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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

NCT04695717 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 864

Last updated 2023-07-03

No results posted yet for this study

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.

Conditions

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).

Sponsors & Collaborators

  • Institute of Vaccines and Medical Biologicals, Vietnam

    collaborator INDUSTRY

  • Vietstar Biomedical Research

    collaborator INDUSTRY

  • Vietnam Military Medical University

    lead OTHER

Principal Investigators

  • Pham N Hung, Prof. · Vietnam Military Medical University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-05
Primary Completion
2020-12-20
Completion
2022-04-01

Countries

  • Vietnam

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04695717 on ClinicalTrials.gov