Immunogenicity and Safety of V70P5 Revaccination Subjects

Study Overview
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Brief Summary
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This study will evaluate the safety and immunogenicity of children previously primed in the V70P5 study when revaccinated with adjuvanted or unadjuvanted seasonal influenza vaccine.

Official Title
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A Phase IIIB, Observer-Blind, Randomized, Parallel Groups, Extension Study to Evaluate the Immunogenicity and Safety Following a Single Intramuscular Dose of a Sub-unit Adjuvanted or a Non-adjuvanted Influenza Vaccines in Healthy Children Previously Vaccinated in the V70P5 Study

Conditions
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Influenza

Intervention / Treatment
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* Biological: Adjuvanted seasonal influenza vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male or female children that have previously participated in the V70P5 study in Finland. Exclusion Criteria: Any condition which in the opinion of the investigator may interfere with the evaluation of the study objectives.

Ages Eligible for Study
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Minimum Age: 18 Months
Maximum Age: 96 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: Group 1<br> | Biological: Adjuvanted seasonal influenza vaccine<br>* Full or half dose of adjuvanted seasonal influenza vaccine; Full or half dose of unadjuvanted seasonal influenza vaccine<br>|
| Experimental: Group 2<br> | Biological: Adjuvanted seasonal influenza vaccine<br>* Full or half dose of adjuvanted seasonal influenza vaccine; Full or half dose of unadjuvanted seasonal influenza vaccine<br>|
| Experimental: Group 3<br> | Biological: Adjuvanted seasonal influenza vaccine<br>* Full or half dose of adjuvanted seasonal influenza vaccine; Full or half dose of unadjuvanted seasonal influenza vaccine<br>|
| Experimental: Group 4<br> | Biological: Adjuvanted seasonal influenza vaccine<br>* Full or half dose of adjuvanted seasonal influenza vaccine; Full or half dose of unadjuvanted seasonal influenza vaccine<br>|
| Experimental: Group 5<br> | Biological: Adjuvanted seasonal influenza vaccine<br>* Full or half dose of adjuvanted seasonal influenza vaccine; Full or half dose of unadjuvanted seasonal influenza vaccine<br>|
| Experimental: Group 6<br> | Biological: Adjuvanted seasonal influenza vaccine<br>* Full or half dose of adjuvanted seasonal influenza vaccine; Full or half dose of unadjuvanted seasonal influenza vaccine<br>|
| Experimental: Group 7<br> | Biological: Adjuvanted seasonal influenza vaccine<br>* Full or half dose of adjuvanted seasonal influenza vaccine; Full or half dose of unadjuvanted seasonal influenza vaccine<br>|
| Experimental: Group 8<br> | Biological: Adjuvanted seasonal influenza vaccine<br>* Full or half dose of adjuvanted seasonal influenza vaccine; Full or half dose of unadjuvanted seasonal influenza vaccine<br>|
| Experimental: Group 9<br> | Biological: Adjuvanted seasonal influenza vaccine<br>* Full or half dose of adjuvanted seasonal influenza vaccine; Full or half dose of unadjuvanted seasonal influenza vaccine<br>|
| Experimental: Group 10<br> | Biological: Adjuvanted seasonal influenza vaccine<br>* Full or half dose of adjuvanted seasonal influenza vaccine; Full or half dose of unadjuvanted seasonal influenza vaccine<br>|
| Experimental: Group 11<br> | Biological: Adjuvanted seasonal influenza vaccine<br>* Full or half dose of adjuvanted seasonal influenza vaccine; Full or half dose of unadjuvanted seasonal influenza vaccine<br>|
| Experimental: Group 12<br> | Biological: Adjuvanted seasonal influenza vaccine<br>* Full or half dose of adjuvanted seasonal influenza vaccine; Full or half dose of unadjuvanted seasonal influenza vaccine<br>|
| Experimental: Group 13<br> | Biological: Adjuvanted seasonal influenza vaccine<br>* Full or half dose of adjuvanted seasonal influenza vaccine; Full or half dose of unadjuvanted seasonal influenza vaccine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate immunogenicity of children primed and revaccinated with adjuvanted influenza vaccine by GMR, seroprotection |  | 22 days post vaccination | 
| Evaluate immunogenicity of children primed and revaccinated with a half dose of adjuvanted influenza vaccine by GMR, Seroprotection and seroconversion |  | 22 days post vaccination | 
| Evaluate immunogenicity of children primed with adjuvanted influenza vaccine and revaccinated with unadjuvanted influenza vaccine by GMR, Seroprotection and seroconversion |  | 22 days post vaccination | 
| Safety and tolerability of a single dose of adjuvanted or unadjuvanted influenza vaccine stratified according to previous influenza vaccine received |  | 22 days post vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary immunogenicity outcomes as per CBER criteria |  | Day 22 | 
| Compare Immunogenicity of each randomization arm by GMT, GMR, seroconversion and seroprotection by Homologous and Heterologous strains |  | Day 22 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza, Trivalent, Adjuvanted, Vaccine, Children