Study to Compare Pediacel® to Infanrix®-IPV+Hib When Both Are Co-Administered With Prevenar® in Infants and Toddlers

Study Overview
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Brief Summary
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The purpose of this study is to evaluate safety and immunogenicity of Pediacel® in infants and toddlers when given at 2,3,4 and 12-18 months of age. Primary Objectives: To compare the post-dose 3 immunogenicity of Pediacel® to Infanrix®-IPV+Hib when both are co-administered with Prevenar®. To describe the post-dose 3 pertussis antibody responses. Secondary Objectives: To compare the post-dose 4 immunogenicity of Pediacel® to Infanrix®-IPV+Hib when both are co-administered with Prevenar®. To describe the safety after each vaccination following co-administration with Prevenar®.

Official Title
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Immunogenicity and Safety of PEDIACEL®, a Combined Diphtheria, Tetanus, Five Component Acellular Pertussis, Inactivated Poliomyelitis and Haemophilus Influenzae Type b Conjugate Vaccine (Adsorbed), Compared to Infanrix®-IPV+Hib When Both Vaccines Are Co-Administered With Prevenar® to Infants and Toddlers at 2, 3, 4 and 12-18 Months of Age

Conditions
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Diphtheria, Tetanus, Pertussis, Poliomyelitis, Haemophilus Influenzae Type b

Intervention / Treatment
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* Biological: PEDIACEL® and Prevenar®
* Biological: Infanrix®-IPV+Hib and Prevenar®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants 55 to 75 days old, inclusive on the day of first vaccination Born at full term of pregnancy (> 37 weeks) Informed consent form signed by the parent(s) or the legal guardian Parents or the legal guardian able to read and write in the local language Parent(s) or the 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 first study vaccination Planned participation in another clinical trial during the present study period Received diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b or a pneumococcal vaccine separately or in combination prior to study vaccination Received any vaccination in the 30 days preceding the first study vaccination and/or is planning any vaccination within 6 weeks following any of the study vaccinations 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 previous 30 days Systemic or local hypersensitivity to any of the study vaccine components (including neomycin, streptomycin, polymyxin B and formaldehyde) History of life-threatening reaction(s) (such as encephalopathy, Hypotonic-Hyporesponsive Episode, 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 since birth Known Human immunodeficiency virus (HIV) seropositivity Known thrombocytopenia or other 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: 55 Days
Maximum Age: 75 Days

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>PEDIACEL co-administered with Prevenar | Biological: PEDIACEL® and Prevenar®<br>* 0.5 mL each, IM (opposite thigh)<br>* Other names: Prevenar®: Pneumococcal saccharide conj. vaccine, adsorbed;|
| Active Comparator: Group 2<br>Infanrix-IPV+Hib co-administered with Prevenar | Biological: Infanrix®-IPV+Hib and Prevenar®<br>* 0.5 mL each, IM (opposite thigh)<br>* Other names: Prevenar®: Pneumococcal saccharide conj vaccine, adsorbed.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To provide information concerning the immunogenicity of PEDIACEL® and Infanrix®-IPV+Hib |  | 1 month post-vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To provide information concerning the safety after administration of PEDIACEL® and Infanrix®-IPV+Hib |  | Entire study | 

 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, Pneumococcal infections