Clinical trial NCT00355654: Study to Compare Booster Vaccination With Pediacel® to Infanrix® Hexa When Both Are Co-Administered With Prevenar®
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infant
Healthy
Keywords: Diphtheria
Tetanus
Pertussis
Poliomyelitis
Haemophilus influenzae type b
Hepatitis B
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-07-24
Enrollment: 847
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: To provide information concerning the safety after administration of PEDIACEL® booster dose
timeFrame: 0 to 3 Days post-vaccination
Secondary outcomes:
measure: To provide information concerning the safety (as fever rate) after administration of PEDIACEL® Vaccine
timeFrame: 4 days post-vaccination
Other outcomes:
Locations:
city: Aalen
country: Germany
city: Aisch
country: Germany
city: Alsfeld
country: Germany
city: Augsburg
country: Germany
city: Bad Oeynhausen
country: Germany
city: Bad Säckingen
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Bernau b. Berlin
country: Germany
city: Bielefeld
country: Germany
city: Bramsche
country: Germany
city: Bretten
country: Germany
city: Bönnigheim
country: Germany
city: Cham
country: Germany
city: Datteln
country: Germany
city: Detmold
country: Germany
city: Eisenberg
country: Germany
city: Erfurt
country: Germany
city: Espelkamp
country: Germany
city: Frankenthal
country: Germany
city: Freiburg
country: Germany
city: Freiburg
country: Germany
city: Gerolstein
country: Germany
city: Gersthofen
country: Germany
city: Goch
country: Germany
city: Göttingen
country: Germany
city: Gütersloh
country: Germany
city: Hamburg
country: Germany
city: Hamburg
country: Germany
city: Herbolzheim
country: Germany
city: Herrsching
country: Germany
city: Jena
country: Germany
city: Karlsruhe
country: Germany
city: Karlstadtm
country: Germany
city: Kehl
country: Germany
city: Kempten
country: Germany
city: Korbach
country: Germany
city: Krefeld
country: Germany
city: Köln
country: Germany
city: Königstein/Taunus
country: Germany
city: Landshut
country: Germany
city: Lauf/Pegnitz
country: Germany
city: Lauffen
country: Germany
city: Leinfelden-Echte
country: Germany
city: Lindenberg
country: Germany
city: Lingen 49 (Ems)
country: Germany
city: Ludwigshafen
country: Germany
city: Ludwigshafen
country: Germany
city: Magdeburg
country: Germany
city: Magdeburg
country: Germany
city: Mainz-Hechtsheim
country: Germany
city: Mainz
country: Germany
city: Mainz
country: Germany
city: Mannheim
country: Germany
city: Marburg
country: Germany
city: Marktoberdorf
country: Germany
city: Marktredwitz
country: Germany
city: Melle
country: Germany
city: Mönchengladbach
country: Germany
city: Mönchengladbach
country: Germany
city: Mönchengladbach
country: Germany
city: München
country: Germany
city: München
country: Germany
city: München
country: Germany
city: München
country: Germany
city: München
country: Germany
city: Nabburg
country: Germany
city: Neumünster
country: Germany
city: Niedernhausen
country: Germany
city: Prüm
country: Germany
city: Schwieberdingen
country: Germany
city: Schwäbisch Hall
country: Germany
city: Schwäbisch-Gmünd
country: Germany
city: Solingen
country: Germany
city: Solingen
country: Germany
city: Traunreut
country: Germany
city: Ulm
country: Germany
city: Unterschleißheim
country: Germany
city: Weinheim
country: Germany
city: Wiesbaden
country: Germany
city: Wildeshausen
country: Germany
city: Wolfenbüttel
country: Germany
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.