A Study of Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine FLU-Q-QIV in Adults Aged 18 Years and Older

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Influenza

Treatments: Biological: FLULAVAL® QUADRIVALENT

Study type: Interventional

Funder types: Industry

Identifiers

NCT01440387

115418

Details and patient eligibility

About

The purpose of this study is to evaluate the immunogenicity and the safety of GlaxoSmithKline (GSK) Biologicals' investigational quadrivalent split virion influenza vaccine FLU-Q-QIV in adults 18 years of age and older.

Enrollment: 112 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects who the investigator believes that they can and will comply with the requirements of the protocol.

• Written informed consent obtained from the subject

• Male and female adults, 18 years of age and older in stable health as determined by investigator's clinical examination and assessment of subjects' medical history.

• Female subjects of non-childbearing potential may be enrolled in the study.

• Female subjects of childbearing potential may be enrolled in the study, if the subject:

  • has practiced adequate contraception for 30 days prior to vaccination, and
  • has a negative pregnancy test on the day of vaccination, and
  • has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination

Exclusion criteria

• Administration of any influenza vaccine within 6 months preceding the study start or planned use of such vaccines during the study period.
• Administration of any other vaccine(s) within 30 days prior to study enrolment or during the study period.
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
• Acute disease and/or fever at the time of enrolment.
• Significant acute or chronic, uncontrolled medical or psychiatric illness.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• Acute, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, based on history and physical examination.
• Insulin-dependent diabetes mellitus.
• Presence of blood dyscrasias, including hemoglobinopathies and myelo- or lymphoproliferative disorder.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to study vaccine dose.
• A history of any demyelinating disease including Multiple Sclerosis and Guillain-Barré syndrome.
• Presence of an active neurological disorder.
• History of chronic alcohol abuse and/or drug abuse as deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
• Any significant disorder of coagulation that increases the risk of intramuscular injections or treatment with coumadin derivatives or heparin. Persons receiving prophylactic anti-platelet medications, e.g. low-dose aspirin, and without a clinically apparent bleeding tendency are eligible
• Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study.
• Any known or suspected allergy to any constituent of FLU-Q-QIV and/or a history of anaphylactic type reaction to consumption of eggs, and/or reactions to products containing mercury.
• A history of severe adverse reaction to a previous influenza vaccination.
• Pregnant and/or lactating/nursing female.
• Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 2 patient groups

FLULAVAL QUADRIVALENT Adult Group

Experimental group

Description:

Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.

Treatment:

Biological: FLULAVAL® QUADRIVALENT

FLULAVAL QUADRIVALENT Elderly Group

Experimental group

Description:

Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.

Treatment:

Biological: FLULAVAL® QUADRIVALENT