NCT01617239

Clinical Study for Safety and Immunogenicity Study of Influenza Vaccine

A Phase I, Open Label, Randomized Study in Healthy Adults to Compare Safety and Immunogenicity of Different Administration Schedules of Virosomal Influenza Vaccine

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Crucell Holland BV · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The goal of the study is to assess the safety and immune response after vaccination with different doses and vaccination schedules of virosomal influenza vaccine.

Detailed description

Virosomal influenza vaccine is usually administered intramuscularly as a single 0.5 mL dose. The aim of this study is to evaluate the safety and immunogenicity of different doses and vaccination schedules. A total of 84 healthy adults aged 18-50 years will be randomized (1:1:1) into 3 treatment groups: subjects of group 1 will receive a standard dose (0.5 mL) at Days 1, 29, and 57; subjects of group 2 will receive a double dose (1.0 mL) at Day 1 and a standard dose (0.5 mL) at Day 57; subjects of group 3 will receive a triple dose (0.5 mL) at Day 1. Local and systemic solicited adverse events up to Day 4 after each vaccination will be documented. To assess the subjects' humoral and cellular immune response against homologous and heterologous virus strains, blood will be drawn from each participant at baseline (Day 1), at the 4 subsequent monthly visits (Months 1 to 4) and at Month 12.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Virosomal influenza vaccine	Virosomal influenza vaccine with the recommended vaccine composition for season 2011-2012: * 15 μg HA antigen of A/California/7/2009 (H1N1)-like virus * 15 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus * 15 μg HA antigen of B/Brisbane/60/2008-like virus Intramuscular (i.m.) administration (M. deltoideus or M. vastus lateralis)

Timeline

• Start date: 2012-06-01
• Primary completion: 2013-06-01
• Completion: 2013-12-01
• First posted: 2012-06-12
• Last updated: 2014-08-20

Locations

1 site across 1 country: Belgium