Safety and immunogenicity of seasonal and pandemic inactivated whole virion influenza vaccine in healthy adults

Completed

• Conditions: infection; influenza; 10047438

• Registration Number: NL-OMON36142
• Lead Sponsor: Stichting Leveronderzoek

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

Age 18 to 49 years
Good health according to the investigator

Exclusion Criteria

- having had an infectious disease with fever (including influenza) within the last 14 days
- present evidence of serious disease(s) demanding medical treatment that might interfere with the results of the study such as diseases which interfere with the immune system
- known or suspected allergy to any of the vaccine components: egg components, chicken protein, ovalbumin (by medical history)
- known or suspected immune deficiency
- history of any neurologic disorder, including epilepsy
- females: positive pregnancy test
- positive HIV, HBV or HCV serology
- previous vaccination with an influenza vaccine in the previous three winter seasons
- abnormal pre-treatment laboratory parameters which are clinically relevant according to the investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Objective: to assess the safety of seasonal and pandemic inactivated<br /><br>whole virion influenza vaccine.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Objective(s): to assess immunogenicity of seasonal and pandemic<br /><br>inactivated whole virion influenza vaccine, and to compare the safety profile<br /><br>of the whole virion vaccines with a split virion vaccine.</p><br>