A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Candidate Vaccine (GSK2321138A) Manufactured Using a New Process in Adults and Children

Completed · Phase 3

Conditions studied: Influenza

In brief

The purpose of this trial is to demonstrate the acceptable safety profile and the immunological non-inferiority of the FLU D-QIV vaccine manufactured with this investigational process (FLU D-QIV Investigational Process \[IP\]) compared to FLU D-QIV manufactured with the current licensed process (FLU D-QIV Licensed Process \[LP\]).

Key facts

Study ID

NCT02207413

Run by

GlaxoSmithKline

People needed

1886

Starts

2014-08-18

Expected to finish

2015-04-18

Last updated by the study team

2018-06-06

Who can join

Age: 1 and older, up to 49. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Adults 18-49 years cohort:
• A male or female between, and including, 18 and 49 years of age at the time of vaccination.
• 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 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Rochester, New York, United States
• GSK Investigational Site — Warwick, Rhode Island, United States
• GSK Investigational Site — Nashville, Tennessee, United States
• GSK Investigational Site — Dhaka, Bangladesh
• GSK Investigational Site — Brno, Czechia
• GSK Investigational Site — Chlumec nad Cidlinou, Czechia
• GSK Investigational Site — Děčín, Czechia
• GSK Investigational Site — Jindřichův Hradec, Czechia
• GSK Investigational Site — Liberec, Czechia
• GSK Investigational Site — Lipník nad Bečvou, Czechia
• GSK Investigational Site — Náchod, Czechia
• GSK Investigational Site — Odolena Voda, Czechia
• GSK Investigational Site — Ostrava - Poruba, Czechia
• GSK Investigational Site — Pardubice, Czechia
• GSK Investigational Site — Prague, Czechia
• GSK Investigational Site — Aix-en-Provence, France
• GSK Investigational Site — Dax, France
• GSK Investigational Site — Draguignan, France
• GSK Investigational Site — Essey-lès-Nancy, France
• GSK Investigational Site — Le Havre, France
• GSK Investigational Site — Nantes, France
• GSK Investigational Site — Nice, France
• GSK Investigational Site — Kehl, Baden-Wurttemberg, Germany
• GSK Investigational Site — Stuttgart, Baden-Wurttemberg, Germany
• GSK Investigational Site — Wichita, Kansas, United States

Full record on ClinicalTrials.gov

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