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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
864
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).
CDC Ha Nam
Phủ Lý, Ha Nam, Vietnam
CDC Thai Binh
Thái Bình, Vietnam
Number of Subjects Experiencing Solicited Local and Systemic Adverse Events (AE)
Solicited local and systemic AEs were assessed by study staff 30 minutes after vaccination.
Time frame: Within 30 minutes of vaccination
Number of Subjects Experiencing Solicited Local and Systemic Adverse Events (AE)
Solicited local AEs were assessed by study staff 30 minutes after vaccination then daily for 7 days
Time frame: within 7 days (day 1 to 7) of each vaccination
Number of Subjects Experiencing Unsolicited Adverse Events (AE)
Unsolicited AEs were observed by study staff while the subject is at a clinic for a study visit or reported by the subject at any time. Any sign or symptom that would normally be considered a "solicited AE" (for example, fever, nausea, injection site pain) starting after 7 days post-vaccination was to be recorded as an unsolicited AE
Time frame: within 21 days (age group 9-17 and older than 60 years) or 49 days (group 6 months to 8 years) after each vaccination
Number of Subjects Experiencing Unsolicited Serious Adverse Events (SAE)
A serious adverse event (SAE) is defined as an AE that meets one of the following conditions: * Deadly. * Life-threatening. * Requires inpatient hospital admission or extended stay in hospital. * Causes birth defects. * Causes permanent or permanent injury or disability. * Critical medical events that may not be fatal, not life-threatening, or require inpatient treatment will be considered a SAE if it is judged by professional judgment that the incident would be potentially dangerous. subject's health and the need for medical or surgical intervention to prevent one of the aforementioned consequences
Time frame: Day 1 to Day 91
Number of Subjects With Seroconversion of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens, Overall and by Age Group
Serum specimens during Phase 3 were tested for the presence and titer of HAI antibodies to each one of the influenza strains represented in the vaccine
Time frame: Day 22 (+7) for groups 9 years and above or 49 (+7) for groups of 6 months to under 9 years
Number of Subjects With Hemagglutination Inhibition (HAI) Antibody tiers ≥ 1:40 for each antigenic component of the vaccine
Serum specimens during Phase 3 were tested for the presence and titer of HAI antibodies to each one of the influenza strains represented in the vaccine
Time frame: Day 22 or 49 after vaccination ( depending on age group)
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22 or 49 after vaccination (depending on age group) for each antigenic component of the vaccine
Serum specimens during Phase 3 were tested for the presence and titer of HAI antibodies to each one of the influenza strains represented in the vaccine
Time frame: Day 0, Day 22 and Day 49
Geometric Mean Fold Change in HAI Antibody Titer, by Strain, Age Group, and Baseline Titer
Serum specimens during Phase 3 were tested for the presence and titer of HAI antibodies to each one of the influenza strains represented in the vaccine
Time frame: Day 0, Day 22 and Day 49
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