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Completed Phase 3 Interventional Accepts healthy volunteers

Study of the Safety, Immunogenicity and Lot Comparability of DAPTACEL When Administered With Other Recommended Vaccine

ClinicalTrials.gov ID: NCT00662870

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.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 8:53 PM EDT

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
Lead sponsor
Sanofi
Industry
Enrollment
1,941 participants

Conditions and interventions

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
May 2001 (Type not available)
Primary completion
Jan 2004 (Actual)
Completion
Jan 2004 (Actual)
Last update posted
Jan 31, 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 31, 2012 · 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 NCT00662870 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →