Status:
COMPLETED
Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children (3 to < 9 Years)
Lead Sponsor:
Novartis Vaccines
Conditions:
Influenza
Eligibility:
All Genders
3-8 years
Phase:
PHASE2
PHASE3
Brief Summary
This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in healthy young children.
Eligibility Criteria
Inclusion
- Children 3 to \< 9 years 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 :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
1357 Patients enrolled
Trial Details
Trial ID
NCT00972816
Start Date
September 1 2009
End Date
October 1 2010
Last Update
April 14 2016
Active Locations (35)
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1
Premier Health Research Center, LLC
Downey, California, United States, 90241-4982
2
Madera Family Medical Group
Madera, California, United States, 93637
3
Center for Clincal Trials, LLC
Paramount, California, United States, 90723
4
Center for Clinical Trials, LLC
Paramount, California, United States, 90723