Active immunization of healthy children during their second year of life against measles, mumps, rubella and varicella diseases.
Conditions
Interventions
Product Name: Priorix-Tetra
Product Code: MeMuRu-OKA
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Live attenu
Sponsors
GlaxoSmithKline
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? 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) should be enrolled in the study. ? A male or female subjects between 11 to 21 months of age at the time of the first vaccination. ? Written informed consent obtained from the parent or guardian of the subject. ? Free of obvious health problems as established by medical history and clinical examination before entering into the study. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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. ? Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, ? 0.5 mg/kg/day. Inhaled and topical steroids are allowed.) ? Planned administration/ administration of a vaccine not foreseen by the study protocol from 30 days prior to the first vaccination until study end (Week 12). ? Previous vaccination against measles, mumps, rubella and/or varicella. ? History of measles, mumps, rubella and/or varicella/zoster diseases. ? Known exposure to measles, mumps, rubella and/or varicella/zoster within 30 days prior to the start of the present trial. ? Any confirmed or suspected immunosuppressive or immunodeficient condition, 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 vaccine(s). ? Major congenital defects or serious chronic illness. ? History of any neurologic disorders or seizures. ? Residence in the same household as the following persons: – New-born infants (0-4 weeks of age). – Pregnant mother/women with a negative history of chickenpox disease and without recorded vaccination against chickenpox. – Persons with known immunodeficiency. ? Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e., axillary temperature <37.5°C / Rectal temperature <38.0°C. ? Rectal temperature ?38.0°C or axillary temperature ?37.5°C at the time of vaccination. ? Administration of immunoglobulins and/or any blood products within the six months before entering the study or planned administration during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: ? To establish an observed seroconversion rate for mumps of at least 90% for each lot after the first dose by neutralization assay.; Secondary Objective: ? To assess immunogenicity of study vaccines in terms of mumps seroconversion rate post dose 1 by neutralization assay (sequential analysis): (1) To demonstrate LL of 95% CI mumps SC-rate is at least 90% after the first dose of MeMuRu-OKA Lot A-FRESH. (2) To demonstrate LL of 95% CI mumps SC-rate is at least 90% after the first dose of MeMuRu-OKA Lot A-AGED. (3) To demonstrate LL of 95% CI mumps SC-rate is at least 90% after the first dose of MeMuRu-OKA Lot B-AGED. ? To assess immunogenicity: - mumps SC-rate post dose 1 (ELISA) - measles-rubella-varicella SC-rates post dose 1. - antibody titres to each vaccine component post dose 1. - SC-rates and antibody titres to each vaccine component post dose 2. ? To assess reactogenicity & safety after each dose. ;Primary end point(s): ? Mumps seroconversion rate after the first dose by neutralisation assay. | — |
Countries
Finland, Germany
Outcome results
None listed