Pentavalent DTaP-Hep B-IPV

Exclusion Criteria

• •Mother positive for hepatitis B surface antigen (HBsAg) or whose antigen status is unknown
• •Mother positive for human immunodeficiency virus (HIV) or whose antigen status is unknown
• •Mother positive for rapid plasma reagin (RPR) (syphilis) or whose antigen status is unknown
• •Mother or immediate family member has impaired immunologic function
• •Mother is expected to take immune suppressant medications during the last trimester of pregnancy
• •Mother is expected to receive blood, blood products or immunoglobulin preparation (including hepatitis B immune globulin \[HBIG\]) during the last trimester of the pregnancy
• •Mother with insulin dependent diabetes
• •Mother with pre-eclampsia, eclampsia or abruptio placentae
• •Pregnancy associated with known congenital defects
• •Mother participating in another study with a non-Food and Drug Administration (FDA) approved drug, vaccine or device
• •Parent(s)/guardian cannot be contacted by telephone
• •Parent(s)/guardian will not continue well child care at a Kaiser Permanente study clinic
• •Mother who is requesting that cord blood be retained for stem cell preservation
• •Other maternal conditions that, in the opinion of the investigator, would interfere with the study
• •Current receipt of antibiotics for suspected infection in mother or newborn (based on presence of maternal fever greater than or equal to 38.0 degrees Celsius or prolonged rupture of membranes greater than or equal to 18 hours)
• •Rectal temperature greater than or equal to 38.0 degrees Celsius
• •Newborn receiving resuscitation \[including intubation, mechanical ventilation or intravenous (IV) medication\] at birth
• •Suspected medical, congenital, developmental or surgical disease, including immunodeficiency, neurology disorder or seizure disorder, severe congenital anomalies or multi-organ dysfunction
• •Prior receipt of hepatitis B vaccine or any other vaccine
• •Received or plans to receive any immunosuppressant medication
• •Receipt of blood products or immunoglobulin \[including Hepatitis B Immune Globulin (HBIG)\]
• •Clinically significant findings on review of medical history and physical exam determined by the investigator or sub-investigator to be sufficient for exclusion
• •Mother of newborn with insulin dependent diabetes
• •Mother of newborn with pre-eclampsia, eclampsia or abruptio placentae
• •Mother of newborn positive for HBsAG, HIV or RPR (syphilis) or whose antigen status is unknown
• •Impaired immunologic function in newborn or family member
• •Any condition determined by the investigator that would interfere with the evaluation of the vaccine or be a potential health risk to the subject
• •Newborn is participating in another research study or has received a non-FDA approved drug or vaccine (excluding formula preparations) prior to study entry
• •Parent(s)/guardian who are unable to be contacted by telephone