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Safety & Immunogenicity of 1 Dose of GSK134612 in Children 12-14 Months and 3-5 Years Old

NCT00196976 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 461

Last updated 2018-06-08

Study results available
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Summary

The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of one dose of four different formulations of the MenACWY conjugate vaccine when given to healthy children aged 12-14 months and 3-5 years. The selection of the best formulation will be based on data obtained up to one month after the vaccine dose.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

  • Infections, Meningococcal

Interventions

BIOLOGICAL

Conjugated meningococcal ACWY-TT (vaccine)

One intramuscular dose during the primary vaccination

BIOLOGICAL

DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib)

One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Greece only

BIOLOGICAL

DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™)

One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Austria only

BIOLOGICAL

Meningitec™

One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age

BIOLOGICAL

Mencevax™ACWY

One subcutaneous dose during the primary vaccination study in subjects of 3-5 years of age (Group E) and intramuscular administration of 1/5 dose during the booster vaccination study in subjects of 12-14 months of age (Groups A and E)

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
60 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-03-24
Primary Completion
2006-03-01
Completion
2006-03-03

Countries

  • Austria
  • Greece

Study Locations

More Related Trials

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 NCT00196976 on ClinicalTrials.gov