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NCT01346293 · ClinicalTrials.gov registry record · Phase 3

Study of DTap-IPV Compared to DAPTACEL® and IPOL® as the 5th Dose in Children 4 to 6 Years of Age

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

Completed
Registry status
Phase 3
Development phase
3,372
Enrollment target
20
Study locations

NCT01346293 is a Phase 3 study of Diphtheria and Tetanus that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 3,372 participants, above the 1,642-participant average among 15 other Diphtheria trials with a reported enrollment target (105% higher). The trial reports 20 study locations across 7 states.

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The verdict

NCT01346293, a Phase 3 study of Diphtheria and Tetanus, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.

COMPLETED
Registry status
Phase 3
Development phase
3,372 participants
Enrollment target
20
Study locations

Study Summary

The study was designed to compare the safety and immunogenicity of DTap-IPV with DAPTACEL® + IPOL® as the 5th dose booster in children ≥ 4 to \< 7 years of age in the US and Puerto Rico who were previously vaccinated with DAPTACEL® and/or Pentacel® vaccines only. Primary Objectives: * To compare the pertussis \[Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN), and Fimbriae Types 2 and 3 (FIM)\] booster responses and geometric mean concentrations (GMCs) (as measured by enzyme-linked immunosorbent assay \[ELISA\]) following DTap-IPV vaccination to those elicited following DAPTACEL® + IPOL® vaccination when administered as a 5th dose. * To compare the diphtheria and tetanus booster responses and GMCs (as measured by ELISA) following DTap-IPV vaccination with those elicited following DAPTACEL® + IPOL® vaccinations when administered as a 5th dose . * To compare the Inactivated Poliovirus Vaccine booster responses (as measured by neutralizing assay) following DTap-IPV vaccination with those elicited following DAPTACEL® + IPOL® vaccinations. Observational Objectives: * To compare the polio (types 1, 2, and 3) geometric mean titers (GMTs) following DTap-IPV vaccination with those elicited following DAPTACEL® + IPOL® vaccinations. * To assess the safety of DTap-IPV vaccine or DAPTACEL® + IPOL® vaccine when administered as the fifth dose booster vaccine in participants previously vaccinated with DAPTACEL and/or Pentacel vaccines.

Conditions Studied

Diphtheria Tetanus Pertussis Measles Polio

Interventions

  • BIOLOGICAL Diphtheria and Tetanus Toxoids and Acellular Pertussis + Measles, Mumps, Rubella + Varicella Virus
  • BIOLOGICAL Diphtheria and Tetanus Toxoids and Acellular Pertussis + Poliovirus + MMR + Varicella Virus

Study Locations (20)

Alabama

  • - Birmingham
  • - Birmingham
  • - Birmingham
  • - Pinson
  • - Trussville

California

  • - La Puente
  • - Paramount
  • - Roseville
  • - Santa Clara
  • - West Covina

Arizona

  • - Chandler
  • - Scottsdale
  • - Scottsdale

Arkansas

  • - Jonesboro
  • - Little Rock

Colorado

  • - Longmont
  • - Thornton

Georgia

  • - Marietta
  • - Woodstock

Florida

  • - St. Petersburg

Trial Details

FieldValue
Enrollment Target 3,372 participants
Start Date 2011-04
Est. Completion 2013-09
Phase Phase 3

Sponsor

Sanofi Pasteur, a Sanofi Company

153 total trials

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What the Registry Record Tells You About NCT01346293

The ClinicalTrials.gov registry entry for NCT01346293 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 3,372 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 1,642-participant average among 15 other Diphtheria trials with a reported enrollment target (105% higher). The listed sponsor is Sanofi Pasteur, a Sanofi Company, which has 153 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 Diphtheria and Tetanus Toxoids and Acellular Pertussis + Measles, Mumps, Rubella + Varicella Virus is the first listed.

NCT01346293 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Alabama, California, Arizona.

Frequently Asked Questions

What is clinical trial NCT01346293 about?

NCT01346293 is a clinical study titled "Study of DTap-IPV Compared to DAPTACEL® and IPOL® as the 5th Dose in Children 4 to 6 Years of Age". The study was designed to compare the safety and immunogenicity of DTap-IPV with DAPTACEL® + IPOL® as the 5th dose booster in children ≥ 4 to \< 7 years of age in the US and Puerto Rico who were previously vaccinated with DAPTACEL® and/or Pentacel® vaccines only. Primary Objectives: * To compare t...

What is the current status of trial NCT01346293?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,372 participants. The study started on 2011-04. Estimated completion is 2013-09.

What conditions does trial NCT01346293 study?

This clinical trial studies the following conditions: Diphtheria, Tetanus, Pertussis, Measles, Polio.

What interventions are being tested in trial NCT01346293?

The interventions under investigation include: Diphtheria and Tetanus Toxoids and Acellular Pertussis + Measles, Mumps, Rubella + Varicella Virus (BIOLOGICAL), Diphtheria and Tetanus Toxoids and Acellular Pertussis + Poliovirus + MMR + Varicella Virus (BIOLOGICAL).

Who is sponsoring clinical trial NCT01346293?

This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01346293 being conducted?

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

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.