Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Influenza Vaccines GSK2654911A and GSK2654909A Administered to Adults 18 to 64 Years of Age

NCT ID: NCT01659086

Last Updated: 2018-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 422 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-22
• Study Completion Date: 2014-03-19

Brief Summary

The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity of different formulations of a two-dose primary series and booster vaccination of monovalent Influenza H9N2 vaccine manufactured in Quebec, Canada with and without adjuvant, in adults 18 to 64 years of age.

Conditions

Influenza

Study Design

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

Study Groups

Group A

Subjects will receive the investigational vaccine GSK2654911A formulation 1 and placebo

Group Type: EXPERIMENTAL

Investigational H9N2 vaccine GSK2654911A

Intervention Type: BIOLOGICAL

2 or 3 doses of GSK2654911A (different formulations) followed by 1 or 0 dose of saline placebo respectively, depending in the treatment group. All doses to be administered intramuscularly (IM) in deltoid region of arm.

Placebo

Intervention Type: BIOLOGICAL

1 dose of saline placebo administered intramuscularly (IM) in deltoid region of arm.

Group B

Subjects will receive the investigational vaccine GSK2654911A formulation 2 and placebo

Group Type: EXPERIMENTAL

Investigational H9N2 vaccine GSK2654911A

Intervention Type: BIOLOGICAL

2 or 3 doses of GSK2654911A (different formulations) followed by 1 or 0 dose of saline placebo respectively, depending in the treatment group. All doses to be administered intramuscularly (IM) in deltoid region of arm.

Placebo

Intervention Type: BIOLOGICAL

1 dose of saline placebo administered intramuscularly (IM) in deltoid region of arm.

Group C

Subjects will receive the investigational vaccine GSK2654911A formulation 3 and placebo

Group Type: EXPERIMENTAL

Investigational H9N2 vaccine GSK2654911A

Intervention Type: BIOLOGICAL

2 or 3 doses of GSK2654911A (different formulations) followed by 1 or 0 dose of saline placebo respectively, depending in the treatment group. All doses to be administered intramuscularly (IM) in deltoid region of arm.

Placebo

Intervention Type: BIOLOGICAL

1 dose of saline placebo administered intramuscularly (IM) in deltoid region of arm.

Group D

Subjects will receive the investigational vaccine GSK2654911A formulation 4 and placebo

Group Type: EXPERIMENTAL

Investigational H9N2 vaccine GSK2654911A

Intervention Type: BIOLOGICAL

2 or 3 doses of GSK2654911A (different formulations) followed by 1 or 0 dose of saline placebo respectively, depending in the treatment group. All doses to be administered intramuscularly (IM) in deltoid region of arm.

Placebo

Intervention Type: BIOLOGICAL

1 dose of saline placebo administered intramuscularly (IM) in deltoid region of arm.

Group E

Subjects will receive the investigational vaccine GSK2654909A and placebo

Group Type: EXPERIMENTAL

Investigational H9N2 vaccine GSK2654909A

Intervention Type: BIOLOGICAL

2 or 3 doses of GSK2654909A followed by 1 or 0 dose of saline placebo, respectively (treatment 5). All doses to be administered IM in deltoid region of arm.

Placebo

Intervention Type: BIOLOGICAL

1 dose of saline placebo administered intramuscularly (IM) in deltoid region of arm.

Group F

Subjects will receive the investigational vaccine GSK2654911A formulation 5

Group Type: EXPERIMENTAL

Investigational H9N2 vaccine GSK2654911A

Intervention Type: BIOLOGICAL

2 or 3 doses of GSK2654911A (different formulations) followed by 1 or 0 dose of saline placebo respectively, depending in the treatment group. All doses to be administered intramuscularly (IM) in deltoid region of arm.

Group G

Subjects will receive the investigational vaccine GSK2654911A formulation 6

Group Type: EXPERIMENTAL

Investigational H9N2 vaccine GSK2654911A

Intervention Type: BIOLOGICAL

2 or 3 doses of GSK2654911A (different formulations) followed by 1 or 0 dose of saline placebo respectively, depending in the treatment group. All doses to be administered intramuscularly (IM) in deltoid region of arm.

Group H

Subjects will receive the investigational vaccine GSK2654911A formulation 7

Group Type: EXPERIMENTAL

Investigational H9N2 vaccine GSK2654911A

Intervention Type: BIOLOGICAL

2 or 3 doses of GSK2654911A (different formulations) followed by 1 or 0 dose of saline placebo respectively, depending in the treatment group. All doses to be administered intramuscularly (IM) in deltoid region of arm.

Group I

Subjects will receive the investigational vaccine GSK2654911A formulation 8

Group Type: EXPERIMENTAL

Investigational H9N2 vaccine GSK2654911A

Intervention Type: BIOLOGICAL

2 or 3 doses of GSK2654911A (different formulations) followed by 1 or 0 dose of saline placebo respectively, depending in the treatment group. All doses to be administered intramuscularly (IM) in deltoid region of arm.

Group J

Subjects will receive the investigational vaccine GSK2654909A

Group Type: EXPERIMENTAL

Investigational H9N2 vaccine GSK2654909A

Intervention Type: BIOLOGICAL

2 or 3 doses of GSK2654909A followed by 1 or 0 dose of saline placebo, respectively (treatment 5). All doses to be administered IM in deltoid region of arm.

Placebo Group

Subjects will receive Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

1 dose of saline placebo administered intramuscularly (IM) in deltoid region of arm.

Interventions

Investigational H9N2 vaccine GSK2654911A

2 or 3 doses of GSK2654911A (different formulations) followed by 1 or 0 dose of saline placebo respectively, depending in the treatment group. All doses to be administered intramuscularly (IM) in deltoid region of arm.

Intervention Type: BIOLOGICAL

Investigational H9N2 vaccine GSK2654909A

2 or 3 doses of GSK2654909A followed by 1 or 0 dose of saline placebo, respectively (treatment 5). All doses to be administered IM in deltoid region of arm.

Intervention Type: BIOLOGICAL

Placebo

1 dose of saline placebo administered intramuscularly (IM) in deltoid region of arm.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Male or female adults from 18 to 64 years of age (inclusive) at 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.
• Body weight of at least 110 lbs (49.9 kg).
• 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 (i.e., a common-use phone serving multiple rooms or apartments).
• 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 booster dose administration.

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.

• Persons with a history of cancer who are disease-free without treatment for three 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, but other histologic types of skin cancer are exclusionary.
• Women who are disease-free three years or more after treatment for breast cancer and receiving long-term prophylaxis may enroll.
• Presence of a temperature ≥ 38.0ºC (≥100.4ºF), 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 (no laboratory testing required).
• Receipt of systemic glucocorticoids (e.g., prednisone ≥ 10 mg/day for more than 14 consecutive days) within 30 days prior to the first dose of study vaccine, or any other cytotoxic, immunosuppressive or immune-modifying drugs within 365 days of study enrollment. 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/product.
• Planned administration of any vaccine other than the study vaccine/product before blood sampling at the Day 42 visit.
• Previous administration of any H9 vaccine or physician-confirmed H9 disease.
• Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Receipt of any immunoglobulins and/or any blood products within 90 days before study enrolment 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 vaccination.
• Lactating or nursing women.
• Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.

• Minimum Eligible Age: 18 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

Edison, New Jersey, United States

GSK Investigational Site

Austin, Texas, United States

GSK Investigational Site

Sherbrooke, Quebec, Canada

Countries

United States; Canada

References

Madan A, Collins H, Sheldon E, Frenette L, Chu L, Friel D, Drame M, Vaughn DW, Innis BL, Schuind A. Evaluation of a primary course of H9N2 vaccine with or without AS03 adjuvant in adults: A phase I/II randomized trial. Vaccine. 2017 Aug 16;35(35 Pt B):4621-4628. doi: 10.1016/j.vaccine.2017.07.013. Epub 2017 Jul 15.

Reference Type: DERIVED

PMID: 28720281 (View on PubMed)

Other Identifiers

116358

Identifier Type: -

Identifier Source: org_study_id