Clinical trial NCT00343421: Study to Compare Pediacel® to Infanrix®-IPV+Hib When Both Are Co-Administered With Prevenar® in Infants and Toddlers
Official title: 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 Co-Administered With Prevenar® to Infants and Toddlers at 2, 3, 4 and 12-18 Months of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diphtheria
Tetanus
Pertussis
Poliomyelitis
Haemophilus Influenzae Type b
Keywords: Diphtheria
Tetanus
Pertussis
Poliomyelitis
Haemophilus influenzae type b
Pneumococcal infections
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-06-23
Enrollment: 588
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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®.


Eligibility criteria: 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.

Primary outcomes:
measure: To provide information concerning the immunogenicity of PEDIACEL® and Infanrix®-IPV+Hib
timeFrame: 1 month post-vaccination
Secondary outcomes:
measure: To provide information concerning the safety after administration of PEDIACEL® and Infanrix®-IPV+Hib
timeFrame: Entire study
Other outcomes:
Locations:
city: Paris
country: France
city: Poznan
country: Poland
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Grimprel E, Wysocki J, Boisnard F, Thomas S, Mwawasi G, Reynolds D. Immunogenicity and safety of fully liquid DTaP(5)-IPV-Hib compared with DTaP(3)-IPV/Hib when both coadministered with a heptavalent pneumococcal conjugate vaccine (PCV7) at 2, 3, 4, and 12 to 18 months of age: a phase III, single-blind, randomised, controlled, multicentre study. Vaccine. 2011 Oct 6;29(43):7370-8. doi: 10.1016/j.vaccine.2011.07.078. Epub 2011 Jul 30.