Comparison of the Efficacy of Inflexal V With a Commercially Available Influenza Vaccine in Young Children

Study Overview
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Brief Summary
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A study to assess whether the Northern Hemisphere 2009/2010 season influenza vaccine Inflexal V is as immunogenic as a locally sourced competitor vaccine in young children.

Official Title
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Observer-blind, Randomized, Controlled Study to Determine the Immunogenicity and Safety of a Two-dose Regimen of Virosomal Subunit Influenza Vaccine Inflexal V in Healthy Young Children (≥6 Months to ≤35 Months) in Comparison With the Subunit Influenza Vaccine Agrippal

Conditions
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Influenza

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥6months to ≤35 months-old healthy children (male or female) born at term after normal pregnancy Recording of medical history and physical examination reveal no abnormality The parent/legal guardian of the participating child must sign the written informed consent and agree to provide a blood sample taken from the child pre- and post-immunization Exclusion criteria: Hypersensitivity to eggs, chicken proteins, polymyxin B, neomycin or any component of the vaccine Previous vaccination against influenza At time of enrollment, presentation of clinical symptoms of active infection and/or body temperature ≥38°C Confirmation or suspicion of immunosuppressed status (including cancer), or confirmation of immunodeficiency disease (congenital or acquired including HIV) Medical treatment (>2 weeks) with immune suppressant or immune modulating drugs including systemic steroids during the last 3 months before immunization or at present, as follows: long-term oral prednisone or other equivalent steroid: ≥0.5mg/kg/day (note: administration of local or inhaled steroids before or during the study is allowed) Treatment with immunoglobulins or blood products during the last 3 months before immunization or such treatment scheduled during the study Participation in other clinical trials during the last 3 months before immunization or intention to participate during this study period At present or during the last 6 months before immunization: radiotherapy or treatment with cytotoxic drugs Other vaccination with a killed vaccine within 14 days before immunization or with an attenuated vaccine within 28 days before immunization (note: after subject inclusion vaccines of the immunization program for children are allowed upon the physician's discretion. However, immunization on the same day must be avoided) Family history of Guillain-Barré Syndrome Severe congenital deficiency or disease Antecedent of neurological disease or epileptic attack Severe cardiopulmonary disease with possibility to influence the study result Disturbance of coagulation or under anticoagulant treatment, likely to be contraindicated to i.m. injection 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inflexal 0.5 mL<br> | Biological: Inflexal V<br>* Inflexal V influenza vaccine, formulated for the WHO requirements of the 2009-2010 season, containing per 0.5 mL dose: 15 µg hemagglutinin (HA) antigen of A/Brisbane/59/2007 (H1N1)-like virus 15 µg HA antigen of A/Brisbane/10/2007 (H3N2)-like virus 15 µg HA antigen of B/Brisbane/60/2008-like virus Dose: intramuscular administration (M. deltoideus) of a single dose of 0.5 mL on Days 0 and 28<br>|
| Experimental: Inflexal 0.25 mL<br> | Biological: Inflexal V<br>* Inflexal V influenza vaccine, formulated for the WHO requirements of the 2009-2010 season, containing per 0.5 mL dose: 15 µg HA antigen of A/Brisbane/59/2007 (H1N1)-like virus 15 µg HA antigen of A/Brisbane/10/2007 (H3N2)-like virus 15 µg HA antigen of B/Brisbane/60/2008-like virus Dose: intramuscular administration (M. deltoideus) of a single dose of 0.25 mL on Days 0 and 28<br>|
| Experimental: Agrippal 0.25 mL<br> | Biological: Agrippal<br>* Agrippal influenza vaccine Dose: intramuscular administration (M. deltoideus) of a single dose of 0.25 mL on Days 0 and 28<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity, Assessed by the Haemagglutination (HI) Test | Seroconversion rate post-immunization. Seroconversion is defined as a post-vaccination titer of ≥1:40 for those with a pre-vaccination HI titer of <1:10 and as ≥ four-fold increase in HI titer for those with a pre-vaccination HI titer of ≥1:10. | 3 weeks after the 2nd vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fold Increase in Geometric Mean Titer (GMT) | GMT-fold increase - calculated as the GMT on Day 49 divided by the baseline GMT value | 3 weeks after the 2nd vaccination | 
| Seroprotection | Seroprotection rate, defined as a post-vaccination HI titer of 1:40. | 3 weeks after the 2nd vaccination | 
| Safety: Incidence of Solicited and Unsolicited Adverse Events | Safety assessements were made by the investigator at baseline and on Days 28 and 49, as well as by the subjects themselves (in Subjects Diaries) for the 4-day period following each vaccination. | Solicited AEs: Days 1-4 and 28-31, and Days 28 and 49; unsolicited AEs: until study end | 

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