Safety and Immunogenicity of Fluzone® Quadrivalent and Fluzone® High-Dose, Influenza Vaccines, 2016-2017...
InfluenzaThe aim of the study was 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. Observational Objectives: 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 participants (30 participants 3 to < 9 years of age and 30 participants 18 to < 65 years of age who receive Fluzone Quadrivalent vaccine, and 30 participants ≥ 65 years of age who receive Fluzone High-Dose vaccine) to Center for Biologics Evaluation and Research (CBER) for further analysis by the World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) to support formulation recommendations for subsequent influenza vaccines.
Safety of a Quadrivalent Influenza Vaccine (VaxigripTetra™) in Subjects Aged 6 Months and Older...
InfluenzaThe primary objective of this study is to describe the safety of the Quadrivalent Influenza Vaccine (QIV). Safety is assessed throughout the study period, and includes solicited injection site and systemic reactions (Day 0 to Day 7 post-vaccination); unsolicited adverse events up to Day 28, and serious adverse events occurring throughout the study.
Recombinant Influenza Vaccine Containing Different H3 Antigens in Healthy Adults 18 to 30 Years...
InfluenzaThe primary objectives of the study are: To describe the safety profile of the different quadrivalent recombinant influenza vaccine (RIV) formulations. To describe the hemagglutination inhibition (HAI) and seroneutralization (SN) antibody responses against hemagglutinin (HA) (H1, H3, B/Victoria, and B/Yamagata) antigens present in the control vaccine in all groups at all timepoints. The secondary objectives of the study are: To describe antigenic coverage in each group by assessing the HAI and SN antibody responses against a panel of H3 antigens (not present in any of the vaccine formulations). To describe HAI and SN antibody responses in each group against each of the H3 antigens. To compare the HAI and SN antibody responses for the groups with different H3 antigens to the control group.
Phase 3 Pivotal Trial of NanoFlu™ in Older Adults
InfluenzaHumanA Phase 3, randomized, observer-blinded, active-controlled trial to evaluate the immunogenicity and safety of a recombinant quadrivalent nanoparticle influenza vaccine with Matrix-M1 adjuvant (NanoFlu) compared with a licensed quadrivalent inactivated influenza vaccine in adults ≥ 65 years of age. Both vaccines were formulated with the 4 influenza strains recommended for the 2019-20 Northern hemisphere influenza season. 2654 subjects were enrolled and randomized into 1 of 2 treatment groups to receive either NanoFlu or active comparator. Subjects were followed for approximately 1 year following injection; with primary immunogenicity analyses based on Day 28 sera. This trial was conducted in the United States at approximately 19 clinical sites.
The Immunogenicity and Safety of the Vaccination of Inactivated Enterovirus 71 Vaccine and Seasonal...
Seasonal InfluenzaHand1 moreThe purpose of this study is to evaluate the Immunogenicity and safety of the simultaneously vaccination of Inactivated Enterovirus 71 Vaccine (EV71) and seasonal influenza vaccine(SIV)
Preventive Effectiveness, Safety and Immunogenicity of a Allantoic Split Inactivated Seasonal Influenza...
Human InfluenzaThe study is Multicenter, phase 3, Open-Label trial that explored the preventive effectiveness, safety and immunogenicity of single dose a allantoic split inactivated seasonal influenza vaccine in healthy adults.
Safety of LAIV4 in Children With Asthma
Asthma in ChildrenVaccine Adverse Reaction4 moreThis is a prospective randomized, open label clinical trial in approximately 300 children aged 5-11 years with a physician diagnosis of persistent asthma. Participants will be randomized 1:1 to receive either a single intranasal dose of licensed quadrivalent LAIV (LAIV4) or an intramuscular injection of quadrivalent IIV4 (IIV4).
A Study in Healthy Adults to Assess Priming With Antigenically Mismatched Live Attenuated A/H7N3...
InfluenzaThe purpose of this study is to assess priming with antigenically mismatched live attenuated A/H7N3 influenza virus vaccine followed by inactivated A/H7N9 influenza virus vaccine in healthy adults.
Immunogenicity and Safety of the Shenzhen Trivalent Inactivated Influenza Vaccine Versus a Trivalent...
InfluenzaFluThis was a blind-observer, monocenter, randomized, comparative, Phase IV study designed to evaluate the immunogenicity and safety of the Sanofi Pasteur Shenzhen Trivalent Influenza Vaccine (SP Shz TIV) versus the Trivalent Influenza Vaccine manufactured by Hualan Biological Engineering Inc (Hualan TIV) comparator in healthy Chinese participants aged 18 to 59 years.
A Study to Evaluate the Safety and Efficacy(Immunogenicity) of GC3114 in Healthy Adults
InfluenzaHumanHealthy adults will be once administered GC3114A(High-dose Quadrivalent influenza vaccine) or GCFLU Quadrivalent Pre-filled syringe inj..