Day 0 and Menactra on Day 30)<br>* Other names: IPOL;|
| Experimental: Group 2<br>DAPTACEL® + Menactra® on Day 0 and IPOL on Day 30 | Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine<br>* 0.5 mL, IM of each vaccine. (DAPTACEL® + Menactra® on Day 0 and IPOL on Day 30)<br>* Other names: IPOL;|
| Experimental: Group 3<br>Menactra® + IPOL on Day 0 and DAPTACEL® on Day 30 | Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine<br>* 0.5 mL, IM of each vaccine (Menactra® + IPOL on Day 0 and DAPTACEL® on Day 30)<br>* Other names: IPOL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Antibodies Against Diphtheria and Tetanus at ≥ 1.0 IU/mL After DAPTACEL Vaccination | Serum antibody titers were assessed for diphtheria by a seroneutralization assay and for tetanus by enzyme linked immunosorbent assay. | Day 30 post-vaccination (Visit 1) | 
| Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W-135 After Menactra Vaccination at Visit 1. | Serum antibody titers against meningococcal serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA HC) | Day 30 post-vaccination (Visit 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Concentrations (GMCs) of Antibodies Against the Pertussis Antigens After DAPTACEL Vaccination at Visit 1 | Serum antibody titers against pertussis were assessed for pertussis toxoid (PT), filamentous hemagglutinin (FHA), Fimbriae types 2 and 3 (FIM), and pertactin (RN) by enzyme linked immunosorbent assay (ELISA). | Day 30 post-vaccination 1 | 
| Serum Bactericidal Assay Using Human Complement Geometric Mean Titers for Serogroups A, C, Y, and W-135 After Menactra Vaccination | Serum antibody titers against meningococcal serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA HC) | Day 30 post-vaccination | 
| Number of Participants Reporting Fever When DAPTACEL and Menactra Vaccines Were Administered Concomitantly and Those Reporting When DAPTACEL Was Administered With IPOL Vaccine | Fever was defined as a maximum oral temperature of ≥ 100.4ºF. | Day 0 through Day 7 post-vaccination at Visit 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Meningococcal meningitis, Tetanus, Diphtheria, Pertussis, Poliomyelitis, Neisseria meningitidis