Safety and Immunogenicity of DAPTACEL® as 5th Dose in Children 4 to 6 Years Old After 4 Doses of Pentacel™ or DAPTACEL®
NCT ID: NCT00258895
Last Updated: 2016-04-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
649 participants
INTERVENTIONAL
2005-03-31
2007-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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DAPTACEL Primed
Participants received Daptacel in Study P3T06.
DAPTACEL®: DTaP
0.5 mL, Intramuscular
Pentacel Primed
Participants received Pentacel in Study P3T06
DAPTACEL®: DTaP
0.5 mL, Intramuscular
Interventions
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DAPTACEL®: DTaP
0.5 mL, Intramuscular
DAPTACEL®: DTaP
0.5 mL, Intramuscular
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
4 Years
6 Years
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Sanofi Pasteur Inc.
Locations
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Fayetteville, Arkansas, United States
Jonesboro, Arkansas, United States
Little Rock, 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
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
La Crosse, Wisconsin, United States
Marshfield, Wisconsin, United States
Countries
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Related Links
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Related Info
Other Identifiers
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P3T11
Identifier Type: -
Identifier Source: org_study_id
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