Last updated on March 2019

GlaxoSmithKline's (GSK) Safety and Immunogenicity Study of GSK Meningococcal Group B and 13-valent Pneumococcal Vaccines Administered Together With Routine Infant Vaccines in Healthy Infants

Brief description of study

The purpose of this study is to evaluate the safety and immunogenicity of Bexsero (meningococcal group B vaccine-rMenB+OMV NZ) in North American infants 6 weeks through 12 months of age, when administered concomitantly with Pneumococcal conjugate vaccine (PCV 13) and other recommended routine infant vaccines(RIV).

Detailed Study Description

This study will be divided into 3 timepoints:

  • Epoch 1- Primary- From day 1 to day 301
  • Epoch 2-Secondary-From day 301 to day 331
  • Epoch 3-Safety follow up -From day 331 to study end (day 661) In addition to receiving the study vaccines, infants will also receive non-study vaccines such as Diphtheria, tetanus toxoids and acellular pertussis adsorbed vaccine (DTPa, Infanrix) and Haemophilus influenzae type b Conjugate Vaccine (Hib, Hiberix), to ease the disruption to the standard infant vaccine schedule caused by participating in this study.

Clinical Study Identifier: NCT03621670

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GSK Investigational Site

Layton, UT United States
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