Comparison of Safety and Immunogenicity of Pediacel™ and Infanrix™ IPV+Hib (Penta) Given in a 3 Dose Schedule in Infants

Sanofi

Status and phase

Completed

Phase 3

Conditions

Poliomyelitis

Haemophilus Influenzae Type b

Diphtheria

Tetanus

Pertussis

Treatments

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

Biological: Infanrix® -IPV+Hib

Study type

Interventional

Funder types

Industry

Identifiers

NCT00287092

A5I15

Details and patient eligibility

About

Pediacel™ is currently licensed in the UK for use as a 3 dose regimen for the active immunisation of infants against Diphtheria, Tetanus, Pertussis, Poliomyelitis and invasive infections caused by Haemophilus influenzae type b. However there are currently no clinical data supporting the use of Pediacel™ using a 3, 5, and 12 months of age vaccination schedule. This study is designed to provide safety and immunogenicity data to support the use of Pediacel™ according to a 3, 5, and 12 months schedule.

Enrollment

807 patients

Sex

All

Ages

80 to 120 days old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Infants aged 80 to 120 days inclusive on the day of inclusion.
Born at full term of pregnancy (> 37 weeks)
Informed consent form signed by the parent(s) or other legal representative according to local regulations
Parent(s) or legal representative able to attend all scheduled visits and to understand and comply with the study procedures (able to read and write; access to a telephone).

Exclusion criteria

Rectal temperature ≥ 38.0°C
Moderate or severe acute illness with or without fever
Participation in another clinical trial in the 4 weeks preceding the first trial vaccination
Having received any DTaP, IPV, or Hib vaccines prior to study initiation or any vaccination in the 4 weeks preceding the first trial vaccination
Planned participation in another clinical trial during the present trial period
Known history of diphtheria, tetanus, pertussis, H. influenzae type b infections, poliomyelitis
Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
Systemic hypersensitivity to any of the vaccine components (including neomycin, streptomycin, polymyxin B and formaldehyde)
History of a life-threatening reaction (such as encephalopathy, Hypotonic Hyporesponsive Episode, severe fever, convulsions, etc.) to the trial vaccine or a vaccine containing the same substances
Blood or blood-derived products (immunoglobulins) received in the past 4 weeks
Vaccination planned in the 6 weeks following any trial vaccination
Known HIV seropositivity
Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
History of seizures or progressive, evolving or unstable neurological condition
Clinically significant findings on review of systems that might interfere with correct vaccination or which, in the opinion of the Investigator, would interfere with the evaluation of the vaccine or pose a health risk to the subject.