Single-blind, Dose-ranging Study of Novel Swine Influenza Virus Vaccine in Japanese Pediatric Subjects
A Multi-center, Randomized, Single-blind, Dose-Ranging Study to Evaluate Immunogenicity, Safety and Tolerability of Different Doses of Adjuvanted Cell-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Japanese Pediatric Subjects
1 other identifier
interventional
123
1 country
1
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 based on European Medicines Agency's Committee for Medicinal Products for Human Use (EMEA/CHMP) criteria, and safety and tolerability.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2009
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 21, 2009
CompletedFirst Posted
Study publicly available on registry
October 22, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedDecember 1, 2016
January 1, 2012
2 months
October 21, 2009
November 30, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Seroprotection, GMRs and Seroconversion rate at Weeks 0, 3 and 6
6 weeks
Secondary Outcomes (1)
AEs, vital signs, laboratory tests
6 weeks
Study Arms (2)
1
EXPERIMENTALDose ranging
2
EXPERIMENTALDose ranging
Interventions
High dose group and low dose group of adjuvanted vaccines
Eligibility Criteria
You may qualify if:
- Healthy Japanese aged 6 months to 19 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sites 1,2,3,4,5
Kagoshima, Japan
Related Publications (1)
Yasuda Y, Komatsu R, Matsushita K, Minami T, Suehiro Y, Sawata H, Nakura N, Jaeger RK, Lattanzi M. Comparison of half and full doses of an MF59-adjuvanted cell culture-derived A/H1N1v vaccine in Japanese children. Adv Ther. 2010 Jul;27(7):444-57. doi: 10.1007/s12325-010-0043-4. Epub 2010 Jun 25.
PMID: 20586002RESULT
Study Officials
- STUDY CHAIR
Novartis Vaccines
Novartis Vaccines
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2009
First Posted
October 22, 2009
Study Start
October 1, 2009
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
December 1, 2016
Record last verified: 2012-01