Safety and Immunogenicity of H1N1 Vaccines in Adults Aged 18 Years and Older

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Influenza

Treatments: Biological: GSK2340273A; Biological: GSK2340274A; Biological: Saline placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00985088

113440

Details and patient eligibility

About

The purpose of this study is to characterize the safety and immunogenicity of the H1N1 (swine) flu vaccines GSK2340273A and GSK2340274A in adults 18 years of age or older.

This protocol posting has been updated for sections impacted by the Protocol amendment 1, Sept 2009.

Full description

Collaborators: United States Department of Health and Human Services, Office of Biomedical Advanced Research and Development Authority

Enrollment: 1,343 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects who the investigator believes can and will comply with the requirements of the protocol.
• Written informed consent obtained from the subject.
• Male and female adults, >= 18 years of age at the time of the first vaccination.
• Safety laboratory test results within the parameters specified in the protocol.
• Satisfactory baseline medical assessment by history and physical examination.
• Comprehension of the study requirements, ability to comprehend and comply with procedures for collection of safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits as documented by signature on the informed consent document.
• Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or other multiple-user device.
• Female subjects of non-childbearing potential may be enrolled in the study.
• Female subjects of childbearing potential may be enrolled in the study, if the subject:
• has practiced adequate contraception for 30 days prior to vaccination, and
• has a negative pregnancy test on the day of first vaccination, and
• has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion criteria

• Medical history of physician-confirmed infection with an A/California/7/2009 (H1N1)v-like virus
• Previous vaccination at any time with an H1N1v-like virus vaccine or a medical history of physician-confirmed infection with an H1N1v-like virus.
• Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, even if stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
• Presence of a temperature >= 38.0ºC (>=100.4ºF), or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
• Diagnosed with cancer, or treatment for cancer, within 3 years.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
• Receipt of systemic glucocorticoids within 1 month prior to study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. Topical, intra-articularly injected, or inhaled glucocorticoids, topical calcineurin inhibitors or imiquimod are allowed.
• Receipt of any immunoglobulins and/or any blood products within 3 months of study enrollment or planned administration of any of these products during the study period.
• Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin outside of 24 hours prior to vaccination, are eligible. Persons receiving prophylactic antiplatelet medications, e.g., low-dose acetylsalicylic acid, and without a clinically-apparent bleeding tendency, are eligible.
• An acute evolving neurological disorder or history of Guillain-Barré syndrome within 6 weeks of receipt of seasonal influenza vaccine
• With the exception of seasonal influenza vaccination, administration of any vaccine(s) within 30 days before study vaccination on Day 0. Seasonal influenza vaccine may be administered up to 14 days prior to study vaccination on Day 0.
• Planned administration of any vaccine not foreseen by the study protocol between Day 0 and the Day 42 phlebotomy, including seasonal influenza vaccine or a monovalent pandemic H1N1 vaccine other than the study vaccines.
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine/product, or planned use during the study period.
• Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.
• Known pregnancy or a positive urine beta-human chorionic gonadotropin test result prior to the first vaccination.
• Lactating or nursing women.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,343 participants in 8 patient groups

GSK2340274A F1_2D Group

Experimental group

Description:

Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 1 (F1) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.

Treatment:

Biological: GSK2340274A

GSK2340274A F2_2D Group

Experimental group

Description:

Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340274A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.

Treatment:

Biological: GSK2340274A

GSK2340274A F2_1D Group

Experimental group

Description:

Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.

Treatment:

Biological: GSK2340274A

Biological: Saline placebo

GSK2340274A F1_1D Group

Experimental group

Description:

Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline placebo at Day 21, administered intramuscularly into the deltoid region of the dominant arm.

Treatment:

Biological: GSK2340274A

Biological: Saline placebo

GSK2340273A F1_1D Group

Experimental group

Description:

Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 1 (F1) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm.

Treatment:

Biological: Saline placebo

Biological: GSK2340273A

GSK2340273A F2_2D Group

Experimental group

Description:

Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 2 (F2) of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.

Treatment:

Biological: GSK2340273A

GSK2340273A F2_1D Group

Experimental group

Description:

Healthy male or female subjects, above and including 18 years of age, who received one dose of Formulation 2 (F2) of GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and one dose of saline at Day 21, administered intramuscularly into the deltoid region of the dominant arm. Subjects above (\>) 60 years old received an additional dose of Formulation 2 (F2) of GSK2340273A vaccine after Day 42, administered into the deltoid region of the non-dominant arm.

Treatment:

Biological: Saline placebo

Biological: GSK2340273A

GSK2340273A F3_2D Group

Experimental group

Description:

Healthy male or female subjects, above and including 18 years of age, who received 2 doses of Formulation 3 of GSK2340273A vaccine: at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm and at Day 21, administered intramuscularly into the deltoid region of the dominant arm.

Treatment:

Biological: GSK2340273A