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Pentavalent DTaP-Hep B-IPV

NCT00133445 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2011-11-07

No results posted yet for this study

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

Interventions

BIOLOGICAL

DTaP-Hep B-IPV Vaccine

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

BIOLOGICAL

Monovalent Hep B Vaccine

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.

DRUG

Placebo

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

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
5 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2006-08-31
Completion
2006-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00133445 on ClinicalTrials.gov