ABOUT THIS STUDY
- Subjects and/or subjects' parent(s)/Legally Acceptable Representative(s) (LARs) who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- A male or female who has received a primary vaccination with the MenACWY-TT, Meningitec or Mencevax ACWY vaccines in study MenACWY-TT-027 (NCT00427908).
- In alignment with local laws and regulations, written informed consent obtained from parents/LAR(s) of the subject and written informed assent obtained from the subject if the subject is less than 15 years of age, or written informed consent obtained from the subject if the subject has achieved the 15th birthday. The subjects ≥15 years of age at the time of enrollment will sign the informed consent form, even if the parent/ LAR previously signed the ICF before the subject reached the legal age of consent.
- Healthy subjects as established by medical history and history-directed physical examination before entering into the study.
All subjects must satisfy the following additional criteria prior to entry of the booster phase:
- Female subjects of non-childbearing potential may be enrolled in the study.
- Non-childbearing potential is defined as pre-menarche, hysterectomy or bilateral ovariectomy.
- Male subjects able to father children and female subjects of childbearing potential (including females who have had tubal ligation) and at risk of pregnancy may be enrolled in the study, if the subject:
- has practiced adequate contraception for 30 days prior to vaccination, and
- has a negative pregnancy test on the day of vaccination (for females only), and
- has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination.
- Child in care.
- Previous vaccination with meningococcal polysaccharide or conjugate vaccine outside of
Note: Subjects who were revaccinated with a monovalent MenC conjugate vaccine because of
suboptimal response during the persistence phase of the MenACWY-TT-027 study (i.e.
MenACWY-TT-028, -029, -030, -031 and -032) are allowed to participate as they will be
followed for the persistence of MenA, MenW-135 and MenY.
- History of meningococcal disease due to serogroup A, C, W-135 or Y.
- Previous vaccination with meningococcal B vaccine.
- 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).
- Family history of congenital or hereditary immunodeficiency.
- Major congenital defects or serious chronic illness.
- History of chronic alcohol consumption and/or drug abuse.
- Subjects who withdrew consent to be contacted for follow-up studies.
Additional exclusion criteria for booster phase at Month 126 study entry (to be checked at
Month 126) for all subjects:
- Use of any investigational or non-registered product (drug or vaccine) other than the
study vaccine within 30 days preceding the booster dose of study vaccine, or planned
use during the follow-up period.
- Administration of a vaccine not foreseen by the study protocol in the period starting
30 days before the booster dose of study vaccine or planned administration within 30
days after vaccination, with the exception of a licensed inactivated influenza
- Chronic administration of immunosuppressants or other immune-modifying drugs within
six months prior to the booster vaccine dose . Inhaled and topical steroids are
- Administration of immunoglobulins and/or any blood products within the three months
preceding the booster vaccination or planned administration during the follow-up
- 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 .
- History of any reaction or hypersensitivity likely to be exacerbated by any component
of the vaccines.
- 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 vaccination.
- Fever is defined as temperature ≥ 37.5°C for oral, axillary, tympanic, or ≥38.0°C
for rectal route. The preferred route for recording temperature in this study
will be oral.
- Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory
infection) without fever may, be enrolled at the discretion of the investigator.
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive
- Male subjects able to father children who are planning to discontinue contraceptive
- Subjects who are investigational site staff members directly involved in the conduct
of the study and their family members, site staff members otherwise supervised by the
investigator, or subjects who are Pfizer employees directly involved in the conduct of
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