Pentavalent DTaP-Hep B-IPV

NCT00133445 | Completed Phase 2

• 1 other identifier: 03-062
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diphtheria; Hepatitis B; Poliomyelitis; Pertussis; Tetanus

Keywords

Pentavalent vaccine, Pediarix, DTaP-Hep B-IPV vaccine

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 0-5, Day 53-70, Day 113-130, Day 173-190, and Visit 4 + (28-42 days).

Secondary Outcomes (1)

• To assess vaccine safety, systemic and local immediate reactions.

  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.

Study Arms (2)

Group A

EXPERIMENTAL

Group A will receive DTaP-HepB-IPV (Pediarix™) vaccine along with other required vaccines at birth, 2 and 6 months of age.

Biological: DTaP-Hep B-IPV Vaccine; Drug: Placebo

Group B

ACTIVE COMPARATOR

Group B will receive the monovalent HepB vaccine (Engerix-B) at birth, the DTaP-HepB-IPV (Pediarix™) vaccine with other vaccines at 2, 4 and 6 months of age.

Biological: DTaP-Hep B-IPV Vaccine; Biological: Monovalent Hep B Vaccine

Interventions

DTaP-Hep B-IPV Vaccine BIOLOGICAL

U.S. licensed 13-Dec-2002. Dosage equal to 0.5 mL administered intramuscularly. Combination vaccine.

Group A; Group B

Monovalent Hep B Vaccine BIOLOGICAL

U.S. licensed monovalent hepatitis B vaccine; each 0.5 mL dose contains 10 mcg of hepatitis B surface antigen absorbed on 0.25 mg aluminum hydroxide. The vaccine is given to infants as a 0.5 mL dose intramuscularly.

Group B

Placebo DRUG

Commercially prepared normal saline. The dose will be 0.5 mL administered intramuscularly.

Group A

Eligibility Criteria

• Age: Up to 5 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

UCLA Center For Vaccine Research

Torrance, California, 90502, United States

Location

MeSH Terms

Conditions

Diphtheria; Hepatitis B; Poliomyelitis; Whooping Cough; Tetanus

Condition Hierarchy (Ancestors)

Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Blood-Borne Infections; Communicable Diseases; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Myelitis; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases; Bordetella Infections; Gram-Negative Bacterial Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Clostridium Infections

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 19, 2005
• First Posted: August 23, 2005
• Study Start: December 1, 2005
• Primary Completion: August 1, 2006
• Study Completion: August 1, 2006
• Last Updated: November 7, 2011

Record last verified: 2009-10

Locations

US (1)