Skip to main content
OpenTrials
Completed

NCT Number: NCT02935192

Phase 3 Trial of Serbian Seasonal Influenza Vaccine

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinical Center of Serbia: Clinic for Infectious and Tropical Diseases, Belgrade, Serbia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

Placebo

Other

Phosphate buffered saline, 0.5 mL by IM injection

Primary outcomes

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

    Time frame: 30-minute post-vaccination period

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

  2. Number of Participants With Solicited Local Adverse Events (Local Reactogenicity)

    Time frame: 5-day period (Days 1-5) post-vaccination

    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

  3. Number of Participants With Solicited Systemic Adverse Events (Systemic Reactogenicity)

    Time frame: 5-day period (Days 1-5) post-vaccination

    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.

  4. Number of Participants With Unsolicited Adverse Events

    Time frame: Within 21 days post vaccination

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

  5. Number of Participants With Serious Adverse Events (SAE)

    Time frame: Over the entire study period (Day 91)

    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.

  6. Number and Percentage of Seroconverted Subjects

    Time frame: Day 22

    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

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

    Time frame: Day 1 and Day 22

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

  8. Geometric Mean Titers (GMTs) of Serum HAI Antibodies

    Time frame: Day 1 and Day 22

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

  9. Geometric Mean Fold Rises (GMFRs) of Serum HAI Antibodies

    Time frame: Day 1 and Day 22

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

Sponsors and collaborators

Lead sponsor

Institute of Virology, Vaccines and Sera, Torlak

Other

Collaborators

  • Comac Medical
  • PATH
  • World Health Organization

Registry information

Official study title

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

Acronym: Torlak-300

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 17, 2016
Registry last updated
Apr 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.