Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Immunogenicity of DAPTACEL® as 5th Dose in Children 4 to 6 Years Old After 4 Doses of Pentacel™ or DAPTACEL®

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00258895
Recruitment Status : Completed
First Posted : November 28, 2005
Results First Posted : September 28, 2009
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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 or disease Intervention/treatment Phase
Diphtheria Tetanus Pertussis Biological: DAPTACEL®: DTaP Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 649 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity of DAPTACEL® Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With DAPTACEL® or Pentacel®
Study Start Date : March 2005
Actual Primary Completion Date : December 2006
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: DAPTACEL Primed
Participants received Daptacel in Study P3T06.
 Biological: DAPTACEL®: DTaP
0.5 mL, Intramuscular
Other Name: DAPTACEL®
Experimental: Pentacel Primed
Participants received Pentacel in Study P3T06
 Biological: DAPTACEL®: DTaP
0.5 mL, Intramuscular
Other Name: DAPTACEL®


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination [ Time Frame: 0 to 7 days Post-Dose 5 ]
  2. Percentage of Participants With Anti-Pertussis 4-Fold Rises Post-Dose 5 of DAPTACEL® Vaccination [ Time Frame: Day 28 to 48 Post-dose 5 ]
    Anti-Pertussis (anti-Pertussis, anti-Filamentous Haemagglutinin, anti-Fimbriae, and anti-Pertactin) Fold-rise is calculated as post-Dose 5/pre-Dose 5 titer.

  3. Percentage of Participants With Anti-Pertussis Booster Response Post-Dose 5 of DAPTACEL® Vaccination [ Time Frame: Day 28 to 48 Post-Dose 5 ]
    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.

  4. Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Toxoids Responses Pre- and Post-Dose 5 of DAPTACEL® Vaccination. [ Time Frame: Day 0 and between Days 28-48 Post-dose 5 ]
  5. Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination [ Time Frame: Day 0 and between Days 28-48 post-dose 5 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   4 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
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 Inactivated Poliovirus Vaccine (IPV) vaccine and/or a 2nd dose of Measles, Mumps, and Rubella (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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00258895


Locations
Layout table for location information
United States, Arkansas
Fayetteville, Arkansas, United States
Jonesboro, Arkansas, United States
Little Rock, Arkansas, United States
United States, California
Fountain Valley, California, United States
United States, Colorado
Centennial, Colorado, United States
United States, Connecticut
Norwich, Connecticut, United States
United States, Georgia
Marietta, Georgia, United States
United States, Kentucky
Bardstown,, Kentucky, United States
United States, Louisiana
Bossier City, Louisiana, United States
United States, New York
Rochester, New York, United States
United States, North Carolina
Pembroke, North Carolina, United States
Sylva, North Carolina, United States
United States, Pennsylvania
Norristown, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States, 15213
Pittsburgh, Pennsylvania, United States, 15241
United States, Tennessee
Kingsport, Tennessee, United States
United States, Texas
Fort Worth, Texas, United States
San Antonio, Texas, United States
United States, Utah
Provo, Utah, United States
United States, Washington
Spokane, Washington, United States
United States, Wisconsin
LaCrosse, Wisconsin, United States
Marshfield, Wisconsin, United States
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Layout table for investigator information
Study Director: Medical Director Sanofi Pasteur Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00258895    
Other Study ID Numbers: P3T11
First Posted: November 28, 2005    Key Record Dates
Results First Posted: September 28, 2009
Last Update Posted: April 14, 2016
Last Verified: April 2016
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
DAPTACEL®
Pentacel™
Diphtheria
Tetanus
 Pertussis
Whooping cough
Acellular Pertussis Vaccine Adsorbed
Additional relevant MeSH terms:
Layout table for MeSH terms
Whooping Cough
Tetanus
Diphtheria
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
 Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Corynebacterium Infections
Actinomycetales Infections