Phase 2
Completed N=881
Study of Menactra® in Children Aged 4 to 6 Years When Administered Concomitantly With a Fifth Dose of DAPTACEL®
Source: ClinicalTrials.gov NCT00355121 ↗Enrolled (actual)
881
Serious AEs
0.4%
Results posted
Aug 2011
Primary outcomePrimary: Number of Participants With Antibodies Against Diphtheria and Tetanus at ≥ 1.0 IU/mL After DAPTACEL Vaccination — 249; 238; 246; 236 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Antibodies Against Diphtheria and Tetanus at ≥ 1.0 IU/mL After DAPTACEL Vaccination |
249; 238; 246; 236 | — |
| PRIMARY Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W-135 After Menactra Vaccination at Visit 1. |
10.8; 10.4; 8.1; 7.8; 18.1; 26.2 | — |
| SECONDARY Geometric Mean Concentrations (GMCs) of Antibodies Against the Pertussis Antigens After DAPTACEL Vaccination at Visit 1 |
70.0; 71.0; 133; 145; 123; 113 | — |
| SECONDARY Serum Bactericidal Assay Using Human Complement Geometric Mean Titers for Serogroups A, C, Y, and W-135 After Menactra Vaccination |
6.7; 10.4; 3.3; 7.8; 6.5; 26.2 | — |
| SECONDARY Number of Participants Reporting Fever When DAPTACEL and Menactra Vaccines Were Administered Concomitantly and Those Reporting When DAPTACEL Was Administered With IPOL Vaccine |
27; 18 | — |
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT00355121). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.