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Immune Response and Safety Comparison of 3 Lots of GSK Biologicals' DTaP-IPV Candidate Vaccine to DTaP + IPV Vaccines

NCT00148941 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4209

Last updated 2020-02-05

Study results available
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Summary

The aims of this trial are to demonstrate the consistency of three manufacturing lots of GSK Biologicals' DTaP-IPV candidate vaccine in terms of immunogenicity and to evaluate the non-inferiority of GSK Biologicals' DTaP-IPV vaccine with respect to immunogenicity and safety compared to the control vaccines (separate injections of GSK Biologicals' DTaP vaccine \[Infanrix\] and Aventis Pasteur's IPV vaccine \[IPOL\]) when administered as a 5th dose of DTaP and a 4th dose of inactivated poliovirus vaccine in subjects 4 to 6 years of age. Vaccines will be co-administered with the second dose of M-M-RII, which is recommended at this age. Concomitant administration of a US-licensed influenza vaccine will be allowed according to seasonal availability of vaccine and at the discretion of the investigator.

Conditions

  • Tetanus
  • Acellular Pertussis
  • Diphtheria

Interventions

BIOLOGICAL

SB213503 lot 1

SB213503 lot 1 vaccine was administered as a single dose by intramuscular injection in the deltoid at Day 0.

BIOLOGICAL

SB213503 lot 2

SB213503 lot 2 vaccine was administered as a single dose by intramuscular injection in the deltoid at Day 0.

BIOLOGICAL

SB213503 lot 3

SB213503 lot 3 vaccine was administered as a single dose by intramuscular injection in the deltoid at Day 0.

BIOLOGICAL

Infanrix

Infanrix vaccine was administered as a single dose by intramuscular injection in the deltoid at Day 0.

BIOLOGICAL

IPOL

IPOL vaccine was administered as a single dose by subcutaneous injection in the deltoid at Day 0.

BIOLOGICAL

M-M-R II

M-M-R II vaccine was administered as a single dose by subcutaneous injection in the deltoid at Day 0.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-01-06
Primary Completion
2006-11-01
Completion
2006-12-04

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT00148941 on ClinicalTrials.gov