immunogenicity of gsks' mmr vaccine (209762) vs. m-m-r® ii, when given with routine vaccines at 12-15 months of age

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

Summary: the purpose of this study is to compare two measles, mumps and rubella conjugate vaccines (manufactured by gsk and merck and company ) in terms of the immune response elicited and safety with a six month follow-up after first vaccination. additionally, antibody persistence will be assessed one and two years after administration of mmr vaccine. the protocol posting has been updated following protocol amendment 1 and 2, oct 2009.


Eligibility criteria:
inclusion criteria: * subjects for whom the investigator believes their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study. * male or female between 12 and 15 months of age (e.g. from age 12 months until the day before age 16 months) at the time of vaccination. * written informed consent obtained from the parent/guardian of the subject. * healthy subjects as established by medical history and clinical examination before entering into the study. * have previously received three doses of 7-valent pneumococcal conjugate vaccine within the first year of life with the third dose administered at least 30 days prior to enrolment and vaccination with study vaccines. exclusion criteria: * use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * 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 product (pharmaceutical product or device). * chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * planned administration/ administration of a vaccine not foreseen by the study protocol from 30 days prior to vaccination until 42 days after vaccination, except for influenza vaccine and hib vaccine. * previous vaccination against measles, mumps, rubella and/or varicella. * previous vaccination against hepatitis a or receipt of a fourth dose of pneumococcal conjugate vaccine. * history of measles, mumps, rubella, varicella/zoster and hepatitis a diseases. * known exposure to measles, mumps, rubella and/or varicella/zoster within 30 days prior to the start of the study. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required), including human immunodeficiency virus (hiv) infection. * a family history of congenital or hereditary immunodeficiency. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccines. * hypersensitivity to latex * major congenital defects or serious chronic illness. * history of any neurologic disorders or seizures, including febrile seizures. * acute disease at the time of enrolment. * administration of polyclonal immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period.

Keywords: measles, mumps, rubella, varicella vaccine children immunogenicity safety humans combined vaccine vaccines