Institute Of Vaccines And Medical Biologicals, Vietnam

This prospective, single-center, randomized, placebo-controlled (phase 1) and active-controlled (phase 2), observer-blind Phase 1/2 study includes two separate parts.
After completing the phase 1 interim analysis, 2 doses (3mcg and 6mcg) were selected for phase 2.
In Part 2 of this combined Phase 1/2 study, 374 adults aged 18-75 years will be randomized (1:1:1) to AZD1222, or COVIVAC 3 µg being evaluated in Phase 1 or the intermediate dose of COVIVAC 6 µg being selected after consideration of phase 1 results.

This prospective, single-center, randomized, placebo-controlled, observer-blind Phase 1/2 study includes two separate parts.
Part 1 is a first-in-human, Phase 1 study designed to evaluate the safety, tolerability and immunogenicity of the COVIVAC vaccine at three different dose levels (1, 3, and 10 µg) without adjuvant, and at one dose level (1 µg) with the adjuvant CpG 1018, in a total of 120 subjects aged 18-59 years.
In Part 2 of this combined Phase 1/2 study, 300 adults aged 18-75 years will be randomized (2:5:5) to placebo, or one of two selected formulations of COVIVAC being evaluated in Phase 1

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.