Safety and Immunogenicity of DAPTACEL® as 5th Dose in Children 4 to 6 Years Old After 4 Doses of Pentacel™ or DAPTACEL®
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diphtheria; Tetanus; Pertussis
Intervention: DAPTACEL® (Biological)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Sanofi-Aventis Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: sanofi pasteur
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.
Clinical Details
Study design: Prevention, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Eligibility
Minimum age: 4 Years.
Maximum age: 6 Years.
Gender(s): Both.
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.
Locations and Contacts
Fayetteville, Arkansas, United States
Little Rock, Arkansas, United States
Jonesboro, Arkansas, United States
Fountain Valley, California, United States
Centennial, Colorado, United States
Norwich, Connecticut, United States
Marietta, Georgia, United States
Bardstown,, Kentucky, United States
Bossier City, Louisiana, United States
Rochester, New York, United States
Pembroke, North Carolina, United States
Sylva, North Carolina, United States
Norristown, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Kingsport, Tennessee, United States
Fort Worth, Texas, United States
San Antonio, Texas, United States
Provo, Utah, United States
Spokane, Washington, United States
LaCrosse, Wisconsin, United States
Marshfield, Wisconsin, United States
Additional Information
Starting date: March 2005
Last updated: September 14, 2007
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