Humoral and Cell Mediated Immunity and Safety of MF59C.1-adjuvanted Subunit Influenza Vaccine or a Conventional Subunit Influenza Vaccine in Previously Unvaccinated Healthy Subjects

Study Overview
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Brief Summary
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This study aims to evaluate the immunogenicity, by means of cell mediated immunity (CMI) and hemagglutination inhibition (HI) assay, and also the safety of a MF59C.1-adjuvanted subunit influenza vaccine compared with a conventional subunit vaccine in previously unvaccinated children aged 6 to <36 months.

Official Title
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A Phase II, Randomized, Controlled, Observer-Blind, Clinical Study to Evaluate the Humoral and Cell Mediated Immunity and Safety of Two Intramuscular Doses of MF59C.1-adjuvanted Subunit Influenza Vaccine or Conventional Subunit Influenza Vaccine in Previously Unvaccinated Healthy Subjects Aged 6 to <36 Months

Conditions
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Seasonal Influenza, Influenza, Influenza Due to Unspecified Influenza Virus, Human Influenza

Intervention / Treatment
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* Biological: MF59C.1-adjuvanted subunit influenza vaccine
* Biological: Sub unit, Inactivated, Influenza vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female previously unvaccinated healthy children aged 6 to <36 months. Exclusion Criteria: Any known or suspected impairment of the immune system, any serious disease. Any subjects receiving licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study. Individuals who have had influenza vaccine or documented suspected influenza disease prior to day 1.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 36 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Biological: MF59C.1-adjuvanted subunit influenza vaccine<br>* 2 x 0.25 ml doses administered intramuscularly in the deltoid muscle of (preferably) the non dominant arm<br>|
| Active Comparator: Arm 2<br> | Biological: Sub unit, Inactivated, Influenza vaccine<br>* 2 x 0.25 ml doses administered intramuscularly in the deltoid muscle of (preferably) the non dominant arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | The CMI responses were determined by intracellular staining/Fluorescence-Activated Cell Sorting(ICS/FACS) after in-vitro restimulation of PBMC with vaccine antigens on day 0 and day 50. | Day 1, Day 50 | 
| Number of Subjects Reporting Unsolicited Adverse Events After Receiving Two Doses of aTIV and TIV | The number of subjects reporting unsolicited AEs between Day 1 and the study termination i.e., Day 50, after receiving two doses of aTIV and TIV. Data are reported based on the Safety Set. | Day 1 to Day 50 post vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects Achieving Seroconversion or Significant Increase in HI Titer | To evaluate the immune responses by seroconversion of aTIV or TIV according to CHMP criteria for seasonal influenza vaccines as determined by hemagglutination inhibition (HI) test on plasma from previously unvaccinated healthy children aged 6 to < 36 months for all three strains. Criteron: The proportion of subjects achieving seroconversion or significant increase in HI titer should be > 40%. | Day 50 | 
| Geometric Mean Ratios (GMR) | To evaluate the immune responses by mean geometric increase (GMR) of aTIV or TIV according to CHMP criteria for seasonal influenza vaccines as determined by hemagglutination inhibition (HI) test on plasma from previously unvaccinated healthy children aged 6 to < 36 months for all three strains. Criterion: Mean geometric increase (GMR) should be > 2.5. | Day 50/Day 1 | 
| Percentage of Subjects With HI Titers >1:40 | To evaluate the immune responses by proportion of subjects with HI titers >1:40 of aTIV or TIV according to CHMP criteria for seasonal influenza vaccines as determined by hemagglutination inhibition (HI) test on plasma from previously unvaccinated healthy children aged 6 to < 36 months for all three strains. Criterion: The proportion of subjects with HI titers >1:40 should be > 70% | Day 50 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cell mediated immunity, cell mediated immune response, Children, adjuvanted