Track topics on Twitter Track topics that are important to you
The aim of the study is to describe the safety and immunogenicity of the 2016-2017 formulations of Fluzone Quadrivalent vaccine in children 3 to < 9 years of age and in adults 18 to < 65 years or age, and of the 2016-2017 formulation of Fluzone High-Dose vaccine in adults ≥ 65 years of age.
Primary Observational Objectives
- To describe the safety of the 2016-2017 formulation of Fluzone Quadrivalent vaccine in children 3 to < 9 years of age and adults 18 to < 65 years of age, and the safety of the 2016-2017 formulation of Fluzone High-Dose vaccine in adults ≥ 65 years of age.
- To describe the immunogenicity of the 2016-2017 formulation of Fluzone Quadrivalent vaccine in children 3 to < 9 years of age and adults 18 to < 65 years of age, and the immunogenicity of the 2016-2017 formulation of Fluzone High-Dose vaccine in adults ≥ 65 years of age.
- To submit available sera from approximately 90 subjects (30 subjects 3 to < 9 years of age and 30 subjects 18 to < 65 years of age who receive Fluzone Quadrivalent vaccine, and 30 subjects ≥ 65 years of age who receive Fluzone High-Dose vaccine) to CBER for further analysis by the WHO, the CDC, and the FDA to support formulation recommendations for subsequent influenza vaccines.
All participants will receive a 0.5-mL intramuscular dose of their assigned vaccine at Visit 1. For subjects 3 to < 9 years of age for whom 2 doses of influenza vaccine are recommended per Advisory Committee on Immunization Practices (ACIP) guidance, a second dose of Fluzone Quadrivalent vaccine (of the same volume) will be administered during Visit 2.
Participants will be followed from Visit 1 to Visit 2 for evaluation of safety outcomes. Solicited adverse event information will be collected for 7 days after vaccination. Unsolicited non-serious adverse events (AEs) and serious adverse events (SAEs) will be collected from Visit 1 to Visit 2, or to Visit 3 for those subjects receiving 2 doses of study vaccine.
Immunogenicity will be evaluated in all subjects prior to vaccination on day 0 (Visit 1) and on day 28 for 3 to < 9 year olds and 21 days for adults 18 years and older, following final vaccination.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Fluzone Quadrivalent vaccine, 2016 2017 formulation, No Preservative, Fluzone Quadrivalent vaccine, 2016 2017 formulation, No Preservative, Fluzone High Dose, vaccine, 2016 2017 formulation
Bardstown, KY 40004
Published on BioPortfolio: 2016-09-20T20:38:21-0400
The aim of the study is to evaluate the safety and immunogenicity of the 2015-2016 formulations of Fluzone Quadrivalent and Fluzone Intradermal Quadrivalent vaccines in adults 18 to < 65 y...
The study will evaluate the safety and immunogenicity of the 2015-2016 formulation of Fluzone Quadrivalent vaccine, administered in a 1- or 2-dose schedule, in accordance with the Advisory...
The aim of this study is to evaluate the safety and immunogenicity of Fluzone® Quadrivalent vaccine in participants aged 6 months to < 9 years at enrollment, divided into 2 age strata (6 ...
The aim of the study was to assess the immunogenicity and safety of Fluzone Quadrivalent influenza vaccine Southern Hemisphere (SH) 2015 formulation in participants aged 18 to 60 years as ...
This multicenter, open-label, Phase IV study was designed to describe the safety and immunogenicity of Fluzone Quadrivalent vaccine in children 6 months to < 9 years of age and adults 18 t...
Intranasally administered live attenuated influenza vaccine (LAIV) was initially licensed in the United States in 2003 as a trivalent formulation (LAIV3) (FluMist, MedImmune, LLC). Quadrivalent live a...
The objective of our study was to assess meningococcal ACWY (MenACWY) vaccine uptake among men who have sex with men (MSM) during an ongoing, invasive meningococcal disease outbreak in Southern Califo...
The Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination of persons aged 11-12 years with human papillomavirus (HPV) vaccine, quadrivalent meningococcal conjugate vaccine...
People living with HIV have increased Human Papillomavirus (HPV) related lesions and malignancies. We describe HPV DNA recovered from the cervix and anal canal, explore the effect of vaccination on HP...
It has not yet been demonstrated whether two doses of inactivated quadrivalent influenza vaccine (IIV4) prime a booster response in infants. We evaluated the anamnestic immune response to an IIV4 in c...
A vaccine containing L1 capsid proteins from four types of HPV (ALPHAPAPILLOMAVIRUS), types 6, 11, 16 and 18 that is used to prevent infections from HUMAN PAPILLOMAVIRUSES of these subtypes.
A combined vaccine used to prevent infection with diphtheria and tetanus toxoid. This is used in place of DTP vaccine (DIPHTHERIA-TETANUS-PERTUSSIS VACCINE) when PERTUSSIS VACCINE is contraindicated.
A live vaccine containing attenuated poliovirus, types I, II, and III, grown in monkey kidney cell tissue culture, used for routine immunization of children against polio. This vaccine induces long-lasting intestinal and humoral immunity. Killed vaccine induces only humoral immunity. Oral poliovirus vaccine should not be administered to immunocompromised individuals or their household contacts. (Dorland, 28th ed)
A bacterial vaccine for the prevention of brucellosis in man and animal. Brucella abortus vaccine is used for the immunization of cattle, sheep, and goats.
A live attenuated virus vaccine of chick embryo origin, used for routine immunization of children and for immunization of adolescents and adults who have not had mumps or been immunized with live mumps vaccine. Children are usually immunized with measles-mumps-rubella combination vaccine.
A vaccine is a biological preparation that improves immunity to a particular disease. A vaccine typically contains an agent that resembles a disease-causing microorganism, and is often made from weakened or killed forms of the microbe, its toxins or one ...
Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...