Immunogenicity and Safety of an Inactivated Split-virion 2009 Pandemic Influenza A H1N1 Vaccine in Infants

Study Overview
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Brief Summary
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The aim of this study is to investigate the immunogenicity and safety of the inactivated split-virion vaccine in infants.

Official Title
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Immunogenicity and Safety of an Inactivated Split-virion 2009 Pandemic Influenza A H1N1 Vaccine in Infants

Conditions
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Influenza

Intervention / Treatment
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* Biological: split-virion, non-adjuvanted vaccine of 7.5 μg
* Biological: split-virion, non-adjuvanted H1N1 vaccine of 15 μg
* Biological: split-virion, non-adjuvanted vaccine of seasonal influenza


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy infants aged between 6 and 35 months full-term birth with birth weight above 2,500 grams Subject and parent/legal representative should be present at all scheduled visits and to obey all trial procedures Exclusion Criteria: Volunteers in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination Volunteers allergic to ingredient of vaccine composition (can be checked from vaccination history), especially to egg History of progressive or severe neurologic disorder Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain Known or suspected impairment/alteration of immune function, for example receiving immunosuppressive therapy or receiving blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation Asthma that is unstable or required emergent care, hospitalization or intubation during the past two years or that required the use of oral or intravenous corticosteroids Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws History of thyroidectomy or thyroid disease that required medication within the past 12 months Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years Guillain-Barre Syndrome Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C Any other vaccines or immunoglobulin preparation within 1 weeks prior to enrollment Axillary temperature ≥ 38.0 degrees Celsius within 3 days of intended study vaccination Any conditions may influence the evaluation

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: split-virion, non-adjuvanted vaccine of 7.5 μg<br>split-virion, non-adjuvanted H1N1 vaccine of 7.5 μg. | Biological: split-virion, non-adjuvanted vaccine of 7.5 μg<br>* 120 infants were assigned to receive 2 dose of 7.5μg split-virion, non-adjuvanted H1N1 vaccine.<br>|
| Experimental: split-virion, non-adjuvanted vaccine of 15 μg<br>split-virion, non-adjuvanted H1N1 vaccine of 15 μg. | Biological: split-virion, non-adjuvanted H1N1 vaccine of 15 μg<br>* 120 infants were assigned to receive 2 dose of 15μg split-virion, non-adjuvanted H1N1 vaccine.<br>|
| Placebo Comparator: split-virion, non-adjuvanted vaccine of seasonal influenza<br>split-virion, non-adjuvanted H1N1 vaccine of seasonal influenza. | Biological: split-virion, non-adjuvanted vaccine of seasonal influenza<br>* 120 infants were assigned to receive 2 dose of split-virion, non-adjuvanted seasonal influenza vaccine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemagglutination inhibition antibody titer |  | Days 35 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of solicited local and systemic adverse events after vaccination |  | Day0-42 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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H1N1, Vaccine, Immunogenicity, Safety, infants