Phase-II Immunogenicity Study of a DTaP-IPV-Hep B-PRP~T C... | EligiMed

Phase-II Immunogenicity Study of a DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age in Healthy Argentinean Infants

CompletadoFase 2ClinicalTrials.gov

ID: NCT00831311Tipo: INTERVENTIONALInicio: 1 de oct de 2004Fin estimado: 1 de mar de 2007

Gastroenterología Enfermedades Infecciosas Pediatría

Traducción no disponible, mostrando original

Resumen

Primary Objective: * 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.

Elegibilidad

Edad mínima: 50 DaysEdad máxima: 70 DaysSexo: ALL

Criterios de inclusión

Infant of either gender, aged 50 to 70 days inclusive
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.

Criterios de exclusión

Axillary temperature ≥37.1°C on the day of inclusion
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.

Intervenciones

biological

DTaP-IPV-HB-PRP~T

0.5 mL, Intramuscular

biological

DTaP-IPV//PRP~T combined vaccine & Recombinant hep B vaccine

0.5 mL, Intramuscular (right and left thighs, respectively)

Ubicaciones

Córdoba, Argentina

Patrocinadores

PrincipalSanofi Pasteur, a Sanofi Company

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