Primary & Booster Immunogenicity Study of GSK Biologicals' Hib-MenC Versus a Licensed Men-C Vaccine

NCT00258700 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 478

Last updated 2016-09-21

No results posted yet for this study

Summary

The purpose of this study is to demonstrate the non-inferiority of the candidate Hib-MenC conjugate vaccine co-administered with Infanrix™-IPV versus a licensed meningococcal serogroup C vaccine co-administered with Pediacel™ when given according to a 2, 3, 4 month schedule and the immunogenicity of the Hib-MenC vaccine when given as a booster dose at 12-15 months of age.

Conditions

  • Haemophilus Influenzae Type b
  • Neisseria Meningitidis

Interventions

BIOLOGICAL

Haemophilus influenzae type b- and meningococcal (vaccine)

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
12 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2006-07-31
Completion
2006-07-31

Countries

  • Poland
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT00258700 on ClinicalTrials.gov