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

April 12, 2016 updated by: Sanofi Pasteur, a Sanofi Company

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

989

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
      • Little Rock, Arkansas, United States, 72205
    • California
      • Oakland, California, United States, 94612
      • Torrance, California, United States, 90502
    • Florida
      • Orlando, Florida, United States, 32806
    • Georgia
      • Atlanta, Georgia, United States, 30322
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
      • Woburn, Massachusetts, United States, 01801
    • Nebraska
      • Omaha, Nebraska, United States, 68131
    • New York
      • Albany, New York, United States, 12208
      • Rochester, New York, United States, 14620
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
      • Sylva, North Carolina, United States, 28779
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15241
    • Tennessee
      • Nashville, Tennessee, United States, 37232
    • Texas
      • San Antonio, Texas, United States, 78205
    • Utah
      • Layton, Utah, United States, 84041
    • Washington
      • Vancouver, Washington, United States, 98664
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 6 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
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®)
0.5 mL, Intramuscular
Other Names:
  • DAPTACEL®

What is the study measuring?

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®
Time Frame: 0 to 3 days post-dose 5 vaccination

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With 4-Fold Rises in Anti-Pertussis Post-vaccination With DAPTACEL® as a Fifth Dose.
Time Frame: Day 28 to 48 Post-dose 5

Anti-pertussis (anti-Pertussis, anti-Filamentous Haemagglutinin, anti-Fimbriae, and anti-Pertactin).

Fold-rise is calculated as Post-Dose 5/Pre-Dose 5 titer.
Day 28 to 48 Post-dose 5
Percentage of Participants With Anti-Pertussis Booster Response Post-vaccination With DAPTACEL® as a Fifth Dose
Time Frame: Day 28 to 48 Post-dose 5
Booster response calculation: If Pre-Dose 5 titer < 4x limit of quantitation (LOQ), a 4-fold rise of Post-dose 5/Pre-dose 5; If Pre-dose 5 titer ≥ 4x LOQ, a 2-fold rise of Post-dose 5/Pre-dose 5.
Day 28 to 48 Post-dose 5
Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Seroprotection Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose
Time Frame: Day 28 to 48 Post-dose 5
Seroprotection is defined as a titer of ≥ 0.01 IU/mL for both Diphtheria and Tetanus before the fifth dose booster vaccination
Day 28 to 48 Post-dose 5
Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose
Time Frame: Pre-dose 5 and Day 28 to 48 Post-dose 5
Pre-dose 5 and Day 28 to 48 Post-dose 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi Pasteur, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Primary Completion (ACTUAL)

June 1, 2005

Study Completion (ACTUAL)

September 1, 2005

Study Registration Dates

First Submitted

December 4, 2008

First Submitted That Met QC Criteria

December 4, 2008

First Posted (ESTIMATE)

December 5, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

April 14, 2016

Last Update Submitted That Met QC Criteria

April 12, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P3T10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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