For the provision of active surveillance of adverse events following immunisation with pertussis containing vaccines

An 18 month booster dose of pertussis-containing vaccine has been approved for addition to the National Immunisation Program (NIP), with program rollout anticipated to commence in October 2015. The successful Tenderer will provide active vaccine safety surveillance activities, undertaken over a minimum of three years and monitoring all types of adverse events following immunisation (AEFI) with pertussis containing vaccines, at 18 months of age and at four years of age, with a particular focus on the adverse event of special interest, extensive limb swelling (ELS). It is anticipated that the activities will:

• include a retrospective surveillance element to collect baseline data on ELS;
• be undertaken in all states and territories (i.e. minimum of eight areas);
• incorporate at least 24 participating sites, including a mix of hospitals, GP and council based immunisation services;
• recruit a minimum number of participants (6500 per year based on an estimated ELS rate of 2 percent of the expected 325,000 cohort size);
• use a range of digital technologies, such as SMS, email, web based, telephone, and photographic documentation to follow up with participating parents/carers after their child receives a booster dose of diphtheria, tetanus and acellular pertussis (DTPa) vaccine;
• undertake daily AEFI data analysis and monthly reporting to the Department;
• ensure that case reports of all serious AEFI identified though the active surveillance activities are reported immediately to the Therapeutic Goods Administration (TGA); and
• provide rapid (i.e. real time) reporting of any potential safety signal.

These services are required to be undertaken from commencement of the re-introduction of the 18 month booster dose of DTPa to the NIP.