MedTrace Logo

A Study of a Seasonal Trivalent Split, Inactivated Influenza Vaccine

NCT02585700 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-01-15

Study results available
· View outcomes & findings →

Summary

This is a phase I, double-blind, randomized, placebo-controlled trial with two groups of participants to receive seasonal trivalent split, inactivated influenza vaccine (A/H1N1; A/H3N2 and B) or placebo (phosphate buffered saline). A total of 60 healthy male and female adults 18 through 45 years of age will be randomized to receive vaccine (30) or placebo (30).

Conditions

  • Influenza, Human

Interventions

BIOLOGICAL

Influenza vaccine, split inactivated

Seasonal trivalent inactivated influenza vaccine (TIV), inactivated split virion, purified by sucrose gradient ultracentrifugation. The vaccine is produced in hen's eggs, and inactivated with beta-propiolactone.

OTHER

Placebo

0.5 mL of phosphate buffered saline

Sponsors & Collaborators

Principal Investigators

  • Goran Stevanovic, PhD · Clinic for Infectious and Tropical Diseases

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • Serbia

Study Locations

More Related Trials

Entities

Companies

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 NCT02585700 on ClinicalTrials.gov