Safety and Immunogenicity of Tdap Vaccine Compared to DTaP Vaccine in Children 4 to 6 Years of Age
Public ClinicalTrials.gov record NCT00467519. 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 Tdap Vaccine Compared to DTaP Vaccine as Fifth Dose Booster in Children 4 to 6 Years of Age
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Currently, there is no 5-component acellular pertussis vaccine licensed for the 5th dose in US children aged 4 to 6 years.This study is aimed at providing evidence of sero-protection, booster response and safety of this formulation as a 5th dose. Primary Objective: \- To compare the immune responses of Tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) Vaccine to Diphtheria, tetanus and acellular pertussis (DTaP) vaccine (all antigens) when each is administered as a 5th dose and given concurrently, to children aged 4 to 6 years. Secondary/Observational Objectives: * To compare the immune responses for pertussis antigens of Tdap Vaccine to DTaP vaccine (for pertussis antigens) when each is administered as a 5th dose and given concurrently, to children aged 4 to 6 years. * To present the long-term immunogenicity at 1-, 3-, and 5-years post-vaccination after each long-term follow-up. * To describe the safety profile following vaccine administration.
Study identification
- NCT ID
- NCT00467519
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,045 participants
Conditions and interventions
Conditions
Interventions
- Tdap (Tetanus Toxoid Reduced Diphtheria Toxoid/Acellular Pertussis) Biological
- DTaP (Diphtheria & Tetanus Toxoids & Acellular Pertussis Adsorbed) Biological
Biological
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
- Apr 2007 (Type not available)
- Primary completion
- Nov 2009 (Actual)
- Completion
- Dec 2009 (Actual)
- Last update posted
- Feb 7, 2014
2007 – 2009
United States locations
- U.S. sites
- 42
- U.S. states
- 20
- U.S. cities
- 37
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Birmingham | Alabama | 35205 | — |
| Not listed | Birmingham | Alabama | 35244 | — |
| Not listed | Fayetteville | Arkansas | 72703 | — |
| Not listed | Jonesboro | Arkansas | 72401 | — |
| Not listed | Little Rock | Arkansas | 72205 | — |
| Not listed | Fountain Valley | California | 92708 | — |
| Not listed | Huntington Beach | California | 92647 | — |
| Not listed | Oakland | California | 94611 | — |
| Not listed | Roseville | California | 95661 | — |
| Not listed | Sacramento | California | 95815 | — |
| Not listed | Norwich | Connecticut | 06360 | — |
| Not listed | Marietta | Georgia | 30062 | — |
| Not listed | Woodstock | Georgia | 30189 | — |
| Not listed | Bardstown | Kentucky | 40004 | — |
| Not listed | Crestview Hills | Kentucky | 41017 | — |
| Not listed | Louisville | Kentucky | 40291 | — |
| Not listed | Bossier City | Louisiana | 71111 | — |
| Not listed | Frederick | Maryland | 21702 | — |
| Not listed | Bellevue | Nebraska | 68123 | — |
| Not listed | Omaha | Nebraska | 68124 | — |
| Not listed | Omaha | Nebraska | 68131 | — |
| Not listed | Omaha | Nebraska | 68132 | — |
| Not listed | Rochester | New York | 14618 | — |
| Not listed | Fargo | North Dakota | 58103 | — |
| Not listed | Cleveland | Ohio | 44121 | — |
| Not listed | Gresham | Oregon | 97030 | — |
| Not listed | Erie | Pennsylvania | 16505 | — |
| Not listed | Norristown | Pennsylvania | 19401 | — |
| Not listed | Pittsburgh | Pennsylvania | 15236 | — |
| Not listed | Pittsburgh | Pennsylvania | 15241 | — |
| Not listed | Rydal | Pennsylvania | 19046 | — |
| Not listed | Uniontown | Pennsylvania | 15401 | — |
| Not listed | Kingsport | Tennessee | 37660 | — |
| Not listed | Tullahoma | Tennessee | 37388 | — |
| Not listed | San Antonio | Texas | 78229 | — |
| Not listed | Layton | Utah | 84041 | — |
| Not listed | Springville | Utah | 84663 | — |
| Not listed | Chesapeake | Virginia | 23321 | — |
| Not listed | Midlothian | Virginia | 23113 | — |
| Not listed | Spokane | Washington | 99202 | — |
| Not listed | Spokane | Washington | 99218 | — |
| Not listed | La Crosse | Wisconsin | 54601 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00467519, 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 Feb 7, 2014 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00467519 live on ClinicalTrials.gov.