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

Sanofi

Status and phase: Completed; Phase 2

Conditions: Poliomyelitis; Diphtheria; Meningococcal Meningitis; Pertussis; Tetanus

Treatments: Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00355121

MTA43

Details and patient eligibility

About

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.

Enrollment: 882 patients

Sex: All

Ages: 4 to 7 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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882 participants in 3 patient groups

Group 1

Experimental group

Description:

DAPTACEL® + IPOL on Day 0 and Menactra on Day 30

Treatment:

Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine

Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine

Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine

Group 2

Experimental group

Description:

DAPTACEL® + Menactra® on Day 0 and IPOL on Day 30

Treatment:

Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine

Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine

Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine

Group 3

Experimental group

Description:

Menactra® + IPOL on Day 0 and DAPTACEL® on Day 30

Treatment:

Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine

Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine

Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine