Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2006/2007) When Administered to Subjects 18 Years of Age or Older

A Phase II, Open-Label, Uncontrolled, Single Center Study to Evaluate Safety and Immunogenicity of a Commercially Available Surface Antigen, Inactivated Influenza Vaccine, Formulation 2006-2007, When Administered to Non-Elderly Adult and Elderly Subjects

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00342940

Enrollment

Registered

2006-06-21

Start date

2006-10-31

Completion date

Unknown

Last updated

2017-04-20

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

Conditions

Influenza

Keywords

influenza, influenza vaccine, flu, vaccination, immunogenicity

Brief summary

The present study aims to evaluate safety and immunogenicity of one dose of a commercially available Surface Antigen, Inactivated Influenza Vaccine, Formulation 2006-2007, in non-elderly adult and elderly subjects.

Interventions

BIOLOGICALinfluenza surface antigen inactivated vaccine

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Inclusion criteria

* Male and female subjects 18 years of age or older

Exclusion criteria

* any auto-immune disease or other serious acute, chronic or progressive disease * hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine * known or suspected (or high risk of developing) impairment/alteration of immune function * within the past 7 days any acute disease or infections requiring systemic antibiotic or antiviral therapy * history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine

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

United Kingdom

Outcome results

None listed

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