Phase 3 Trial of Serbian Seasonal Influenza Vaccine

NCT02935192 | Completed Phase 3 Results

• 2 other identifiers: Torlak-300VAC 053
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Influenza

Keywords

seasonal influenza; vaccine

Outcome Measures

Primary Outcomes (9)

• Number of Participants With Solicited Adverse Events (Local & Systemic Reactogenicity)

  Number of participants experiencing one or more solicited local AEs, including redness /erythema, swelling / induration and pain

  30-minute post-vaccination period

• Number of Participants With Solicited Local Adverse Events (Local Reactogenicity)

  Number of subjects reporting one or more solicited local reactions (redness/erythema, swelling/induration, pain, and tenderness) at the injection site post-vaccination with study vaccine or placebo

  5-day period (Days 1-5) post-vaccination

• Number of Participants With Solicited Systemic Adverse Events (Systemic Reactogenicity)

  Number of subjects reporting one or more solicited systemic reactions (fever, fatigue/malaise, muscle aches, joint aches, chills, nausea, vomiting, and headache) post-vaccination with study vaccine or placebo.

  5-day period (Days 1-5) post-vaccination

• Number of Participants With Unsolicited Adverse Events

  Unsolicited AEs occurring in 1% or more of study participants; includes events irrespective of causality

  Within 21 days post vaccination

• Number of Participants With Serious Adverse Events (SAE)

  Number of participants reporting one or more of all anticipated and unanticipated serious adverse events, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.

  Over the entire study period (Day 91)

• Number and Percentage of Seroconverted Subjects

  Seroconversion is defined as a serum HAI antibody titer meeting the following criteria: * Pre-vaccination titer \<1:10 and a post-vaccination titer measured on Day 22 of ≥1:40; or * Pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination measured on Day 22. Measured against each of the 3 antigens

  Day 22

• Number and Percentage of Participants With a HAI Antibody Titer ≥1:40 (Seroprotection)

  Seroprotective Titers is considered as HAI antibody Titre ≥1:40; measured for each of the 3 antigens

  Day 1 and Day 22

• Geometric Mean Titers (GMTs) of Serum HAI Antibodies

  Serum HAI Antibodies GMTs Pre- (Day 1) and Post-vaccination (Day 22); measured for each of the 3 antigens

  Day 1 and Day 22

• Geometric Mean Fold Rises (GMFRs) of Serum HAI Antibodies

  GMFR calculated as GMT for of Serum HAI Antibodies Post-vaccination/Pre-vaccination; measured for each of the 3 antigens

  Day 1 and Day 22

Study Arms (2)

Vaccine Arm

EXPERIMENTAL

Seasonal trivalent split, inactivated influenza vaccine

Biological: Vaccine

Placebo Arm

PLACEBO COMPARATOR

Phosphate buffered saline

Other: Placebo

Interventions

Vaccine BIOLOGICAL

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

Vaccine Arm

Placebo OTHER

Phosphate buffered saline, 0.5 mL by IM injection

Placebo Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 65 years on the day of screening/enrollment.
• Literate (by self-report) and willing to provide written informed consent.
• Able to attend all scheduled visits and to comply with all trial procedures.
• Healthy or medically stable, as established by medical history and physical examination. For individuals with medical conditions, symptoms/signs, if present must be stable under control or unchanged for the past three months. If medication is used to treat the condition, the medication dose must have been stable for at least one month preceding vaccination.
• For female participants:
• Not breast feeding, non-pregnant (based on negative urine pregnancy test) and no plan to become pregnant up to Day 22.
• Women who are not surgically sterile (hysterectomy or tubal ligation) or post-menopausal for more than one year must be willing to use effective contraceptive method to prevent pregnancy until three weeks (Day 22) after vaccination. Effective methods include intrauterine device, hormonal contraceptives (oral, injectable, patch, implant, ring) or double barrier contraceptives (condom or diaphragm with spermicide). Women with credible history of abstinence may be enrolled at the discretion of the investigator.

You may not qualify if:

• Participation in another clinical trial involving any therapy within the previous three months or planned enrollment in such a trial during the period of this study.
• Receipt of influenza vaccine in the last 10 months.
• Receipt of any non-study vaccine within four weeks prior to enrollment or refusal to postpone receipt of such vaccines until after the Day 22 visit.
• Receipt of immune globulin or other blood products within three months prior to study enrollment or planned receipt of such products prior to the Day 22 visit.
• Known or suspected congenital or acquired immunodeficiency.
• Chronic administration (defined as more than 14 consecutively-prescribed days) of immunosuppressants or other immune-modulating therapy within six months prior to study enrollment. (For corticosteroids, this means prednisone or equivalent, ≥ 0.5 mg per kg per day; topical steroids are allowed.)
• Unstable illness by history or physical examination that in the opinion of the investigator, might interfere with the conduct or results of the study or pose additional risk to the participant.
• Hypersensitivity after previous administration of any vaccine.
• Suspected or known hypersensitivity to any of the study vaccine components, including chicken or egg protein or antibiotics.
• Bleeding disorder or receipt of anticoagulants in the three weeks preceding enrollment.
• Known active tuberculosis or symptoms of active tuberculosis, regardless of cause (self-report).
• Current alcohol or drug addiction that in the opinion of the Investigator, might interfere with the ability to comply with trial procedures.
• History of Guillain-Barré Syndrome.
• Neoplastic disease or any hematologic malignancy. Allowed: localized skin or prostate cancer that is no longer being treated and is stable at the time of vaccination and participants who have a history of neoplastic disease and who have been disease free for ≥ 5 years.
• Any condition that, in the opinion of the investigator, would increase the health risk to the participant if he/she participates in the study, or would interfere with the evaluation of the study objectives.

Sponsors & Collaborators

• Institute of Virology, Vaccines and Sera, Torlak: lead
• PATH: collaborator
• Comac Medical: collaborator
• World Health Organization: collaborator

Study Sites (6)

Clinical Center of Serbia: Clinic for Infectious and Tropical Diseases

Belgrade, Serbia

Location

Clinical Center of Serbia: Clinic for Pulmonology

Belgrade, Serbia

Location

Institute for Students' Healthcare

Belgrade, Serbia

Location

Institute of Health Care of Workers of the Ministry of Internal Affairs

Belgrade, Serbia

Location

Jevremova Special gynecology hospital with maternity

Belgrade, Serbia

Location

General Hospital Vrsac

Vršac, Serbia

Location

Related Publications (1)

• Stevanovic G, Obradovic A, Ristic S, Petrovic D, Milenkovic B, Mitrovic D, Vignjevic SF, Ilic K, Stoiljkovic V, Lavadinovic L, Pelemis M, Petrovic S, Vidmanic A, Popovic O, Eremic N, Sparrow E, Torelli G, Socquet M, Holt R, Ilieva-Borisova Y, Tang Y, Scorza FB, Flores J, Rathi N. Safety and immunogenicity of a seasonal trivalent inactivated split influenza vaccine: a double blind, phase III randomized clinical trial in healthy Serbian adults. Ther Adv Vaccines Immunother. 2020 May 25;8:2515135520925336. doi: 10.1177/2515135520925336. eCollection 2020.

  PMID: 32518891 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Limitations and Caveats

No limitations

Results Point of Contact

• Title: Katarina Ilic
• Organization: Institute of Virology, Vaccines and Sera, Torlak

kilic@torlak.rs

+381 11 3953 700

Study Officials

• Goran Stevanovic, MD

  Clinical Center of Serbia, Clinic for Infectious and Tropical Diseases

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2016
• First Posted: October 17, 2016
• Study Start: November 28, 2016
• Primary Completion: January 8, 2017
• Study Completion: March 25, 2017
• Last Updated: April 19, 2019
• Results First Posted: April 19, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (6)