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

Novartis Vaccines47 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Avian Influenza

Interventions

H5N1 influenza vaccineBIOLOGICAL

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 vaccineBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (3)

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, Italy

Outcomes

Primary Outcomes

Number and percentage of subjects with at least one local reaction between 1 and 7 days after vaccination.

Time frame: 7 days

Number and percentage of subjects with at least one systemic reaction between 1 and 7 days after vaccination.

Time frame: 7 days

Secondary Outcomes

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

Data from ClinicalTrials.gov

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