Safety of the Seasonal Trivalent Inactivated Split Virion Influenza Vaccine (IVACFLU-S) — IVACFLU-S  

Influenza Clinical Trial

Official title: A Phase 1 Double Blinded, Randomized, Placebo Controlled Study in Vietnamese Healthy Adult Volunteers to Assess the Safety and Immunogenicity of a Seasonal Trivalent Inactivated Split Vision Influenza Vaccine (IVACFLU-S) Produced by IVAC

Status Completed

Clinical Trial Summary

This is a phase I, double-blind, randomized, placebo-controlled trial with two groups of subjects to assess the safety of the seasonal trivalent inactivated split virion influenza vaccine (A/H1N1; A/H3N2 and B strains). A total of 60 healthy male and female adults, aged from 18 through 45 years will be randomized to receive the vaccine (n=30) or placebo (n=30). In addition, immune responses induced by the vaccine will be evaluated.

Clinical Trial Description

A single dose of seasonal trivalent inactivated split virion influenza vaccine (IVACFLU-S) at the dose level tested will be tested for safety and immunogenicity in healthy adults.

The vaccine is produced in eggs, and formalin -inactivated, purified through sucrose gradient ultracentrifugation in IVAC facility. Each dose of the vaccine contains 15 mcg of each of the three components per 0.5 mL. The vaccine strains are:

• NYMC BX-51B reassortant of B/Massachusetts/2/2012

• NYMC X‐179A reassortant of A/California/7/2009 (H1N1)

• NYMC X-223A reassortant of H3/A/Texas/50/2012 (H3N2)

The vaccine safety profile will be assessed by the number and percentage of subjects with, the following:

• Adverse events occurring over the immediate 30-minute post-vaccination period.

• Solicited local reactogenicity, including redness, swelling, induration, pain and tenderness over a 7-day period (Days 1-7) post-vaccination.

• Solicited systemic reactogenicity, including fever, fatigue/malaise, muscle aches, joint aches, chills, nausea, vomiting, and headache over a 7-day period (Days 1-7) post-vaccination.

• Abnormal laboratory values observed post-vaccination (Day 8) in comparison to baseline values (Day 1).

• Unsolicited adverse events occurring within 21 days post vaccination.

• Serious adverse events (SAEs) occurring over the entire study period (Day 91).

The immunogenicity assessment against each one of the vaccine components includes:

• Numbers and percentages of subjects with a serum Hemagglutination Inhibition (HAI) antibody titer ≥ 1:40 to each of the 3 vaccine components measured on Day 22 post-vaccination.

• Numbers and percentages of subjects seroconverted against each of the 3 antigens on Day 22 post-vaccination. Seroconversion is defined as a serum HAI titer meeting the following criteria:

• pre-vaccination titer <1:10 and a post-vaccination titer ≥ 1:40 or

• pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination measured on Day 22.

• Geometric mean titers (GMTs) of serum HAI antibodies pre- (Day 1) and post-vaccination (Day 22) for each of the 3 antigens.

• Numbers and percentages of subjects with four-fold rise from baseline for each of the influenza vaccine strain-specific H1, H3, and B microneutralizing antibodies (MNT).

• Geometric mean antibody titers of neutralizing antibodies (MNT) pre- (Day 1) and post-vaccination (Day 22) for each of the 3 antigens. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

• NCT number: NCT02809209
• Study type: Interventional
• Source: National Institute of Hygiene and Epidemiology, Vietnam
• Status: Completed
• Phase: Phase 1
• Start date: October 2015
• Completion date: April 2016