Immunogenicity of a Surface Antigen, Inactivated Influenza Vaccine Formulation 2007-2008

A Phase II, Open-Label, Uncontrolled, Single Center Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated Influenza Vaccine Ph.Eur, Formulation 2007-2008, When Administered to Non-Elderly Adult and Elderly Subjects

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00518453

Enrollment

129

Registered

2007-08-20

Start date

2007-07-31

Completion date

2007-08-31

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

Influenza

Keywords

Influenza vaccine

Brief summary

Due to antigenic changes of influenza viruses, the virus strains used in influenza vaccines are adjusted every year according to WHO and CPMP recommendations. Immunogenicity and tolerability of the newly composed vaccines are subject for evaluation in a yearly clinical trial in non-elderly adults and elderly subjects (CPMP/BWP/214/96).

Interventions

BIOLOGICALSurface antigen inactivated influenza vaccine

1 dose of Fluvirin 2007/2008 Northern Hemisphere vaccine composition

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 84 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy Subjects eligible for enrollment into this study are male and female adult volunteers

Exclusion criteria

* Any serious disease

Design outcomes

Primary

Measure	Time frame
evaluate the antibody response to each influenza vaccine antigen	21 days post-immunization

Secondary

Measure	Time frame
Safety and tolerability of the study vaccine in the study population	Throughout the study

Countries

United Kingdom

Outcome results

None listed

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