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

Completed · Phase 3

Conditions studied: Diphtheria, Tetanus, Pertussis

In brief

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.

Key facts

Study ID

NCT00258895

Run by

Sanofi Pasteur, a Sanofi Company

People needed

649

Starts

2005-03-01

Expected to finish

2007-04-01

Last updated by the study team

2016-04-14

Who can join

Age: 4 and older, up to 6. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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™).

You may not qualify if…

• 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.

Where it is running

• Study site — Fayetteville, Arkansas, United States
• Study site — Jonesboro, Arkansas, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Fountain Valley, California, United States
• Study site — Centennial, Colorado, United States
• Study site — Norwich, Connecticut, United States
• Study site — Marietta, Georgia, United States
• Study site — Bardstown, Kentucky, United States
• Study site — Bossier City, Louisiana, United States
• Study site — Rochester, New York, United States
• Study site — Pembroke, North Carolina, United States
• Study site — Sylva, North Carolina, United States
• Study site — Norristown, Pennsylvania, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Kingsport, Tennessee, United States
• Study site — Fort Worth, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Provo, Utah, United States
• Study site — Spokane, Washington, United States
• Study site — La Crosse, Wisconsin, United States
• Study site — Marshfield, Wisconsin, United States

Full record on ClinicalTrials.gov

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