This Study Was Conducted to Evaluate the Safety and Immunogenicity of IVACFLU-S Produced in Children From 6 Months to Under 18 Years Old and the Elderly Over 60 Years Old in Vietnam

PHASE3CompletedINTERVENTIONAL
Enrollment

864

Participants

Timeline

Start Date

September 5, 2020

Primary Completion Date

December 20, 2020

Study Completion Date

April 1, 2022

Conditions
Influenza
Interventions
BIOLOGICAL

IVACFLU-S

"The Seasonal Inactivated, Split Virion, Trivalent Influenza Vaccine (TIV) were purified by the method of super centrifugation to create gradient segments in sucrose sugar produced by IVAC, or placebo produced by IVAC. Vaccines are produced on eggs, inactivated with formaldehyde. The dose of the vaccine tested was 15 mcg of HA for each antigen component in 0.5 ml.~The influenza virus strains used to produce the 2020-2021 seasonal vaccine will also be provided by the NIBSC, which will be used according to WHO's recommendation, which is expected to include the following Southern Hemisphere strains:~Influenza A / H1N1 strain: Recombinant strain IVR-190 44250 E12 of the strain (A / Brisbane / 02/2018).~Influenza strain A / H3N2: strain IVR-197 (H3N2) 44850 E14 recombinant strain (A / South Australia / 34/2019).~Flu strain B (B / Washington / February 2019)."

Trial Locations (2)

18000

CDC Ha Nam, Phủ Lý

410000

CDC Thai Binh, Thái Bình

Sponsors
All Listed Sponsors
collaborator

Institute of Vaccines and Medical Biologicals, Vietnam

INDUSTRY

collaborator

Vietstar Biomedical Research

INDUSTRY

lead

Vietnam Military Medical University

OTHER

NCT04695717 - This Study Was Conducted to Evaluate the Safety and Immunogenicity of IVACFLU-S Produced in Children From 6 Months to Under 18 Years Old and the Elderly Over 60 Years Old in Vietnam | Biotech Hunter | Biotech Hunter