Active immunization of healthy children aged 11 to 21 months against measles, mumps, rebella and varicella diseases
Conditions
Sponsors
GlaxoSmithKline GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Free of obvious health problems as established by medical history and clinical examination before entering into the study. •Birth weight > 2000g. •Subjects who the investigator believes that 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, collection of blood samples) should be enrolled in the study. •A male or female between 11 and 21 months of age at the time of the first vaccination if the investigator can assure that the subject will receive the second vaccination within an interval of 6 to 8 weeks and before the second birthday. •Written informed consent obtained from the parent or guardian of the subject before any study procedure. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Previous vaccination against measles, mumps, rubella and/or varicella. •History of previous measles, mumps, rubella and/or varicella/zoster diseases. •Children from pregnant mothers who have a negative history of chickenpox. •Known exposure to measles, mumps, rubella and/or varicella/zoster within 30 days prior to the start of the present trial. •Use of any investigational or non-registered 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. •Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination. (For corticosteroids, this will mean prednisone, or equivalent, ? 0.5 mg/kg/day. Inhaled steroids are allowed). •Chronical administration of salicylates •Administration of a licensed vaccine not foreseen by the study protocol during the period starting from 30 days prior to study start and until study end (week 12) •Children who have received immunoglobulins and/or any blood products within six months preceding the first dose or with planned administration of any of these products during the study period. •Confirmed or suspected tuberculosis. •Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, or 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 obvious allergic reactions to neomycin and/or egg proteins. •Major congenital defects or serious chronic illness. •History of any progressive neurologic disorders or seizures. •Acute disease* at the time of enrolment. •Residence in a household in which a person with high risk resides (e.g., newborns between 0-4 weeks old of mothers with negative history of chickenpox and without recorded vaccination against chickenpox, susceptible immunocompromised persons including those with HIV) •Rectal temperature ? 38.0 °C (100.4 °F) at time of vaccination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate GMT and seroconversion rate to VZV before and after intramuscular and subcutaneous injection of GSK’s MeMuRu-OKA vaccine. ;Secondary Objective: •To evaluate the cell-mediated immunity to varicella and measles after intramuscular and subcutaneous injection of GSK’s MeMuRu-OKA vaccine. •To quantify the immediate vaccination pain after intramuscular and subcutaneous injection of GSK’s MeMuRu-OKA vaccine. •To evaluate GMT and seroconversion rate to measles, mumps, and rubella, after intramuscular and subcutaneous injection of GSK’s MeMuRu-OKA vaccine. •To evaluate incidence, nature and severity of local, general, and serious adverse events after intramuscular and subcutaneous injection of GSK’s MeMuRu-OKA vaccine. ;Primary end point(s): •Seroconversion rate to VZV after intramuscular and subcutaneous injection of GSK’s MeMuRu-OKA vaccine, 42-56 days after Visit 2. | — |
Countries
Germany
Outcome results
None listed