A Phase IV Study to Assess the Safety of EupentaTM Inj

Exclusion Criteria

• •1. Past or present medical history of known or suspected diphtheria, tetanus, pertussis, polio, HB and/or Hib diseases
• •2. Any history of allergy to any of the components or excipients of EupentaTM Inj., including aluminum hydroxide, sodium hydrogen phosphate heptahydrate, monobasic sodium phosphate dihydrate, polysorbate and thimerosal
• •3. Any medical condition which can compromise the infant's safety, as per Investigator's discretion
• •4. History of seizures or abnormal cerebral signs in the newborn period or other serious neurological abnormality
• •5. History of bleeding tendencies
• •6. Household contact and/or intimate exposure with a confirmed case of diphtheria, pertussis, HB, polio and/or Hib diseases within in 30 days prior to screening
• •7. History of fever ≥ 38°C/ 100.4°F within 3 days prior to screening and/or intake of anti-pyretic/analgesic medication. Subjects who meet this criterion will be rescreened to check the temperature after the temporary condition has resolved and if they are within the window period for age of first vaccination at the time of re-scheduled visit
• •8. History of previous diphtheria-tetanus-pertussis (DTP), and/or Hib vaccination doses
• •9. History of previous or concurrent vaccinations other than Bacillus Calmette-Guérin (BCG), HB vaccination at birth, Polio, Rotavirus and Pneumococcal vaccines
• •10. Known or suspected immune disorders, or, received immunosuppressive therapy
• •11. Participation 30 days prior to screening in the study or simultaneously in another study and/or received any investigational product