Immunogenocity and Safety of Flubio (Influenza HA) Vaccine in Infants and Children (Bridging Study)

Study Overview
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Brief Summary
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To Asses the Immunogenicity and Safety of Flubio (Influenza HA) Vaccine in Infants and Children (Bridging Study)

Detailed Description
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Too see percentage of subjects with HI titer >= 1:40, 28 days after two doses in infants and children (6 months-8 years old) and one dose in children 9-11 years old for each strain.

Official Title
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Phase II b Study of Immunogenicity and Safety of Flubio Vaccine in Infants and Children

Conditions
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Healthy

Intervention / Treatment
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* Biological: Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Parents have been informed properly regarding the study and signed the informed consent form Parents will commit themselves to comply with the instructions of the investigator and the schedule of the trial Exclusion Criteria: Subjects concomitantly enrolled or scheduled to be enrolled in another trial Evolving mild, moderate, or severe illness, especially infectious diseases or fever (axillary temperature >=37oC) Known history of allergy to egg and/or chicken protein or any other component of the vaccines Known history of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection Subject who has received a treatment likely to alter the immune response in the previous 4 weeks (intravenous immunoglobulins, blood-derived products or long term corticotherapy (>2 weeks)). Any abnormality or chronic disease justified by investigator that might interfere assessment of the trial objectives. Subjects has been immunized with influenza vaccine within 1 year Subjects receives any vaccination within 1 months before and after immunization of Flubio.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 11 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
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaccine<br>Vaccine Flubio (Influenza HA) vaccine 2 doses for infants and children (6 months - 8 years old) 1 doses for children (9-11 years old) The vaccine will be given intramuscularly | Biological: Vaccine<br>* Flubio (Influenza HA) Vaccine The vaccine will be given intramuscularly.<br>* Other names: Flubio;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To asses the immunogenicity of Flubio vaccine 28 days after 2 doses immunization in infants and children (6 months-8 years of age) and 1 dose immunization in children (9-11 years of age) | Percentage of subjects with anti HI titer >=1:40 | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe the seroconversion after 2 doses of Flubio vaccine in infants and children (6 months-8 years old) | Percentage subjects with increasing antibody titer >=4 times | 2 months | 
| To describe seroconversion after 1 dose of Flubio vaccine in children (9-11 years old) | Percentage of subjects with transition of seronegative to seropositive | 1 months | 
| To asses the safety of Flubio vaccine | Local and Systemic Reaction following immunization | 1-2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Flubio Vaccine (Influenza HA), Infants, Children, Safety, Immunogenicity