Safety and Immunogenicity of an Adjuvanted Influenza Vaccine in Subjects Aged 65 Years and Over.

A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated, (Adjuvanted With MF59C.1) Influenza Vaccine, Formulation 2005-2006, When Administered to Elderly Subjects.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00316628

Enrollment

Registered

2006-04-21

Start date

2005-06-30

Completion date

Unknown

Last updated

2006-09-14

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

Conditions

Influenza

Keywords

influenza, elderly, vaccine

Brief summary

The purpose of this study is to evaluate safety and immunogenicity of a single intramuscular (IM) injection of an adjuvanted influenza vaccine in elderly subjects.

Interventions

BIOLOGICALinfluenza vaccine

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

Inclusion criteria

* 65 years of age or older and in good health

Exclusion criteria

* Any serious disease such as: cancer, autoimmune disease, advanced arteriosclerotic disease or complicated diabetes mellitus, chronic obstructive pulmonary disease (COPD) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure. * any acute disease or infections requiring systemic antibiotic or antiviral therapy * hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine * history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine * known or suspected (or high risk of developing) impairment/alteration of immune function within the past 7 days

Design outcomes

Primary

Measure	Time frame
CHMP criteria for evaluation of flu vaccines e.g Seroprotection, GMR's and Seroconversion rate at day 21 following vaccination.	—

Secondary

Measure	Time frame
Number and percentage of subjects with at least one local reaction between Day 0 and Day 3 after vaccine injection.	—
Number and percentage of subjects with at least one systemic reaction between Day 0 and Day 3 after vaccine injection.	—
Number and percentage of subjects with at least one adverse event between Day 0 and the study termination visit (Day 21, window: 20-24).	—

Countries

Italy

Outcome results

None listed

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