Safety and Immunogenicity of Two 0.25 mL or 0.5 mL Doses of Two Different Influenza Vaccines in Healthy Children Aged 6 to <60 Months

Study Overview
=================
Brief Summary
-----------------
This a multicenter phase II trial will evaluate safety and immunogenicity of two 0.25 mL or 0.5 mL doses of investigational influenza vaccine and active control influenza vaccine in healthy children aged 6 to <60 months.

Official Title
-----------------
A Phase II, Observer-Blind, Randomized, Multi-center Study to Evaluate the Safety and Immunogenicity of Two 0.25 mL or 0.5 mL Doses of Investigational Vaccine and Active Influenza Vaccine in Healthy Children Aged 6 to <60 Months

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

Intervention / Treatment
-----------------
* Biological: Influenza Trivalent Inactivated vaccines Novartis
* Biological: Influenza Trivalent Inactivated vaccines


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children of 6 to <60 months of age, whose parents/legal guardians have given written informed consent prior to study entry. In good health as determined by: medical history, physical examination, clinical judgment of the investigator. Able to comply with all study procedure Exclusion Criteria: Any serious disease, such as: cancer,autoimmune disease (including rheumatoid arthritis), diabetes mellitus, chronic pulmonary disease, acute or progressive hepatic and renal disease, acute or progressive neurological or neuromuscular disease; History of any anaphylaxis or serious reaction following administration of vaccine, or hypersensitivity to eggs, egg protein, chicken feathers, influenza viral protein, or any other vaccine component, chemically related substance, or component of the potential packaging materials; Known or suspected impairment/alteration of immune function, including: immunosuppressive therapy, cancer chemotherapy, receipt of immunostimulants within 60 days prior to Visit 1, receipt of parenteral immunoglobulin known HIV infection or HIV-related disease; Bleeding diathesis; Surgery planned during the study period; Receipt of another investigational agent within 90 days Laboratory-confirmed influenza disease within 6 months prior to Visit 1; Ever received two doses of an influenza vaccine before the study Receipt of an influenza vaccine within 6 months prior to Visit 1; Experienced a temperature 38.0°C within 3 days prior to Visit 1

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 59 Months

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Biological: Influenza Trivalent Inactivated vaccines Novartis<br>* Children 6 to <36 months of age will receive two 0.25 mL doses, and children 36 to <60 months of age will receive two 0.5 mL doses of investigational influenza vaccine, administered four weeks apart intramuscularly (IM) in the deltoid muscle preferably of the non-dominant arm.<br>|
| Active Comparator: 2<br> | Biological: Influenza Trivalent Inactivated vaccines<br>* Children 6 to <36 months of age will receive two 0.25 mL doses, and children 36 to <60 months of age will receive two 0.5 mL doses of active control influenza vaccine, administered four weeks apart intramuscularly (IM) in the deltoid muscle preferably of the non-dominant arm.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability of one and two doses of investigational vaccines or active control influenza vaccine in unprimed healthy children aged 6 months to <36 months. |  | 211 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the immunogenicity of two doses of investigational influenza vaccine or active control influenza vaccines, as measured by HI assay in children aged 36 to <60 months. |  | 211 days | 

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