Pentavalent DTaP-Hep B-IPV

• Status: Completed
• Trial end date: 2006-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety of administering a combination vaccine (DTaP-HepB-IPV; Pediarix™) to infants at birth, 2 and 6 months compared to the administration of a HepB vaccine at birth and the same combination vaccine at 2, 4, and 6 months of age. Additionally, researchers will assess the body's antibody response (proteins produced by the body's immune system that help fight infections) following each vaccine dose. The study will enroll 5 healthy newborns, ages 0-5 days. Participants will be involved in study related procedures for up to 288 days, including blood sample collection and 5 study visits.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Vaccines

Criteria

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 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

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 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