Status:
COMPLETED
Study of DAPTACEL® Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With PENTACEL™
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Diphtheria
Tetanus
Eligibility:
All Genders
4-6 years
Phase:
PHASE4
Brief Summary
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. * ...
Detailed Description
This study is designed to assess the safety and immunogenicity of DAPTACEL® vaccine administered at 4 to 6 years of age according to the US standard of care. The study population consists of PENTACEL™...
Eligibility Criteria
Inclusion
- Inclusion Criteria :
- 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™.
- Exclusion Criteria :
- 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.
Exclusion
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2005
Estimated Enrollment :
989 Patients enrolled
Trial Details
Trial ID
NCT00802867
Start Date
February 1 2004
End Date
September 1 2005
Last Update
April 14 2016
Active Locations (19)
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1
Jonesboro, Arkansas, United States, 72401
2
Little Rock, Arkansas, United States, 72205
3
Oakland, California, United States, 94612
4
Torrance, California, United States, 90502