At a glance
ClinicalIndex Comparison Record- ✓Aged 4 to 6 years at time of study vaccination
- ✓Documented complete infant DTaP series and 4th dose of DAPTACEL® or Pentacel™ from prior study P3T06
- ✓In good health per medical history and physical examination
- ✓Able and willing to attend scheduled visits and comply with study procedures
- ✕Prior 5th dose of DTaP-containing vaccine
- ✕For DAPTACEL® arm: Prior 4th IPV dose or 2nd MMR dose scheduled at 4–6 years of age
- ✕For Pentacel™ arm: Prior 2nd MMR dose scheduled at 4–6 years of age
- ✕Severe hypersensitivity or anaphylactic reaction to vaccine components
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Immunogenicity of DAPTACEL® Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With DAPTACEL® or Pentacel®
In Brief
A Phase 3 clinical trial evaluating DAPTACEL®: DTaP for Diphtheria and 2 related conditions. Completed, enrolled 649 participants across 22 sites.
Detailed Summary
Primary Objectives: 1. To present the safety profile after a 5th dose of DAPTACEL® in children 4 to 6 years of age who have previously received 4 doses of DAPTACEL® or Pentacel™. 2. To present the pre-Dose 5 and post-Dose 5 antibody responses to the antigens in DAPTACEL® in children 4 to 6 years of age who have previously received 4 doses of DAPTACEL® or Pentacel™. Observational Objectives: 1. To compare under equivalence criteria the pre-Dose 5 and post-Dose 5 antibody responses to the antigens in DAPTACEL® in children 4 to 6 years of age who have previously received 4 doses of DAPTACEL® or Pentacel™. 2. To present the pre-vaccination anti-poliovirus GMTs and seroprotection rates. 3. To present the post-vaccination anti-poliovirus GMTs and seroprotection rates among subjects receiving a 4th dose of IPV concurrently with the 5th dose of DAPTACEL and a 2nd dose of MMR.
Study Details
Timeline
Interventions
0.5 mL, Intramuscular
0.5 mL, Intramuscular