Immunogenicity and Safety Study of Different Formulations of GlaxoSmithKline (GSK) Biologicals H7N1 Influenza Vaccine Administered to Adults 21 to 64 Years of Age

NCT ID: NCT01934127

Last Updated: 2017-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 427 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-26
• Study Completion Date: 2014-10-20

Brief Summary

The purpose of this study is to evaluate the safety and immunogenicity of different formulations of GSK Biologicals H7N1 influenza vaccine in subjects 21 to 64 years of age. The study will evaluate safety related events and antibody immune responses to different formulations of study vaccine and placebo.

Conditions

Influenza

Study Design

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

Study Groups

Formulation 1 Group

Subjects in this group will receive two doses of GSK2789869A H7N1 vaccine formulation 1 at a 21 day interval

Group Type: EXPERIMENTAL

Investigational H7N1 vaccine GSK2789869A

Intervention Type: BIOLOGICAL

One dose of GSK2789869A H7N1 vaccine administered intramuscularly at the deltoid region of the non-dominant arm at Day 0 while second dose of GSK2789869A H7N1 vaccine administered intramuscularly at the deltoid region of the dominant arm at Day 21

Formulation 2 Group

Subjects in this group will receive two doses of GSK2789869A H7N1 vaccine formulation 2 at a 21 day interval

Group Type: EXPERIMENTAL

Investigational H7N1 vaccine GSK2789869A

Intervention Type: BIOLOGICAL

One dose of GSK2789869A H7N1 vaccine administered intramuscularly at the deltoid region of the non-dominant arm at Day 0 while second dose of GSK2789869A H7N1 vaccine administered intramuscularly at the deltoid region of the dominant arm at Day 21

Formulation 3 Group

Subjects in this group will receive two doses of GSK2789869A H7N1 vaccine formulation 3 at a 21 day interval

Group Type: EXPERIMENTAL

Investigational H7N1 vaccine GSK2789869A

Intervention Type: BIOLOGICAL

One dose of GSK2789869A H7N1 vaccine administered intramuscularly at the deltoid region of the non-dominant arm at Day 0 while second dose of GSK2789869A H7N1 vaccine administered intramuscularly at the deltoid region of the dominant arm at Day 21

Formulation 4 Group

Subjects in this group will receive two doses of GSK2789869A H7N1 vaccine formulation 4 at a 21 day interval

Group Type: EXPERIMENTAL

Investigational H7N1 vaccine GSK2789869A

Intervention Type: BIOLOGICAL

One dose of GSK2789869A H7N1 vaccine administered intramuscularly at the deltoid region of the non-dominant arm at Day 0 while second dose of GSK2789869A H7N1 vaccine administered intramuscularly at the deltoid region of the dominant arm at Day 21

Formulation 5 Group

Subjects in this group will receive two doses of GSK2789868A H7N1 vaccine formulation 5 at a 21 day interval

Group Type: EXPERIMENTAL

Investigational H7N1 vaccine GSK2789868A

Intervention Type: BIOLOGICAL

One dose of GSK2789868A H7N1 vaccine administered intramuscularly at the deltoid region of the non-dominant arm at Day 0 while the second dose of GSK2789868A H7N1 vaccine administered intramuscularly at the deltoid region of the dominant arm at Day 21

Placebo Group

Subjects in this group will receive two doses of placebo at a 21 day interval

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

One dose of placebo administered intramuscularly at the deltoid region of the non-dominant arm at Day 0 while the second dose of placebo administered intramuscularly at the deltoid region of the dominant arm at Day 21

Interventions

Investigational H7N1 vaccine GSK2789869A

One dose of GSK2789869A H7N1 vaccine administered intramuscularly at the deltoid region of the non-dominant arm at Day 0 while second dose of GSK2789869A H7N1 vaccine administered intramuscularly at the deltoid region of the dominant arm at Day 21

Intervention Type: BIOLOGICAL

Investigational H7N1 vaccine GSK2789868A

One dose of GSK2789868A H7N1 vaccine administered intramuscularly at the deltoid region of the non-dominant arm at Day 0 while the second dose of GSK2789868A H7N1 vaccine administered intramuscularly at the deltoid region of the dominant arm at Day 21

Intervention Type: BIOLOGICAL

Placebo

One dose of placebo administered intramuscularly at the deltoid region of the non-dominant arm at Day 0 while the second dose of placebo administered intramuscularly at the deltoid region of the dominant arm at Day 21

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Male or female adults who are 21 to 64 years of age (inclusive) at the time of first study vaccination.
• Written informed consent obtained from the subject.
• Subjects who the investigator believes can and will comply with the requirements of the protocol.
• Healthy subjects as established by medical history and physical examination.
• 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.
• For subjects who undergo a screening visit, results of all safety laboratory tests obtained at the screening visit must be within reference ranges. Results of any repeat testing cannot be used to qualify a subject for enrollment.
• Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause.
• Female subjects of childbearing potential may be enrolled in the study, if they

• have practiced adequate contraception for 30 days prior to vaccination, and
• have a negative pregnancy test on the day of vaccination, and
• agree to continue to practice adequate contraception until 2 months after the last dose administered.

Exclusion Criteria

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

1. Persons with a history of cancer who are disease-free without treatment for three years or more are eligible.

2. Persons with a history of histologically-confirmed basal cell carcinoma of the skin successfully treated with local excision only are excepted and are eligible, but other histologic types of skin cancer are exclusionary.

3. Women who are disease-free three years or more after treatment for breast cancer and receiving long-term prophylaxis are eligible.

• Diagnosed with excessive daytime sleepiness (unintended sleep episodes during the day present almost daily for at least one month), or narcolepsy.
• History of narcolepsy in subject's parent, sibling or child
• Presence of a temperature ≥ 38.0ºC (≥100.4ºF), or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.

NOTE: The subject may be vaccinated at a later date, provided symptoms have resolved, and all other eligibility criteria continue to be satisfied.

• Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
• Receipt of systemic glucocorticoids within 30 days prior to the first dose of study vaccine/placebo, or any other cytotoxic, immunosuppressive or immune-modifying drugs within 6 months of first study vaccine/ placebo dose. Topical, intra-articularly injected, or inhaled glucocorticoids, topical calcineurin inhibitors or imiquimod are allowed.
• 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 aspirin, and without a clinically-apparent bleeding tendency, are eligible.
• An acute evolving neurological disorder or Guillain Barré Syndrome within 42 days of receipt of prior seasonal or pandemic influenza vaccine.
• Administration of an inactive vaccine within 14 days or of a live attenuated vaccine within 30 days before the first dose of study vaccine/placebo.
• Planned administration of any vaccine other than the study vaccine/placebo before blood sampling at the Day 42 visit.
• Previous administration of any H7 vaccine or physician-confirmed H7 disease.
• Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine/placebo, or planned use during the study period.
• Receipt of any immunoglobulins and/or any blood products within 90 days before the first dose of study vaccine/placebo, or planned administration of any of these products during the study period.
• Any known or suspected allergy to any constituent of influenza vaccines or component used in the manufacturing process of the study vaccine including 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 before the first dose of study vaccine/placebo.
• Lactating or nursing women.
• Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 64 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

Miami, Florida, United States

GSK Investigational Site

Stockbridge, Georgia, United States

GSK Investigational Site

Las Vegas, Nevada, United States

GSK Investigational Site

Rochester, New York, United States

GSK Investigational Site

Cleveland, Ohio, United States

GSK Investigational Site

Austin, Texas, United States

GSK Investigational Site

Truro, Nova Scotia, Canada

GSK Investigational Site

Greater Sudbury, Ontario, Canada

GSK Investigational Site

Toronto, Ontario, Canada

Countries

United States; Canada

References

Madan A, Ferguson M, Sheldon E, Segall N, Chu L, Toma A, Rheault P, Friel D, Soni J, Li P, Innis BL, Schuind A. Immunogenicity and safety of an AS03-adjuvanted H7N1 vaccine in healthy adults: A phase I/II, observer-blind, randomized, controlled trial. Vaccine. 2017 Mar 7;35(10):1431-1439. doi: 10.1016/j.vaccine.2017.01.054. Epub 2017 Feb 7.

Reference Type: DERIVED

PMID: 28187952 (View on PubMed)

Study Documents

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: Dataset Specification

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

View Document

Document Type: Clinical Study Report

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

Document Type: Study Protocol

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

View Document

Related Links

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Other Identifiers

115415

Identifier Type: -

Identifier Source: org_study_id