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Safety and Immunogenicity of DAPTACEL® as 5th Dose in Children 4 to 6 Years Old After 4 Doses of Pentacel™ or DAPTACEL®
This study has been completed.
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00258895
  Purpose

Primary Objectives:

  1. To present the safety profile after a 5th dose of DAPTACEL® in children 4 to 6 years of age who have previously received 4 doses of DAPTACEL® or Pentacel™.
  2. To present the pre-Dose 5 and post-Dose 5 antibody responses to the antigens in DAPTACEL® in children 4 to 6 years of age who have previously received 4 doses of DAPTACEL® or Pentacel™.

Observational Objectives:

  1. To compare under equivalence criteria the pre-Dose 5 and post-Dose 5 antibody responses to the antigens in DAPTACEL® in children 4 to 6 years of age who have previously received 4 doses of DAPTACEL® or Pentacel™.
  2. To present the pre-vaccination anti-poliovirus GMTs and seroprotection rates.
  3. To present the post-vaccination anti-poliovirus GMTs and seroprotection rates among subjects receiving a 4th dose of IPV concurrently with the 5th dose of DAPTACEL and a 2nd dose of MMR.

Condition Intervention Phase
Diphtheria
Tetanus
Pertussis
Biological: DTaP
Phase III

MedlinePlus related topics: Diphtheria Tetanus Whooping Cough
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • Provide information concerning the safety of DAPTACEL® [ Time Frame: 180 Days post-vaccination ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To provide information concerning the immunogenicity of DAPTACEL® [ Time Frame: 28-48 days post-vaccination ] [ Designated as safety issue: No ]

Enrollment: 650
Study Start Date: March 2005
Study Completion Date: April 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
DAPTACEL Primed
Biological: DTaP
0.5 mL, Intramuscular
2: Experimental
Pentacel Primed
Biological: DTaP
0.5 mL, Intramuscular

  Eligibility

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

Inclusion Criteria:

  • Aged >=4 and <7 years from date of birth at the time of study vaccination
  • Signed and dated Investigational Review Board (IRB)-approved informed consent from a parent or legally authorized representative. Signed and dated IRB-approved assent from subject if required by IRB
  • 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 the 4th dose of DAPTACEL® or Pentacel™ in Study P3T06 (i.e., 4 previous administrations of DAPTACEL® or Pentacel™).

Exclusion Criteria:

  • Received a 5th dose of DTaP-containing vaccine
  • a. For subjects in the DAPTACEL® arm: Received a 4th dose of IPV vaccine and/or a 2nd dose of MMR vaccine scheduled at 4 to 6 years of age. b. For subjects in the Pentacel™ arm: Received a 2nd dose of MMR vaccine scheduled at 4 to 6 years of age
  • Severe hypersensitivity to any component of the vaccine such as an anaphylactic reaction observed following a previous vaccination
  • Serious underlying chronic disease, including, but not limited to:·Diabetes mellitus; malignancy; cardiopulmonary disease; renal, endocrinologic, or hepatic dysfunction; or hematologic disorder·Unstable or evolving neurologic disorders that may predispose the subject to seizures or neurologic deterioration. These may include progressive neurologic disorders (e.g., infantile spasms, uncontrolled progressive encephalopathy) and encephalopathy within 7 days following previous vaccination
  • Known or suspected primary or acquired disease of the immune system
  • Administration of immune globulin, other blood products within the last 3 months, injected or oral corticosteroids or other immunomodulator therapy within 6 weeks prior to study vaccination. 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 4 weeks prior to study vaccination
  • Receipt of any other vaccine within 30 days prior to study vaccination, or planning to receive another vaccine within 30 days before the Visit 2 blood draw (if applicable)
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00258895

  Show 21 Study Locations
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: Medical Director 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 Director )
Study ID Numbers: P3T11
Study First Received: November 24, 2005
Last Updated: September 22, 2008
ClinicalTrials.gov Identifier: NCT00258895  
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:
DAPTACEL®
Pentacel™
Diphtheria
Tetanus
Pertussis
Whooping cough
Acellular Pertussis Vaccine Adsorbed

Study placed in the following topic categories:
Bacterial Infections
Gram-Positive Bacterial Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Cough
Whooping Cough
Diphtheria
Clostridium Infections
Tetanus
Whooping cough
Gram-Negative Bacterial Infections

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

ClinicalTrials.gov processed this record on January 14, 2009