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

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00258895

Purpose

Primary Objectives:

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™.
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:

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™.
To present the pre-vaccination anti-poliovirus GMTs and seroprotection rates.
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: DAPTACEL®: DTaP	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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®

Resource links provided by NLM:

MedlinePlus related topics: Cough Diphtheria Tetanus Whooping Cough

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination [ Time Frame: 0 to 7 days Post-Dose 5 ] [ Designated as safety issue: Yes ]
Percentage of Participants With Anti-Pertussis 4-Fold Rises Post-Dose 5 of DAPTACEL® Vaccination [ 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-Dose 5 of DAPTACEL® Vaccination [ 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 Toxoids Responses Pre- and Post-Dose 5 of DAPTACEL® Vaccination. [ Time Frame: Day 0 and between Days 28-48 Post-dose 5 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Enrollment:	649
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
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®

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 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00258895

Show 22 Study Locations

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Medical Director

Sanofi Pasteur Inc.

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Medical Director, Sanofi Pasteur Inc
ClinicalTrials.gov Identifier:	NCT00258895 History of Changes
Other Study ID Numbers:	P3T11
Study First Received:	November 24, 2005
Results First Received:	August 18, 2009
Last Updated:	April 28, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

DAPTACEL®
Pentacel™
Diphtheria
Tetanus

Pertussis
Whooping cough
Acellular Pertussis Vaccine Adsorbed

Additional relevant MeSH terms:

Diphtheria
Whooping Cough
Tetanus
Tetany
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Respiratory Tract Infections

Infection
Respiratory Tract Diseases
Clostridium Infections
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Hypocalcemia
Calcium Metabolism Disorders
Metabolic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on February 09, 2012