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

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ClinicalTrials.gov Identifier: NCT00561184
Recruitment Status : Completed
First Posted : November 20, 2007
Last Update Posted : December 1, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

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

Condition or disease Intervention/treatment Phase
Avian Influenza Biological: H5N1 influenza vaccine Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2007
Actual Primary Completion Date : December 2007
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Number and percentage of subjects with at least one local reaction between 1 and 7 days after vaccination. [ Time Frame: 7 days ]
  2. Number and percentage of subjects with at least one systemic reaction between 1 and 7 days after vaccination. [ Time Frame: 7 days ]

Secondary Outcome Measures :
  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. [ Time Frame: 8 months ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
Responsible Party: Novartis Vaccines
ClinicalTrials.gov Identifier: NCT00561184     History of Changes
Other Study ID Numbers: V87P1E1
2007-000165-38
First Posted: November 20, 2007    Key Record Dates
Last Update Posted: December 1, 2016
Last Verified: February 2012

Keywords provided by Novartis ( Novartis Vaccines ):
H5N1 Pandemic

Additional relevant MeSH terms:
Influenza, Human
Influenza in Birds
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs