Safety and Immunogenicity of a Booster Dose of -H5N1 Influenza Vaccine

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00561184
• Other study ID #: V87P1E1
• Secondary ID: 2007-000165-38
• Status: Completed
• Phase: Phase 2
• First received: November 16, 2007
• Last updated: November 30, 2016
• Start date: October 2007
• Est. completion date: June 2008

Study information

• Verified date: February 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministero della Salute, EMEA
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Avian Influenza
• Influenza, Human

Intervention

Biological:
• H5N1 influenza vaccine
One 0.5 ml booster injection 12 months after the second injection, of influenza vaccine containing 7.5 micrograms of H5N1 influenza antigen
• H5N1 influenza vaccine
One 0.5 ml booster injection 12 months after the second injection, of influenza vaccine containing 15.0 micrograms of H5N1 influenza antigen

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Vaccines

Country where clinical trial is conducted

Italy, 

References & 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 — View Citation

Outcome

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