Status:
COMPLETED
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
Lead Sponsor:
Novartis Vaccines
Collaborating Sponsors:
Novartis
Conditions:
Influenza
Eligibility:
All Genders
6-35 years
Phase:
PHASE2
PHASE3
Brief Summary
This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 2009 (swine flu) vaccine in healthy young children
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
654 Patients enrolled
Trial Details
Trial ID
NCT00996307
Start Date
October 1 2009
End Date
December 1 2010
Last Update
May 30 2017
Active Locations (29)
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1
Bentonville, Arkansas, United States, 72712
2
Fort Smith, Arkansas, United States, 72903
3
Canoga Park, California, United States, 91306
4
Dinuba, California, United States, 93618