InfluenzaPhase 3Torlak-300NCT02935192
Phase 3 Trial of Serbian Seasonal Influenza Vaccine
A Phase 3 study testing Vaccine in people with Influenza, run by Institute of Virology, Vaccines and Sera, Torlak at 6 sites in Serbia.
Trial summary
A Phase 3, double-blind, randomized, placebo-controlled trial of a seasonal, trivalent, split, inactivated influenza vaccine produced by InstituteTorlak. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- 6 sitesSerbia
- Study dates
- 28 Nov 2016to 25 Mar 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.)
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- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Serbia6 sites
Clinical Center of Serbia: Clinic for Infectious and Tropical Diseases
Belgrade
Clinical Center of Serbia: Clinic for Pulmonology
Belgrade
Institute for Students' Healthcare
Belgrade
Institute of Health Care of Workers of the Ministry of Internal Affairs
Belgrade
Jevremova Special gynecology hospital with maternity
Belgrade
General Hospital Vrsac
Vršac
About this study
Official 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
A Phase 3, double-blind, randomized, placebo-controlled trial of a seasonal, trivalent, split, inactivated influenza vaccine produced by InstituteTorlak.
Read the 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
- Being tested
- Vaccine, Placebo
- Keywords
- seasonal influenza, vaccine
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VaccineBiological
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
PlaceboOther
Phosphate buffered saline, 0.5 mL by IM injection
| Study group | Role | What they receive |
|---|---|---|
| Vaccine Arm | Experimental | Seasonal trivalent split, inactivated influenza vaccine Receives: Biological: Vaccine |
| Placebo Arm | Placebo comparator | Phosphate buffered saline Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 1 and Day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study start28 Nov 2016
- Primary completion8 Jan 2017
- Study completion25 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Virology, Vaccines and Sera, Torlak
- Sponsor type
- University, hospital or other
- Collaborators
- PATH, Comac Medical, World Health Organization
- Responsible party
- Sponsor
- Investigators
- Goran Stevanovic, MD, Study chair, Clinical Center of Serbia, Clinic for Infectious and Tropical Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02935192
- Sponsor's protocol ID
- Torlak-300
- Other IDs
- VAC 053
- Acronym
- Torlak-300
- Status last verified
- Jan 2019
- First submitted
- 13 Oct 2016
- Last updated
- 19 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 32518891
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02935192
- Acronym / sponsor ID
- Torlak-300 / Torlak-300
- Conditions
- Influenza
- Keywords
- seasonal influenza, vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Institute of Virology, Vaccines and Sera, TorlakUniversity, hospital or other
- Collaborators
- PATH, Comac Medical, World Health Organization
- Study start
- 28 Nov 2016 (actual)
- Primary completion
- 8 Jan 2017 (actual)
- Study completion
- 25 Mar 2017 (actual)
- First posted
- 17 Oct 2016 (estimated)
- Results
- Posted 19 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccine Arm | Experimental | Biological: VaccineSeasonal trivalent split, inactivated influenza vaccine |
| Placebo Arm | Placebo comparator | Other: PlaceboPhosphate buffered saline |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- Not breast feeding, non-pregnant (based on negative urine pregnancy test) and no plan to become pregnant up to Day 22.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VaccineSeasonal 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 | Biological | Vaccine Arm |
| PlaceboPhosphate buffered saline, 0.5 mL by IM injection | Other | Placebo Arm |
Primary outcome
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
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
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.
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
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.
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
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32518891Stevanovic 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Goran Stevanovic, MD study chair
Clinical Center of Serbia, Clinic for Infectious and Tropical Diseases
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vaccine in people with Influenza, run by Institute of Virology, Vaccines and Sera, Torlak at 6 sites in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Solicited Adverse Events (Local & Systemic Reactogenicity) (time frame: 30-minute post-vaccination period). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02935192, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2019.