At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 60 enrolled

Drug / intervention

Influenza vaccine, split inactivated +1 morebiological

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02585700

NCT02585700Phase 1Completed

Compare CT.gov

A Phase 1 Double Blinded, Randomized, Placebo-Controlled Study to Examine the Safety and Immunogenicity of a Seasonal Trivalent Split, Inactivated Influenza Vaccine Produced by Torlak in Healthy Adult Volunteers in Serbia

Institute of Virology, Vaccines and Sera, Torlak·interventional·Posted Oct 23, 2015·Updated Jan 15, 2019

In Brief

A Phase 1 clinical trial evaluating Influenza vaccine, split inactivated and Placebo for Influenza, Human. Completed, enrolled 60 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsInfluenza, Human

CountriesSerbia

CollaboratorsDepartment of Health and Human Services, World Health Organization, PATH, Comac Medical

Timeline

Phase 1CompletedFinished

20162017201820192020202120222023202420252026

First PostedOct 2015

Enrollment StartNov 2015

Primary CompletionMar 2016

TodayJul 2026

First PostedOct 23, 2015

Enrollment StartNov 1, 2015

Primary CompletionMar 1, 2016

TodayJul 2, 2026

Enrollment to primary: 4 monthsPosted 10.7 years ago

Interventions

Influenza vaccine, split inactivatedbiological

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.

Placeboother

0.5 mL of phosphate buffered saline