Immunogenicity & Safety of GSK's Avian Flu Vaccine 1557484A Given to Adults Aged ≥18 Years

NCT ID: NCT00719043

Last Updated: 2018-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 841 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-11
• Study Completion Date: 2011-02-18

Brief Summary

The purpose of this study is to determine whether GSK's avian flu vaccine GSK 1557484A is immunogenic and safe when given to adults aged >=18 years.

This Protocol Posting has been updated following Amendments 1-3 of the Protocol, Dec 2009. The impacted sections are study design and outcome measures.

Detailed Description

All subjects will receive 3 doses of study vaccine, including 2 doses of active vaccine and 1 dose of placebo. All subjects will attend formal study center visits for safety and immunogenicity assessments on Days 0, 10, 42, 182, 192, 224, 549, 559, 591, and 729. A telephone contact to assess safety will be made at Day 364 and Day 909.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

A/Indonesia primed-A/turkey Influenza (H5N1)-F1-Placebo Group

Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.

Group Type: EXPERIMENTAL

A/turkey H5N1 vaccine

Intervention Type: BIOLOGICAL

Administered as an intramuscular (IM) injection

Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia)

Intervention Type: BIOLOGICAL

Administered as an intramuscular (IM) injection

Placebo

Intervention Type: BIOLOGICAL

Administered as an intramuscular (IM) injection

A/Indonesia primed-A/turkey Influenza (H5N1)-F2-Placebo Group

Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.

Group Type: EXPERIMENTAL

A/turkey H5N1 vaccine

Intervention Type: BIOLOGICAL

Administered as an intramuscular (IM) injection

Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia)

Intervention Type: BIOLOGICAL

Administered as an intramuscular (IM) injection

Placebo

Intervention Type: BIOLOGICAL

Administered as an intramuscular (IM) injection

A/Indonesia primed-A/turkey Influenza (H5N1)-F3-Placebo Group

Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.

Group Type: EXPERIMENTAL

A/turkey H5N1 vaccine

Intervention Type: BIOLOGICAL

Administered as an intramuscular (IM) injection

Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia)

Intervention Type: BIOLOGICAL

Administered as an intramuscular (IM) injection

Placebo

Intervention Type: BIOLOGICAL

Administered as an intramuscular (IM) injection

A/Indonesia primed-Placebo-A/turkey Influenza (H5N1)-F1-Group

Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.

Group Type: EXPERIMENTAL

A/turkey H5N1 vaccine

Intervention Type: BIOLOGICAL

Administered as an intramuscular (IM) injection

Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia)

Intervention Type: BIOLOGICAL

Administered as an intramuscular (IM) injection

Placebo

Intervention Type: BIOLOGICAL

Administered as an intramuscular (IM) injection

A/Indonesia primed-Placebo-A/turkey Influenza (H5N1)-F4-Group

Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.

Group Type: EXPERIMENTAL

A/turkey H5N1 vaccine

Intervention Type: BIOLOGICAL

Administered as an intramuscular (IM) injection

Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia)

Intervention Type: BIOLOGICAL

Administered as an intramuscular (IM) injection

Placebo

Intervention Type: BIOLOGICAL

Administered as an intramuscular (IM) injection

A/Indonesia primed-Placebo-A/turkey Influenza (H5N1)-F2-Group

Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.

Group Type: EXPERIMENTAL

A/turkey H5N1 vaccine

Intervention Type: BIOLOGICAL

Administered as an intramuscular (IM) injection

Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia)

Intervention Type: BIOLOGICAL

Administered as an intramuscular (IM) injection

Placebo

Intervention Type: BIOLOGICAL

Administered as an intramuscular (IM) injection

Naïve Placebo-A/turkey Influenza (H5N1)-F3-Group

Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.

Group Type: PLACEBO_COMPARATOR

A/turkey H5N1 vaccine

Intervention Type: BIOLOGICAL

Administered as an intramuscular (IM) injection

Placebo

Intervention Type: BIOLOGICAL

Administered as an intramuscular (IM) injection

Interventions

A/turkey H5N1 vaccine

Administered as an intramuscular (IM) injection

Intervention Type: BIOLOGICAL

Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia)

Administered as an intramuscular (IM) injection

Intervention Type: BIOLOGICAL

Placebo

Administered as an intramuscular (IM) injection

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• A male or female 18 years of age or older at the time of the first vaccination.
• Written informed consent obtained from the subject.
• Stable health status as defined by absence of a health event satisfying the definition of a serious adverse event, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within 1 month prior to enrollment.
• 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.
• Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits.
• Subjects who the investigator believes can and will comply with the requirements of the protocol

Exclusion Criteria

• Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, even if clinically stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
• Diagnosed with cancer, or treatment for cancer, within 3 years.

• Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible.
• Persons with a history of histologically-confirmed basal cell carcinoma of the skin successfully treated with local excision only are excepted and may enroll within 3 years of diagnosis, but other histologic types of skin cancer require a 3 year untreated and disease-free window as above.
• Women who are disease-free 3 years or more after treatment for breast cancer and receiving long-term prophylactic tamoxifen are excepted and may enroll.
• Presence of an oral temperature ≥ 37.8ºC, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
• Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
• Receipt of systemic glucocorticoids (prednisone >= 10 mg/day for more than 14 consecutive days) within 1 month prior to study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment.
• Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin.
• Administration of any vaccines within 30 days before the first study vaccine dose.
• Previous administration of any H5N1 vaccine.
• Use of any investigational or non-registered product (drug or vaccine) or planned participation in another investigational study within 30 days prior to study enrollment, or during the 18 months following the first test article dose. Use of any investigational or non-registered product with immunosuppressive properties is exclusionary at any time during the trial.
• Receipt of any immunoglobulins and/or any blood products within 6 months of study enrollment or planned administration of any of these products during the study period.
• Any known or suspected allergy to any constituent of influenza vaccines (including egg proteins or mercurial preservatives); a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
• Known pregnancy or a positive urine beta-human chorionic gonadotropin (β-hCG) test result prior to vaccination.
• Lactating or nursing.
• Women of child bearing potential who lack a history of reliable contraceptive practices. The provision of this history does NOT replace the requirement to perform, and obtain negative results in pregnancy urine tests prior to treatments.
• Known receipt of analgesic or antipyretic medication with the specific intent of prophylaxis of vaccine reactogenicity on the day of first or any treatment. Subjects on stable chronic regimens of potentially analgesic or anti-pyretic medications for pre-existing diagnoses are not required to discontinue them (to do so would represent evaluation of combined vaccine reactogenicity AND treatment withdrawal - which is not the intent of the protocol).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Denver, Colorado, United States

GSK Investigational Site

Chicago, Illinois, United States

GSK Investigational Site

Metairie, Louisiana, United States

GSK Investigational Site

Milford, Massachusetts, United States

GSK Investigational Site

Kansas City, Missouri, United States

GSK Investigational Site

Missoula, Montana, United States

GSK Investigational Site

Winston-Salem, North Carolina, United States

GSK Investigational Site

Bristol, Tennessee, United States

GSK Investigational Site

Austin, Texas, United States

GSK Investigational Site

Fort Worth, Texas, United States

GSK Investigational Site

Halifax, Nova Scotia, Canada

GSK Investigational Site

Montreal, Quebec, Canada

GSK Investigational Site

Sherbrooke, Quebec, Canada

Countries

United States; Canada

Study Documents

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

110624

Identifier Type: -

Identifier Source: org_study_id