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NCT00662870 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Diphtheria and Tetanus, sponsored by Sanofi.

Completed
Registry status
Phase 3
Development phase
1,941
Enrollment target
20
Study locations

NCT00662870 is a Phase 3 study of Diphtheria and Tetanus that has completed, run by Sanofi. The registered enrollment target is 1,941 participants, above the 1,737-participant average among 15 other Diphtheria trials with a reported enrollment target (12% higher). The trial reports 20 study locations across 16 states.

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The verdict

NCT00662870, a Phase 3 study of Diphtheria and Tetanus, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 3
Development phase
1,941 participants
Enrollment target
20
Study locations

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.

Conditions Studied

Diphtheria Tetanus Whooping Cough Haemophilus Influenzae Type b Polio

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

713 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, categorized as Phase 3. The registered enrollment target is 1,941 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 1,737-participant average among 15 other Diphtheria trials with a reported enrollment target (12% higher). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.

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.

NCT00662870 reports 20 study locations spanning 16 distinct geographic areas - top geographies include Arkansas, Pennsylvania, California.

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.

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).

Who is sponsoring clinical trial NCT00662870?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

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.

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