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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. 

Safety and immunogenicity of a primary series and booster dose of the meningococcal serogroup B-factor H binding protein vaccine (MenB-FHbp) in healthy children aged 1–9 years: two phase 2 randomised, controlled, observer-blinded studies

The meningococcal serogroup B-factor H binding protein vaccine (MenB-FHbp) is licensed for use in children aged 10 years or older for protection against invasive serogroup B meningococcal disease. Because young children are at increased risk of invasive meningococcal disease, MenB-FHbp clinical data in this population are needed.

Evidence of maternal transfer of antigen-specific antibodies in serum and breast milk to infants at high-risk of S. pneumoniae and H. influenzae disease

Children in low-mid income countries, and First Nations children in high-income countries, experience disproportionately high rates of Streptococcus pneumoniae and Haemophilus influenzae infections and diseases including pneumonia and otitis media.

Australia-wide point prevalence survey of antimicrobial prescribing in neonatal units: How much and how good?

This is the first Australia-wide point prevalence survey of neonatal antimicrobial prescribing in tertiary children's hospitals.

Group a streptococcal carriage and seroepidemiology in children up to 10 years of age in Australia.

This study aimed to acquire nationally representative epidemiological data on GAS in Australia to scope the appropriate age for vaccination with a potential...

Immune responses to a recombinant, four-component, meningococcal serogroup B vaccine (4CMenB) in adolescents

This trial evaluated the lot consistency, early immune responses and safety of the vaccine against serogroup B Neisseria meningitidis (4CMenB) - in 11 to 17...

Comparison of text-messaging to voice telephone interviews for active surveillance of adverse events following immunisation.

This study was designed to compare data collected via SMS and telephone for the purposes of monitoring vaccine safety.

Antibody persistence in Australian adolescents following meningococcal C conjugate vaccination

In Australia, following the introduction of serogroup C meningococcal (MenC) conjugate vaccine for toddlers and catch-up immunization through adolescence,...

A randomized phase I study of the safety and immunogenicity

In this study of healthy adults aged 50-85 and 18-24 years, SA3Ag elicited a rapid and robust immune response and was well tolerated, with no notable safety...

Post hoc analysis of the PATRICIA randomized trial of the efficacy of human papillomavirus type 16 (HPV-16)/HPV-18 AS04-adjuvanted vaccine

The efficacy of the human papillomavirus type 16 (HPV-16)/HPV-18 AS04-adjuvanted vaccine against cervical infections with HPV...