Pivotal, Multicenter, Observer-Blind, Randomized Study of Influenza A (H1N1)2009 Monovalent Subunit Vaccine With and Without Adjuvant in Children Ages 6 to <36 Months
Status: | Completed |
---|---|
Conditions: | Influenza |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | Any |
Updated: | 10/14/2017 |
Start Date: | October 2009 |
End Date: | December 2010 |
Pivotal, Multicenter, Observer-Blind, Randomized Study of Influenza A (H1N1) 2009 Monovalent Subunit Vaccine With and Without Adjuvant in Children Ages 6 to <36 Months
This study will evaluate the safety and immunogenicity of different combinations of A/H1N1
2009 (swine flu) vaccine in healthy young children
2009 (swine flu) vaccine in healthy young children
Inclusion Criteria:
- Children 6 to 35 months of age in good health as determined by medical history,
physical assessment and clinical judgement of the investigator and without influenza
within the past 6 months
Exclusion Criteria:
- History of serious disease.
- History of serious reaction following administration of vaccine or hypersensitivity to
vaccine components.
- Known or suspected impairment/alteration of immune function.
- Receipt or planned receipt of seasonal trivalent influenza vaccine within 1 week
before or after each study vaccination
For additional entry criteria, please refer to protocol
We found this trial at
29
sites
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