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Completed

NCT Number: NCT01999842

Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Influenza Vaccine(s) GSK3206641A and GSK3206640A Administered in Adults 18 to 64 Years of Age

The purpose of this study is to evaluate the safety and immunogenicity of different formulations of GSK Biologicals' H7N9 influenza vaccine in subjects 18 to 64 years of age.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site, Truro, Nova Scotia, Canada

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female adults who are 18 to 64 years of age (inclusive) at the time of first study vaccination.
  • Written informed consent obtained from 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.
  • 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 enrolment.
  • 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.
  • Diagnosed with excessive daytime sleepiness, or narcolepsy; or history of narcolepsy in a 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.
  • 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.
  • Any significant disorder of coagulation or treatment with warfarin derivatives or heparin.
  • 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.

Treatment and study plan

Investigational H7N9 vaccine GSK3206641A

Biological

One dose of GSK3206641A H7N9 vaccine administered intramuscularly (IM) in the deltoid region of arm at Day 0 and the second dose of GSK3206641A H7N9 vaccine administered IM in the deltoid region of arm at Day 21

Investigational H7N9 vaccine GSK3206640A

Biological

One dose of GSK3206640A H7N9 vaccine administered IM at the deltoid region of arm at Day 0 and the second dose of GSK3206640A H7N9 vaccine administered IM at the deltoid region of arm at Day 21

Placebo

Biological

One dose of placebo administered IM at the deltoid region of arm at Day 0 and the second dose of placebo administered IM at the deltoid region of arm at Day 21

Primary outcomes

  1. Humoral immune response in terms of vaccine-homologous hemagglutination inhibition (HI) antibody titers

    Time frame: At Day 42

    The following aggregate variables will be calculated for each adjuvanted H7N9 vaccine group: • Seroconversion rates (SCR); • Seroprotection rates (SPR); • Mean Geometric Increase (MGI)

  2. Occurrence of each solicited local symptom

    Time frame: During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccination

  3. Occurrence of each solicited general symptom

    Time frame: During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccination

  4. Occurrence of clinical safety laboratory abnormalities reported for samples

    Time frame: At Day 0 visit

  5. Occurrence of clinical safety laboratory abnormalities reported for samples

    Time frame: At Day 7 visit

  6. Occurrence of clinical safety laboratory abnormalities reported for samples

    Time frame: At Day 21 visit

  7. Occurrence of clinical safety laboratory abnormalities reported for samples

    Time frame: At Day 28 visit

  8. Occurrence of clinical safety laboratory abnormalities reported for samples

    Time frame: At Day 42 visit

  9. Occurrence of unsolicited adverse events

    Time frame: 21 days after each dose

  10. Occurrence of Medically Attended Adverse Events (MAEs), potential Immune Mediated Diseases (pIMDs) and Serious Adverse Events (SAEs)

    Time frame: From Day 0 until the Day 42

Secondary outcomes

  1. Humoral immune response in terms of vaccine-homologous hemagglutination inhibition (HI) antibody titers

    Time frame: At Day 42

    The following aggregate variables will be calculated for each adjuvanted (GSK3206641A) vaccine group which successfully meets CBER and CHMP criteria, and for the unadjuvanted (GSK3206640A) plain antigen vaccine group: • Geometric mean reciprocal serum HI antibody titers (GMTs); • SCR

  2. Humoral immune response in terms of vaccine-homologous hemagglutination inhibition (HI) antibody titers

    Time frame: At Day 42

    The following aggregate variables will be calculated for the unadjuvanted plain antigen vaccine group: • SCR; • SPR; • MGI

  3. Humoral immune response in terms of vaccine-homologous (H7N9) HI antibody titers

    Time frame: GMTs and Seropositivity rates at Days 0, 21, 42 and Months 6 and 12; SCR and MGI at Day 21, 42 (Placebo group only) and Months 6 and 12; SPR at Days 0, 21, 42 (Placebo group only) and Months 6 and 12

    The following aggregate variables will be calculated for each study group: • GMTs; • Seropositivity rates; • SCR; • SPR; • MGI

  4. Humoral immune response in terms of vaccine-homologous (H7N9) HI antibody titers by age stratum

    Time frame: GMTs, Seropositivity rates and SPR at Days 0, 21, 42 and Months 6 and 12; SCR and MGI at Day 21, 42 and Months 6 and 12

    The following aggregate variables will be calculated for each study group by age stratum (18-40 years; 41-64 years): • GMTs; • Seropositivity rates; • SCR; • SPR; • MGI

  5. Humoral immune response in terms of vaccine homologous (H7N9) neutralizing (MN) antibody titers

    Time frame: GMTs and Seropositivity rates at Days 0, 21, 42 and Month 6; VRR at Days 21, 42 and Month 6

    The following parameters will be calculated for a subset of subjects in each study group: • GMTs; • Seropositivity rates; • Vaccine response rate (VRR)

  6. Occurrence of MAEs, pIMDs and SAEs

    Time frame: Until the Month 12 visit

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

An Observer-blind Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine(s) GSK3206641A and GSK3206640A Administered in Adults 18 to 64 Years of Age

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Dec 3, 2013
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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