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Safety Study of Pandemic Candidate Influenza Vaccines in the Elderly Population

NCT00306995 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 385

Last updated 2020-02-10

Study results available
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Summary

Influenza pandemics are caused by viruses that possess an Hemagglutinin molecule to which most of the population lacks immunity. If such virus is pathogenic to human and demonstrates the ability to transmit from person to person, the result is a global outbreak of disease that affects a high percentage of individuals in a short period of time and is likely to cause substantially increased mortality and morbidity in all countries of the world. Recently, purely avian influenza viruses, including the H5N1, H9N2 and H7N7 subtypes, have been directly transmitted to humans, raising concern over the possibility of a new influenza pandemic among the world's immunologically naive populations. In order to face this kind of situation, a pandemic influenza vaccine has to be developed.

Conditions

Interventions

BIOLOGICAL

SB218352_15

Non-adjuvanted pandemic influenza A formulation 1 vaccine

BIOLOGICAL

SB218352_8

Non-adjuvanted pandemic influenza A formulation 2 vaccine

BIOLOGICAL

SB218352_4

Non-adjuvanted pandemic influenza A formulation 3 vaccine

BIOLOGICAL

SB218352_2

Non-adjuvanted pandemic influenza A formulation 4 vaccine

BIOLOGICAL

SB218352_8AL

Pandemic influenza A formulation 2 aluminium-adjuvanted vaccine

BIOLOGICAL

SB218352_4AL

Pandemic influenza A formulation 3 aluminium-adjuvanted vaccine

BIOLOGICAL

SB218352_2AL

Pandemic influenza A formulation 4 aluminium-adjuvanted vaccine

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-11
Primary Completion
2006-07-04
Completion
2006-07-04

Countries

  • Germany

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 NCT00306995 on ClinicalTrials.gov