Safety and tolerability of a 2009 trivalent inactivated split-virion influenza vaccine in infants, children and adolescents.

ABSTRACT:

Objective

To evaluate the safety of CSL's split-virion inactivated trivalent 2009 Southern Hemisphere formulation influenza vaccine (TIV) in children.

Methods

We enrolled 1992 healthy children into three groups: Cohorts A, ≥ 6 months to <3 years; B, ≥ 3 years to <9 years; and C, ≥ 9 years to <18 years. Children received one or two doses of 0.25 ml (22.5 μg haemagglutinin) or 0.5 ml (45 μg) TIV, depending on age and prior vaccination history. We collected post-vaccination solicited adverse event (AE) data (days 0-6), including fever (temperature: ≥ 37.5°C axilla, ≥ 38.0°C oral), unsolicited AEs (days 0-29) and serious AEs (SAEs) and new-onset chronic illnesses (NOCIs; to day 180 after last vaccination).

Results

At least one solicited AE was reported by 80%/78%/78% of c

SUBMITTER: Lambert SB 

PROVIDER: S-EPMC5781200 | biostudies-literature | 2013 Sep

REPOSITORIES: biostudies-literature