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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Infant, Healthy

Intervention / Treatment
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* Biological: DT5aP-IPV-Hib 5-component Pertussis vaccine
* Biological: DT3aP-HBs-IPV


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 11 Months
Maximum Age: 18 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diphtheria, Tetanus, Pertussis, Poliomyelitis, Haemophilus influenzae type b, Hepatitis B