Study of DAPTACEL® Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With PENTACEL™

Completed · Phase 4

Conditions studied: Diphtheria, Tetanus, Pertussis, Polio, Haemophilus Infection

In brief

Objectives: * To present the rates of adverse reactions after a dose of DAPTACEL® vaccine administered to children 4 to 6 years of age who have previously received four doses of PENTACEL™ vaccine. * To present immunogenicity before and after a single dose of DAPTACEL® vaccine administered to children 4 to 6 years of age who have previously received four doses of PENTACEL™ vaccine.

Key facts

Study ID

NCT00802867

Run by

Sanofi Pasteur, a Sanofi Company

People needed

989

Starts

2004-02-01

Expected to finish

2005-09-01

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 years and 6 years.
• Signed and dated Investigational Review Board-approved informed consent from a parent or legally authorized representative.
• 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 4th dose in Study 494-01 or Study 494-03, consisting of four previous administrations of PENTACEL™.

You may not qualify if…

• Received a 5th dose of DTaP-containing vaccine scheduled at 4 to 6 years of age.
• Serious underlying chronic disease, including, but not limited to:
• Diabetes mellitus; malignancy; cardiopulmonary disease; renal, endocrinologic, or hepatic dysfunction; or hematologic disorder; or
• Unstable or evolving neurologic disorders that may predispose the subject to seizures or neurologic deterioration.
• Known or suspected primary or acquired disease of the immune system.
• Administration of immune globulin or other blood products within the last 3 months, or injected or oral corticosteroids or other immunomodulatory therapy within 6 weeks of the study vaccine. 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 the last 4 weeks.
• Receipt of any other vaccine within the past 30 days, or planning to receive another vaccine within 30 days before the Visit 2 blood draw, with the exclusion of M-M-R®II and IPV.
• 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.
• Temporary contraindications:
• A subject who meets either of the following criteria at the time of planned vaccination will have enrollment deferred until complete resolution of symptoms:
• Oral temperature ≥ 100.4°F (≥ 38.0ºC) (Note: A tympanic thermometer should not be used).
• Any moderate or severe acute illness with or without fever.

Where it is running

• Study site — Jonesboro, Arkansas, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Oakland, California, United States
• Study site — Torrance, California, United States
• Study site — Orlando, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Boston, Massachusetts, United States
• Study site — Woburn, Massachusetts, United States
• Study site — Omaha, Nebraska, United States
• Study site — Albany, New York, United States
• Study site — Rochester, New York, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Sylva, North Carolina, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Nashville, Tennessee, United States
• Study site — San Antonio, Texas, United States
• Study site — Layton, Utah, United States
• Study site — Vancouver, Washington, United States
• Study site — Marshfield, Wisconsin, United States

Full record on ClinicalTrials.gov

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