Safety and immunogenicity study of GSK Biologicals’ Quadrivalent Influenza Vaccine (GSK2321138A) manufactured with a new process in adults and children.
- Conditions
- Healthy volunteers (Active immunization of adults and children against influenza)MedDRA version: 17.0Level: LLTClassification code 10059430Term: Influenza immunizationSystem Organ Class: 100000004865MedDRA version: 17.0Level: LLTClassification code 10022002Term: Influenza A virus infectionSystem Organ Class: 100000004862MedDRA version: 17.0Level: LLTClassification code 10022003Term: Influenza B virus infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2014-000955-10-CZ
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1860
All subjects
•Subjects who the investigator believes that they/their parent(s)/Legally Acceptable Representatives (LAR(s)) can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits).
•Written informed consent obtained from the subject/their parent(s)/LAR(s) before any study procedure.
•Written informed assent obtained from the subject if/as required by local regulations.
•Subjects in stable health as determined by the investigator's clinical examination and assessment of subject's medical history.
•Subjects are eligible regardless of history of administration of influenza vaccine in a previous season.
•Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
•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 for 2 months after vaccination.
Pediatric cohort
United States:
•A male or female subject between, and including, the ages of 3 and 17 years in the United States.
Rest of the World:
•A male or female subject between, and including, the ages of 6 months to 17 years all countries with the exception of the United States.
All participating countries:
•Subjects who the investigator believes that they/their parent(s)/Legally Acceptable Representatives (LAR(s)) can and will comply with the requirements of the protocol.
•Written informed consent obtained from the subject/parent(s)/LAR(s) of the subject.
•Written informed assent obtained from the subject if/as required by local regulations.
•Healthy subjects or those with chronic well-controlled disease as established by medical history and clinical examination before entering into the study.
•Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy.
•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 series.
Are the trial subjects under 18? yes
Number of subjects for this age range: 1740
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
Adults aged 18-49 years cohort
•Child in care.
•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
•Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical or device).
•Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose. Inhaled and topical steroids are allowed.
•Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
•Any administration of a long-acting immune-modifying drug within 6 months before study start, or planned administration during the study period.
•Administration of an influenza vaccine during the 6 months preceding entry into the study.
•Administration of a vaccine not foreseen by the study protocol within 30 days before vaccination or planned administration during the study period.
•Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
•Any known or suspected allergy to any constituent of influenza vaccines (including egg proteins); a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
•Acute or un-controlled, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests.
•Any history of Guillain-Barré Syndrome.
•Acute disease and/or fever at the time of enrolment. Fever is defined as temperature = 38.0ºC/100.4ºF.
•Pregnant or lactating female.
•Female planning to become pregnant or planning to discontinue contraceptive precautions.
•History of chronic alcohol consumption and/or drug abuse.
•Any contra-indication to intramuscular administration of influenza vaccines.
•Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study.
Pediatric cohort
•Child in care.
•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
•Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical or device).
•Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccination dose. Inhaled and topical steroids are allowed.
•Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
•Any administration of a long-acting immune-modifying drug within 6 months before study start, or planned administration during the study period.
•Administration of an influenza vaccine during the 6 months preceding entry into the study.
•Administration of a vaccine not foreseen by the study protocol within 30 days before vaccination or planned administration during the study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method