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
weeks of age, when administered concomitantly with Pneumococcal conjugate vaccine (PCV 13)
and other recommended routine infant vaccines(RIV).
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.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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