Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO in Argentinean Infants
Condition: Diphtheria; Tetanus; Pertussis; Haemophilus Influenzae Type b; Poliomyelitis
MeSH terms: Whooping Cough; Tetanus; Diphtheria; Poliomyelitis
Intervention: DTaP-IPV-HB-PRP~T; DTaP-IPV//PRP~T combined vaccine & Recombinant hep B vaccine
Intervention description: 0.5 mL, Intramuscular; 0.5 mL, Intramuscular (right and left thighs, respectively)
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 624.0
Sex: All
Minimum age: 50 Days
Maximum age: 70 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Diphtheria; Tetanus; Pertussis; Whooping cough; Hepatitis B; Poliomyelitis; Haemophilus influenzae type b

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria :

          -  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.

        Exclusion Criteria :

          -  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.