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Phase 3 Trial of Serbian Seasonal Influenza Vaccine

NCT02935192 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2019-04-19

Study results available
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Summary

A Phase 3, double-blind, randomized, placebo-controlled trial of a seasonal, trivalent, split, inactivated influenza vaccine produced by InstituteTorlak.

Conditions

Interventions

BIOLOGICAL

Vaccine

Seasonal trivalent split, inactivated influenza vaccine 15 mcg hemagglutinin antigen (HA) of each of A/H1N1; A/H3N2 and B strains; 0.5 mL by IM injection

OTHER

Placebo

Phosphate buffered saline, 0.5 mL by IM injection

Sponsors & Collaborators

  • PATH

    collaborator OTHER

  • Comac Medical

    collaborator INDUSTRY

  • World Health Organization

    collaborator OTHER

  • Institute of Virology, Vaccines and Sera, Torlak

    lead OTHER

Principal Investigators

  • Goran Stevanovic, MD · Clinical Center of Serbia, Clinic for Infectious and Tropical Diseases

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-11-28
Primary Completion
2017-01-08
Completion
2017-03-25

Countries

  • Serbia

Study Locations

More Related Trials

Entities

Diseases
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 NCT02935192 on ClinicalTrials.gov