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

Influenza Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01999842
• Other study ID #: 201072
• Status: Completed
• Phase: Phase 1
• First received: November 21, 2013
• Last updated: May 26, 2017
• Start date: November 25, 2013
• Est. completion date: January 19, 2015

Study information

• Verified date: May 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 424
• Est. completion date: January 19, 2015
• Est. primary completion date: February 1, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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 (ß-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.

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Investigational H7N9 vaccine GSK3206641A
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
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
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

Locations

Country	Name	City	State
Canada	GSK Investigational Site	Sherbrooke	Quebec
Canada	GSK Investigational Site	Truro	Nova Scotia
Canada	GSK Investigational Site	Woodstock	Ontario
United States	GSK Investigational Site	Boise	Idaho
United States	GSK Investigational Site	Erie	Pennsylvania
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	Seattle	Washington
United States	GSK Investigational Site	Stockbridge	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Humoral immune response in terms of vaccine-homologous hemagglutination inhibition (HI) antibody titers	The following aggregate variables will be calculated for each adjuvanted H7N9 vaccine group: • Seroconversion rates (SCR); • Seroprotection rates (SPR); • Mean Geometric Increase (MGI)	At Day 42
Primary	Occurrence of each solicited local symptom		During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccination
Primary	Occurrence of each solicited general symptom		During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccination
Primary	Occurrence of clinical safety laboratory abnormalities reported for samples		At Day 0 visit
Primary	Occurrence of clinical safety laboratory abnormalities reported for samples		At Day 7 visit
Primary	Occurrence of clinical safety laboratory abnormalities reported for samples		At Day 21 visit
Primary	Occurrence of clinical safety laboratory abnormalities reported for samples		At Day 28 visit
Primary	Occurrence of clinical safety laboratory abnormalities reported for samples		At Day 42 visit
Primary	Occurrence of unsolicited adverse events		21 days after each dose
Primary	Occurrence of Medically Attended Adverse Events (MAEs), potential Immune Mediated Diseases (pIMDs) and Serious Adverse Events (SAEs)		From Day 0 until the Day 42
Secondary	Humoral immune response in terms of vaccine-homologous hemagglutination inhibition (HI) antibody titers	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	At Day 42
Secondary	Humoral immune response in terms of vaccine-homologous hemagglutination inhibition (HI) antibody titers	The following aggregate variables will be calculated for the unadjuvanted plain antigen vaccine group: • SCR; • SPR; • MGI	At Day 42
Secondary	Humoral immune response in terms of vaccine-homologous (H7N9) HI antibody titers	The following aggregate variables will be calculated for each study group: • GMTs; • Seropositivity rates; • SCR; • SPR; • MGI	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
Secondary	Humoral immune response in terms of vaccine-homologous (H7N9) HI antibody titers by age stratum	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	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
Secondary	Humoral immune response in terms of vaccine homologous (H7N9) neutralizing (MN) antibody titers	The following parameters will be calculated for a subset of subjects in each study group: • GMTs; • Seropositivity rates; • Vaccine response rate (VRR)	GMTs and Seropositivity rates at Days 0, 21, 42 and Month 6; VRR at Days 21, 42 and Month 6
Secondary	Occurrence of MAEs, pIMDs and SAEs		Until the Month 12 visit

External Links

•   Results for study 201072 can be found on the GSK Clinical Study Register