Study of the Safety, Immunogenicity and Lot Comparability of DAPTACEL When Administered With Other Recommended Vaccine
Public ClinicalTrials.gov record NCT00662870. 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, Immunogenicity and Lot Comparability of DAPTACEL™ (Aventis Pasteur Classic Five-component Pertussis Vaccine in Combination With Tetanus and Diphtheria Toxoids Adsorbed) When Administered With Other Recommended Vaccines at 2, 4, 6, and 15 to 16 Months of Age.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study was designed to assess the lot comparability of DAPTACEL, as well as the safety and immunogenicity of DAPTACEL when co-administered with other recommended infant vaccines. Stage I Primary Objectives: 1. To assess the lot-comparability of immunogenicity of DAPTACEL by when co-administered with other recommended vaccines. 2. To compare the immune response to DTaP-IPV/Hib (Pentacel) with those of three lots of DAPTACEL when co-administered with other recommended vaccines. 3. To compare the immune response of PRP-T antigen in Pentacel with that of ActHIB concurrently administered in a different injection site with DAPTACEL when these vaccines are co-administered with other recommended vaccines. Stage II Primary Objectives: 1. To compare the immune response of DAPTACEL when the 4th dose is co-administered with Hib or other infant vaccines. 2. To compare the the immune response of Pentacel with those elicited by DAPTACEL when co-administered with ActHIB in toddlers.
Study identification
- NCT ID
- NCT00662870
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,941 participants
Conditions and interventions
Interventions
- DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine) Biological
- Pentacel: DTaP-IPV/Hib Biological
Biological
Eligibility (public fields only)
- Age range
- 42 Days to 84 Days
- 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 30, 2001
- Primary completion
- Dec 31, 2003
- Completion
- Dec 31, 2003
- Last update posted
- Jan 30, 2012
2001 – 2004
United States locations
- U.S. sites
- 26
- U.S. states
- 19
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Fayetteville, AR 72703 | Arkansas | 72703 | — |
| Not listed | Jonesboro, AR 72401 | Arkansas | 7240 | — |
| Not listed | Little Rock, AR 72211 | Arkansas | 72211 | — |
| Not listed | Fountain Valley, CA 92708 | California | 92708 | — |
| Not listed | Englewood, CO 80112 | Colorado | 80112 | — |
| Not listed | Norwich, CT 06360 | Connecticut | 06360 | — |
| Not listed | Orlando, FL 32856 | Florida | 32856 | — |
| Not listed | Marietta, GA 30062 | Georgia | 30062 | — |
| Not listed | Chicago, IL 60614 | Illinois | 60614 | — |
| Not listed | Bardstown, KY 40004 | Kentucky | 40004 | — |
| Not listed | Bossier City, LA 71111 | Louisiana | 71111 | — |
| Not listed | Bridgeton, MO 63044 | Missouri | 63044 | — |
| Not listed | Rochester, NY 14620 | New York | 14620 | — |
| Not listed | Chapel Hill, NC 27514 | North Carolina | 27514 | — |
| Not listed | Portland, OR 97201 | Oregon | 97201 | — |
| Not listed | Norristown, PA 19401 | Pennsylvania | 19401 | — |
| Not listed | Pittsburgh, PA 15213 | Pennsylvania | 15213 | — |
| Not listed | Pittsburgh, PA 15241 | Pennsylvania | 15241 | — |
| Not listed | Kingsport, TN 37664 | Tennessee | 37664 | — |
| Not listed | Austin, TX 78758 | Texas | 78758 | — |
| Not listed | Fort Worth, TX 76107 | Texas | 76106 | — |
| Not listed | San Antonio, TX 78205 | Texas | 78205 | — |
| Not listed | Provo, UT 84604 | Utah | 84604 | — |
| Not listed | Spokane, WA 99220 | Washington | 99220 | — |
| Not listed | LaCrosse, WI 54601 | Wisconsin | 54601 | — |
| Not listed | Marshfield, WI 54449 | 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.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00662870, 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 Jan 30, 2012 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00662870 live on ClinicalTrials.gov.