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NCT01311557 · ClinicalTrials.gov registry record · Phase 4

Study of Adacel® Vaccine Administered to Persons 10 Years of Age

A Phase 4 study of Diphtheria and Tetanus, sponsored by Sanofi.

Completed
Registry status
Phase 4
Development phase
1,302
Enrollment target
20
Study locations

NCT01311557: Completed Phase 4 study of Diphtheria and Tetanus, sponsored by Sanofi.

NCT01311557 is a Phase 4 study of Diphtheria and Tetanus that has completed, run by Sanofi. The registered enrollment target is 1,302 participants, below the 1,780-participant average among 15 other Diphtheria trials with a reported enrollment target (27% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01311557, a Phase 4 study of Diphtheria and Tetanus, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 4
Development phase
1,302 participants
Enrollment target
20
Study locations

Study Summary

The purpose of study Td519 is to demonstrate that Adacel® vaccine (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Adsorbed) is safe and immunogenic in persons 10 years of age. Primary Objectives: * To compare pertussis antibody responses induced by Adacel® in persons 10 to \<11 years of age to those induced by Adacel in persons 11 to \<12 years of age. * To compare the booster responses against pertussis antigens induced by Adacel in persons 10 to \<11 years of age to those induced by Adacel in persons 11 to \<12 years of age. * To compare booster responses against tetanus and diphtheria induced by Adacel in persons 10 to \<11 years of age to those induced by Adacel in persons 11 to \<12 years of age. Secondary Objective: * To compare seroprotection rates against tetanus and diphtheria induced by Adacel in persons 10 to \<11 years of age to those induced by Adacel in persons 11 to \<12 years of age.

Primary Outcome

Anti-Pertussis titers (Pertussis toxoid \[PT\], Filamentous hemagglutinin \[FHA\], Pertactin \[PRN\], Fimbriae types 2 and 3 \[FIM\]) geometric mean titers were assessed by enzyme-linked immunosorbent assay (ELISA).

Conditions Studied

Diphtheria Tetanus Pertussis

Interventions

  • BIOLOGICAL Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Adsorbed

Study Locations (20)

Kentucky

  • - Bardstown
  • - Crestview Hills
  • - Louisville
  • - Madisonville

Arkansas

  • - Jonesboro
  • - Little Rock

Georgia

  • - Marietta
  • - Woodstock

Louisiana

  • - Haughton
  • - Metairie

Arizona

  • - Chandler

California

  • - Sacramento

Colorado

  • - Longmont

Connecticut

  • - Norwich

Trial Details

FieldValue
Enrollment Target 1,302 participants
Start Date 2011-03
Est. Completion 2012-01
Phase Phase 4
Sanofi

713 total trials

What the finished NCT01311557 record still lists

NCT01311557 is an interventional study that assigns participants to a tested intervention. Its 1,302 participants enrollment target places it among the larger protocols in the corpus, below the 1,780-participant average among 15 other Diphtheria trials with a reported enrollment target (27% lower).

The record links to 3 conditions, with Diphtheria appearing as the primary indexed condition, and to 1 intervention - of which Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Adsorbed is the first listed.

NCT01311557 names 20 study sites across 14 states, led by Kentucky, Arkansas, Georgia.

Frequently Asked Questions

What is clinical trial NCT01311557 about?

NCT01311557 is a clinical study titled "Study of Adacel® Vaccine Administered to Persons 10 Years of Age". The purpose of study Td519 is to demonstrate that Adacel® vaccine (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Adsorbed) is safe and immunogenic in persons 10 years of age. Primary Objectives: * To compare pertussis antibody responses induced by Adacel® in persons 10 to \<11 ...

What is the current status of trial NCT01311557?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,302 participants. The study started on 2011-03. Estimated completion is 2012-01.

What conditions does trial NCT01311557 study?

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

What interventions are being tested in trial NCT01311557?

The interventions under investigation include: Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Adsorbed (BIOLOGICAL).

Who is sponsoring clinical trial NCT01311557?

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

Where is trial NCT01311557 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. 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 NCT01311557's enrollment target sits among peer trials

1,302 8th of 15 higher than 8 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 NCT01311557, the US trial registry maintained by the National Library of Medicine. NCT01311557 (large enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.