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A Phase 3, Randomized, Double-Blind, Comparator-Controlled Study to Evaluate Safety, Tolerability, and Immunogenicity of V114, a 15-Valent Pneumococcal Conjugate Vaccine, in Allogeneic Hematopoietic Cell Transplant Recipients (PNEU-STEM)

Individuals who receive allogeneic hematopoietic cell transplant (allo-HCT) are immunocompromised and at high risk of pneumococcal infections, especially in the months following transplant. This study evaluated the safety and immunogenicity of V114 (VAXNEUVANCE; Merck, Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA), a 15-valent pneumococcal conjugate vaccine (PCV), when given to allo-HCT recipients. 

A phase 3, multicenter, randomized, double-blind study to evaluate the interchangeability of V114, a 15-valent pneumococcal conjugate vaccine, and PCV13 with respect to safety, tolerability, and immunogenicity in healthy infants (PNEU-DIRECTION)

Pneumococcal disease (PD) remains a major health concern globally. In children, pneumococcal conjugate vaccines (PCVs) provide protection against PD from most vaccine serotypes, but non-vaccine serotypes contribute to residual disease. V114 is a 15-valent PCV containing all 13 serotypes in Prevnar 13™ and public health important serotypes 22F and 33F. This phase 3 study evaluated safety and immunogenicity of mixed PCV13/V114 regimens using a 3 + 1 dosing schedule when changing from PCV13 to V114 at doses 2, 3, or 4. 

A phase III, multicenter, randomized, double-blind, active comparator-controlled study to evaluate the safety, tolerability, and immunogenicity of catch-up vaccination regimens of V114, a 15-valent pneumococcal conjugate vaccine(PNEU-PLAN)

Despite widespread use of pneumococcal conjugate vaccines (PCVs) in children, morbidity and mortality caused by pneumococcal disease (PD) remain high. In addition, many children do not complete their PCV course on schedule. V114 is a 15-valent PCV that contains two epidemiologically important serotypes, 22F and 33F, in addition to the 13 serotypes present in PCV13, the licensed 13-valent PCV.

A phase 3, randomized, double-blinded, placebo-controlled trial toevaluate the efficacy and safety of a respiratory syncytial virus (RSV) prefusion F subunit vaccine in infants born to women vaccinated during pregnancy (Matisse)

Respiratory syncytial virus (RSV) is a common, highly contagious virus that causes infections of the lungs and respiratory tract.

A Phase I/II, Multicentre, Observer-blinded, Randomized, Active Controlled, Clinical Trial to Assess the Reactogenicity, Safety and Immunogenicity of a combined Tetanus, Diphtheria, Acellular Pertussis and Poliomyelitis Vaccine (SIIPL Tdap-IPV) in Compari

We are looking for children and teenagers to take part in an important study investigating the effectiveness of a new combination booster vaccine designed to protect against tetanus, diphtheria, pertussis (whooping cough) and polio.

ATOMIC Ears: A Phase IIB randomised controlled trial to assess safety, tolerability and acceptability of a 5-day Dornase alfa treatment as an adjunct therapy to ventilation tube insertion for otitis media in children

Chris Jennifer Lea-Ann Peter Ruth Brennan-Jones Kent Kirkham Richmond Thornton PhD RN PhD MBBS MRCP(UK) FRACP PhD Head, Ear and Hearing Health

COVALIA (COVid vaccine trial for austrALIA): A phase I, double-blind, dose-ranging, randomised, placebo-controlled trial to study the safety and immunogenicity of a DNA-based vaccine against COVID-19 (COVIGEN) in healthy participants aged 18 to 75 years o

To address the urgent need for a vaccine for COVID-19, BioNet’s gene-based vaccine, COVIGEN, will be investigated in this first-in-human, Phase I study.

Short- versus standard-course intravenous antibiotics for peri-prosthetic joint infections managed with debridement and implant retention: a randomised pilot trial using a desirability of outcome ranking (DOOR) endpoint

Peri-prosthetic joint infection (PJI) is a devastating complication of joint replacement surgery. Determining the optimal duration of intravenous (IV) antibiotics for PJI managed with debridement and implant retention (DAIR) is a research priority.

A Phase 3, Randomized, Observer-Blind, Placebo-Controlled, Group-Sequential Study to Determine the Immunogenicity and Safety of a Respiratory Syncytial Virus (RSV) F Nanoparticle Vaccine with Aluminium in Healthy Third-trimester Pregnant Women; and Safety

Elke Jennifer Peter Seppanen Kent Richmond BSc PhD RN MBBS MRCP(UK) FRACP Program Manager, Bacterial Respiratory Infectious Disease Group Clinical

Protocol for the systematic review of the epidemiology of superficial Streptococcal A infections (skin and throat) in Australia

We have produced a protocol for the comprehensive systematic review of the current literature around superficial group A Streptococcal infections in Australia.