Healthy, Infant
Conditions
Keywords
Diphtheria, Tetanus, Pertussis, Poliomyelitis, Haemophilus influenzae type b, Hepatitis B
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.
Interventions
0.5 mL, IM
BIOLOGICALDT3aP-HBs-IPV
0.5 mL, IM
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
11 Months to 18 Months
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To provide information concerning the safety after administration of PEDIACEL® booster dose | 0 to 3 Days post-vaccination |
Secondary
| Measure | Time frame |
|---|---|
| To provide information concerning the safety (as fever rate) after administration of PEDIACEL® Vaccine | 4 days post-vaccination |
Countries
Germany
Outcome results
None listed