Evaluation of immunogenicity and safety of VARIVAX™ New Seed Process (NSP) in children.

ABSTRACT: Prior to availability of an effective vaccine, an estimated 4 million cases of varicella occurred annually in the United States, resulting in 10,000 hospitalizations and over 100 deaths. With the increased usage of a two-dose varicella vaccine (as recommended by the ACIP), approval of other VZV-containing products and the adoption of varicella vaccination in additional countries, the demand for VZV-containing vaccines has increased. This study (NCT02062502) evaluated the safety, tolerability, and immunogenicity of VARIVAX™ (VAR, varicella vaccine live) manufactured using a new seed manufacturing process (VAR_NSP) compared to the currently licensed VAR. Healthy children 12-23 months were randomized (1:1) into Group 1 (2 doses of VAR_NSP given concomitantly with M-M-R™ II

SUBMITTER: Senders SD 

PROVIDER: S-EPMC5806650 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature