MedTrace Logo

Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline Biologicals' Influenza Vaccine in Elderly People

NCT00992784 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 370

Last updated 2018-09-21

Study results available
· View outcomes & findings →

Summary

The purpose of the study is to evaluate the safety of GSK Biologicals' influenza vaccine. Elderly subjects were randomized in the primary study (NCT00760617) and will now receive the same vaccine for the third time. For this study the masking is "observer-blind" for elderly subjects and "open" for young adult subjects.

Conditions

Interventions

BIOLOGICAL

GSK investigational vaccine 2186877A

Single dose, intramuscular injection

BIOLOGICAL

FluarixTM

Single dose, intramuscular injection

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-10-15
Primary Completion
2010-05-27
Completion
2010-05-27

Countries

  • Germany
  • Netherlands
  • Sweden

Study Locations

More Related Trials

Entities

Diseases
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 NCT00992784 on ClinicalTrials.gov