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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 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.

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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.

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

Sponsor

Sanofi

713 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01311557

The ClinicalTrials.gov registry entry for NCT01311557 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 1,302 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,780-participant average among 15 other Diphtheria trials with a reported enrollment target (27% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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.

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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.