Immunogenicity and Safety of a Single 0.5 mL Dose of Inflexal V With a 0.25 mL 2-dose Regimen of Inflexal V

Study Overview
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Brief Summary
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The study aims to evaluate the immunogenicity of a single full (0.5 mL) dose and a 0.25 mL 2-dose regime of Inflexal V in unprimed children aged 6 - <36 months, using the EMA guideline for the re-registration of the seasonal influenza vaccine in adults (aged ≥18 ≤60 years) as reference.

Official Title
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A Phase III Open, Randomized, Parallel, Multi-center Study in Children Aged 6 - 35 Months to Compare the Immunogenicity and Safety of a Single 0.5 mL Dose of Inflexal V With a 0.25 mL 2-dose Regimen of Inflexal V Administered According to a 0/4 Week Schedule

Conditions
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Influenza

Intervention / Treatment
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* Biological: Inflexal V
* Biological: Inflexal V


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and female children Aged ≥6 to <36 months on Day 1 Born at a gestational age ≥37 weeks Written informed consent No previous influenza vaccination Exclusion Criteria: Acute respiratory infection or other acute disease Acute febrile illness (≥38.0 °C) Past vaccination with an influenza vaccine, including vaccination against the influenza strain A/California/7/2009 (H1N1)-like virus Laboratory-confirmed infection with any influenza strain, including the pandemic influenza strain H1N1 (A/California/7/2009 (H1N1)-like virus) Known hypersensitivity to any vaccine component Known history of egg protein allergy or severe atopy Known blood coagulation disorder Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of the study vaccine, incl. oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent for ≥14 days (inhaled or topical steroids are allowed) Known immunodeficiency (including leukemia, cancer, HIV seropositivity) Investigational medicinal product received in the past 3 months (90 days) Treatment with immunoglobulins or blood transfusion(s) received in the past 3 months (90 days) Vaccination with the MMR vaccine in the past 4 weeks, or planned within the study period Participation in another clinical trial Child or legal charge of the investigator or an employee at the study site, or living in the same household as the investigator/employee and/or dependent on the investigator/employee Suspected non-compliance

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 35 Months

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Inflexal V 0.25 mL x 2<br> | Biological: Inflexal V<br>* vaccination with Inflexal V 0.25 mL administered twice, 4 weeks apart<br>|
| Experimental: Inflexal V 0.5 mL x 1<br> | Biological: Inflexal V<br>* Inflexal V 0.5 mL administrated once only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference | Seroprotection rate | This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen | 
| Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference | Seroconversion rate | This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen | 
| Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference | GMT-fold increase - calculated as the GMT on Day 22 divided by the baseline GMT value | This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Local and Systemic Adverse Events as a Measure of Safety and Tolerability |  | Solicited local and systemic AEs were collected from Day 1 (day of vaccination) to Day 4 inclusive using a subject diary | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza, Virus, Vaccination, Immunisation