Investigators: Beth Arrowsmith, Camille Gibson, Christina Anthony, Fiona McDonald, Jan Jones, Jane Jones, Jennifer Gatens, Jennifer Kent, Krist Ewe, Nikki Schultz, Peter Richmond, Tanya Stoney
The study is a phase 3, Multicentre, Randomised, Double-blind, Active Comparator-controlled Study to Evaluate the Safety and Tolerability of V114 in Health Infants.
The purpose of the study is to assess the safety of the new Pneumococcal Conjugate Vaccine (V114), which contains 15 serotypes: the 13 in Prevenar13TM plus an additional two, (22F and 33F), and assess the immune response to the new PCV in preterm babies.
Enrolled babies will be randomised to V114 or Prevenar13TM (blinded) at 6 to 8 weeks, 4, 6 and 12 months of age.
• Term babies (≥ 37 wks) have 5 in 6 (83%) chance of receiving V114
• Preterm babies (< 37 wks) have a 1 in 2 (50%) chance of receiving V114
Project partner: Merck Sharp Dohme