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Study of DAPTACEL® Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With PENTACEL™
This study has been completed.
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00802867
  Purpose

Observational Objectives:

  • To present the rates of adverse reactions after a dose of DAPTACEL® vaccine administered to children 4 to 6 years of age who have previously received four doses of PENTACEL™ vaccine.
  • To present immunogenicity before and after a single dose of DAPTACEL® vaccine administered to children 4 to 6 years of age who have previously received four doses of PENTACEL™ vaccine.

Condition Intervention Phase
Diphtheria
Tetanus
Pertussis
Polio
Haemophilus Influenzae Type B
Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis (DAPTACEL®)
Phase IV

MedlinePlus related topics: Diphtheria Flu Tetanus Whooping Cough
Drug Information available for: Tetanus Vaccine
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title: Safety and Immunogenicity of DAPTACEL® (CP10/5/5/3DT Aventis Pasteur 5-Component Pertussis Vaccine in Combination With Tetanus and Diphtheria Toxoids Adsorbed) Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With PENTACEL™ (HCP20/20/5/3DT-mIPV//PRP-T)

Further study details as provided by Sanofi-Aventis:

Secondary Outcome Measures:
  • To provide information concerning the safety of DAPTACEL® vaccine [ Time Frame: 7 days post-vaccination and entire study duration. ] [ Designated as safety issue: Yes ]

Enrollment: 989
Study Start Date: February 2004
Study Completion Date: September 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Subjects in Study 494-01 and Study 494-03 who had received 4 doses of Pentacel™ vaccine.
Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis (DAPTACEL®)
0.5 mL, Intramuscular

Detailed Description:

This study is designed to assess the safety and immunogenicity of DAPTACEL® vaccine administered at 4 to 6 years of age according to the US standard of care. The study population consists of PENTACEL™-primed subjects from Aventis Pasteur's pivotal studies 494-01 and 494-03. These children will receive DAPTACEL® vaccine as a 5th dose immunization between 4 to 6 years of age.

  Eligibility

Ages Eligible for Study:   4 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria :

  • Aged >=4 years and <7 years.
  • Signed and dated Investigational Review Board-approved informed consent from a parent or legally authorized representative.
  • Judged to be in good health on the basis of reported medical history and physical examination.
  • Able and willing to attend the scheduled visits and to comply with the study procedures.
  • Has documented complete infant series and 4th dose in Study 494-01 or Study 494-03, consisting of four previous administrations of PENTACEL™.

Exclusion Criteria :

  • Received a 5th dose of DTaP-containing vaccine scheduled at 4 to 6 years of age.
  • Serious underlying chronic disease, including, but not limited to:
  • Diabetes mellitus; malignancy; cardiopulmonary disease; renal, endocrinologic, or hepatic dysfunction; or hematologic disorder; or
  • Unstable or evolving neurologic disorders that may predispose the subject to seizures or neurologic deterioration.
  • Known or suspected primary or acquired disease of the immune system.
  • Administration of immune globulin or other blood products within the last 3 months, or injected or oral corticosteroids or other immunomodulatory therapy within 6 weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting <7 days may be included in the trial as long as they have not received more than 1 course within the last 2 weeks prior to enrollment.
  • Had allergy shots started or had changes in regimen or dosing of allergy shots within the last 4 weeks.
  • Receipt of any other vaccine within the past 30 days, or planning to receive another vaccine within 30 days before the Visit 2 blood draw, with the exclusion of M-M-R®II and IPV.
  • Any other condition which, in the opinion of the Investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.
  • Enrolled in another vaccine trial.
  • Personal history of physician-diagnosed or laboratory-confirmed pertussis disease within the past 30 months.
  • Known or suspected allergy to any of the vaccines or vaccine components intended for use in this study.

Temporary contraindications:

  • A subject who meets either of the following criteria at the time of planned vaccination will have enrollment deferred until complete resolution of symptoms:

Oral temperature >= 100.4°F (>= 38.0ºC) (Note: A tympanic thermometer should not be used).

  • Any moderate or severe acute illness with or without fever.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00802867

Locations
United States, Arkansas
Little Rock, Arkansas, United States, 72205
Jonesboro, Arkansas, United States, 72401
United States, California
Oakland, California, United States, 94612
Torrance, California, United States, 90502
United States, Florida
Orlando, Florida, United States, 32806
United States, Georgia
Atlanta, Georgia, United States, 30322
United States, Massachusetts
Boston, Massachusetts, United States, 02115
Woburn, Massachusetts, United States, 01801
United States, Nebraska
Omaha, Nebraska, United States, 68131
United States, New York
Albany, New York, United States, 12208
Rochester, New York, United States, 14620
United States, North Carolina
Chapel Hill, North Carolina, United States, 27514
Sylva, North Carolina, United States, 28779
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States, 15241
United States, Tennessee
Nashville, Tennessee, United States, 37232
United States, Texas
San Antonio, Texas, United States, 78205
United States, Utah
Layton, Utah, United States, 84041
United States, Washington
Vancouver, Washington, United States, 98664
United States, Wisconsin
Marshfield, Wisconsin, United States, 54449
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: Medical Monitor Sanofi Pasteur Inc.
  More Information

Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

Responsible Party: Sanofi Pasteur Inc. ( Medical Monitor )
Study ID Numbers: P3T10
Study First Received: December 4, 2008
Last Updated: December 4, 2008
ClinicalTrials.gov Identifier: NCT00802867  
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:
DAPTACEL®
PENTACEL™
Diphtheria
Tetanus
Pertussis
Haemophilus influenzae type b

Study placed in the following topic categories:
Bacterial Infections
Haemophilus influenzae
Whooping Cough
Cough
Diphtheria
Orthomyxoviridae Infections
Tetanus
Whooping cough
Gram-Negative Bacterial Infections
Virus Diseases
Gram-Positive Bacterial Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Poliomyelitis
Influenza, Human
Clostridium Infections

Additional relevant MeSH terms:
Bordetella Infections
RNA Virus Infections
Corynebacterium Infections
Infection
Actinomycetales Infections

ClinicalTrials.gov processed this record on January 16, 2009