Safety and Immunogenicity of Preservative Free Inactivated Split Influenza Vaccine, Using the Strain Composition 2006/2007 in Non-Elderly Adult and Elderly Subjects

A Phase III, Multicenter, Uncontrolled, Open-Label Study to Demonstrate Safety and Immunogenicity of a Commercially Available Preservative Free Inactivated Split Influenza Vaccine, Using the Strain Composition 2006/2007 When Administered to Non-Elderly Adult and Elderly Subjects

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00354016

Enrollment

125

Registered

2006-07-19

Start date

2006-07-31

Completion date

Unknown

Last updated

2007-03-13

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 (World Health Organization) and CHMP (Committee for Medicinal Products for Human Use) recommendations. Immunogenicity and tolerability of the newly composed vaccines are subject for evaluation in a yearly clinical trial in non-elderly and elderly subjects (CPMP/BWP/214/96).

Interventions

BIOLOGICALpreservative free inactivated split influenza vaccine using the strain composition 2006/2007

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Healthy adults aged \>18 years

Exclusion criteria

* serious chronic diseases or significant acute infections requiring systemic antibiotic treatment * history of any anaphylaxis, serious vaccine reactions * hypersensitivity against vaccine components * history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine * known or suspected impairment/alteration of immune function * more than one injection of influenza vaccine received or laboratory confirmed influenza disease * within last 6 months: influenza vaccination received

Design outcomes

Primary

Measure	Time frame
antibody titers to each influenza strain measured by hemagglutination inhibition (HI) test on Day 0 and on Day 21	—

Secondary

Measure	Time frame
safety of a single IM dose of the split influenza vaccine using solicited local and systemic reactions and adverse event reporting	—

Countries

Germany

Outcome results

None listed

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