A Phase 1, Randomized, Observer Blind, Antigen and Adjuvant Dosage-Finding Study to Evaluate the Safety and Immunogenicity of an Adjuvanted, Trivalent Subunit Influenza Vaccine in Elderly Subjects ≥65 Years of Age

NCT02126761 Phase 1 COMPLETED

In this study, the safety and immunogenicity of the current formulation of aTIV will be compared to aTIV-modified formulations in which the dosage of the MF59 adjuvant will be doubled or tripled and/or the dosage of the 3 influenza virus strains will be doubled, in independently-living elderly subjects ≥ 65 years of age.

Details

Lead sponsor	Seqirus
Phase	Phase 1
Status	COMPLETED
Enrolment	196
Start date	2014-06
Completion	2015-11

Conditions

• Influenza

Interventions

• Adjuvanted, trivalent subunit influenza vaccine
• Adjuvant level modified adjuvanted, trivalent subunit influenza vaccine
• Antigen level modified adjuvanted, trivalent subunit influenza vaccine
• Antigen and adjuvant level modified adjuvanted, trivalent subunit influenza vaccine

Primary outcomes

• Reactogenicity up to 7 days after vaccination — Days 1-7 post-vaccination
  Safety of aTIV or aTIV-modified formulations
• Unsolicited AEs within 28 days after vaccination — Days 1-28 post-vaccination
• SAEs, non-scheduled physician visits, unsolicited medically attended AEs, unsolicited AEs leading to study withdrawal, NOCDs, and AESIs from study start to study completion. — Days 1-366 post-vaccination
• Seroconversion/significant increase in antibody HI titers; ≥4-fold rise in MN titer 21 days post-vaccination. — Day 22 post-vaccination
  Antibody responses to all three influenza virus vaccine strains, 21days after a dose or doses of aTIV or aTIV-modified formulations, as measured by hemagglutination inhibition (HI) assay and microneutralization (MN) assay.
• HI and MN GMT and GMR at baseline and 21 days post-vaccination. — Day 1; Day 22 post-vaccination

Countries

Germany