MedTrace Logo

Safety and Immune Response of Different Pediatric Combination Vaccines.

NCT00255047 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2167

Last updated 2014-02-14

Study results available
· View outcomes & findings →

Summary

The overall aim of the study is to corroborate that a schedule consisting of 3 doses of Pentacel™ and a 4th dose of DAPTACEL® and ActHIB® or 4 doses of Pentacel™ or 4 doses of Quadracel and ActHIB® is as safe and immunogenic as a standard of care schedule based on 3 doses of the licensed-equivalent vaccines DAPTACEL®, Vero cell derived Inactivated Poliovirus vaccine (IPOL®), and ActHIB® and a 4th dose of DAPTACEL® and ActHIB®.

Conditions

  • Diphtheria
  • Polio
  • Pertussis

Interventions

BIOLOGICAL

DAPTACEL®. (DTaP), IPOL®., and ActHIB®.

0.5 mL, Intramuscular

BIOLOGICAL

Pentacel®: DTaP-IPV/Hib combined

0.5 mL, Intramuscular

BIOLOGICAL

DTaP-IPV and ActHIB®

0.5 mL, Intramuscular

BIOLOGICAL

Pentacel®: DTaP-IPV/Hib combined

0.5 mL, Intramuscular

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
42 Days
Max Age
89 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2008-07-31
Completion
2009-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT00255047 on ClinicalTrials.gov