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

Sanofi

Status and phase

Completed

Phase 3

Conditions

Poliomyelitis

Haemophilus Influenzae Type b

Diphtheria

Pertussis

Tetanus

Treatments

Biological: Infanrix®-IPV+Hib and Prevenar®

Biological: PEDIACEL® and Prevenar®

Study type

Interventional

Funder types

Industry

Identifiers

NCT00343421

A5I16

Details and patient eligibility

About

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®.

Enrollment

588 patients

Sex

All

Ages

55 to 75 days old

Volunteers

Accepts Healthy Volunteers

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.