Immunogenicity and Safety of an Inactivated Split-virion 2009 Pandemic Influenza A H1N1 Vaccine in Infants
NCT ID: NCT01494740
Last Updated: 2011-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
312 participants
INTERVENTIONAL
2009-12-31
2010-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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split-virion, non-adjuvanted vaccine of 7.5 μg
split-virion, non-adjuvanted H1N1 vaccine of 7.5 μg.
split-virion, non-adjuvanted vaccine of 7.5 μg
120 infants were assigned to receive 2 dose of 7.5μg split-virion, non-adjuvanted H1N1 vaccine.
split-virion, non-adjuvanted vaccine of 15 μg
split-virion, non-adjuvanted H1N1 vaccine of 15 μg.
split-virion, non-adjuvanted H1N1 vaccine of 15 μg
120 infants were assigned to receive 2 dose of 15μg split-virion, non-adjuvanted H1N1 vaccine.
split-virion, non-adjuvanted vaccine of seasonal influenza
split-virion, non-adjuvanted H1N1 vaccine of seasonal influenza.
split-virion, non-adjuvanted vaccine of seasonal influenza
120 infants were assigned to receive 2 dose of split-virion, non-adjuvanted seasonal influenza vaccine.
Interventions
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split-virion, non-adjuvanted vaccine of 7.5 μg
120 infants were assigned to receive 2 dose of 7.5μg split-virion, non-adjuvanted H1N1 vaccine.
split-virion, non-adjuvanted H1N1 vaccine of 15 μg
120 infants were assigned to receive 2 dose of 15μg split-virion, non-adjuvanted H1N1 vaccine.
split-virion, non-adjuvanted vaccine of seasonal influenza
120 infants were assigned to receive 2 dose of split-virion, non-adjuvanted seasonal influenza vaccine.
Eligibility Criteria
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Inclusion Criteria
2. full-term birth with birth weight above 2,500 grams
3. Subject and parent/legal representative should be present at all scheduled visits and to obey all trial procedures
Exclusion Criteria
2. Volunteers allergic to ingredient of vaccine composition (can be checked from vaccination history), especially to egg
3. History of progressive or severe neurologic disorder
4. Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
5. 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
6. 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
7. 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
8. History of thyroidectomy or thyroid disease that required medication within the past 12 months
9. Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years
10. Guillain-Barre Syndrome
11. Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C
12. Any other vaccines or immunoglobulin preparation within 1 weeks prior to enrollment
13. Axillary temperature ≥ 38.0 degrees Celsius within 3 days of intended study vaccination
14. Any conditions may influence the evaluation
6 Months
36 Months
ALL
Yes
Sponsors
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Shanghai Institute Of Biological Products
INDUSTRY
Responsible Party
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Locations
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Hunan Provincial Center of Disease Prevention and Control Changsha, Hunan, China
Changsha, , China
Countries
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References
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Wang S, Dong J, Chai W, Li F, Wang S, Sun B, Chen Z. Immunogenicity of a monovalent 2009 influenza A (H1N1) vaccine in infants: randomized, observer-masked, single-center clinical study. Springerplus. 2014 Jul 31;3:397. doi: 10.1186/2193-1801-3-397. eCollection 2014.
Other Identifiers
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SIBP-2009-1
Identifier Type: -
Identifier Source: org_study_id