At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 2 clinical trial evaluating Polysaccharide Diphtheria Toxoid Conjugate Vaccine for Meningococcal Meningitis and 4 related conditions. Completed, enrolled 882 participants across 26 sites.
Detailed 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.
Study Details
Timeline
Interventions
0.5 mL IM of each vaccine. (DAPTACEL® + IPOL on Day 0 and Menactra on Day 30)
0.5 mL, IM of each vaccine. (DAPTACEL® + Menactra® on Day 0 and IPOL on Day 30)
0.5 mL, IM of each vaccine (Menactra® + IPOL on Day 0 and DAPTACEL® on Day 30)