Immunogenicity and Safety of Influenza Virus Vaccine, AdimFlu-S (A/H1N1), in Pediatric Population

Study Overview
=================
Brief Summary
-----------------
This is a laboratory-blinded study in healthy toddlers, children, and teenagers designed to investigate the safety, reactogenicity, and immunogenicity of an inactivated influenza H1N1 vaccine (AdimFlu-S). There are 3 age strata, and each contains at least 50 subjects: greater than or equal to 1 year to less than 3 years, greater than or equal to 3 years to less than 6 years, and greater than or equal to 6 years to less than 18 years. In each age strata, all eligible subjects received 2 injections of AdimFlu-S (A/H1N1) at a designated dosage level (7.5 μg, 15 μg and 15 μg for 1 <3, 3 <6 and 6 <18 years, respectively) at 3 weeks apart. Following immunization, safety is measured by assessment of adverse events for 6 weeks following the first vaccination, serious adverse events and new-onset chronic medical conditions through 7 months post first vaccination, and reactogenicity to the vaccines for 7 days following each vaccination. Immunogenicity testing includes hemagglutination inhibition (HAI) testing on serum obtained before first vaccination, and three and six weeks after first vaccination.

Official Title
-----------------
A Clinical Study to Assess the Immunogenicity and Safety of Influenza Virus Vaccine, AdimFlu-S (A/H1N1), in Healthy Subjects Aged Over 1 Year Old to 18 Years Old

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Biological: Influenza A (H1N1) 2009 monovalent vaccine, inactivated


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Boys or girls aged ≧ 1 year old to 18 years old on the day of first vaccination; Subject and/or parents(s)/legal guardian(s) was willing to comply with planned study procedures and be available for all study visits; Subject was in good physical health on the basis of medical history, physical examination; Subject and/or parents(s)/legal guardian(s) must read and signed the study-specific informed consent prior to initiation of any study procedure. Exclusion Criteria: Subject ever received influenza vaccine within the previous 6 months; History of hypersensitivity to eggs or egg protein or similar pharmacological effects to study medication (AdimFlu-S (A/H1N1)); Personal or family history of Guillain-Barré Syndrome; An acute febrile illness within the last 72 hours prior to vaccination; Subject with bleeding disorder or has any coagulation disorder that needs receipt of anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular injection; Subjects with influenza-like illness as defined by the presence of fever (temperature ≧38.5℃ ) and at least two of the following four symptoms: headache, muscle/joint aches and pains (e.g. myalgia/arthralgia), sore throat and cough; Female subjects who are pregnant, lactating or likely to become pregnant during the study; Women of childbearing potential disagree to use an acceptable method of contraception (e.g., hormonal contraceptives, IUD, barrier device or abstinence) throughout the study; Treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent; Immunodeficiency, immunosuppressive or household contact with immunosuppression; History of wheezing or bronchodilator use within 3 months prior to study vaccine; Receipt of live virus vaccine within 1 month prior to study vaccination or expected receipt within 2 months after first study vaccination; Receipt of any inactivated vaccine within 2 weeks prior to study vaccination or expected receipt vaccination within 3 weeks after the immunogenicity evaluation period; Receipt of any blood products, including immunoglobulin in the prior 3 months; Underlying condition in the investigator's opinion may be inappropriate for vaccination; Significant chronic illness for which inactivated influenza vaccine is recommended or commonly used.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: H1N1 vaccine of 15 μg HA on Day 0 and 21<br>15 μg HA (0.5 mL) per injection, 2 injections 50 children (aged over 3 years old to 6 years old) and 50 children/teenagers (aged over 6 years old to 18 years old) were assigned to receive two injections of H1N1 vaccine 3 weeks apart | Biological: Influenza A (H1N1) 2009 monovalent vaccine, inactivated<br> <br> * Other names: AdimFlu-S (A/H1N1);|
| Experimental: H1N1 vaccine of 7.5 μg HA on Day 0 and 21<br>7.5 μg HA (0.25 mL) per injection, 2 injections 50 toddlers (aged over 1 year old to 3 years old) were assigned to receive two injections of H1N1 vaccine 3 weeks apart | Biological: Influenza A (H1N1) 2009 monovalent vaccine, inactivated<br> <br> * Other names: AdimFlu-S (A/H1N1);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary immunogenicity objective is to assess the antibody response following a single dose of study vaccine, grouped by age of recipient, when administered at the 7.5 or 15 μg HA doses. |  |  | 
| The primary safety objective of this study is to assess the safety of the study vaccine when administered at the 7.5 or 15 μg HA doses. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary immunogenicity objective is to assess the antibody response following 2 doses of study vaccine, grouped by age of recipient, when administered at the 7.5 or 15 μg HA doses. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Influenza, H1N1, vaccine, Immunogenicity