Safety profile of the adjuvanted recombinant zoster vaccine: Pooled analysis of two large randomised phase 3 trials.

Background: The ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229) phase 3 clinical trials showed that the adjuvanted recombinant zoster vaccine (RZV) was ≥90% efficacious in preventing herpes zoster in adults. Here we present a comprehensive overview of the safety data from these studies.

Methods: Adults aged ≥50 (ZOE-50) and ≥70 (ZOE-70) years were randomly vaccinated with RZV or placebo.

Efficacy and safety of methionine aminopeptidase 2 inhibition in type 2 diabetes: a randomised, placebo-controlled clinical trial.

Aims/hypothesis: This multicentre randomised double-blind placebo-controlled clinical trial assessed the efficacy and safety of a methionine aminopeptidase 2 (MetAP2) inhibitor, beloranib, in individuals with obesity (BMI ≥30 kg/m) and type 2 diabetes (HbA 53-97 mmol/mol [7-11%] and fasting glucose <15.6 mmol/l).

Methods: Participants were randomised (via a centralised interactive web response system) to placebo, 1.

Impact of nurse-mediated management on achieving blood pressure goal levels in primary care: Insights from the Valsartan Intensified Primary carE Reduction of Blood Pressure Study.

Background: Blood pressure targets in individuals treated for hypertension in primary care remain difficult to attain.

Aims: To assess the role of practice nurses in facilitating intensive and structured management to achieve ideal BP levels.

Methods: We analysed outcome data from the Valsartan Intensified Primary carE Reduction of Blood Pressure Study.

Safety, immunogenicity, and lot-to-lot consistency of a quadrivalent inactivated influenza vaccine in children, adolescents, and adults: A randomized, controlled, phase III trial.

Background: Inactivated quadrivalent influenza vaccine (IIV4) containing two influenza A strains and one strain from each B lineage (Yamagata and Victoria) may offer broader protection against seasonal influenza than inactivated trivalent influenza vaccine (IIV3), containing a single B strain. This study examined the safety, immunogenicity, and lot consistency of an IIV4 candidate.

Methods: This phase III, randomized, controlled, multicenter trial in children/adolescents (9 through 17 years) and adults (18 through 60 years) was conducted in Australia and in the Philippines in 2012.

More rigorous protocol adherence to intensive structured management improves blood pressure control in primary care: results from the Valsartan Intensified Primary carE Reduction of Blood Pressure study.

Objective: To examine protocol adherence to structured intensive management in the Valsartan Intensified Primary carE Reduction of Blood Pressure (VIPER-BP) study involving 119 primary care clinics and 1562 randomized participants.

Methods: Prospective criteria for assessing adherence to treatment prescription, uptitration, and visit attendance at 6, 10, 14, and 18 weeks postrandomization were applied to 1038 intervention participants. Protocol adherence scores of 1-5 (least to most adherent) were compared to blood pressure (BP) control during 26 weeks of follow-up.

Effect of intensive structured care on individual blood pressure targets in primary care: multicentre randomised controlled trial.

Objective: To determine the effectiveness of intensive structured care to optimise blood pressure control based on individual absolute risk targets in primary care.

Design: Pragmatic multicentre randomised controlled trial.

Setting: General practices throughout Australia, except Northern Territory, 2009-11.

Natural history of Ross River virus-induced epidemic polyarthritis.

Objective: To describe the natural history, treatment and cost of Ross River virus-induced epidemic polyarthritis (RRV disease).

Design: Questionnaire-based longitudinal prospective study.

Participants And Setting: Patients in the greater Brisbane area, Queensland, diagnosed with RRV disease by their general practitioners based on clinical symptoms and paired serological tests between November 1997 and April 1999.