Avian Influenza Clinical Trial
Official title:
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
Verified date | February 2012 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ministero della Salute, EMEA |
Study type | Interventional |
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
Status | Completed |
Enrollment | 47 |
Est. completion date | June 2008 |
Est. primary completion date | December 2007 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Healthy subjects who previously participated in study V87P1, but did not receive the booster dose on day 202 Exclusion Criteria: - Pregnant or breastfeeding - Receipt of another vaccine or any investigational agent within the past 4 weeks - Surgery planned during the study period |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Italy | Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio, Via dei Vestini | Chieti | |
Italy | 01: Dipartimento di Scienze della Salute, Sezione Igiene e Medicina Preventiva, Università di Genova | Genova | |
Italy | 03: Ufficio di Igiene e Sanità Pubblica di Lanciano, ASL Lanciano -Vasto, Via Spaventa, 37, | Lanciano |
Lead Sponsor | Collaborator |
---|---|
Novartis Vaccines |
Italy,
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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number and percentage of subjects with at least one local reaction between 1 and 7 days after vaccination. | 7 days | Yes | |
Primary | Number and percentage of subjects with at least one systemic reaction between 1 and 7 days after vaccination. | 7 days | Yes | |
Secondary | 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 | Yes |
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