Status:
COMPLETED
Single-blind, Dose-ranging Study of Novel Swine Influenza Virus Vaccine in Japanese Pediatric Subjects
Lead Sponsor:
Novartis Vaccines
Conditions:
Swine-Origin Influenza A H1N1 Virus
Eligibility:
All Genders
6-19 years
Phase:
PHASE2
PHASE3
Brief Summary
This study is to identify the preferred vaccine dosage (of antigen and adjuvant) and schedule (one or two administrations) of the cell-derived H1N1sw monovalent vaccine in healthy children/adolescents...
Detailed Description
This is a multi-center, randomized, single-blind, dose-ranging study. Subjects were randomized at a 1:1 ratio to receive either 3.75μg of cell-derived H1N1sw vaccine formulated in half (i.e., half the...
Eligibility Criteria
Inclusion
- Healthy Japanese aged 6 months to 19 years
Exclusion
- History of anaphylaxis, serious vaccine reactions, hypersensitivity to vaccine viral proteins or excipients
- Administration of adjuvanted influenza vaccine or suspected influenza disease within 3 month prior to study start
- Administration of any other vaccines within 4 weeks prior to enrollment expect for seasonal influenza vaccines within 1 week
- History of progressive or severe neurological disorders
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT01000207
Start Date
October 1 2009
End Date
December 1 2009
Last Update
December 1 2016
Active Locations (1)
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1
Sites 1,2,3,4,5
Kagoshima, Japan