Tolerability and Immunogenicity Study of Fluval AB Suspension for Injection

Study Overview
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Brief Summary
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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 (HI) test.

Detailed Description
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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.

Official Title
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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

Conditions
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Influenza Prophylaxis

Intervention / Treatment
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* Biological: Vaccination with Fluval AB suspension for injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: parallel-group, in two age groups
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Age group 1: adults (18-59 years)<br>Intervention: Vaccination with Fluval AB suspension for injection. Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly. | Biological: Vaccination with Fluval AB suspension for injection<br>* Single intramuscular injection with Fluval AB suspension for injection in both age groups<br>|
| Experimental: Age group 2: elderly (> 60 years)<br>Intervention: Vaccination with Fluval AB suspension for injection. Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly. | Biological: Vaccination with Fluval AB suspension for injection<br>* Single intramuscular injection with Fluval AB suspension for injection in both age groups<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Geometric Mean Titre Ratio, A/H1N1 Strain | 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 | 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 | 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 | 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 | 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 | 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 | Percentage of subjects seroprotected Requirement (Age group 1): > 70 % Requirement (Age group 2): > 60 % | 21-28 days after vaccination | 
| Seroprotection, A/H3N2 Strain | Percentage of subjects seroprotected Requirement (Age group 1): > 70 % Requirement (Age group 2): > 60 % | 21-28 days after vaccination | 
| Seroprotection, B Strain | Percentage of subjects seroprotected Requirement (Age group 1): > 70 % Requirement (Age group 2): > 60 % | 21-28 days after vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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uncontrolled, open, multi-centre, immunogenicity and tolerability, two groups according to age (18-59 years and ≥60 years)