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

Conditions: Influenza

Summary: 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 \[lp\]).

this study will enroll 3 age cohorts: adults: 18-49 years, children: 3-17 years and 6-35 months of age.

Eligibility criteria:
inclusion criteria: 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. exclusion criteria: 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 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.

Keywords: quadrivalent influenza vaccine safety children adults immunogenicity