Safety and Immunogenicity of DAPTACEL® as 5th Dose in Children 4 to 6 Years Old After 4 Doses of Pentacel™ or DAPTACEL®
Public ClinicalTrials.gov record NCT00258895. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Safety and Immunogenicity of DAPTACEL® Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With DAPTACEL® or Pentacel®
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT00258895
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 649 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 4 Years to 6 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 2005 (Type not available)
- Primary completion
- Dec 2006 (Actual)
- Completion
- Apr 2007 (Actual)
- Last update posted
- Apr 14, 2016
2005 – 2007
United States locations
- U.S. sites
- 22
- U.S. states
- 15
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Fayetteville | Arkansas | — | — |
| Not listed | Jonesboro | Arkansas | — | — |
| Not listed | Little Rock | Arkansas | — | — |
| Not listed | Fountain Valley | California | — | — |
| Not listed | Centennial | Colorado | — | — |
| Not listed | Norwich | Connecticut | — | — |
| Not listed | Marietta | Georgia | — | — |
| Not listed | Bardstown | Kentucky | — | — |
| Not listed | Bossier City | Louisiana | — | — |
| Not listed | Rochester | New York | — | — |
| Not listed | Pembroke | North Carolina | — | — |
| Not listed | Sylva | North Carolina | — | — |
| Not listed | Norristown | Pennsylvania | — | — |
| Not listed | Pittsburgh | Pennsylvania | 15213 | — |
| Not listed | Pittsburgh | Pennsylvania | 15241 | — |
| Not listed | Kingsport | Tennessee | — | — |
| Not listed | Fort Worth | Texas | — | — |
| Not listed | San Antonio | Texas | — | — |
| Not listed | Provo | Utah | — | — |
| Not listed | Spokane | Washington | — | — |
| Not listed | La Crosse | Wisconsin | — | — |
| Not listed | Marshfield | Wisconsin | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00258895, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 14, 2016 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00258895 live on ClinicalTrials.gov.