The Transparent Safety Study of the 5 in 1 (DTwP-rHepB-Hib) Combination Vaccine Produced by the Indian Serine Institute in Children of Viet Nam Healthy From 6 to 12 Weeks of Age in a 3-dose Regimen, the Interval Between Doses is 4 Weeks

An Open Label, Multicentric, Bridging Study to Assess the Safety of Diphtheria, Tetanus, Pertussis, Hepatitis B and Haemophilus Influenzae Type b Conjugate Vaccine (Adsorbed) Manufactured by Serum Institute of India Pvt. Ltd in Vietnamese Infants Aged 6-12 Weeks, Given as a 3-dose Regime, With 4 Week Intervals Between the Doses

The objective of this study is to evaluate safety and tolerability of Diphtheria, Tetanus, Pertussis, Hepatitis B and Haemophilus influenzae type b Conjugate Vaccine Adsorbed in Vietnamese infants aged 6-12 weeks. This is an open label, single group, bridging study.

This will be an open label, single group, bridging study. Study subjects will be vaccinated with 3 (three) vaccine doses. The first vaccine will be administered intramuscularly starting at 6-12 weeks of age followed by two doses at four-week interval.

This study was performed in strict accordance with Good Clinical Practice.

Inclusion Criteria:

• Healthy infants, both sexes, between 6 and 12 weeks of age on the day of screening and enrollment
• Subject born at full term of pregnancy (greater or equal to 37 weeks) and Birth weight ≥2500 grams
• Weight ≥ 3,300 grams at the time of screeningSubject with good health as determined by the medical history, physical examination and clinical judgment of the Investigator
• Parent / legal representative can understand and be able to comply with the requirements of the protocol
• Subjects born to mothers who are seronegative to HIV, HBV and HCV through a blood test or maternity record.
• Parent / legal representative is willing to voluntarily sign the consent form for the participant

Exclusion Criteria:

• History of diphtheria, tetanus, pertussis, hepatitis B, or Hib infections (confirmed either clinically, serologically or microbiologically)
• Fever (temperature ≥37.50C) or hypothermia (≤35.50C) or acute illness / infection that requires treatment.
• Previous vaccination against diphtheria, tetanus, pertussis and Haemophilus influenzae type b diseases.
• Known allergy to any component of the vaccine;
• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination.
• Being treated with anticoagulants or at high risk of bleeding.
• A family history of SIDS (sudden infant death syndrome)
• Have received any blood products, corticosteroids, cytotoxic drugs, immunosuppressive therapy, radiation therapy in the last 4 weeks.
• Have participated in another clinical trial within 30 days prior to the study vaccination or may participate in the course of the study.
• A family history of congenital or hereditary immunodeficiency.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Major congenital defects.
• History of any neurological disorders or seizures