immunogenicity and safety study of glaxosmithkline (gsk) biologicals' combined measles-mumps-rubella (mmr) vaccine in children in their second year of life

Conditions: Measles; Mumps; Rubella; Measles-Mumps-Rubella Vaccine

Summary: the purpose of this study is to evaluate end of shelf-life potency in terms of the immunogenicity and safety of gsk biologicals' trivalent mmr vaccine, by comparing it to merck \& co., inc.'s mmr vaccine, which is approved for use in the united states (us).

this trial is a phase iiia, randomized, observer-blind, controlled, multi-center, multi-country study with four parallel groups. this study will evaluate the immunogenicity and safety of gsk biologicals' trivalent investigational mmr vaccine (referred to as inv_mmr vaccine, throughout this document) in contrast to the us standard of care comparator vaccine (m-m-r ii, merck and co., inc., referred to as com_mmr throughout this document) in children during their second year of life. the first dose of this two-dose study is designed to establish the end of shelf-life potency of inv_mmr vaccine. the inv_mmr vaccine will be given as one of two lots; one of a minimum potency, designated inv_mmr_min; and the other at a mid-range or medium potency designated inv_mmr_med to two groups. the second dose for both of these inv_mmr groups will have a potency within the release range of the marketed vaccine. the com_mmr vaccine will consist of two lots designated com_mmr_l1 and com_mmr_l2 and will be analyzed as pooled lots within the study. the first mmr vaccine dose will be co-administered with varivax, havrix and (in the us sub-cohort only) prevnar 13 which are routinely administered to children of this age in the us.

Eligibility criteria:
inclusion criteria: * male or female child between 12 and 15 months of age at the time of vaccination. * the investigator believes that the parent(s) or legally acceptable representative(s) (lar(s)) of the child, can, and will comply with the requirements of the protocol. * written informed consent obtained from the parent(s)/lar(s) of the child. * child is in stable health as determined by investigator's clinical examination and assessment of child's medical history. for us children only: • child that previously received a 3-dose series of prevnar 13 with last dose at least 60 days prior to study entry. exclusion criteria: * child in care. * use of any investigational or non-registered product other than the study vaccine(s) during the period starting 30 days before the day of study vaccination or planned use during the entire study period. * concurrently participating in another clinical study, in which the child has been or will be exposed to an investigational or a non-investigational product. chronic administration of immunosuppressants, or other immune-modifying drugs during the period starting 180 days prior to the first vaccine dose or any planned administration of immunosuppressive and immune-modifying drugs during the entire study. * inhaled and topical steroids are allowed. * planned administration / administration of a vaccine not foreseen by the study protocol during the period starting 30 days prior to study vaccination at visit 1 and ending at visit 2 (or ending at visit 3 for the us post-dose 2 sub-cohort). please note: * inactivated influenza (flu) vaccine and haemophilus influenzae type b conjugate vaccine (hib) vaccines may be given at any time during the study, including the day of study vaccination (flu and hib vaccines must be administered at a different location than the study vaccine/s). * any age appropriate vaccine may be given starting at visit 2 (or starting at visit 3 for the us post-dose 2 sub-cohort), and anytime thereafter. * administration of immunoglobulins and/or any blood products during the period starting 180 days prior to study vaccination at visit 1 or planned administration from the date of vaccination through the immunogenicity evaluation at visit 2, or at visit 3 for the us post-dose 2 sub-cohort. * history of measles, mumps, rubella, varicella/zoster and/or hepatitis a diseases. * known exposure to measles, mumps, rubella and/or varicella/zoster during the period starting 30 days prior to the first study vaccination. * previous vaccination against measles, mumps, rubella, hepatitis a and/or varicella virus. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * a family history of congenital or hereditary immunodeficiency. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including hypersensitivity to neomycin, latex or gelatin. * blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems. * acute disease at the time of enrollment. acute disease is defined as the presence of a moderate or severe illness with or without fever. fever is defined as temperature ≥38°c/100.4°f by any age appropriate route. all vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection without fever. * active untreated tuberculosis based on medical history. * any other condition which, in the opinion of the investigator, prevents the child from participating in the study. for us children only: • a child that previously received a fourth dose of any pneumococcal conjugate vaccine.

Keywords: safety measles, mumps and rubella diseases immunogenicity