Study to Compare Booster Vaccination With Pediacel® to Infanrix® Hexa When Both Are Co-Administered With Prevenar®

January 6, 2015 updated by: Sanofi Pasteur, a Sanofi Company

Safety and Immunogenicity of Booster Vaccination With PEDIACEL®, a Combined Diphtheria, Tetanus, Five Component Acellular Pertussis, Inactivated Poliomyelitis and Haemophilus Influenzae Type b Conjugate Vaccine (Adsorbed), Compared to Booster Vaccination With Infanrix® Hexa When Both Vaccines Are Co-Administered With Prevenar® to Toddlers 11-18 Months of Age

The purpose of the study is to provide data on the safety and immunogenicity of Pediacel® to allow its use as a fourth dose administered to 11-18 months old toddlers at the same time as Prevenar®.

Primary Objective:

To evaluate the safety of Pediacel® booster dose co-administered with Prevenar® to toddlers at 11-18 months of age.

Secondary Objectives:

  • To describe the incidence rate of severe fever within four days post-vaccination
  • To describe the antibody responses to all antigens in a subgroup of subjects at baseline and post-vaccination.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

847

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

  • Germany
      • Aalen, Germany, 73433
      • Aisch, Germany, 91413
      • Alsfeld, Germany, 36304
      • Augsburg, Germany, 86150
      • Bad Oeynhausen, Germany, 32549
      • Bad Säckingen, Germany, 79713
      • Berlin, Germany, 10115
      • Berlin, Germany, 13125
      • Berlin, Germany, 10783
      • Berlin, Germany, 13403
      • Bernau b. Berlin, Germany, 16321
      • Bielefeld, Germany, 33611
      • Bramsche, Germany, 49565
      • Bretten, Germany, 75015
      • Bönnigheim, Germany, 74357
      • Cham, Germany, 93413
      • Datteln, Germany, 45711
      • Detmold, Germany, 32756
      • Eisenberg, Germany, 07607
      • Erfurt, Germany, 99086
      • Espelkamp, Germany, 32339
      • Frankenthal, Germany, 67227
      • Freiburg, Germany, 79106
      • Freiburg, Germany, 79111
      • Gerolstein, Germany, 54568
      • Gersthofen, Germany, 86368
      • Goch, Germany, 47574
      • Göttingen, Germany, 37083
      • Gütersloh, Germany, 33332
      • Hamburg, Germany, 22305
      • Hamburg, Germany, 22415
      • Herbolzheim, Germany, 79336
      • Herrsching, Germany, 82211
      • Jena, Germany, 07745
      • Karlsruhe, Germany, 76137
      • Karlstadtm, Germany, 97753
      • Kehl, Germany, 77694
      • Kempten, Germany, 87435
      • Korbach, Germany, 34497
      • Krefeld, Germany, 47829
      • Köln, Germany, 51145
      • Königstein/Taunus, Germany, 61462
      • Landshut, Germany, 84032
      • Lauf/Pegnitz, Germany, 91207
      • Lauffen, Germany, 74348
      • Leinfelden-Echte, Germany, 70771
      • Lindenberg, Germany, 88161
      • Lingen 49 (Ems), Germany, 49808
      • Ludwigshafen, Germany, 67069
      • Ludwigshafen, Germany, 67053
      • Magdeburg, Germany, 39130
      • Magdeburg, Germany, 39116
      • Mainz, Germany, 55116
      • Mainz, Germany, 55118
      • Mainz-Hechtsheim, Germany, 55129
      • Mannheim, Germany, 68167
      • Marburg, Germany, 35039
      • Marktoberdorf, Germany, 87616
      • Marktredwitz, Germany, 95615
      • Melle, Germany, 49324
      • Mönchengladbach, Germany, 41061
      • Mönchengladbach, Germany, 41236
      • Mönchengladbach, Germany, 41068
      • München, Germany, 81241
      • München, Germany, 81479
      • München, Germany, 80634
      • München, Germany, 80939
      • München, Germany, 81735
      • Nabburg, Germany, 92507
      • Neumünster, Germany, 24534
      • Niedernhausen, Germany, 65527
      • Prüm, Germany, 54595
      • Schwieberdingen, Germany, 71701
      • Schwäbisch Hall, Germany, 74523
      • Schwäbisch-Gmünd, Germany, 73525
      • Solingen, Germany, 42699
      • Solingen, Germany, 42719
      • Traunreut, Germany, 83301
      • Ulm, Germany, 89077
      • Unterschleißheim, Germany, 85716
      • Weinheim, Germany, 69469
      • Wiesbaden, Germany, 65205
      • Wildeshausen, Germany, 27793
      • Wolfenbüttel, Germany, 38300

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

11 months to 1 year (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Toddlers 11-18 months of age (from the 11th month birthday to one day prior to the 19th month birthday) who previously received the primary immunisation series with a hexavalent vaccine (consisting of three doses of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and Haemophilus influenza type b combined vaccine administered within the first 6 months of life)
  • Informed consent form signed by both parents or by the legal guardian
  • Parents or a legal guardian able to read and write the local language
  • Parents or a legal guardian able to attend all scheduled visits and to comply with the study procedures.

Exclusion Criteria:

  • Presence of fever (defined as rectal body temperature ≥ 38.0°C) reported within the last 72 hours
  • Moderate or severe acute illness with or without fever
  • Participation in another clinical trial in the 30 days preceding study vaccination
  • Planned participation in another clinical trial during the present study period
  • Immunisation with a pneumococcal vaccine prior to study vaccination or planned during the participation in the study
  • Received more than 3 doses of a hexavalent vaccine prior to study vaccination
  • Received any vaccination in the 30 days preceding the trial
  • History of serological/microbiologically-confirmed diagnosis of infection due to pertussis, tetanus, diphtheria, poliomyelitis, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae
  • Congenital or acquired humoral/cellular immunodeficiency or immunosuppressive therapy such as long-term systemic corticosteroids therapy (≥ 2 mg/kg/day prednisone equivalent for ≥ 14 days in the 30 days prior to study vaccination)
  • Systemic or local hypersensitivity to any of the study vaccine components (including neomycin, streptomycin, polymyxin B and formaldehyde)
  • History of a life-threatening reaction (such as encephalopathy, Hypotonic-Hyporesponsive Episode (HHE), rectal body temperature ≥ 40.0°C, convulsions with or without fever) to any vaccine containing the same components as the study vaccines
  • Blood or blood-derived products (immunoglobulins) received during 3 months prior to study vaccination
  • Known HIV seropositivity
  • Known thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
  • History of encephalopathy, seizures or progressive, evolving or unstable neurological condition
  • Clinically significant findings on review of systems that might interfere with study vaccination or which, in the opinion of the Investigator, would interfere with the evaluation of the study vaccine/objectives 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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Participants will receive PEDIACEL with Prevenar at Visit 1 and ENGERIX-B Kinder at Visit 2
Biological: DT5aP-IPV-Hib 5-component Pertussis vaccine
0.5 mL, IM
Other Names:
  • Pediacel™
Active Comparator: Group 2
Participants will receive Infanrix hexa with Prevenar at Visit 1
Biological: DT3aP-HBs-IPV
0.5 mL, IM
Other Names:
  • Infanrix® hexa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To provide information concerning the safety after administration of PEDIACEL® booster dose
Time Frame: 0 to 3 Days post-vaccination
0 to 3 Days post-vaccination

Secondary Outcome Measures

Outcome Measure
Time Frame
To provide information concerning the safety (as fever rate) after administration of PEDIACEL® Vaccine
Time Frame: 4 days post-vaccination
4 days post-vaccination

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

September 1, 2006

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

July 20, 2006

First Submitted That Met QC Criteria

July 20, 2006

First Posted (Estimate)

July 24, 2006

Study Record Updates

Last Update Posted (Estimate)

January 7, 2015

Last Update Submitted That Met QC Criteria

January 6, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • A5I19

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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