Study of DAPTACEL® Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With PENTACEL™

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00802867
First received: December 4, 2008
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

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 Infection
Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis (DAPTACEL®)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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)

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® [ Time Frame: 0 to 3 days post-dose 5 vaccination ] [ Designated as safety issue: Yes ]

    Solicited local reactions: Redness, swelling, tenderness at injection site, change in limb circumference, and limb function.

    Systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, vomiting, diarrhea, and rash.



Other Outcome Measures:
  • Percentage of Participants With 4-Fold Rises in Anti-Pertussis Post-vaccination With DAPTACEL® as a Fifth Dose. [ Time Frame: Day 28 to 48 Post-dose 5 ] [ Designated as safety issue: No ]

    Anti-pertussis (anti-Pertussis, anti-Filamentous Haemagglutinin, anti-Fimbriae, and anti-Pertactin).

    Fold-rise is calculated as Post-Dose 5/Pre-Dose 5 titer.


  • Percentage of Participants With Anti-Pertussis Booster Response Post-vaccination With DAPTACEL® as a Fifth Dose [ Time Frame: Day 28 to 48 Post-dose 5 ] [ Designated as safety issue: No ]
    Booster response calculation: If Pre-Dose 5 titer < 4x limit of quantitation (LOQ), a 4-fold rise of Post-dose 5/Pre-dose 5; If Pre-dose 5 titer ≥ 4x LOQ, a 2-fold rise of Post-dose 5/Pre-dose 5.

  • Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Seroprotection Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose [ Time Frame: Day 28 to 48 Post-dose 5 ] [ Designated as safety issue: No ]
    Seroprotection is defined as a titer of ≥ 0.01 IU/mL for both Diphtheria and Tetanus before the fifth dose booster vaccination

  • Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose [ Time Frame: Pre-dose 5 and Day 28 to 48 Post-dose 5 ] [ Designated as safety issue: No ]

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
Experimental: 1
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
Other Name: DAPTACEL®

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 6 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00802867

Locations
United States, Arkansas
Jonesboro, Arkansas, United States, 72401
Little Rock, Arkansas, United States, 72205
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 Pasteur, a Sanofi Company
Investigators
Study Director: Medical Monitor Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00802867     History of Changes
Other Study ID Numbers: P3T10
Study First Received: December 4, 2008
Results First Received: September 24, 2009
Last Updated: January 10, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Whooping Cough
Tetanus
Diphtheria
Haemophilus Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Corynebacterium Infections
Actinomycetales Infections
Pasteurellaceae Infections

ClinicalTrials.gov processed this record on October 19, 2014