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

Sponsor
Sanofi Pasteur, a Sanofi Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00355654
Collaborator
(none)
847
Enrollment
84
Locations
2
Arms
22
Duration (Months)
10.1
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: DT5aP-IPV-Hib 5-component Pertussis vaccine
  • Biological: DT3aP-HBs-IPV
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
847 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
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
Study Start Date :
Sep 1, 2006
Actual Primary Completion Date :
Sep 1, 2007
Actual Study Completion Date :
Jul 1, 2008

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To provide information concerning the safety after administration of PEDIACEL® booster dose [0 to 3 Days post-vaccination]

    Secondary Outcome Measures

    1. To provide information concerning the safety (as fever rate) after administration of PEDIACEL® Vaccine [4 days post-vaccination]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    11 Months to 18 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aalen Germany 73433
    2 Aisch Germany 91413
    3 Alsfeld Germany 36304
    4 Augsburg Germany 86150
    5 Bad Oeynhausen Germany 32549
    6 Bad Säckingen Germany 79713
    7 Berlin Germany 10115
    8 Berlin Germany 10783
    9 Berlin Germany 13125
    10 Berlin Germany 13403
    11 Bernau b. Berlin Germany 16321
    12 Bielefeld Germany 33611
    13 Bramsche Germany 49565
    14 Bretten Germany 75015
    15 Bönnigheim Germany 74357
    16 Cham Germany 93413
    17 Datteln Germany 45711
    18 Detmold Germany 32756
    19 Eisenberg Germany 07607
    20 Erfurt Germany 99086
    21 Espelkamp Germany 32339
    22 Frankenthal Germany 67227
    23 Freiburg Germany 79106
    24 Freiburg Germany 79111
    25 Gerolstein Germany 54568
    26 Gersthofen Germany 86368
    27 Goch Germany 47574
    28 Göttingen Germany 37083
    29 Gütersloh Germany 33332
    30 Hamburg Germany 22305
    31 Hamburg Germany 22415
    32 Herbolzheim Germany 79336
    33 Herrsching Germany 82211
    34 Jena Germany 07745
    35 Karlsruhe Germany 76137
    36 Karlstadtm Germany 97753
    37 Kehl Germany 77694
    38 Kempten Germany 87435
    39 Korbach Germany 34497
    40 Krefeld Germany 47829
    41 Köln Germany 51145
    42 Königstein/Taunus Germany 61462
    43 Landshut Germany 84032
    44 Lauf/Pegnitz Germany 91207
    45 Lauffen Germany 74348
    46 Leinfelden-Echte Germany 70771
    47 Lindenberg Germany 88161
    48 Lingen 49 (Ems) Germany 49808
    49 Ludwigshafen Germany 67053
    50 Ludwigshafen Germany 67069
    51 Magdeburg Germany 39116
    52 Magdeburg Germany 39130
    53 Mainz-Hechtsheim Germany 55129
    54 Mainz Germany 55116
    55 Mainz Germany 55118
    56 Mannheim Germany 68167
    57 Marburg Germany 35039
    58 Marktoberdorf Germany 87616
    59 Marktredwitz Germany 95615
    60 Melle Germany 49324
    61 Mönchengladbach Germany 41061
    62 Mönchengladbach Germany 41068
    63 Mönchengladbach Germany 41236
    64 München Germany 80634
    65 München Germany 80939
    66 München Germany 81241
    67 München Germany 81479
    68 München Germany 81735
    69 Nabburg Germany 92507
    70 Neumünster Germany 24534
    71 Niedernhausen Germany 65527
    72 Prüm Germany 54595
    73 Schwieberdingen Germany 71701
    74 Schwäbisch Hall Germany 74523
    75 Schwäbisch-Gmünd Germany 73525
    76 Solingen Germany 42699
    77 Solingen Germany 42719
    78 Traunreut Germany 83301
    79 Ulm Germany 89077
    80 Unterschleißheim Germany 85716
    81 Weinheim Germany 69469
    82 Wiesbaden Germany 65205
    83 Wildeshausen Germany 27793
    84 Wolfenbüttel Germany 38300

    Sponsors and Collaborators

    • Sanofi Pasteur, a Sanofi Company

    Investigators

    • Study Director: Medical Director, Sanofi Pasteur Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Sanofi Pasteur, a Sanofi Company
    ClinicalTrials.gov Identifier:
    NCT00355654
    Other Study ID Numbers:
    • A5I19
    First Posted:
    Jul 24, 2006
    Last Update Posted:
    Jan 7, 2015
    Last Verified:
    Jan 1, 2015
    Keywords provided by Sanofi Pasteur, a Sanofi Company
    Diphtheria
    Tetanus
    Pertussis
    Poliomyelitis
    Haemophilus influenzae type b
    Hepatitis B

    Study Results

    No Results Posted as of Jan 7, 2015