NCT02126761 - Safety and Immunogenicity of Different Formulations of an Adjuvanted, Trivalent Subunit Influenza Vaccine in Elderly Subjects 65 Years of Age and Above | Biotech Hunter

Enrollment

196

Participants

Timeline

Start Date

June 30, 2014

Primary Completion Date

November 30, 2015

Study Completion Date

November 30, 2015

Conditions

Influenza

Interventions

BIOLOGICAL

Adjuvanted, trivalent subunit influenza vaccine

Group 1 and group 5 are active comparators; group 5 includes placebo comparator as a second injection in contralateral deltoid

BIOLOGICAL

Adjuvant level modified adjuvanted, trivalent subunit influenza vaccine

Group 2 and group 6 are experimental; group 2 has double dosage of MF59 in a single injection; group 6 has triple dosage of MF59 and includes placebo comparator in contralateral deltoid

BIOLOGICAL

Antigen level modified adjuvanted, trivalent subunit influenza vaccine

Group 3 is experimental with double the usual antigen dosage

BIOLOGICAL

Antigen and adjuvant level modified adjuvanted, trivalent subunit influenza vaccine

Group 4 and 7 are experimental; group 4 has one injection with double the antigen and adjuvant; group 7 has two injections with double the antigen and adjuvant

Trial Locations (1)

14050

PAREXEL Early Phase Clinical Unit, Berlin