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

The Extensive, Double-blind, Randomized, Placebo-controlled Phase 3 Study to Evaluate the Safety and Immunogenicity of the Seasonal Inactivated, Split Virion, Trivalent Influenza Vaccine (IVACFLU-S) Produced in Children and the Elderly in Vietnam

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 864 (actual)
• Sponsor: Vietnam Military Medical University · Academic / Other
• Sex: All
• Age: 6 Months
• Healthy volunteers: Accepted

Summary

This was an extensive, double-blind, randomized, placebo-controlled phase 3 study that aimed to evaluate the safety and immunogenicity of the seasonal inactivated, split virion, trivalent influenza vaccine (IVACFLU-S) in children from 6 months to under 18 years old and the elderly over 60 years old in Vietnam. The main target: Evaluating the safety of the single or double dose of seasonal influenza vaccine (IVACFLU-S) in Vietnamese children aged 6 months to 17 years and adults over 60 years old. Evaluating the immunogenicity of the seasonal inactivated, split virion, trivalent influenza vaccine (IVACFLU-S) after 1st injection on day 22 (+7) for groups ≥ 9 years old or day 49 (+7) for groups of 6 months to 8 years for each antigenic component of the vaccine.

Detailed description

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 recommendations, which are 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). Extensive phase 3 was conducted 2 sites: District Health Center (DHC) of Vu Thu, Thai Binh, Vietnam; and DHC of Binh Luc, Ha Nam. Subjects were from two age groups: 6 months-under 18 years and over 60 years. Both safety and immunogenicity were assessed

Conditions

• Influenza

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2020-09-05
• Primary completion: 2020-12-20
• Completion: 2022-04-01
• First posted: 2021-01-05
• Last updated: 2023-07-03

Locations

2 sites across 1 country: Vietnam