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

NCT ID: NCT00802867

Last Updated: 2016-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 989 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2005-09-30

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.
• 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

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.

Conditions

Diphtheria; Tetanus; Pertussis; Polio; Haemophilus Infection

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1

Subjects in Study 494-01 and Study 494-03 who had received 4 doses of Pentacel™ vaccine.

Group Type: EXPERIMENTAL

Diphtheria and Tetanus Toxoids and Acellular Pertussis (DAPTACEL®)

Intervention Type: BIOLOGICAL

0.5 mL, Intramuscular

Interventions

Diphtheria and Tetanus Toxoids and Acellular Pertussis (DAPTACEL®)

0.5 mL, Intramuscular

Intervention Type: BIOLOGICAL

Other Intervention Names

DAPTACEL®

Eligibility Criteria

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Sanofi Pasteur Inc.

Locations

Jonesboro, Arkansas, United States

Little Rock, Arkansas, United States

Oakland, California, United States

Torrance, California, United States

Orlando, Florida, United States

Atlanta, Georgia, United States

Boston, Massachusetts, United States

Woburn, Massachusetts, United States

Omaha, Nebraska, United States

Albany, New York, United States

Rochester, New York, United States

Chapel Hill, North Carolina, United States

Sylva, North Carolina, United States

Pittsburgh, Pennsylvania, United States

Nashville, Tennessee, United States

San Antonio, Texas, United States

Layton, Utah, United States

Vancouver, Washington, United States

Marshfield, Wisconsin, United States

Countries

United States

Related Links

http://www.sanofipasteur.com

Related Info

Other Identifiers

P3T10

Identifier Type: -

Identifier Source: org_study_id