Safety & Immunogenicity of an Alternative Immunization Schedule of GSK Bio's Pandemic Influenza Vaccine (GSK1119711A)

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Influenza Vaccines; Influenza

Treatments: Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 2; Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT00430521

2006-005477-22 (EudraCT Number)

107495

Details and patient eligibility

About

The aim of the study is to assess the safety & immunogenicity of a pandemic influenza vaccine administered at 2 different time points. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Enrollment: 512 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
• A male or female between, and including, 18 and 60 years of age at the time of the first vaccination.
• Written informed consent obtained from the subject.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• If the subject is female, she must be of non-childbearing potential; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to first vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.

Exclusion criteria

• Administration of licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study.
• History of vaccination with investigational influenza pandemic vaccine.
• History of administration of an experimental/licensed vaccine
• Planned administration of a vaccine not foreseen by the study protocol during the following periods: from Day 0 up to Day 51; from 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to Month 6 and Month 12; from Month 6 up to Month 6 + 30 days; from Month 12 up to Month 12 + 30 days.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first administration of the candidate vaccines
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
• History of hypersensitivity to vaccines.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• History of chronic alcohol consumption and/or drug abuse.
• Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
• Serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination.
• Acute disease at the time of enrolment.
• Administration of immunoglobulins and/or any blood products within the three months preceding the first administration of the candidate vaccine or during the study.
• Lactating women.
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to the first vaccination, or planned use during the study period.
• Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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512 participants in 8 patient groups

GSK1562902A V/I/6 Group

Experimental group

Description:

Subjects received 1 dose of vaccine formulated from VT strain at Day 0 and 1 dose of the vaccine including IN at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.

Treatment:

Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 1

Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 2

GSK1562902A V/V/6 Group

Experimental group

Description:

Subjects received 2 doses of vaccine formulated from VT strain, 1 at Day 0 and 1 at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.

Treatment:

Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 1

GSK1562902A 2V/I/6 Group

Experimental group

Description:

Subjects received 2 doses of vaccine formulated from VT strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN strain at Month 6.The vaccine was administered in the deltoid region of the non-dominant arm.

Treatment:

Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 1

Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 2

GSK1562902A 2V/V/6 Group

Experimental group

Description:

Subjects received 2 doses of vaccine formulated from VT strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 6. The vaccine was administered in the deltoid region of the non-dominant arm.

Treatment:

Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 1

GSK1562902A V/I/12 Group

Experimental group

Description:

Subjects received 1 dose of vaccine formulated from VT strain at Day 0 and 1 dose of the vaccine including IN strain at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.

Treatment:

Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 1

Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 2

GSK1562902A V/V/12 Group

Experimental group

Description:

Subjects received 2 doses of vaccine formulated from VT strain, 1 at Day 0 and 1 at Month 12. The vaccine was administered in the deltoid region of the non-dominant arm.

Treatment:

Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 1

GSK1562902A 2V/I/12 Group

Experimental group

Description:

Subjects received 2 doses of vaccine formulated from VT strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including IN strain at Month 12.The vaccine was administered in the deltoid region of the non-dominant arm.

Treatment:

Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 1

Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 2

GSK1562902A 2V/V/12 Group

Experimental group

Description:

Subjects received 2 doses of vaccine formulated from VT strain, 1 at Day 0 and 1 at Day 21 and a 3rd dose of vaccine including VT strain at Month 12.The vaccine was administered in the deltoid region of the non-dominant arm.

Treatment:

Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 1