Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Elderly Subjects

Phase 2 Completed 1393 enrolled Novartis Vaccines Department of Health and Human Services · collab

RandomizedParallel-groupDouble-blindPrevention

Summary

Evaluate Safety, Tolerability and Immune response of adjuvanted H5N1 cell culture derived influenza vaccine in elderly subjects

Timeline

Start: 2013-01
Primary completion: 2013-07
Completion: 2014-07

Outcome

Met primary endpoint

paper CBER and CHMP criteria were met by both age groups. PMID 30968056 ↗

paper In adult and elderly participants, the full-dose aH5N1c vaccine formulation was well tolerated and met US and European licensure criteria for pandemic vaccines. PMID 30968056 ↗

Publications

Frey SE, Shakib S, Chanthavanich P, Richmond P, Smith T, Tantawichien T, Kittel C, Jaehnig P, Mojares Z, Verma B, Kanesa-Thasan N, Hohenboken M. Safety and Immunogenicity of MF59-Adjuvanted Cell Culture-Derived A/H5N1 Subunit Influenza Virus Vaccine: Dose-Finding Clinical Trials in Adults and the Elderly. Open Forum Infect Dis. 2019 Mar 1;6(4):ofz107. doi: 10.1093/ofid/ofz107. eCollection 2019 Apr.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Adjuvanted H5N1 pandemic influenza vaccine	Vaccine	3.75 ug	—
Subject	Adjuvanted H5N1 pandemic influenza vaccine	Vaccine	7.5 ug	—