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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00561184

Enrollment

Registered

2007-11-20

Start date

2007-10-31

Completion date

2008-06-30

Last updated

2016-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Avian Influenza

Keywords

H5N1 Pandemic

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

Interventions

BIOLOGICALH5N1 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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026