Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO in Argentinean Infants
NCT ID: NCT00831311
Last Updated: 2013-12-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
624 participants
INTERVENTIONAL
2004-10-31
2007-03-31
Brief Summary
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* To demonstrate that the immune response of the DTaP-IPV-Hep B-PRP\~T is non-inferior for all valences to those of the association of PENTAXIM™ and ENGERIX B® PEDIATRICO one month after a three-dose primary series.
Secondary Objectives:
* To describe in each group the immunogenicity parameters one month after the three-dose primary series.
* To describe safety profile after each vaccination in both groups.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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1
DTaP IPV HB-PRP\~T vaccine group
DTaP-IPV-HB-PRP~T
0.5 mL, Intramuscular
2
PENTAXIM™ and ENGERIX B® vaccines group
DTaP-IPV//PRP~T combined vaccine & Recombinant hep B vaccine
0.5 mL, Intramuscular (right and left thighs, respectively)
Interventions
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DTaP-IPV-HB-PRP~T
0.5 mL, Intramuscular
DTaP-IPV//PRP~T combined vaccine & Recombinant hep B vaccine
0.5 mL, Intramuscular (right and left thighs, respectively)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Mother is negative for HBsAg
* Born at full term of pregnancy (≥37 weeks) and with a birth weight ≥2.5 kg
* Written informed consent form signed by at least one parent or by another legal representative and an independent witness
* Parent/legal representative able to attend scheduled visits and to comply with the trial procedures during the entire duration of the trial.
Exclusion Criteria
* Current or planned enrolment in another clinical trial during the clinical trial period
* Known mother's history of Human Immunodeficiency Virus (HIV) infection
* Known immunodeficiency (congenital or acquired) or induced by immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy since birth, or systemic corticosteroids in the last 4 weeks (≥0.5 mg per kilogram and per day equivalent prednisolone and lasting more than 7 days)
* Receipt of blood-derived products since birth
* Acute symptoms or severe chronic illness (e.g. cardiac, renal insufficiency, diabetes, auto immune disorders, congenital defect) that may interfere with conduct or completion of trial
* Occurrence of seizures since birth
* Hypersensitivity to any of the vaccine components
* Coagulopathy contraindicating intramuscular injection
* History of (documented) clinical or serological/microbiological confirmed infection due to pertussis, tetanus, diphtheria, polio, Haemophilus influenzae type b (Hib) or hepatitis B (HB) diseases
* History of vaccination against pertussis, tetanus, diphtheria, polio, Hib or HB infections
* Vaccination within the last 4 weeks.
50 Days
70 Days
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Sanofi Pasteur Inc.
Locations
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Córdoba, , Argentina
Countries
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References
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Tregnaghi MW, Zambrano B, Santos-Lima E. Immunogenicity and safety of an investigational hexavalent diphtheria-tetanus-acellular pertussis-inactivated poliovirus-hepatitis B-Haemophilus influenzae B conjugate combined vaccine in healthy 2-, 4-, and 6-month-old Argentinean infants. Pediatr Infect Dis J. 2011 Jun;30(6):e88-96. doi: 10.1097/INF.0b013e318212eb80.
Related Links
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Related Info
Other Identifiers
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A3L02
Identifier Type: -
Identifier Source: org_study_id