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

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Brief Title

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

Official Title

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)

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.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel®


Condition

Diphtheria

Intervention

Diphtheria and Tetanus Toxoids and Acellular Pertussis (DAPTACEL®)

Study Arms / Comparison Groups

 1
Description:  Subjects in Study 494-01 and Study 494-03 who had received 4 doses of Pentacel™ vaccine.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

989

Start Date

February 2004

Completion Date

September 2005

Primary Completion Date

June 2005

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.
      

Gender

All

Ages

4 Years - 6 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Medical Monitor, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00802867

Organization ID

P3T10


Responsible Party

Sponsor

Study Sponsor

Sanofi Pasteur, a Sanofi Company


Study Sponsor

Medical Monitor, Study Director, Sanofi Pasteur Inc.


Verification Date

April 2016