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

Study Overview
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Brief Summary
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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.

Detailed Description
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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™-primed subjects from Aventis Pasteur's pivotal studies 494-01 and 494-03. These children will receive DAPTACEL® vaccine as a 5th dose immunization between 4 to 6 years of age.

Official Title
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Safety and Immunogenicity of DAPTACEL® (CP10/5/5/3DT Aventis Pasteur 5-component Pertussis Vaccine in Combination With Tetanus and Diphtheria Toxoids Adsorbed) Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With PENTACEL™ (HCP20/20/5/3DT-mIPV//PRP-T)

Conditions
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Diphtheria, Tetanus, Pertussis, Polio, Haemophilus Infection

Intervention / Treatment
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* Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis (DAPTACEL®)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Subjects in Study 494-01 and Study 494-03 who had received 4 doses of Pentacel™ vaccine. | Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis (DAPTACEL®)<br>* 0.5 mL, Intramuscular<br>* Other names: DAPTACEL®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® | Solicited local reactions: Redness, swelling, tenderness at injection site, change in limb circumference, and limb function. Systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, vomiting, diarrhea, and rash. | 0 to 3 days post-dose 5 vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DAPTACEL®, PENTACEL™, Diphtheria, Tetanus, Pertussis, Haemophilus influenzae type b