Status:
COMPLETED
Immunogenicity and Safety of an Inactivated Split-virion 2009 Pandemic Influenza A H1N1 Vaccine in Infants
Lead Sponsor:
Shanghai Institute Of Biological Products
Conditions:
Influenza
Eligibility:
All Genders
6-36 years
Phase:
PHASE2
Brief Summary
The aim of this study is to investigate the immunogenicity and safety of the inactivated split-virion vaccine in infants.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
312 Patients enrolled
Trial Details
Trial ID
NCT01494740
Start Date
December 1 2009
End Date
January 1 2010
Last Update
December 19 2011
Active Locations (1)
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1
Hunan Provincial Center of Disease Prevention and Control Changsha, Hunan, China
Changsha, China