Seasonal Influenza Clinical Trial
Official title:
An Exploratory Clinical Trial to Evaluate the Immunogenicity and Safety of One vs Two Doses of Quadrivalent Influenza Vaccine in Children Aged 3-8 Years Old
This is an open-label, randomized and controlled phase Ⅳ clinical trial of quadrivalent influenza vaccine manufactured by Sinovac Biotech Co. , the purpose of this study is to compare the immunogenicity and safety after 1 dose of quadrivalent influenza vaccine with that of 2 doses in vaccine-unprimed children aged 3-8 years old,to compare the immunogenicity and safety after 1 dose of quadrivalent influenza vaccine in vaccine-unprimed children aged 3-8 years old with that of 1 dose in vaccine-primed children and to compare the immunogenicity and safety after 2 doses of quadrivalent influenza vaccine in vaccine-unprimed children aged 3-8 years old with that of 1 dose in vaccine-primed children.
This study is open-label, randomized and controlled phase Ⅳ clinical trial of quadrivalent influenza vaccine.The purpose of this study is to compare the immunogenicity and safety after 1 dose of quadrivalent influenza vaccine with that of 2 doses in vaccine-unprimed children aged 3-8 years old,to compare the immunogenicity and safety after 1 dose of quadrivalent influenza vaccine in vaccine-unprimed children aged 3-8 years old with that of 1 dose in vaccine-primed children and to compare the immunogenicity and safety after 2 doses of quadrivalent influenza vaccine in vaccine-unprimed children aged 3-8 years old with that of 1 dose in vaccine-primed children.A total of 600 subjects including 400 vaccine-unprimed children and 200 vaccine-primed children will be enrolled,400 vaccine-unprimed children will be randomly divided into two groups in a 1:1 ratio.Subjects in group 1(experimental group 1 ) will receive two doses of quadrivalent influenza vaccine on the immunization schedule of day 0,28 and subjects in group 2 (experimental group 2) will receive one dose of quadrivalent influenza vaccine.200 vaccine-primed children (experimental group 3) will receive one dose of quadrivalent influenza vaccine. ;
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 |
NCT01207232 -
The Effect of a Planning Prompt on Seasonal Influenza Vaccination Rates
|
N/A | |
Completed |
NCT01072799 -
Safety and Immunogenicity of an A (H1N1) 2009 Influenza Virus-like Particle (VLP) Vaccine
|
Phase 2 | |
Completed |
NCT00957996 -
Safety Study of IV Peramivir in Hospitalized Subjects With Confirmed or Suspected Influenza
|
Phase 3 | |
Completed |
NCT05512494 -
Lot-to-lot Consistency of Quadrivalent Influenza Vaccine (Split Virion), Inactivated
|
Phase 4 | |
Completed |
NCT01011582 -
Characteristics and Outcomes of Intensive Care Unit Patients Admitted With Novel H1N1 Influenza or Seasonal Influenza
|
N/A | |
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 |
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 | |
Completed |
NCT05415462 -
A Study of mRNA-1010 Seasonal Influenza Vaccine in Adults
|
Phase 3 |