A randomised, controlled, double blind study of the 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 given to infants using a three dose immunisation schedule (Nordic schedule” 3-5-12 months)

Sanofi Pasteur Incorporated0 sites800 target enrollmentNovember 24, 2005

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: PEDIACEL® is a fully liquid combination vaccine indicated for infants from 2 months of age to protect against diseases caused by 5 common pathogens: Haemophilus influenzae type b, Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, and poliovirus types 1, 2 and 3.
Sponsor: Sanofi Pasteur Incorporated
Enrollment: 800
Status: Active, not recruiting
Last Updated: 14 years ago

No summary available.

Registry

who.int

Start Date

November 24, 2005

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Sanofi Pasteur Incorporated

•1\. Infants aged 80 to 120 days inclusive on the day of inclusion.
•2\. Born at full term of pregnancy (\>37 weeks).
•3\. Informed consent form signed by the parent(s) or other legal representative according to local regulations.
•4\. 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).
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) no
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) no
•F.1\.3\.1 Number of subjects for this age range

•1\. Rectal temperature \=38\.0°C
•2\. Moderate or severe acute illness with or without fever
•3\. Participation in another clinical trial in the 4 weeks preceding the first trial vaccination.
•4\. Having received any DTaP, IPV, or Hib vaccines prior to study initiation or any vaccination in the 4 weeks preceding the first trial vaccination.
•5\. Planned participation in another clinical trial during the present trial period.
•6\. Known history of diphtheria, tetanus, pertussis, H. influenzae type b infections, poliomyelitis.
•7\. Congenital or acquired immunodeficiency, immunosuppressive therapy such as long\-term systemic corticosteroids therapy.
•8\. Systemic hypersensitivity to any of the vaccine components (including neomycin, streptomycin, polymyxin B and formaldehyde).
•9\. 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.
•10\. Blood or blood\-derived products (immunoglobulins) received in the past 4 weeks.