Safety and Immunogenicity in Adults of Revaccination With Adacel® Vaccine 10 Years After a Previous Dose
Public ClinicalTrials.gov record NCT01439165. 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.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to describe the safety and immunogenicity of repeat administration of Adacel vaccine approximately 10 years following initial administration of the vaccine. Antibody levels prior to revaccination will also be used to characterize antibody persistence following initial vaccination 10 years earlier. Primary Objectives: * To compare seroprotection rates against tetanus and diphtheria induced by Adacel vaccine to those induced by Td Adsorbed vaccine. * To compare booster response rates against tetanus and diphtheria induced by Adacel vaccine to those induced by Td Adsorbed vaccine. * To compare anti-pertussis geometric mean antibody concentrations (GMCs) induced by Adacel vaccine to the GMCs induced by Daptacel® vaccine given to infants. Secondary Objectives: * To describe the rates of immediate reactions, solicited reactions, unsolicited adverse events (AEs), and serious adverse events (SAEs) following vaccination with Adacel or Td Adsorbed vaccine. * To describe booster response rates for pertussis antigens following revaccination with Adacel vaccine.
Study identification
- NCT ID
- NCT01439165
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 1,330 participants
Conditions and interventions
Conditions
Interventions
- Tetanus Toxoid, Diphtheria Toxoid and Pertussis Vaccine Biological
- Tetanus and Diphtheria Toxoids Adsorbed For Adult Use Biological
Biological
Eligibility (public fields only)
- Age range
- 18 Years to 64 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
- Nov 2011 (Type not available)
- Primary completion
- Dec 2015 (Actual)
- Completion
- Feb 2017 (Actual)
- Last update posted
- Apr 28, 2022
2011 – 2017
United States locations
- U.S. sites
- 31
- U.S. states
- 20
- U.S. cities
- 31
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Huntsville | Alabama | 35802 | — |
| Not listed | Jonesboro | Arkansas | 72401 | — |
| Not listed | Little Rock | Arkansas | 72205 | — |
| Not listed | San Diego | California | 92108 | — |
| Not listed | Boulder | Colorado | 80304 | — |
| Not listed | Marietta | Georgia | 30062 | — |
| Not listed | Woodstock | Georgia | 30189 | — |
| Not listed | Peoria | Illinois | 61602 | — |
| Not listed | Mishawaka | Indiana | 46545 | — |
| Not listed | Louisville | Kentucky | 40202 | — |
| Not listed | Rockville | Maryland | 20850 | — |
| Not listed | Woburn | Massachusetts | 01801 | — |
| Not listed | Columbia | Missouri | 65212 | — |
| Not listed | St Louis | Missouri | 63104 | — |
| Not listed | Albuquerque | New Mexico | 87108 | — |
| Not listed | Brooklyn | New York | 11201 | — |
| Not listed | Ithaca | New York | 14850 | — |
| Not listed | Rochester | New York | 14618 | — |
| Not listed | Raleigh | North Carolina | 27612 | — |
| Not listed | Winston-Salem | North Carolina | 27103 | — |
| Not listed | Cincinnati | Ohio | 45229 | — |
| Not listed | Cleveland | Ohio | 44121 | — |
| Not listed | Clairton | Pennsylvania | 15025 | — |
| Not listed | Hershey | Pennsylvania | 17033 | — |
| Not listed | Latrobe | Pennsylvania | 15650 | — |
| Not listed | Pittsburgh | Pennsylvania | 15224 | — |
| Not listed | Syracuse | Utah | 84075 | — |
| Not listed | Virginia Beach | Virginia | 23456 | — |
| Not listed | Vancouver | Washington | 98686 | — |
| Not listed | Chippewa Falls | Wisconsin | 54729 | — |
| Not listed | Marshfield | Wisconsin | 54449 | — |
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 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01439165, 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 28, 2022 · Synced Oct 17, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01439165 live on ClinicalTrials.gov.