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

Phase 2

Completed

• Conditions: Avian Influenza
• Interventions: Biological: H5N1 influenza vaccine

• Registration Number: NCT00561184
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-11-16
• Study First Submitted QC: 2007-11-16
• Study First Posted: 2007-11-20
• Primary Completion: 2007-12
• Study Completion: 2008-06
• Status Verified: 2012-02
• Last Update Submitted: 2016-11-30
• Last Update Posted: 2016-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	H5N1 influenza vaccine	-
2	H5N1 influenza vaccine	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

03: Ufficio di Igiene e Sanità Pubblica di Lanciano, ASL Lanciano -Vasto, Via Spaventa, 37,; 🇮🇹 Lanciano, 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