Study to Compare Pediacel® to Infanrix®-IPV+Hib When Both Are Co-Administered With Prevenar® in Infants and Toddlers
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diphtheria; Tetanus; Pertussis; Poliomyelitis; Haemophilus Influenzae Type B
Intervention: PEDIACEL® and Prevenar® (Biological); Infanrix®-IPV+Hib and Prevenar® (Biological)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Sanofi-Aventis Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: sanofi pasteur
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®.
Clinical Details
Study design: Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: To provide information concerning the immunogenicity of PEDIACEL® and Infanrix®-IPV+Hib
Secondary outcome: To provide information concerning the safety after administration of PEDIACEL® and Infanrix®-IPV+Hib
Eligibility
Minimum age: 55 Days.
Maximum age: 75 Days.
Gender(s): Both.
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 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.
Locations and Contacts
Paris, France
Poznan, Poland
Additional Information
Starting date: July 2006
Ending date: July 2009
Last updated: April 7, 2008
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