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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00561184
First received: November 16, 2007
Last updated: February 14, 2012
Last verified: February 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Avian Influenza
 Biological: H5N1 influenza vaccine
 Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Bird Flu Flu
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Number and percentage of subjects with at least one local reaction between 1 and 7 days after vaccination. [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
  • Number and percentage of subjects with at least one systemic reaction between 1 and 7 days after vaccination. [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]

Enrollment: 47
Study Start Date: October 2007
Study Completion Date: June 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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
Experimental: 2 Biological: 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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjectswho 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00561184

Locations
Italy
Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio, Via dei Vestini
Chieti, Italy, 66100
01: Dipartimento di Scienze della Salute, Sezione Igiene e Medicina Preventiva, Università di Genova
Genova, Italy, 16129
03: Ufficio di Igiene e Sanità Pubblica di Lanciano, ASL Lanciano -Vasto, Via Spaventa, 37,
Lanciano, Italy, 66034
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines Novartis Vaccines
  More Information

Publications:

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00561184     History of Changes
Other Study ID Numbers: V87P1E1, 2007-000165-38
Study First Received: November 16, 2007
Last Updated: February 14, 2012
Health Authority: Italy: Ministero della Salute, EMEA

Keywords provided by Novartis:
H5N1 Pandemic

Additional relevant MeSH terms:
Influenza in Birds
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013