Study of DTap-IPV Compared to DAPTACEL® and IPOL® as the 5th Dose in Children 4 to 6 Years of Age
Public ClinicalTrials.gov record NCT01346293. 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 DTap-IPV (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Combined With Inactivated Poliovirus Vaccine) Compared to DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) + IPOL® (Poliovirus Vaccine Inactivated) as the 5th Dose in Children 4 to 6 Years of Age
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The study was designed to compare the safety and immunogenicity of DTap-IPV with DAPTACEL® + IPOL® as the 5th dose booster in children ≥ 4 to \< 7 years of age in the US and Puerto Rico who were previously vaccinated with DAPTACEL® and/or Pentacel® vaccines only. Primary Objectives: * To compare the pertussis \[Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN), and Fimbriae Types 2 and 3 (FIM)\] booster responses and geometric mean concentrations (GMCs) (as measured by enzyme-linked immunosorbent assay \[ELISA\]) following DTap-IPV vaccination to those elicited following DAPTACEL® + IPOL® vaccination when administered as a 5th dose. * To compare the diphtheria and tetanus booster responses and GMCs (as measured by ELISA) following DTap-IPV vaccination with those elicited following DAPTACEL® + IPOL® vaccinations when administered as a 5th dose . * To compare the Inactivated Poliovirus Vaccine booster responses (as measured by neutralizing assay) following DTap-IPV vaccination with those elicited following DAPTACEL® + IPOL® vaccinations. Observational Objectives: * To compare the polio (types 1, 2, and 3) geometric mean titers (GMTs) following DTap-IPV vaccination with those elicited following DAPTACEL® + IPOL® vaccinations. * To assess the safety of DTap-IPV vaccine or DAPTACEL® + IPOL® vaccine when administered as the fifth dose booster vaccine in participants previously vaccinated with DAPTACEL and/or Pentacel vaccines.
Study identification
- NCT ID
- NCT01346293
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 3,372 participants
Conditions and interventions
Conditions
Interventions
- Diphtheria and Tetanus Toxoids and Acellular Pertussis + Measles, Mumps, Rubella + Varicella Virus Biological
- Diphtheria and Tetanus Toxoids and Acellular Pertussis + Poliovirus + MMR + Varicella Virus 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 2011 (Type not available)
- Primary completion
- May 2013 (Actual)
- Completion
- Sep 2013 (Actual)
- Last update posted
- Jun 3, 2015
2011 – 2013
United States locations
- U.S. sites
- 71
- U.S. states
- 27
- U.S. cities
- 63
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Birmingham | Alabama | 35205 | — |
| Not listed | Birmingham | Alabama | 35235 | — |
| Not listed | Birmingham | Alabama | 35244 | — |
| Not listed | Pinson | Alabama | 35126 | — |
| Not listed | Trussville | Alabama | 35173 | — |
| Not listed | Chandler | Arizona | 85224 | — |
| Not listed | Scottsdale | Arizona | 85255 | — |
| Not listed | Scottsdale | Arizona | 85258 | — |
| Not listed | Jonesboro | Arkansas | 72401 | — |
| Not listed | Little Rock | Arkansas | 72205 | — |
| Not listed | La Puente | California | 91744 | — |
| Not listed | Paramount | California | 90723 | — |
| Not listed | Roseville | California | 95661 | — |
| Not listed | Santa Clara | California | 95051 | — |
| Not listed | West Covina | California | 91790 | — |
| Not listed | Longmont | Colorado | 80501 | — |
| Not listed | Thornton | Colorado | 80233 | — |
| Not listed | St. Petersburg | Florida | 33713 | — |
| Not listed | Marietta | Georgia | 30062 | — |
| Not listed | Woodstock | Georgia | 30189 | — |
| Not listed | Indianapolis | Indiana | 46256 | — |
| Not listed | New Albany | Indiana | 47150 | — |
| Not listed | Overland Park | Kansas | 66213 | — |
| Not listed | Topeka | Kansas | 66604 | — |
| Not listed | Crestview Hills | Kentucky | 41017 | — |
| Not listed | Louisville | Kentucky | 40202 | — |
| Not listed | Louisville | Kentucky | 40207 | — |
| Not listed | Nicholasville | Kentucky | 40356 | — |
| Not listed | Owensboro | Kentucky | 42303 | — |
| Not listed | Bossier City | Louisiana | 71111 | — |
| Not listed | Haughton | Louisiana | 71037 | — |
| Not listed | Annapolis | Maryland | 21401 | — |
| Not listed | Frederick | Massachusetts | 21702 | — |
| Not listed | Woburn | Massachusetts | 01801 | — |
| Not listed | Bridgeton | Missouri | 63044 | — |
| Not listed | Bellevue | Nebraska | 68005 | — |
| Not listed | Boys Town | Nebraska | 68010 | — |
| Not listed | Lincoln | Nebraska | 68504 | — |
| Not listed | Lincoln | Nebraska | 68516 | — |
| Not listed | Omaha | Nebraska | 68198 | — |
| Not listed | Brooklyn | New York | 11201 | — |
| Not listed | Fargo | North Dakota | 58104 | — |
| Not listed | Cincinnati | Ohio | 45245 | — |
| Not listed | Fairfield | Ohio | 45014 | — |
| Not listed | Youngstown | Ohio | 44505 | — |
| Not listed | Midwest City | Oklahoma | 73110 | — |
| Not listed | Gresham | Oregon | 97030 | — |
| Not listed | Collegeville | Pennsylvania | 19426 | — |
| Not listed | Pittsburgh | Pennsylvania | 15241 | — |
| Not listed | Scranton | Pennsylvania | 18510 | — |
| Not listed | Bristol | Tennessee | 37620 | — |
| Not listed | Austin | Texas | 78745 | — |
| Not listed | Dallas | Texas | 75230 | — |
| Not listed | Houston | Texas | 77025 | — |
| Not listed | San Antonio | Texas | 78229 | — |
| Not listed | Clinton | Utah | 84015 | — |
| Not listed | Layton | Utah | 84041 | — |
| Not listed | Murray | Utah | 84107 | — |
| Not listed | Orem | Utah | 84057 | — |
| Not listed | Roy | Utah | 84067 | — |
| Not listed | Springville | Utah | 84663 | — |
| Not listed | Syracuse | Utah | 84075 | — |
| Not listed | Burke | Virginia | 22015 | — |
| Not listed | Charlottesville | Virginia | 22902 | — |
| Not listed | Charlottesville | Virginia | 22903 | — |
| Not listed | Charlottesville | Virginia | 22911 | — |
| Not listed | Midlothian | Virginia | 23113 | — |
| Not listed | Vienna | Virginia | 22180 | — |
| Not listed | Spokane | Washington | 99202 | — |
| Not listed | Spokane | Washington | 99218 | — |
| Not listed | Huntington | West Virginia | 25701 | — |
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 NCT01346293, 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 Jun 3, 2015 · 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 NCT01346293 live on ClinicalTrials.gov.