NCT01636102

Safety and Immunogenicity of a Subunit Trivalent Nonadjuvated Influenza Study Vaccine in Adults Aged 18 Years and Above

A Phase II Open Label, Uncontrolled, Multicenter Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated, Influenza Vaccine (Agrippal®), Formulation 2012/2013, When Administered to Adult and Elderly Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

To evaluate the safety of a single intramuscular (IM) injection of trivalent nonadjuvated influenza study vaccine, formulation 2012/2013, in adult and elderly subjects and the antibody response to each influenza vaccine antigen, as measured by single radial hemolysis (SRH) and hemagglutination inhibition (HI) at approximately 21 days postimmunization in adult and elderly subjects in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines.

Conditions

• Human Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Trivalent influenza virus vaccine (TIV)	A single 0.5 mL dose of the study vaccine supplied in prefilled syringes and administered intramuscularly in the deltoid muscle of (preferably) the non dominant arm

Timeline

• Start date: 2012-07-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2012-07-10
• Last updated: 2015-11-30
• Results posted: 2014-01-29

Locations

1 site across 1 country: Belgium