MedTrace Logo

Immunogenicity and Safety of Vaccine GSK2340272A (H1N1) and GSK Biologicals Fluarix™ Vaccine When Co-administered in Elderly

NCT00968890 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2018-08-20

Study results available
· View outcomes & findings →

Summary

The purpose of the present study is to assess the immunogenicity, safety and reactogenicity of a two-dose schedule with vaccine GSK2340272A when co-administered with GSK Biologicals' Fluarix™ vaccine either at the time of first or second vaccination in elderly subjects aged 61 years and older.

Conditions

Interventions

BIOLOGICAL

Pandemrix (Influenza vaccine GSK2340272A)

Intramuscular injection, 2 doses

BIOLOGICAL

Fluarix™

Intramuscular injection, 1 dose

BIOLOGICAL

Placebo

Intramuscular injection, 1 dose

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
61 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-12
Primary Completion
2010-09-23
Completion
2010-09-23

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Drugs
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 NCT00968890 on ClinicalTrials.gov