Study of the Safety, Immunogenicity and Lot Comparability of DAPTACEL When Administered With Other Recommended Vaccine

January 26, 2012 updated by: Sanofi

Safety, Immunogenicity and Lot Comparability of DAPTACEL™ (Aventis Pasteur Classic Five-component Pertussis Vaccine in Combination With Tetanus and Diphtheria Toxoids Adsorbed) When Administered With Other Recommended Vaccines at 2, 4, 6, and 15 to 16 Months of Age.

This study was designed to assess the lot comparability of DAPTACEL, as well as the safety and immunogenicity of DAPTACEL when co-administered with other recommended infant vaccines.

Stage I Primary Objectives:

  1. To assess the lot-comparability of immunogenicity of DAPTACEL by when co-administered with other recommended vaccines.
  2. To compare the immune response to DTaP-IPV/Hib (Pentacel) with those of three lots of DAPTACEL when co-administered with other recommended vaccines.
  3. To compare the immune response of PRP-T antigen in Pentacel with that of ActHIB concurrently administered in a different injection site with DAPTACEL when these vaccines are co-administered with other recommended vaccines.

Stage II Primary Objectives:

  1. To compare the immune response of DAPTACEL when the 4th dose is co-administered with Hib or other infant vaccines.
  2. To compare the the immune response of Pentacel with those elicited by DAPTACEL when co-administered with ActHIB in toddlers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a two-stage, randomized, multi-center study to assess the safety, immunogenicity and lot comparability of DAPTACEL

Study Type

Interventional

Enrollment (Actual)

1941

Phase

  • Phase 3

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
      • Fayetteville, AR 72703, Arkansas, United States, 72703
      • Jonesboro, AR 72401, Arkansas, United States, 7240
      • Little Rock, AR 72211, Arkansas, United States, 72211
    • California
      • Fountain Valley, CA 92708, California, United States, 92708
    • Colorado
      • Englewood, CO 80112, Colorado, United States, 80112
    • Connecticut
      • Norwich, CT 06360, Connecticut, United States, 06360
    • Florida
      • Orlando, FL 32856, Florida, United States, 32856
    • Georgia
      • Marietta, GA 30062, Georgia, United States, 30062
    • Illinois
      • Chicago, IL 60614, Illinois, United States, 60614
    • Kentucky
      • Bardstown, KY 40004, Kentucky, United States, 40004
    • Louisiana
      • Bossier City, LA 71111, Louisiana, United States, 71111
    • Missouri
      • Bridgeton, MO 63044, Missouri, United States, 63044
    • New York
      • Rochester, NY 14620, New York, United States, 14620
    • North Carolina
      • Chapel Hill, NC 27514, North Carolina, United States, 27514
    • Oregon
      • Portland, OR 97201, Oregon, United States, 97201
    • Pennsylvania
      • Norristown, PA 19401, Pennsylvania, United States, 19401
      • Pittsburgh, PA 15213, Pennsylvania, United States, 15213
      • Pittsburgh, PA 15241, Pennsylvania, United States, 15241
    • Tennessee
      • Kingsport, TN 37664, Tennessee, United States, 37664
    • Texas
      • Austin, TX 78758, Texas, United States, 78758
      • Fort Worth, TX 76107, Texas, United States, 76106
      • San Antonio, TX 78205, Texas, United States, 78205
    • Utah
      • Provo, UT 84604, Utah, United States, 84604
    • Washington
      • Spokane, WA 99220, Washington, United States, 99220
    • Wisconsin
      • LaCrosse, WI 54601, Wisconsin, United States, 54601
      • Marshfield, WI 54449, 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

1 month to 2 months (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria :

  • Healthy infants 2 months of age.
  • Infants with at least 37 weeks of gestation at delivery.
  • Signed informed consent from parent or guardian.
  • Able to attend the scheduled visits and to comply with the study procedure.
  • Subjects must have received the first dose of hepatitis B vaccine from birth to 28 days prior to the first dose of DAPTACEL or Pentacel.

Exclusion Criteria :

  • Clinically significant findings on review of systems or physical examination (determined by investigator or sub-investigator to be sufficient for exclusion).
  • Known or suspected hypersensitivity to any component of the study vaccine to be administered.
  • Known or suspected impairment of immunologic function or receipt of immunosuppressive therapy or immunoglobulin since birth.
  • Known HIV-positive mother.
  • Personal or immediate family history of congenital immune deficiency.
  • Developmental delay or neurologic disorders.
  • Chronic medical, congenital, developmental or surgical disease.
  • Participation in any other experimental vaccine trial.
  • Any condition which, in the opinion of the investigator or sub-investigator, would interfere with the evaluation of the vaccine or pose a health risk to the subject.
  • Prior history of having received more than one dose of hepatitis B vaccine, any diphtheria, tetanus and acellular pertussis combination vaccine (DTaP), diphtheria, tetanus and whole-cell pertussis combination vaccine (DTwP), Haemophilus influenzae type b (Hib)-conjugate vaccine, poliovirus vaccine or pneumococcal conjugate vaccine

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: DAPTACEL Lot 1
Participants receiving Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine (DAPTACEL) Lot 1
Biological: DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine)
0.5 mL, Intramuscular
Other Names:
  • DAPTACEL®
EXPERIMENTAL: DAPTACEL Lot 2
Participants receiving Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine (DAPTACEL) Lot 2
Biological: DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine)
0.5 mL, Intramuscular
Other Names:
  • DAPTACEL®
EXPERIMENTAL: DAPTACEL Lot 3
Participants receiving Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine (DAPTACEL) Lot 3
Biological: DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine)
0.5 mL, Intramuscular
Other Names:
  • DAPTACEL®
ACTIVE_COMPARATOR: Pentacel
Participants receiving Pentacel vaccine
Biological: Pentacel: DTaP-IPV/Hib
0.5 mL, Intramuscular
Other Names:
  • Pentacel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Immunogenicity: To provide information concerning the immune response of DAPTACEL after vaccination.
Time Frame: 30 days post-vaccination 3
30 days post-vaccination 3

Collaborators and Investigators

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

Sponsor

Sanofi

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.

General Publications

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

May 1, 2001

Primary Completion (ACTUAL)

January 1, 2004

Study Completion (ACTUAL)

January 1, 2004

Study Registration Dates

First Submitted

April 17, 2008

First Submitted That Met QC Criteria

April 18, 2008

First Posted (ESTIMATE)

April 21, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

January 31, 2012

Last Update Submitted That Met QC Criteria

January 26, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P3T06

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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