Safety and Immune Response of Different Pediatric Combination Vaccines.

January 21, 2014 updated by: Sanofi Pasteur, a Sanofi Company

Comparative Immunogenicity of Different Multivalent Component Pertussis Vaccine Formulations Based on a 5 Component Acellular Pertussis Vaccine in Infants and Toddlers

The overall aim of the study is to corroborate that a schedule consisting of 3 doses of Pentacel™ and a 4th dose of DAPTACEL® and ActHIB® or 4 doses of Pentacel™ or 4 doses of Quadracel and ActHIB® is as safe and immunogenic as a standard of care schedule based on 3 doses of the licensed-equivalent vaccines DAPTACEL®, Vero cell derived Inactivated Poliovirus vaccine (IPOL®), and ActHIB® and a 4th dose of DAPTACEL® and ActHIB®.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2167

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
    • Alabama
      • Tuscaloosa, Alabama, United States, 35401
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
      • Jonesboro, Arkansas, United States, 72401
      • Little Rock, Arkansas, United States, 72205
    • California
      • Fountain Valley, California, United States
      • Oakland, California, United States, 94609
      • Oakland, California, United States, 94613
      • Oakland, California, United States, 94618
      • Paramount, California, United States, 90723
    • Connecticut
      • Norwich, Connecticut, United States, 06360
    • Florida
      • Palm Beach Gardens, Florida, United States, 33410
    • Georgia
      • Marietta, Georgia, United States, 30062
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
    • Louisiana
      • Bossier City, Louisiana, United States, 71111
    • Maryland
      • Baltimore, Maryland, United States, 21201
    • Massachusetts
      • Woburn, Massachusetts, United States, 01801
    • Nebraska
      • Omaha, Nebraska, United States, 68131
    • New York
      • Ithaca, New York, United States
      • Liverpool, New York, United States, 13088
    • Ohio
      • Huber Heights, Ohio, United States, 45424
      • Youngstown, Ohio, United States, 44514
    • Pennsylvania
      • Norristown, Pennsylvania, United States, 19401
      • Pittsburgh, Pennsylvania, United States, 15241
      • Pittsburgh, Pennsylvania, United States, 15227
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
    • Texas
      • Amarillo, Texas, United States, 79124
      • Ft. Worth, Texas, United States, 76107
      • San Antonio, Texas, United States, 78229
      • San Antonio, Texas, United States, 78205
    • Utah
      • Provo, Utah, United States, 84604
      • South Jordan, Utah, United States, 84095
      • St George, Utah, United States, 84790
    • Washington
      • Spokane, Washington, United States, 99216
      • Vancouver, Washington, United States, 98664
    • West Virginia
      • Huntington, West Virginia, United States, 25701
    • Wisconsin
      • Marshfield, Wisconsin, United States

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 year to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged ≥ 42 days and ≤ 89 days on the day of inclusion
  • Born at full term of pregnancy (≥ 36 weeks)
  • Informed consent form signed by the parent(s) or other legally authorized representative(s) before the 1st study related procedure
  • Vaccination with a hepatitis B vaccine at least 30 days before inclusion
  • Able to attend all scheduled visits and to comply with all trial procedures(i.e., access to a phone)
  • Provide blood sample prior to Dose 1
  • Parent or legal representative willing to take rectal temperatures after each vaccination.

Exclusion Criteria:

  • Participation in another clinical trial in the 4 weeks preceding the (first)trial vaccination
  • Planned participation in another clinical trial during the present trial period
  • Personal or immediate family history of congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
  • Known or suspected systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances as the trial vaccine(s)
  • Chronic illness that could interfere with trial conduct or completion
  • Received blood or blood-derived products since birth
  • Any vaccination in the 2 weeks preceding the first trial vaccination or planned in the 4 weeks after any trial vaccination. Flu vaccine could be administered only 2 weeks after any trial vaccination
  • Previous vaccination with any acellular pertussis- (DTaP) or whole cell pertussis- (DTwP) based combination vaccines, Haemophilus influenzae type b (Hib)-conjugate, poliovirus, or pneumococcal conjugate vaccines
  • Coagulation disorder contraindicating intramuscular (IM) vaccination
  • Clinically significant findings on review of systems (determined by investigator or sub-investigator to be sufficient for exclusion)
  • Developmental delay or neurological disorder
  • Any condition which, in the opinion of the investigator, would interfere with the evaluation of the vaccine or pose a health risk to the subject.

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Group 1: DAPTACEL®, ActHIB®, and IPOL®
Participants will receive 3 doses of DAPTACEL®, ActHIB®, and IPOL® at Months 2, 4, and 6, respectively
Biological: DAPTACEL®. (DTaP), IPOL®., and ActHIB®.
0.5 mL, Intramuscular
Other Names:
  • DAPTACEL®
  • IPOL®
  • ActHIB®
Experimental: Study Group 2: Pentacel®
Participants will receive 3 doses of Pentacel® at Months 2, 4, and 6, respectively
Biological: Pentacel®: DTaP-IPV/Hib combined
0.5 mL, Intramuscular
Other Names:
  • Pentacel®
Experimental: Study Group 3: DTaP-IPV and ActHIB®
Participants will receive 3 doses of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively
Biological: DTaP-IPV and ActHIB®
0.5 mL, Intramuscular
Other Names:
  • ActHIB®
Experimental: Study Group 4: Pentacel®
Participants will receive 3 doses of Pentacel® at Months 2, 4, and 6, respectively
Biological: Pentacel®: DTaP-IPV/Hib combined
0.5 mL, Intramuscular
Other Names:
  • Pentacel®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations.
Time Frame: 30 Days post-dose 3 vaccination
Vaccine response was calculated as a pre-dose 1 titer ≤ Lower Limit of Quantitation (LLOQ) and post-dose 3 titer > LLOQ; or a pre-dose 1 titer > LLOQ and post-dose 3 titer ≥ pre-dose 1 titer.
30 Days post-dose 3 vaccination
Percentage of Participants With a Four-fold Rise in Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations (Seroconversion)
Time Frame: 30 Days post-dose 3 vaccination
30 Days post-dose 3 vaccination
Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations.
Time Frame: 30 Days post-dose 3 vaccination.
30 Days post-dose 3 vaccination.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3
Time Frame: 7 days post-vaccination 3
Solicited injection site reactions: Tenderness, Redness, and Swelling. Solicited systemic reactions: Fever (body temperature), Vomiting, Abnormal crying, Lethargy, Appetite decreased, Irritability, and Rash.
7 days post-vaccination 3

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.

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

November 1, 2005

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

November 15, 2005

First Submitted That Met QC Criteria

November 15, 2005

First Posted (Estimate)

November 17, 2005

Study Record Updates

Last Update Posted (Estimate)

February 14, 2014

Last Update Submitted That Met QC Criteria

January 21, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M5A10

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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