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

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Booster responses to pertussis antigens \[pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM)\] were measured by enzyme-linked immunosorbent assay (ELISA). Booster responses were defined as participants with either a pre-vaccination antibody concentration less than lower limit of quantitation (\<LLOQ), achieving a post-vaccination level ≥4X LLOQ, or pre-vaccination antibody concentrations ≥LLOQ but \<4X LLOQ, achieving a 4-fold rise rate of p

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
Sanofi Pasteur, a Sanofi Company

153 total trials

What the finished NCT01346293 record still lists

NCT01346293 is an interventional study that assigns participants to a tested intervention. Its 3,372 participants enrollment target places it among the larger protocols in the corpus, above the 1,642-participant average among 15 other Diphtheria trials with a reported enrollment target (105% higher).

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 names 20 study sites across 7 states, led by 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.

Learn More About Clinical Trials

Similar trials for Diphtheria

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01346293's enrollment target sits among peer trials

3,372 3rd of 15 higher than 13 of 15 other Diphtheria trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Diphtheria trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT01346293, the US trial registry maintained by the National Library of Medicine. NCT01346293 (large enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.