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

NCT01659086 | Completed Phase 1

• 1 other identifier: 116358
• Study Type: interventional
• Target: 422
• Locations: 2 countries
• Sites: 4

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

Keywords

Influenza; Immunogenicity; H9N2; Safety

Outcome Measures

Primary Outcomes (2)

• Humoral immune response in terms of HI antibodies against H9N2 v-like antigen

  Day 21

• Humoral immune response in terms of HI antibodies against H9N2 v-like antigen

  Day 42

Secondary Outcomes (9)

• Humoral immune response in terms of HI antibodies against H9N2 antigen

  GMTs and seropositivity rates, SPR on Days 0, 7, 21, 28, 42, 182, 191, 385 and 546. SCR and MGI on Days 7, 21, 28, 42, 182, 191, 385 and 546. B-SCR and BF on Days 191, 385 and 546.

• Humoral immune response in terms of HI antibodies against H9N2 antigen for each vaccine group and for age strata (18-40 years; 41-64 years)

  GMTs and seropositivity rates, SPR on Days 0, 7, 21, 28, 42, 182, 191, 385 and 546. SCR and MGI on Days 7, 21, 28, 42, 182, 191, 385 and 546. B-SCR and BF on Days 191, 385 and 546.

• Humoral immune response in terms of HI antibodies against any drift strain from H9N2 antigen or against any other H9 subtype antigen

  GMTs and seropositivity rates on Days 0, 7, 21, 28, 42, 182 , 191, 385 and 546. SCR and MGI on Days 21, 42, 182, 191, 385, 546. SPR on Days 0, 21, 42, 182, 191, 385 and 546. B-SCR and BF on Days 191, 385 and 546.

• Humoral immune response in terms of neutralizing (MN) antibodies against H9N2 and against any drift strain (or other H9 subtype)

  GMTs and seropositivity rate on Days 0, 21, 42, 182, 191, 385 and 546. VRR on Days 21, 42, 182, 191, 385, 546. Booster-VRR on Day 191, 385 and 546.

• Occurrence of local and general symptoms

  During the 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after any vaccination

Study Arms (11)

Group A

EXPERIMENTAL

Subjects will receive the investigational vaccine GSK2654911A formulation 1 and placebo

Biological: Investigational H9N2 vaccine GSK2654911A; Biological: Placebo

Group B

EXPERIMENTAL

Subjects will receive the investigational vaccine GSK2654911A formulation 2 and placebo

Biological: Investigational H9N2 vaccine GSK2654911A; Biological: Placebo

Group C

EXPERIMENTAL

Subjects will receive the investigational vaccine GSK2654911A formulation 3 and placebo

Biological: Investigational H9N2 vaccine GSK2654911A; Biological: Placebo

Group D

EXPERIMENTAL

Subjects will receive the investigational vaccine GSK2654911A formulation 4 and placebo

Biological: Investigational H9N2 vaccine GSK2654911A; Biological: Placebo

Group E

EXPERIMENTAL

Subjects will receive the investigational vaccine GSK2654909A and placebo

Biological: Investigational H9N2 vaccine GSK2654909A; Biological: Placebo

Group F

EXPERIMENTAL

Subjects will receive the investigational vaccine GSK2654911A formulation 5

Biological: Investigational H9N2 vaccine GSK2654911A

Group G

EXPERIMENTAL

Subjects will receive the investigational vaccine GSK2654911A formulation 6

Biological: Investigational H9N2 vaccine GSK2654911A

Group H

EXPERIMENTAL

Subjects will receive the investigational vaccine GSK2654911A formulation 7

Biological: Investigational H9N2 vaccine GSK2654911A

Group I

EXPERIMENTAL

Subjects will receive the investigational vaccine GSK2654911A formulation 8

Biological: Investigational H9N2 vaccine GSK2654911A

Group J

EXPERIMENTAL

Subjects will receive the investigational vaccine GSK2654909A

Biological: Investigational H9N2 vaccine GSK2654909A

Placebo Group

PLACEBO COMPARATOR

Subjects will receive Placebo

Biological: Placebo

Interventions

Investigational H9N2 vaccine GSK2654911A 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 A; Group B; Group C; Group D; Group F; Group G; Group H; Group I

Investigational H9N2 vaccine GSK2654909A 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.

Group E; Group J

Placebo BIOLOGICAL

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

Group A; Group B; Group C; Group D; Group E; Placebo Group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (4)

GSK Investigational Site

Miami, Florida, 33143, United States

Location

GSK Investigational Site

Edison, New Jersey, 08817, United States

Location

GSK Investigational Site

Austin, Texas, 78705, United States

Location

GSK Investigational Site

Sherbrooke, Quebec, J1H 2G2, Canada

Location

Related Publications (1)

• 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.

  PMID: 28720281 DERIVED

Related Links

• Results for study 116358 can be found on the GSK Clinical Study Register

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2012
• First Posted: August 7, 2012
• Study Start: August 22, 2012
• Primary Completion: October 26, 2012
• Study Completion: March 19, 2014
• Last Updated: June 18, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

CA (1); US (3)