immunogenicity, reactogenicity and safety of glaxosmithkline (gsk) biologicals' menacwy-tt vaccine administered 6 years post-menc primary vaccination in healthy subjects who were 12-18 months at primary vaccination

Conditions: Infections, Meningococcal

Summary: the purpose of this study is to evaluate the immunogenicity, reactogenicity and safety of a booster dose of gsk biologicals' menacwy-tt vaccine administered at 6 years post-primary vaccination with either gsk biologicals' hib-menc-tt vaccine (menitorix™) or hiberix™ and meningitec™, in healthy subjects aged 12-18 months at primary vaccination and to evaluate the long-term antibody persistence at 2 years after menacwy-tt booster vaccination. this is an extension study of the hib-menc-tt-016 study (nct number: nct00326118).


Eligibility criteria:
inclusion criteria: * subjects' parent(s)/legally acceptable representative(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, 84 and 95 months of age at the time of the booster vaccination. * written informed consent obtained from the parent(s)/lar(s) of the subject and written informed assent obtained from the subject in accordance with local laws and regulations. * healthy subjects as established by medical history and history-directed physical examination before entering into the study. * having completed the vaccination in the study \[hib-menc-tt-016 (106445)\] as per protocol. exclusion criteria: * child in care. * use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period. * chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. for corticosteroids, this will mean prednisone ≥ 0.5 mg/kg/day, or equivalent. inhaled and topical steroids are allowed. * administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after the study vaccine dose, with the exception of a licensed inactivated influenza vaccine which can be administered at any time during the study according to the local recommendations. * 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. * previous vaccination with meningococcal vaccine except the meningococcal vaccination received in the hib-menc-tt-016 study. * 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). * family history of congenital or hereditary immunodeficiency. * history of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine, and history of serious allergic reaction (anaphylaxis) following the administration of vaccine(s). * major congenital defects or serious chronic illness. * history of any neurological disorders or seizures, including gbs. history of a simple, single febrile seizure is permitted. * acute disease and/or fever at the time of enrollment. * fever is defined as temperature ≥ 37.5°c for oral, axillary or tympanic route, 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. * administration of immunoglobulins and/or any blood products within the 3 months preceding the study vaccination or planned administration during the booster vaccination phase of the study (i.e. between visit 1 and visit 2) and within 3 months preceding the blood sampling at visit 3. the following criteria should be checked for the long-term persistence phase at two years after booster vaccination (visit 3): in case an exclusion criterion becomes applicable, the subject will not enter the long-term follow-up and the reason will be documented. * previous administration of a meningococcal vaccine with the exception of the meningococcal vaccination given in the primary study and the booster vaccination in this particular study. * history of meningococcal disease.

Keywords: immunogenicity booster healthy vaccine response safety neisseria meningiditis antibody persistence meningococcal conjugate vaccine