Randomized Clinical Trial to evaluate the Immunogenicity and Reactogenicity of the Brazilian Hepatitis B Vaccine (Butang®) in Infants using the Ventrogluteal area as an alternative intramuscular injection site

INTERVENTION: All infants will receive hepatitis B vaccine by intramuscular route. First dose Group 1: Hepatitis B vaccine (10 µg) into ventrogluteal area Group 2: Hepatitis B vaccination (10 µg) into anterolateral thigh Second dose (administered 30 days after the first dose) Group 1: Hepatitis B vaccine (10 µg) into ventrogluteal area Group 2: Hepatitis B vaccination (10 µg) into anterolateral thigh Third dose (administered 180 days after the first dose) Group 1: Hepatitis B vaccine (10 µg) into ventrogluteal area Group 2: Hepatitis B vaccination (10 µg) into anterolateral thigh 48 to 72 hours after each vaccine dose, infants will be evaluated in order to detect local (pain, redness, swelling) or systemic (fever, urticaria, persistent crying / screaming) adverse events. Blood samples (5 mL) will be collected 45 days after third hepatitis B vaccine dose in all participants. CONDITION: Hepatitis B vaccine ; Infections and Infestations ; Hepatitis B PRIMARY OUTCOME: Immunogenicity, assessed using blood samples collected 45 days after the third dose. SECONDARY OUTCOME: Reactogenicity, assessed 48‐72 hours after each vaccine dose. These will be scored on visual scales (0: no reaction to 5: highest level of reaction). INCLUSION CRITERIA: 1. Newborn 2. Birth weight of more than or equal to 2.5 kg 3. In good health