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

Sanofi

Status and phase

Completed

Phase 3

Conditions

Healthy

Infant

Treatments

Biological: DT3aP-HBs-IPV

Biological: DT5aP-IPV-Hib 5-component Pertussis vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00355654

A5I19

Details and patient eligibility

About

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.

Enrollment

847 patients

Sex

All

Ages

11 to 18 months old

Volunteers

Accepts Healthy Volunteers

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.