Influenza, Human Clinical Trial
Official title:
A Phase 2/3 Double Blinded, Randomized, Placebo-Controlled Study in Healthy Adult Volunteers in Vietnam to Examine the Safety and Immunogenicity of a Seasonal Trivalent Inactivated Split Virion Influenza Vaccine (IVACFLU-S) Produced by IVAC
This Phase 2/3 study assessed whether a single dose of seasonal trivalent inactivated split virion influenza vaccine (IVACFLU-S) is safe and well-tolerated in adults 18 to 60 years of age; and whether it will induce immune responses to each of the 3 vaccine antigens to meet 1 or both age group-specific Vietnam Ministry of Health (MOH) licensure requirements.
Seasonal influenza viruses circulate widely and cause disease in humans every year. Seasonal
influenza viruses evolve continuously, which means that people can get infected multiple
times throughout their lives. Therefore the components of seasonal influenza vaccines are
reviewed frequently (currently biannually) and updated periodically to ensure continued
effectiveness of the vaccines. The World Health Organization (WHO) recommended that influenza
vaccines for use in the 2016-2017 northern hemisphere influenza season contain the following
viruses:
- NYMC BX-35 reassortant of B/Brisbane/60/2008 (B)
- NYMC X‐179A reassortant of A/California/7/2009 (H1N1)
- NYMC X-263B reassortant of H3/A/Hong Kong/4801/2014 (H3N2)
Among circulating influenza B viruses, there were 2 distinct lineages. The
B/Brisbane/60/2008-like viruses were from the influenza B/Victoria lineage and represented
the predominant circulating influenza B virus. The preclinical evaluation was conducted with
all 3 lots of seasonal vaccine used in the Phase 1 study.The Phase 1 study of the IVACFLU-S
that was completed in March 2016 identified no safety concerns and demonstrated the vaccine
to be highly immunogenic. Given the promising findings, the current study proposed to expand
on the safety data of the vaccine, to confirm the immunological findings, and by including
individuals up to age 60 to seek regulatory approval for indication in nonelderly adults
based on the Vietnam MOH Guidance on Clinical Trial of Influenza Vaccine serological criteria
for assessing seasonal influenza.
Phase 2 was conducted at 1 site (District Health Center of Ben Luc, Long An, Vietnam).
Subjects were from two age groups: 18-45 years and 46-60 years. Vaccine safety was determined
by the Protocol Safety Review Team (PSRT) and approved by Vietnam Ministry of Health (MOH)
before starting Phase 3.
Phase 3 was conducted at 2 sites: District Health Center (DHC) of Ben Luc, Long An, Vietnam;
and DHC of Long Thanh, Dong Nai. Subjects were from two age groups: 18-45 years and 46-60
years. Both safety and immunogenicity were assessed.
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