Safety and Immunogenicity of Hexavalent Vaccine(DTwP-HepB-IPV-Hib) in Healthy Infants

Exclusion Criteria

• •1. Previously received any dose of diphtheria, tetanus, pertussis, polio and/or Hib containing vaccines
• •2. History of previous or concurrent vaccinations other than hepatitis B, Bacillus Calmette-Guerin (BCG), rotavirus and pneumococcal vaccine
• •3. Known or suspected history of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, or Hib diseases
• •4. Household contact and/or intimate exposure in the previous 30 days to an individual with ascertained diphtheria, pertussis, hepatitis B, polio or Hib diseases
• •5. Experienced fever ≥ 38°C (100.4°F) within the past three days prior to screening
• •6. Experienced significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the past seven days prior to screening
• •7. Known or suspected immune disorder or immunodeficient condition
• •8. Receipt of immunoglobulin or blood-derived product since birth
• •9. Chronic administration (defined as more than 14 days) of immunosuppressant or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone, or equivalent, ≥0.5mg/kg/day. Inhaled and topical steroids are allowed.
• •10. History of bleeding disorder contraindicating intramuscular injection
• •11. Major congenital defects or serious chronic illness
• •12. History of any neurological disorders or seizures
• •13. History of allergic reactions to any vaccine components including excipients and preservatives (neomycin, streptomycin, polymyxin B, yeast or etc.)
• •14. History of allergic reactions to latex
• •15. Participation in another interventional trial or received any investigational product within 30 days before to the enrollment
• •16. Plan to leave the area of the study site before the end of the study period
• •17. Infants who are considered unsuitable for the clinical study by the investigator