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

Novartis Vaccines3 sites in 1 country47 target enrollmentOctober 2007

ConditionsAvian Influenza

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Avian Influenza
Sponsor: Novartis Vaccines
Enrollment: 47
Locations: 3
Primary Endpoint: Number and percentage of subjects with at least one local reaction between 1 and 7 days after vaccination.
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

October 2007

End Date

June 2008

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Novartis Vaccines

Responsible Party

Sponsor

Eligibility 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

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.(8 months)