Human InfluenzaPhase 3NCT02387294
Immunogenicity and Tolerability Study of Fluval AB Novo Suspension for Injection for Children and Adolescents
A Phase 3 study testing Vaccination with Fluval AB Novo suspension for injection, half dose of a single intramuscular dose (0.25 ml) and Vaccination with Fluval AB Novo suspension for injection, single intramuscular dose (0.5 ml) in people with Human Influenza, run by Fluart Innovative Vaccine Ltd, Hungary.
Trial summary
Immunogenicity and Tolerability Study of Fluval AB Novo Suspension for Injection (trivalent, seasonal influenza vaccine, active ingredient content: 6 μg HA/strain/0.5 ml) for Children and Adolescents. Read more about this study
- Who is it for?
- Ages 3 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Influenza
- What is being tested?
- Vaccination with Fluval AB Novo suspension for injection, half dose of a single intramuscular dose (0.25 ml) and Vaccination with Fluval AB Novo suspension for injection, single intramuscular dose (0.5 ml)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Dec 2014
- 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 3 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Children aged 3 to 11 years, adolescents aged 12 to 18 years from both sexes;
- Are in good health (as determined by vital signs and existing medical condition) or are in stable medical condition. Subjects will not be excluded with known adequately treated clinically significant organ or systemic diseases (e.g. asthma or diabetes), such that, in the opinion of the investigator, the significance of the disease will not compromise the subject's participation in the study;
- Female volunteers of childbearing potential with a negative result from the urine pregnancy test prior to vaccination who agrees to use an acceptable contraception method or abstinence throughout the trial and not become pregnant for the duration of the study;
- Capability of adolescent participants aged 12 to 18 years and the legitimate representative of all volunteers to understand and comply with planned study procedures;
- Adolescent participants aged 12 to 18 years and the legitimate representative of all volunteers provide written Informed Consent (IC) prior to initiation of study procedures;
- Absence of existence of any exclusion criteria.
Who cannot join
- Pregnancy, breast feeding or positive urine pregnancy test at baseline prior to vaccination. Female subjects who are able to bear children but not willing to use an acceptable contraception method for the duration of the study.
- Known hypersensitivity to eggs, thiomersal, formaldehyde, gentamycin, ciprofloxacin, neomycin, vancomycin or any other component of the vaccine;
- History of Guillain-Barré syndrome;
- History of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine;
- Serious disease, such as cancer, autoimmune disease, advanced arteriosclerotic disease, complicated diabetes mellitus, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure;
- Immunosuppressive therapy within 36 months prior to vaccination;
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- Concomitant corticosteroid therapy, including high-dose inhaled corticosteroids;
- Receipt of immunostimulants,
- Receipt of parenteral immunoglobulin, blood products and/or plasma derivate within 3 months prior to vaccination;
- Suspected or known HIV, HBV or HCV infection;
- Acute disease and/or axillary temperature ≥37oC within 3 days prior to vaccination;
- Vaccine therapy within 4 weeks prior to vaccination;
- Influenza vaccination (any kind) within 6 months prior to vaccination;
- Experimental drug therapy within 4 weeks prior to vaccination;
- Concomitant participation in another clinical study;
- Any condition which, in the opinion of the investigator, may interfere with the evaluation of the study;
- Past or current psychiatric disease of the volunteer or the legitimate representative that upon judgement of the investigator may have effect on the objective decision-making of the volunteer;
- Alcohol or drug abuse of the participant or the legitimate representative.
About this study
Official title: Immunogenicity and Tolerability Study of Fluval AB Novo Suspension for Injection (Trivalent, Seasonal Influenza Vaccine, Active Ingredient Content: 6 μg HA/Strain/0.5 ml) for Children and Adolescents
Immunogenicity and Tolerability Study of Fluval AB Novo Suspension for Injection (trivalent, seasonal influenza vaccine, active ingredient content: 6 μg HA/strain/0.5 ml) for Children and Adolescents.
Read the detailed description
STUDY PERIOD:
Length of enrollment: 2 weeks (estimated) Participation per subject: max. 1 month
OBJECTIVES:
Immunogenicity Objectives:
To assess immunogenicity of a single intramuscular injection of Fluval AB Novo suspension for injection (trivalent, seasonal influenza vaccine, active ingredient content: 6 μg HA/0.5 ml of seasonal A/H1N1, A/H3N2 and B influenza antigens each), as measured by haemagglutination inhibition (HI) test.
Safety and Tolerability Objectives:
To evaluate safety and tolerability (incidence of adverse events) of a single intramuscular injection of Fluval AB Novo suspension for injection.
CLINICAL PHASE:
Phase III
TYPE:
Interventional, prevention
DESIGN:
Non-controlled, open, multi-centre
METHODS:
In this uncontrolled, open, multi-centre immunogenicity and tolerability study subjects were enrolled into two groups according to age:
Age group 1: children (3-11 years): single intramuscular injection of Fluval AB Novo 0.25 ml suspension for injection; Age group 2: adolescents (12-18 years): single intramuscular injection of Fluval AB Novo 0.5 ml suspension for injection; Subjects were observed for 30 minutes after the injection for any immediate reactions.
All adolescent subjects aged 12 to 18 years and the legitimate representatives of all volunteers were requested to complete a Diary Card (DC) to record local reactions (injection site pain, erythema, swelling, induration, numbness, sensitivity and haematoma) and systemic reactions (fever, shivering, headache, malaise, fatigue, sweating, nausea, myalgia, arthralgia, dizziness and urticaria) starting on the day of vaccination on Visit 1 (Day 0) until 7 days following that.
All adverse events were collected during the period of Visit 1 (Day 0) to Visit 2 (between Day 21 and Day 28); Serum samples for immunogenicity assays were collected immediately before immunization on Visit 1 (Day 0) and on Visit 2 (between Day 21 and Day 28) in all subjects. Immunogenicity were evaluated by HI test.
INVESTIGATIONAL MEDICINAL PRODUCT:
Fluval AB Novo suspension for injection (trivalent, seasonal influenza vaccine, active ingredient content: 6 μg HA/0.5 ml of seasonal A/H1N1, A/H3N2 and B influenza antigens each) with aluminium phosphate gel adjuvant.
Lot No.: FL-N-05/13
CONCOMITANT VACCINES:
No concomitant vaccination is permitted for the duration of the study except for post-exposure vaccination in a medical emergency (e.g. tetanus, rabies, hepatitis).
STUDY POPULATION:
Considering approximately 17% of drop-out (one participant out of six), in total 120 subjects (60 subjects in each age group) were enrolled in order to achieve at least 100 evaluable subjects (50 subjects in each age group).
- Conditions
- Human Influenza
- Being tested
- Vaccination with Fluval AB Novo suspension for injection, half dose of a single intramuscular dose (0.25 ml), Vaccination with Fluval AB Novo suspension for injection, single intramuscular dose (0.5 ml)
- Keywords
- immunogenicity, reduced dose, Phase III, tolerability, safety
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccination with Fluval AB Novo suspension for injection, half dose of a single intramuscular dose (0.25 ml)Biological
Also called Fluval AB Novo suspension for injection
vaccination
Vaccination with Fluval AB Novo suspension for injection, single intramuscular dose (0.5 ml)Biological
vaccination
| Study group | Role | What they receive |
|---|---|---|
| Age group 1: children (3-11 years) | Experimental | Intervention: Vaccination with Fluval AB Novo suspension for injection.
Dosage: Half dose of a single dose (0.25 ml) vaccine, administered intramuscularly. Receives: Biological: Vaccination with Fluval AB Novo suspension for injection, half dose of a single intramuscular dose (0.25 ml) |
| Age group 2: adolescents (12-18 years) | Experimental | Intervention: Vaccination with Fluval AB Novo suspension for injection.
Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly. Receives: Biological: Vaccination with Fluval AB Novo suspension for injection, single intramuscular dose (0.5 ml) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in Geometric Mean Titre Ratio, A/H1N1 Strain
Ratio of Day 0 and Day 21-28 antihaemagglutination inhibition titres
Requirement: > 2.5
Measured: 21-28 days after vaccination
Increase in Geometric Mean Titre Ratio, A/H3N2 Strain
Ratio of Day 0 and Day 21-28 antihaemagglutination inhibition titres
Requirement: > 2.5
Measured: 21-28 days after vaccination
Increase in Geometric Mean Titre Ratio, B Strain
Ratio of Day 0 and Day 21-28 antihaemagglutination inhibition titres
Requirement: > 2.5
Measured: 21-28 days after vaccination
Seroconversion, A/H1N1 Strain
Proportion of subjects seroconverted or had a significant increase in titres
Requirement: > 40 %
Measured: 21-28 days after vaccination
Seroconversion, A/H3N2 Strain
Proportion of subjects seroconverted or had a significant increase in titres
Requirement: > 40 %
Measured: 21-28 days after vaccination
Seroconversion, B Strain
Proportion of subjects seroconverted or had a significant increase in titres
Requirement: > 40 %
Measured: 21-28 days after vaccination
Seroprotection, A/H1N1 Strain
Proportion of subjects seroprotected
Requirement: > 70 %
Measured: 21-28 days after vaccination
Seroprotection, A/H3N2 Strain
Proportion of subjects seroprotected
Requirement: > 70 %
Measured: 21-28 days after vaccination
Seroprotection, B Strain
Proportion of subjects seroprotected
Requirement: > 70 %
Measured: 21-28 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2015 (estimated)
- Study startOct 2014
- Primary completionDec 2014
- Study completionDec 2014
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.
- Other trials for Human 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
- Non-randomised
- Intervention model
- Single group
- Model description
- parallel-group study in two paediatric age groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fluart Innovative Vaccine Ltd, Hungary
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02387294
- Sponsor's protocol ID
- FABNovo-H-16
- Status last verified
- Mar 2015
- First submitted
- 16 Oct 2014
- Last updated
- 11 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Tolerability Study of Fluval AB Novo Suspension for Injection (Trivalent, Seasonal Influenza Vaccine, Active Ingredient Content: 6 μg HA/Strain/0.5 ml) for Children and Adolescents
- ClinicalTrials.gov ID
- NCT02387294
- Acronym / sponsor ID
- FABNovo-H-16
- Conditions
- Human Influenza
- Keywords
- immunogenicity, reduced dose, Phase III, tolerability, safety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Fluart Innovative Vaccine Ltd, HungaryIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 13 Mar 2015 (estimated)
- Results
- Posted 11 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Immunogenicity and Tolerability Study of Fluval AB Novo Suspension for Injection (trivalent, seasonal influenza vaccine, active ingredient content: 6 μg HA/strain/0.5 ml) for Children and Adolescents.
Detailed description
STUDY PERIOD:
Length of enrollment: 2 weeks (estimated) Participation per subject: max. 1 month
OBJECTIVES:
Immunogenicity Objectives:
To assess immunogenicity of a single intramuscular injection of Fluval AB Novo suspension for injection (trivalent, seasonal influenza vaccine, active ingredient content: 6 μg HA/0.5 ml of seasonal A/H1N1, A/H3N2 and B influenza antigens each), as measured by haemagglutination inhibition (HI) test.
Safety and Tolerability Objectives:
To evaluate safety and tolerability (incidence of adverse events) of a single intramuscular injection of Fluval AB Novo suspension for injection.
CLINICAL PHASE:
Phase III
TYPE:
Interventional, prevention
DESIGN:
Non-controlled, open, multi-centre
METHODS:
In this uncontrolled, open, multi-centre immunogenicity and tolerability study subjects were enrolled into two groups according to age:
Age group 1: children (3-11 years): single intramuscular injection of Fluval AB Novo 0.25 ml suspension for injection; Age group 2: adolescents (12-18 years): single intramuscular injection of Fluval AB Novo 0.5 ml suspension for injection; Subjects were observed for 30 minutes after the injection for any immediate reactions.
All adolescent subjects aged 12 to 18 years and the legitimate representatives of all volunteers were requested to complete a Diary Card (DC) to record local reactions (injection site pain, erythema, swelling, induration, numbness, sensitivity and haematoma) and systemic reactions (fever, shivering, headache, malaise, fatigue, sweating, nausea, myalgia, arthralgia, dizziness and urticaria) starting on the day of vaccination on Visit 1 (Day 0) until 7 days following that.
All adverse events were collected during the period of Visit 1 (Day 0) to Visit 2 (between Day 21 and Day 28); Serum samples for immunogenicity assays were collected immediately before immunization on Visit 1 (Day 0) and on Visit 2 (between Day 21 and Day 28) in all subjects. Immunogenicity were evaluated by HI test.
INVESTIGATIONAL MEDICINAL PRODUCT:
Fluval AB Novo suspension for injection (trivalent, seasonal influenza vaccine, active ingredient content: 6 μg HA/0.5 ml of seasonal A/H1N1, A/H3N2 and B influenza antigens each) with aluminium phosphate gel adjuvant.
Lot No.: FL-N-05/13
CONCOMITANT VACCINES:
No concomitant vaccination is permitted for the duration of the study except for post-exposure vaccination in a medical emergency (e.g. tetanus, rabies, hepatitis).
STUDY POPULATION:
Considering approximately 17% of drop-out (one participant out of six), in total 120 subjects (60 subjects in each age group) were enrolled in order to achieve at least 100 evaluable subjects (50 subjects in each age group).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- parallel-group study in two paediatric age groups
| Arm | Type | Receives |
|---|---|---|
| Age group 1: children (3-11 years) | Experimental | Biological: Vaccination with Fluval AB Novo suspension for injection, half dose of a single intramuscular dose (0.25 ml)Intervention: Vaccination with Fluval AB Novo suspension for injection. Dosage: Half dose of a single dose (0.25 ml) vaccine, administered intramuscularly. |
| Age group 2: adolescents (12-18 years) | Experimental | Biological: Vaccination with Fluval AB Novo suspension for injection, single intramuscular dose (0.5 ml)Intervention: Vaccination with Fluval AB Novo suspension for injection. Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Children aged 3 to 11 years, adolescents aged 12 to 18 years from both sexes;
- Are in good health (as determined by vital signs and existing medical condition) or are in stable medical condition. Subjects will not be excluded with known adequately treated clinically significant organ or systemic diseases (e.g. asthma or diabetes), such that, in the opinion of the investigator, the significance of the disease will not compromise the subject's participation in the study;
- Female volunteers of childbearing potential with a negative result from the urine pregnancy test prior to vaccination who agrees to use an acceptable contraception method or abstinence throughout the trial and not become pregnant for the duration of the study;
- Capability of adolescent participants aged 12 to 18 years and the legitimate representative of all volunteers to understand and comply with planned study procedures;
- Adolescent participants aged 12 to 18 years and the legitimate representative of all volunteers provide written Informed Consent (IC) prior to initiation of study procedures;
Key exclusion criteria (18 listed)
- Pregnancy, breast feeding or positive urine pregnancy test at baseline prior to vaccination. Female subjects who are able to bear children but not willing to use an acceptable contraception method for the duration of the study.
- Known hypersensitivity to eggs, thiomersal, formaldehyde, gentamycin, ciprofloxacin, neomycin, vancomycin or any other component of the vaccine;
- History of Guillain-Barré syndrome;
- History of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine;
- Serious disease, such as cancer, autoimmune disease, advanced arteriosclerotic disease, complicated diabetes mellitus, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure;
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 |
|---|---|---|
| Vaccination with Fluval AB Novo suspension for injection, half dose of a single intramuscular dose (0.25 ml)Also: Fluval AB Novo suspension for injectionvaccination | Biological | Age group 1: children (3-11 years) |
| Vaccination with Fluval AB Novo suspension for injection, single intramuscular dose (0.5 ml)vaccination | Biological | Age group 2: adolescents (12-18 years) |
Primary outcome
Increase in Geometric Mean Titre Ratio, A/H1N1 Strain
Time frame: 21-28 days after vaccination
Ratio of Day 0 and Day 21-28 antihaemagglutination inhibition titres Requirement: > 2.5
Increase in Geometric Mean Titre Ratio, A/H3N2 Strain
Time frame: 21-28 days after vaccination
Ratio of Day 0 and Day 21-28 antihaemagglutination inhibition titres Requirement: > 2.5
Increase in Geometric Mean Titre Ratio, B Strain
Time frame: 21-28 days after vaccination
Ratio of Day 0 and Day 21-28 antihaemagglutination inhibition titres Requirement: > 2.5
Seroconversion, A/H1N1 Strain
Time frame: 21-28 days after vaccination
Proportion of subjects seroconverted or had a significant increase in titres Requirement: > 40 %
Seroconversion, A/H3N2 Strain
Time frame: 21-28 days after vaccination
Proportion of subjects seroconverted or had a significant increase in titres Requirement: > 40 %
Seroconversion, B Strain
Time frame: 21-28 days after vaccination
Proportion of subjects seroconverted or had a significant increase in titres Requirement: > 40 %
Seroprotection, A/H1N1 Strain
Time frame: 21-28 days after vaccination
Proportion of subjects seroprotected Requirement: > 70 %
Seroprotection, A/H3N2 Strain
Time frame: 21-28 days after vaccination
Proportion of subjects seroprotected Requirement: > 70 %
Seroprotection, B Strain
Time frame: 21-28 days after vaccination
Proportion of subjects seroprotected Requirement: > 70 %
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vaccination with Fluval AB Novo suspension for injection, half dose of a single intramuscular dose (0.25 ml) and Vaccination with Fluval AB Novo suspension for injection, single intramuscular dose (0.5 ml) in people with Human Influenza, run by Fluart Innovative Vaccine Ltd, Hungary.
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 6 inclusion and 18 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 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 11 Mar 2021). 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?
Increase in Geometric Mean Titre Ratio, A/H1N1 Strain (time frame: 21-28 days after vaccination). 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?
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 11 Mar 2021.