Clinical Trials Logo
  1. Home
  2. Seasonal Influenza
  3. NCT03853993

Clinical Trial to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine (15µg/0.5ml)

Seasonal Influenza Clinical Trial

Official title:
Open Phase I and Randomized, Double-blind, Controlled Phase III Clinical Trial to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine in Healthy Subjects Aged Over 3 Years.

Clinical Trial Summary

The purpose of this study is to evaluate the safety and immunogenicity of quadrivalent influenza vaccine in healthy subjects aged over 3 years

Clinical Trial Description

This study is a phase I& III clinical trial. Phase I is open-labelled, and phase III is randomized, double-blind, active-controlled. The purpose of this study is to evaluate the safety and immunogenicity of the quadrivalent influenza vaccine (QIV) (experimental vaccine) manufactured by Sinovac Biotech Co., Ltd in subjects aged over 3 years. In phase I, 60 volunteers received single dose QIV (15µg/0.5ml). In phase III, 2320 volunteers were assigned to receive single dose QIV (15µg/0.5ml) or two commercial trivalent influenza vaccines (TIVs) (15µg/0.5ml) in a ratio of 2:1:1. The commercial TIVs were also manufactured by Sinovac Biotech Co., Ltd. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03853993
Study type Interventional
Source Sinovac Biotech Co., Ltd
Contact
Status Completed
Phase Phase 3
Start date January 23, 2018
Completion date October 8, 2018
View Details
See also
  Status Clinical Trial Phase
Completed NCT01209780 - Safety and Immunogenicity of Trivalent Subunit Inactivated Flu Vaccine Administered to Healthy Children and Adolescents 3 to 17 Years of Age Phase 3
Completed NCT01180621 - Evaluation of Seasonal Influenza Vaccine for 2010-2011 in Young Children Phase 2
Completed NCT01206686 - The Effect of Time-Slot Scheduling on Flu Vaccination Rates N/A
Recruiting NCT06049927 - A Phase III Clinical Trial of Quadrivalent Influenza Vaccine in Healthy Subjects Aged 6 to 35 Months Phase 3
Completed NCT04133584 - The Immunogenicity and Safety of the Vaccination of Inactivated Enterovirus 71 Vaccine and Seasonal Influenza Vaccine Phase 4
Completed NCT05566639 - A Study of mRNA-1010 Seasonal Influenza Vaccine in Adults 50 Years Old and Older Phase 3
Completed NCT00957996 - Safety Study of IV Peramivir in Hospitalized Subjects With Confirmed or Suspected Influenza Phase 3
Completed NCT01072799 - Safety and Immunogenicity of an A (H1N1) 2009 Influenza Virus-like Particle (VLP) Vaccine Phase 2
Completed NCT01207232 - The Effect of a Planning Prompt on Seasonal Influenza Vaccination Rates N/A
Completed NCT04997239 - A Clinical Trial of Quadrivalent Influenza Vaccine in Children Aged 3-8 Years Old Phase 4
Completed NCT05512494 - Lot-to-lot Consistency of Quadrivalent Influenza Vaccine (Split Virion), Inactivated Phase 4
Terminated NCT00958776 - A Study to Evaluate the Efficacy and Safety of IV Peramivir in Addition to Standard of Care Compared to Standard of Care Alone in Adults and Adolescents Who Are Hospitalized Due to Influenza Phase 3
Completed NCT01011582 - Characteristics and Outcomes of Intensive Care Unit Patients Admitted With Novel H1N1 Influenza or Seasonal Influenza N/A
Completed NCT00560066 - Safety of a Influenza Vaccine Produced Either in Mammalian Cell Culture or in Embryonated Hen Eggs in Adults and Elderly With and Without Underlying Medical Conditions, and Immunogenicity in a Subset of Subjects With Underlying Medical Conditions Phase 4
Active, not recruiting NCT05397223 - A Study of Modified mRNA Vaccines in Healthy Adults Phase 1
Completed NCT04896086 - First-in-Human Clinical Trial of a Mosaic Quadrivalent Influenza Vaccine Compared With a Licensed Inactivated Seasonal QIV, in Healthy Adults Phase 1
Completed NCT01342796 - Humoral and Cell Mediated Immunity and Safety of MF59C.1-adjuvanted Subunit Influenza Vaccine or a Conventional Subunit Influenza Vaccine in Previously Unvaccinated Healthy Subjects Phase 2
Completed NCT01344057 - Study to Evaluate Safety and Immunogenicity of Sub-unit Adjuvanted Influenza Vaccine Administered to Elderly Subjects, Formulation 2011-2012 Phase 2
Completed NCT00903552 - Trial to Evaluate Safety and Immunogenicity of Trivalent Seasonal Influenza Virus-Like Particle (VLP) Vaccine (Recombinant) Phase 2
Completed NCT05827068 - A Study of mRNA-1011.1, mRNA-1011.2, and mRNA-1012.1 Candidate Seasonal Influenza Vaccines in Healthy Adults Phase 1/Phase 2