To evaluate the safety of administering the pentavalent combination vaccine to infants at birth, 2 and 6 months and DTaP booster at 15 months of age, along with other immunizations, compared to the administration of the same pentavalent combination vaccine at 2, 4, and 6 months and a DTaP vaccine booster at 15 months of age.To assess age specific antibody responses following each vaccine dose and assess T-and B-cell correlates of maturing immune responsiveness in young infants

Condition	Intervention	Phase
Pertussis Hepatitis B Polio	Vaccine: DTaP-Hep B-IPV Vaccine	Phase II

Further Study Details: 

Expected Total Enrollment:  260

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 U.S. of a pentavalent combination of vaccine (DTaP-Hep B-IPV; Pediarix (TM); GlaxoSmithKline Biologicals) we 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

Ages Eligible for Study:  up to  5 Days,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

Healthy newborns 0 to 5 days of age. Gestational age >37 weeks, < 42 weeks and birth weight >2500 grams. Informed consent obtained from the parent(s) prior to any study procedures.

Exclusion Criteria:

Neonate aged < 37 weeks (premature) or > 42 weeks gestation Neonate < 2,500 grams birth weight Neonate requiring resuscitation at birth, defined as intubation, mechanical ventilation or intravenous medication administration Current receipt of antibiotic(s) for suspected infection in mother or newborn infant based on presence of maternal fever > 38.00C or prolonged rupture of membranes > 18 hrs.

Any prior receipt of non-study vaccine Receipt of blood product, immunoglobulin (including HBIG) or immunosuppressant medications.

Impairment of immunologic function in subject or family member. Suspected medical, congenital, developmental, or surgical disease including immunodeficiency (including HIV), neurological disorder or seizure disorder, severe congenital anomalies or multi-organ dysfunction.

Clinically significant findings on review of medical history and physical exam determined by the investigator or sub-investigator to be sufficient for exclusion.

Any condition determined by the investigator that would interfere with the evaluation of the vaccine or be a potential health risk to the subject.

A rectal temperature >38.0 ºC (vaccines can be administered to infants with a mild illness such as diarrhea, upper respiratory tract infection without a fever, i.e. rectal temperature <38.0 ºC).

Mother known to be HIV, RPR, or HBsAg seropositive or mothers with unknown HIV, RPR or HBsAg serology status.

Mother with insulin dependant diabetes mellitus, pre-eclampsia, eclampsia or abruption of placentae Participation in another research study.

¿ Lack of telephone in the household

Please refer to this study by ClinicalTrials.gov identifier  NCT00133445

Joel Ward      (310) 222-2346    joelward@ucla.edu

California
      UCLA Center For Vaccine Research, Torrance,  California,  90502,  United States

Study ID Numbers:  03-062
Last Updated:  August 22, 2005
Record first received:  August 19, 2005
ClinicalTrials.gov Identifier:  NCT00133445
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-23