None listed
Conditions
Interventions
GROUP 1 Type of group
The DTaP-IPV-HB-PRP-T 0.5 ml IM vaccine will be administered at 2, 4 and 6 months of age.
Group name:GROUP 2 Type of group
The Trltanrix-HepB / Hib ™ 0.5 ml IM and OPB 0.1 ml PO vaccines will be administered at 2, 4 and 6 months of age.
Sponsors
SANOFI PASTEUR S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1) Children 2 months of age (50 to 71 days of age inclusive) on the day of inclusion. 2) Born at full term (> 37 weeks) and with a birth weight> 2.5 kg. 3) Informed consent form signed by one or both parents or by the legal representative. 4) Possibility of attending all scheduled visits and complying with all study procedures. 5) Compliance with the national immunization schedule for the 2 first months of life.
Exclusion criteria
Exclusion criteria: 1) Participation in another clinical study in the 4 weeks prior to the first vaccination of the study. 2) Participation planned in another clinical study during the present clinical study. 3) Congenital or acquired immunodeficiency, immunosuppressive therapies. 4) Individuals from the child s environment who have congenital or acquired immunodeficiency. 5) Systemic hypersensitivity to any of the components of the vaccine, or a history of life-threatening reactions by administration of the study vaccine or a vaccine containing the same substances. 6) Chronic disease in a stage that could interfere with the completion or completion of the study. 7) Administration of blood or blood products from birth. 8) Any vaccination applied in the 4 weeks prior to the first vaccination of the study. 9) Vaccination planned in the 4 weeks following the vaccination of the study. 10) Documented history of infections due to pertussis, tetanus, diphtheria, polio, Haemophilus influenzae type b or hepatitis B. 11) Mother with a known seropositive result of HTV or hepatitis C, or known carrier of hepatitis B surface antigen. 12) Prevaccination against infections due to pertussis, tetanus, diphtheria, poliomyelitis or Haemophilus influenzae type b. 13) Coagulopathy, thrombocytopenia or bleeding disorder for which an IM application is contraindicated. 14) History of seizures. 15) Febrile or acute illness at the day of inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation: rectal temperature of the child in the morning and at night, always at the same time + 2 hours. Measure:Incidence of fever in the first 7 days after vaccination. Timepoints:Daily during the 7 days after the vaccine. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation, using the ICH E2A Guide for Clinical Safety Data Management. Measure:Safety: Adverse reactions in the first 7 days. Adverse reactions in the first 30 days. Serious adverse events. Timepoints:Daily within the first 7 days. Subsequently, at the time the event is presented. ; Outcome name:Antibody titers (Ac) anti-HBs and seroprotection (anti-HBs> 10 mUI / ml) in DI 50, and individual titer index (V06 / V01). Measure:Immunogenicity of the DTaP-IPV-HB-PRP-T vaccine. Timepoints:Before the administration of the vaccines and 150 days after it. | — |
Countries
Mexico, Peru
Outcome results
None listed