• To assess the immune responses to each vaccine antigen over time, antibodies to pertussis (PT, FHA, PRN), diphtheria, tetanus, Hib, polio (Types 1, 2, 3) and hepatitis B (HbsAg) will be evaluated. [ Time Frame: Day 0-5, Day 53-70, Day 113-130, Day 173-190, and Visit 4 + (28-42 days). ] [ Designated as safety issue: No ]
  

• To assess vaccine safety, systemic and local immediate reactions. [ Time Frame: 30 mins after each immunization; 7 days following each vaccination; contacted 2-3 and 8 days following each vaccination to collect AE information; SAEs will be collected throughout study participation. ] [ Designated as safety issue: Yes ]
  

Routine immunization at birth is standard for hepatitis B in the U.S. and for BCG in many countries. Other vaccines have not been routinely administered at birth largely due to concerns relating to immaturity of the neonatal immune system and the possibility of reduced immune response to vaccine antigens. With the recent licensure in the US of a pentavalent combination vaccine (DTaP-Hep B-IPV; Pediarix™; GlaxoSmithKline Biologicals) researchers propose to evaluate a new immunization schedule that includes a birth dose of this vaccine, in an effort to determine adequacy of neonatal immune response to the study vaccine antigens. The primary objectives of this study are: to evaluate the safety of administering the pentavalent combination vaccine (DTaP-HepB-IPV; Pediarix™) to infants at birth, two and six months of age compared to the administration of a HepB vaccine (Engerix-B) at birth and the same pentavalent combination vaccine at two, four and six months of age; and to assess age specific antibody response following each vaccine dose. The study enrolled 5 healthy newborns; 0 to 5 days of age, greater than or equal to 37 weeks gestation, and greater than 2500 gm birth weight were recruited from two Southern California Kaiser Permanente medical centers. Infants were randomized to one of 2 study groups: Group A received DTaP-HepB-IPV (Pediarix™) vaccine along with other required vaccines at birth, two, six months of age; Group B will received the monovalent HepB vaccine (Engerix-B) at birth, the DTaP-HepB-IPV (Pediarix™) vaccine with other vaccines at two, four and six months. Children will be evaluated for post-vaccination adverse events. Blood will be collected and immunogenicity evaluated by standardized humoral immunologic assays. The main outcome measures are to assess immune responses to each vaccine antigen over time, antibodies to pertussis (PT, FHA, PRN), diphtheria, tetanus, Hib, polio (Types 1, 2, 3) and hepatitis B (HbsAg) will be evaluated. The secondary outcome measures are to assess vaccine safety, systemic and local immediate reactions.

Inclusion Criteria:

Prenatal Inclusion Criteria

• Generally healthy, pregnant mother
• Mother will deliver at a Kaiser Permanente Medical Center participating in the study
• Ability of the parent(s) to understand and comply with the requirements of the protocol
• Signed informed consent by parent(s)

Birth Inclusion Criteria

• Healthy newborn 0 to 5 days of age
• Gestational age greater than or equal to 37 weeks to less than or equal to 42 weeks and birth weight greater than 2500 grams
• Signed informed consent obtained
• Mother continues to be eligible by prenatal screening criteria
• Newborn will receive future well child care at a Kaiser Permanente study clinic
• After reviewing with parent(s) the study procedures and informed consent, parent wishes to continue in the study

Exclusion Criteria:

Prenatal Exclusion Criteria

• Mother positive for HBsAg or whose antigen status is unknown
• Mother positive for HIV or whose antigen status is unknown
• Mother positive for 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-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

Birth Exclusion Criteria

• 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 C or prolonged rupture of membranes greater than or equal to 18 hrs)
• Rectal temperature greater than or equal to 38.0 degrees C
• Newborn receiving resuscitation (including intubation, mechanical ventilation or 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 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