Safety and Immunogenicity of Trivalent Split Influenza Vaccine Using the Strain Composition 2007/2008

A Phase III, Multicenter, Uncontrolled, Open-Label Study to Evaluate Safety and Immunogenicity of Preservative Free, Inactivated Split Influenza Vaccine, Using the Strain Composition 2007/2008 When Administered to Adult and Elderly Subjects

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00498303

Enrollment

120

Registered

2007-07-10

Start date

2007-06-30

Completion date

Unknown

Last updated

2008-04-22

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

Conditions

Seasonal Influenza, Vaccine

Keywords

influenza vaccine

Brief summary

Annual trial for registration of trivalent split influenza vaccine with the strain composition of the season 2007/2008 in healthy adult and elderly subjects

Interventions

BIOLOGICALtrivalent split influenza 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

Healthy volunteers

Yes

Inclusion criteria

* ≥ 18 years of age, mentally competent, willing and able to give informed consent prior to study entry * available for all the visits scheduled in the study and able to comply with all study requirements * in good health as determined by: medical history, physical examination, clinical judgment of the investigator

Exclusion criteria

* n/a

Design outcomes

Primary

Measure	Time frame
evaluate the antibody response to each influenza vaccine antigen, as measured by haemagglutination inhibition (HI) test on Day 0 and on Day 21	—
evaluate safety of trivalent split influenza vaccine	—

Countries

Germany

Outcome results

None listed

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