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

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 560

Inclusion Criteria

A potential subject had to meet all of the following criteria to be considered for trial enrolment:
1. Infants 55 to 75 days old, inclusive on the day of first vaccination.
2. Born at full term of pregnancy (> 37 weeks).
3. ICF signed by the parent(s) or the legal guardian (according to local regulations).
4. Parent(s) or the legal guardian was able to read and write in the local language.
5. Parent(s) or the legal guardian was able to attend all scheduled visits and to comply with the study procedures.
Are the trial subjects under 18? yes
Number of subjects for this age range: 588
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

Exclusion Criteria

A potential subject meeting any of the following criteria was ineligible for trial
enrolment:
1. Presence of fever (defined as rectal body temperature = 38.0°C) reported within the last 72 hours.*
2. Moderate or severe acute illness with or without fever.*
3. Participation in another clinical trial in the 30 days preceding first study vaccination.
4. Planned participation in another clinical trial during the present study period.
5. Received diphtheria, tetanus, pertussis, poliomyelitis, H. influenzae type b or a pneumococcal vaccine separately or in combination prior to study vaccination.
6. Received any vaccination during the following periods:
- from 30 days prior to Visit 1 (BS1+Vac1) up to and including Visit 4 (BS2)
- from 30 days prior to Visit 5 (BS3+Vac4) up to and including Visit 6 (BS4).
7. 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.
8. Systemic or local hypersensitivity to any of the study vaccine components (including neomycin, streptomycin, polymyxin B and formaldehyde).
9. History of life-threatening reaction(s) (such as encephalopathy, hypotonichyporesponsive episode (HHE), rectal body temperature = 40.0°C, convulsions with or without fever) to any vaccine containing the same components as the study vaccines.
10. Blood or blood-derived products (immunoglobulins) received since birth.
11. Known human immunodeficiency virus seropositivity.
12. Known thrombocytopenia or other bleeding disorder contraindicating IM vaccination.
13. History of encephalopathy, seizures or progressive, evolving or unstable neurological condition.
14. 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.
*The Investigator was to postpone the vaccination until the condition resolved.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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