Safety Study of Pandemic Candidate Influenza Vaccines in the Elderly Population

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Influenza Vaccines; Influenza

Treatments: Biological: SB218352_4; Biological: SB218352_4AL; Biological: SB218352_2AL; Biological: SB218352_8AL; Biological: SB218352_15; Biological: SB218352_2; Biological: SB218352_8

Study type: Interventional

Funder types: Industry

Identifiers

NCT00306995

102499

Details and patient eligibility

About

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.

Enrollment: 385 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects who the investigator believes that they can and will comply with the requirements of the protocol
• A male or female aged over 60 years at the time of vaccination.
• Written informed consent obtained from the subject.

Exclusion criteria

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
• Participation in an earlier study with a candidate pandemic H9N2 vaccine.
• Acute disease at the time of enrolment.
• Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Drug and/or alcohol dependency.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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385 participants in 7 patient groups

SB218352_15 Group

Experimental group

Description:

Male and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21.

Treatment:

Biological: SB218352_15

SB218352_8 Group

Experimental group

Description:

Male and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21.

Treatment:

Biological: SB218352_8

SB218352_4 Group

Experimental group

Description:

Male and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21.

Treatment:

Biological: SB218352_4

SB218352_2 Group

Experimental group

Description:

Male and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21.

Treatment:

Biological: SB218352_2

SB218352_8AL Group

Experimental group

Description:

Male and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21.

Treatment:

Biological: SB218352_8AL

SB218352_4AL Group

Experimental group

Description:

Male and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21.

Treatment:

Biological: SB218352_4AL

SB218352_2AL Group

Experimental group

Description:

Male and female subjects over 60 years of age, healthy or with underlying disease, received 2 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0 and Day 21.

Treatment:

Biological: SB218352_2AL