An Observer-blind Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine(s) GSK2789869A and GSK2789868A Administered in Adults 21 to 64 Years of Age

GlaxoSmithKline1 site in 1 country427 target enrollmentAugust 26, 2013

ConditionsInfluenza

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Influenza
Sponsor: GlaxoSmithKline
Enrollment: 427
Locations: 1
Primary Endpoint: Humoral immune response in terms of vaccine-homologous hemagglutination inhibition (HI) antibody titers for each adjuvanted H7N1 vaccine group
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 26, 2013

End Date

October 20, 2014

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

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

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 are eligible, 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 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.

Outcomes

Primary Outcomes

Humoral immune response in terms of vaccine-homologous hemagglutination inhibition (HI) antibody titers for each adjuvanted H7N1 vaccine group

Time Frame: At Day 42

The following aggregate variables will be calculated: Seroconversion rates (SCR); Seroprotection rates (SPR); Mean Geometric Increase (MGI);

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

Occurrence of unsolicited adverse events

Time Frame: 21 days after each dose

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

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 visit

Occurrence of clinical safety laboratory abnormalities reported for samples

Time Frame: From Day 0 - 42 after each vaccination (i.e Days 0, 7 , 21, 28, 42)

Secondary Outcomes

Humoral immune response in terms of Geometric mean reciprocal serum HI antibody titers (GMTs ratios)(At Day 42)
Occurrence of MAEs, pIMDs and SAEs(After the Day 42 visit until the Month 12 visit)
Humoral immune response in terms of SCR difference(At Day 42)
Vaccine-homologous (H7N1) HI antibody titers by age stratum(• 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.)
Vaccine-heterologous (H7N9) HI antibody titers(• GMTs and 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.)
Vaccine-homologous (H7N1) HI antibody titers(• 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.)
Vaccine homologous (H7N1) and heterologous (H7N9) neutralizing (MN) antibody titers(• GMTs and Seropositivity rates at Days 0, 21, 42 and Month 6. • VRR at Days 21, 42 and Month 6.)
Humoral immune response in terms of vaccine-homologous HI antibody titers for the unadjuvanted (GSK2789868A) plain antigen vaccine group(At Day 42)