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COMPLETED Phase 3

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

NCT00662870 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • BIOLOGICAL DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine)
  • BIOLOGICAL Pentacel: DTaP-IPV/Hib

Study Locations (20)

Arkansas

  • — Fayetteville, AR 72703
  • — Jonesboro, AR 72401
  • — Little Rock, AR 72211

Pennsylvania

  • — Norristown, PA 19401
  • — Pittsburgh, PA 15213
  • — Pittsburgh, PA 15241

California

  • — Fountain Valley, CA 92708

Colorado

  • — Englewood, CO 80112

Connecticut

  • — Norwich, CT 06360

Florida

  • — Orlando, FL 32856

Georgia

  • — Marietta, GA 30062

Illinois

  • — Chicago, IL 60614

Trial Details

FieldValue
Enrollment Target 1,941 participants
Start Date 2001-05
Est. Completion 2004-01
Phase Phase 3

Sponsor

Sanofi

275 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00662870

The ClinicalTrials.gov registry entry for NCT00662870 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,941 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 5 conditions, with Diphtheria appearing as the primary indexed condition, and to 2 interventions — of which DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00662870 reports 20 study locations spanning 16 distinct geographic areas — top geographies include Arkansas, Pennsylvania, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00662870 about?

NCT00662870 is a clinical study titled "Study of the Safety, Immunogenicity and Lot Comparability of DAPTACEL When Administered With Other Recommended Vaccine". 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-administere...

What is the current status of trial NCT00662870?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,941 participants. The study started on 2001-05. Estimated completion is 2004-01.

What conditions does trial NCT00662870 study?

This clinical trial studies the following conditions: Diphtheria, Tetanus, Whooping Cough, Haemophilus Influenzae Type b, Polio. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00662870?

The interventions under investigation include: DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine) (BIOLOGICAL), Pentacel: DTaP-IPV/Hib (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00662870?

This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00662870 being conducted?

This trial has 20 study locations across Arkansas, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial