Dose-sparing H5N1 A/Indonesia/05/2005 pre-pandemic influenza vaccine in adults and elderly adults: a phase III, placebo-controlled, randomized study.

ABSTRACT:

Background

Highly pathogenic avian influenza H5N1 viruses remain a threat to human health, with potential to become pandemic agents.

Methods

This phase III, placebo-controlled, observer-blinded study evaluated the immunogenicity, cross-reactivity, safety, and lot consistency of 2 doses of oil-in-water (AS03(A)) adjuvanted H5N1 A/Indonesia/05/2005 (3.75 μg hemagglutinin antigen) prepandemic candidate vaccine in 4561 adults aged 18-91 years.

Results

Humoral antibody responses in the H5N1 vaccine groups fulfilled US and European immunogenicity licensure criteria for pandemic vaccines in all age strata 21 days after the second dose. At 6 months after the administration of the primary dose, serum antibody seroconversion rates continued to fulfill licensure criteria. Neutra

SUBMITTER: Langley JM 

PROVIDER: S-EPMC3100510 | biostudies-literature | 2011 Jun

REPOSITORIES: biostudies-literature