- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01863849
Tolerability and Immunogenicity Study of Fluval AB Suspension for Injection
Tolerability and Immunogenicity Study of Fluval AB Suspension for Injection (Trivalent, Seasonal Influenza Vaccine, Active Ingredient Content: 15 μgHA/Strain/0.5mL) for the Use in the Season 2013/2014 in Adult and Elderly Subjects
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Aim of the study:
To assess immunogenicity and safety of Fluval AB seasonal influenza vaccine with 3 x 15 μgHA active ingredient in two age groups (18-59 years and ≥60 years) in accordance with CPMP/BWP/214/96: "Note for Guidance on Harmonization of Requirements for Influenza Vaccines", 12 March 1997
Primary objective:
To assess immunogenicity of a single intramuscular injection of Fluval AB suspension for injection (trivalent, seasonal influenza vaccine, active ingredient content: 15 μgHA/0.5mL of seasonal A/H1N1, A/H3N2 and B influenza antigens each), as measured by haemagglutination inhibition test.
Methods:
In this open label, uncontrolled, multi-centre immunogenicity and tolerability study subjects were enrolled in two groups according to age (18-59 years and ≥60 years) and assigned to the following vaccine group:
Group 1: Single injection of Fluval AB suspension for injection. Subjects were observed for 30 minutes after the injection on Visit 1 (Day 0) for any immediate reactions.
All subjects were requested to complete a diary card to record local reactions (injection site pain, erythema, swelling, induration and ecchymosis) and systemic reactions (fever, shivering, headache, malaise, fatigue, sweating, nausea, myalgia and arthralgia) started on the day of vaccination on Visit 1 (Day 0) until 7 (seven) 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 was evaluated by HI test.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Budapest, Hungary, 1083
- Family Doctor's Office
-
Pilisvorosvar, Hungary, H-2085
- District Doctor's Office
-
Szentendre, Hungary, H-2000
- District Doctor's Office
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult persons aged 18 to 59 years, elderly persons aged ≥60 years from both sexes, mentally competent;
- 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 aged 18-59 years (i.e. participants 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 participants to understand and comply with planned study procedures;
- Participants provide written Informed Consent (IC) prior to initiation of study procedures;
- Absence of existence of any exclusion criteria.
Exclusion Criteria:
- 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, chicken protein, 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;
- 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 that upon judgement of the investigator may have effect on the objective decision-making of the volunteer;
- Alcohol or drug abuse of the participant.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Age group 1: adults (18-59 years)
Intervention: Vaccination with Fluval AB suspension for injection. Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly. |
Single intramuscular injection with Fluval AB suspension for injection in both age groups
|
Experimental: Age group 2: elderly (> 60 years)
Intervention: Vaccination with Fluval AB suspension for injection. Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly. |
Single intramuscular injection with Fluval AB suspension for injection in both age groups
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change 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 (Age group 1): ≥ 2.5 Requirement (Age group 2): ≥ 2.0 |
21-28 days after vaccination
|
Change 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 (Age group 1): ≥ 2.5 Requirement (Age group 2): ≥ 2.0 |
21-28 days after vaccination
|
Change 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 (Age group 1): ≥ 2.5 Requirement (Age group 2): ≥ 2.0 |
21-28 days after vaccination
|
Seroconversion, A/H1N1 Strain
Time Frame: 21-28 days after vaccination
|
Percentage of subjects seroconverted or had a significant increase in titres Requirement (Age group 1): > 40 % Requirement (Age group 2): > 30 % |
21-28 days after vaccination
|
Seroconversion, A/H3N2 Strain
Time Frame: 21-28 days after vaccination
|
Percentage of subjects seroconverted or had a significant increase in titres Requirement (Age group 1): > 40 % Requirement (Age group 2): > 30 % |
21-28 days after vaccination
|
Seroconversion, B Strain
Time Frame: 21-28 days after vaccination
|
Percentage of subjects seroconverted or had a significant increase in titres Requirement (Age group 1): > 40 % Requirement (Age group 2): > 30 % |
21-28 days after vaccination
|
Seroprotection, A/H1N1 Strain
Time Frame: 21-28 days after vaccination
|
Percentage of subjects seroprotected Requirement (Age group 1): > 70 % Requirement (Age group 2): > 60 % |
21-28 days after vaccination
|
Seroprotection, A/H3N2 Strain
Time Frame: 21-28 days after vaccination
|
Percentage of subjects seroprotected Requirement (Age group 1): > 70 % Requirement (Age group 2): > 60 % |
21-28 days after vaccination
|
Seroprotection, B Strain
Time Frame: 21-28 days after vaccination
|
Percentage of subjects seroprotected Requirement (Age group 1): > 70 % Requirement (Age group 2): > 60 % |
21-28 days after vaccination
|
Collaborators and Investigators
Investigators
- Study Chair: Zsolt Németh, Fluart Innovative Vaccines Ltd.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FluvalAB-H-YL2013
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Influenza Prophylaxis
-
Green Cross CorporationCompletedProphylaxis Against Influenza
-
Novartis VaccinesCompletedProphylaxis of Avian InfluenzaFinland
-
ENA Respiratory Pty LtdCompleted
-
Novartis VaccinesCompletedProphylaxis of Avian Influenza VaccineUnited Kingdom
-
PharmaJet, Inc.CompletedInfluenza ProphylaxisUnited States
-
Novartis VaccinesCompletedProphylaxis: InfluenzaUnited States
-
Abbott BiologicalsCompletedProphylaxis of InfluenzaGermany
-
Novartis VaccinesCompleted
-
Universitaire Ziekenhuizen KU LeuvenCompleted
-
Alexion Pharmaceuticals, Inc.Portola Pharmaceuticals, LLC (a wholly owned subsidiary of Alexion Pharmaceuticals)TerminatedVTE ProphylaxisUnited States, United Kingdom, Russian Federation, Ukraine
Clinical Trials on Vaccination with Fluval AB suspension for injection
-
Fluart Innovative Vaccine Ltd, HungaryCompleted
-
Fluart Innovative Vaccine Ltd, HungaryCompletedInfluenza, Human | Novel 2009 Influenza H1N1Hungary
-
Fluart Innovative Vaccine Ltd, HungaryCompleted
-
Fluart Innovative Vaccine Ltd, HungaryCompleted
-
Fluart Innovative Vaccine Ltd, HungaryCompleted
-
Sunnybrook Health Sciences CentreCompleted
-
Vanderbilt University Medical CenterActive, not recruiting
-
Fluart Innovative Vaccine Ltd, HungaryCompleted
-
PfizerRecruitingShingles | Human | Herpes Zoster InfectionUnited States
-
Emergex Vaccines Holding Ltd.Not yet recruitingCOVID-19 | Coronavirus | SARS-CoV-2 InfectionPhilippines