MedTrace Logo

Post-licensure, Modified Double-blind, Multi-center Study Evaluating Safety and Immunogenicity of ADACEL® and BOOSTRIX®

NCT00319553 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 647

Last updated 2012-10-05

Study results available
· View outcomes & findings →

Summary

This is a descriptive study to evaluate the safety and immunogenicity of ADACEL® and BOOSTRIX® vaccines among US adolescents.

Conditions

  • Pertussis
  • Tetanus
  • Diphtheria

Interventions

BIOLOGICAL

ADACEL®:Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed

0.5 mL, IM

BIOLOGICAL

BOOSTRIX®: Tetanus, Reduced Diphtheria and Acellular Pertussis Adsorbed

0.5 mL, IM

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2008-10-31
Completion
2008-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00319553 on ClinicalTrials.gov