Safety and Immunogenicity of a Booster Dose of -H5N1 Influenza Vaccine
A Phase II, Open-label, Multi-Center Study to Evaluate Safety and Immunogenicity of a Booster Dose of -H5N1 (Surface Antigen Adjuvanted With MF59C.1) Influenza Vaccine in Non-elderly Adult and Elderly Subjects
2 other identifiers
interventional
47
1 country
3
Brief Summary
To assess persistence of antibody titers 17-18 months after primary immunization with two 0.5mL intramuscular (IM) doses of H5N1 influenza vaccine containing H5N1 influenza antigen, as measured by Hemagglutination Inhibition (HI), Single Radial Hemolysis (SRH), and Microneutralization (MN) test
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2007
Shorter than P25 for phase_2
3 active sites
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, 2007
CompletedFirst Submitted
Initial submission to the registry
November 16, 2007
CompletedFirst Posted
Study publicly available on registry
November 20, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedDecember 1, 2016
February 1, 2012
2 months
November 16, 2007
November 30, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number and percentage of subjects with at least one local reaction between 1 and 7 days after vaccination.
7 days
Number and percentage of subjects with at least one systemic reaction between 1 and 7 days after vaccination.
7 days
Secondary Outcomes (1)
Number and percentage of subjects with at least one adverse event between day of vaccination and the study termination visit.Safety will be assessed in accordance with available safety data on influenza vaccines.
8 months
Study Arms (2)
1
EXPERIMENTAL2
EXPERIMENTALInterventions
One 0.5 ml booster injection 12 months after the second injection, of influenza vaccine containing 7.5 micrograms of H5N1 influenza antigen
Eligibility Criteria
You may qualify if:
- Healthy subjects who previously participated in study V87P1, but did not receive the booster dose on day 202
You may not qualify if:
- Pregnant or breastfeeding
- Receipt of another vaccine or any investigational agent within the past 4 weeks
- Surgery planned during the study period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio, Via dei Vestini
Chieti, 66100, Italy
01: Dipartimento di Scienze della Salute, Sezione Igiene e Medicina Preventiva, Università di Genova
Genova, 16129, Italy
03: Ufficio di Igiene e Sanità Pubblica di Lanciano, ASL Lanciano -Vasto, Via Spaventa, 37,
Lanciano, 66034, Italy
Related Publications (1)
Fragapane E, Gasparini R, Schioppa F, Laghi-Pasini F, Montomoli E, Banzhoff A. A heterologous MF59-adjuvanted H5N1 prepandemic influenza booster vaccine induces a robust, cross-reactive immune response in adults and the elderly. Clin Vaccine Immunol. 2010 Nov;17(11):1817-9. doi: 10.1128/CVI.00461-09. Epub 2010 Sep 1.
PMID: 20810680RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Novartis Vaccines
Novartis Vaccines
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2007
First Posted
November 20, 2007
Study Start
October 1, 2007
Primary Completion
December 1, 2007
Study Completion
June 1, 2008
Last Updated
December 1, 2016
Record last verified: 2012-02