- Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion
of the investigator, can and will comply with the requirements of the protocol.
- A male or female between, and including, 12 and 14 months of age at the time of the
first vaccination.
- Written informed consent obtained from the parent(s)/LAR(s) of the subject.
- Healthy subjects as established by medical history and clinical examination before
entering into the study.
- Vaccination records showing the completion of the full primary vaccination schedule
with Prevenar 13 and Diphtheria, Tetanus and Pertussis (DTP) containing vaccine
according to local recommendations at least 5 months before the study entry.
- Child in care.
- Use of any investigational or non-registered product (drug or vaccine) other than the
study vaccines within 30 days preceding the first dose of study vaccine or planned use
during the study period.
- Chronic administration (defined as more than 14 days in total) of immunosuppressants
or other immune-modifying drugs within six months prior to the first vaccine dose. For
corticosteroids, this will mean prednisone 0.5 mg/kg/day, or equivalent. Inhaled and
topical steroids are allowed.
- Planned administration/administration of a vaccine not foreseen by the study protocol
within the period starting 30 days before and ending 30 days after the dose of
vaccines, with the exception of a licensed inactivated influenza vaccine. Measles,
Mumps Rubella (MMR) vaccine or Measles Mumps Rubella and Varicella (MMRV) vaccine can
be co-administered with MenACWY-TT and/or Prevenar 13. A DTPa containing vaccine can
be administered after the last blood sampling (at Visit 2 or 4 depending on the
group).
- Concurrently participating in another clinical study, at any time during the study
period, in which the subject has been or will be exposed to an investigational or a
non-investigational vaccine/product (pharmaceutical product or device).
- Previous vaccination against Neisseria meningitidis.
- Previous booster vaccination against Streptococcus pneumoniae.
- Previous booster vaccination against Corynebacterium diphtheriae, Clostridium tetani
and Bordetella pertussis.
- History of meningococcal disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital
or secondary), including human immunodeficiency virus (HIV) infection, based on
medical history and physical examination (no laboratory testing required)*
- Note: With the exception of HIV rapid testing which will be done for subjects in
South Africa.
- Family history of congenital or hereditary immunodeficiency.
- History of any reaction or hypersensitivity, including to diphtheria toxoid, likely to
be exacerbated by any component of the vaccines.
- Major congenital defects or serious chronic illness.
- History of any neurological disorders or seizures, including Guillain-Barré syndrome
(GBS). History of a simple, single febrile seizure is permitted.
- Acute disease and/or fever at the time of enrollment.
- Administration of immunoglobulins and/or any blood products within the 3 months
preceding the first dose of study vaccine or planned administration during the study
period.