Study to Compare Booster Vaccination With Pediacel® to Infanrix® Hexa When Both Are Co-Administered With Prevenar®
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
1 other identifier
interventional
847
1 country
84
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2006
84 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2006
CompletedFirst Posted
Study publicly available on registry
July 24, 2006
CompletedStudy Start
First participant enrolled
September 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedJanuary 7, 2015
January 1, 2015
1 year
July 20, 2006
January 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To provide information concerning the safety after administration of PEDIACEL® booster dose
0 to 3 Days post-vaccination
Secondary Outcomes (1)
To provide information concerning the safety (as fever rate) after administration of PEDIACEL® Vaccine
4 days post-vaccination
Study Arms (2)
Group 1
EXPERIMENTALParticipants will receive PEDIACEL with Prevenar at Visit 1 and ENGERIX-B Kinder at Visit 2
Group 2
ACTIVE COMPARATORParticipants will receive Infanrix hexa with Prevenar at Visit 1
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (84)
Unknown Facility
Aalen, 73433, Germany
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Aisch, 91413, Germany
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Alsfeld, 36304, Germany
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Augsburg, 86150, Germany
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Bad Oeynhausen, 32549, Germany
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Bad Säckingen, 79713, Germany
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Berlin, 10115, Germany
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Berlin, 10783, Germany
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Berlin, 13125, Germany
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Berlin, 13403, Germany
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Bernau B. Berlin, 16321, Germany
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Bielefeld, 33611, Germany
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Bönnigheim, 74357, Germany
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Bramsche, 49565, Germany
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Bretten, 75015, Germany
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Cham, 93413, Germany
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Cologne, 51145, Germany
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Datteln, 45711, Germany
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Detmold, 32756, Germany
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Eisenberg, 07607, Germany
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Erfurt, 99086, Germany
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Espelkamp, 32339, Germany
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Frankenthal, 67227, Germany
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Freiburg im Breisgau, 79106, Germany
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Freiburg im Breisgau, 79111, Germany
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Gerolstein, 54568, Germany
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Gersthofen, 86368, Germany
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Goch, 47574, Germany
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Göttingen, 37083, Germany
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Gütersloh, 33332, Germany
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Hamburg, 22305, Germany
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Hamburg, 22415, Germany
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Hechtsheim, 55129, Germany
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Herbolzheim, 79336, Germany
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Herrsching am Ammersee, 82211, Germany
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Jena, 07745, Germany
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Karlsruhe, 76137, Germany
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Karlstadtm, 97753, Germany
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Kehl, 77694, Germany
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Kempten, 87435, Germany
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Korbach, 34497, Germany
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Königstein/Taunus, 61462, Germany
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Krefeld, 47829, Germany
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Landshut, 84032, Germany
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Lauf/Pegnitz, 91207, Germany
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Lauffen am Neckar, 74348, Germany
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Leinfelden-Echte, 70771, Germany
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Lindenberg, 88161, Germany
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Lingen 49 (Ems), 49808, Germany
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Ludwigshafen, 67053, Germany
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Ludwigshafen, 67069, Germany
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Magdeburg, 39116, Germany
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Magdeburg, 39130, Germany
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Mainz, 55116, Germany
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Mainz, 55118, Germany
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Mannheim, 68167, Germany
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Marburg, 35039, Germany
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Marktoberdorf, 87616, Germany
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Marktredwitz, 95615, Germany
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Melle, 49324, Germany
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Mönchengladbach, 41061, Germany
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Mönchengladbach, 41068, Germany
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Mönchengladbach, 41236, Germany
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München, 80634, Germany
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München, 80939, Germany
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München, 81241, Germany
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München, 81479, Germany
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München, 81735, Germany
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Nabburg, 92507, Germany
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Neumünster, 24534, Germany
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Niedernhausen, 65527, Germany
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Prüm, 54595, Germany
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Schwäbisch Gmünd, 73525, Germany
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Schwäbisch Hall, 74523, Germany
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Schwieberdingen, 71701, Germany
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Solingen, 42699, Germany
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Solingen, 42719, Germany
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Traunreut, 83301, Germany
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Ulm, 89077, Germany
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Unterschleissheim, 85716, Germany
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Weinheim, 69469, Germany
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Wiesbaden, 65205, Germany
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Wildeshausen, 27793, Germany
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Wolfenbüttel, 38300, Germany
Related Publications (1)
Berner R, Boisnard F, Thomas S, Mwawasi G, Reynolds D. Safety and immunogenicity of fully liquid DTaP(5)-IPV-Hib pediatric combination vaccine (Pediacel(R)) compared to DTaP(3)-HBV-IPV/Hib (Infanrix(R) Hexa) when coadministered with heptavalent pneumococcal conjugate vaccine (PCV7) as a booster at 11-18 months of age: a phase III, modified double-blind, randomized, controlled, multicenter study. Vaccine. 2012 Jul 27;30(35):5270-7. doi: 10.1016/j.vaccine.2012.05.064. Epub 2012 Jun 9.
PMID: 22691430DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Sanofi Pasteur Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2006
First Posted
July 24, 2006
Study Start
September 1, 2006
Primary Completion
September 1, 2007
Study Completion
July 1, 2008
Last Updated
January 7, 2015
Record last verified: 2015-01