NCT02935192

Phase 3 Trial of Serbian Seasonal Influenza Vaccine

A Phase 3 Double Blinded, Randomized, Placebo- Controlled Study to Examine the Safety and Immunogenicity of a Seasonal Trivalent Split Inactivated Influenza Vaccine Produced by Institute Torlak in 18-65 Year Old Volunteers in Serbia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 480 (actual)
• Sponsor: Institute of Virology, Vaccines and Sera, Torlak · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

This is a phase 3, 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 about 480 healthy male and female adults 18 through 65 years of age; 320 participants will be randomized to receive vaccine and160 will receive placebo (a 2:1 ratio). At least 25% of the participants (N=120) will be \>/= 45 years of age (80 vaccine and 40 placebo recipients). Safety will be assessed in all participants through Day 91. Immunogenicity will be assessed in serum samples obtained at baseline and 21 days after vaccination in a subset of at least 100 individuals randomized to study vaccine and 50 placebo recipients.

Conditions

• Influenza

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-11-28
• Primary completion: 2017-01-08
• Completion: 2017-03-25
• First posted: 2016-10-17
• Last updated: 2019-04-19
• Results posted: 2019-04-19

Locations

6 sites across 1 country: Serbia