A phase II, open, randomised, comparative study to evaluate the immunogenicity and safety of GlaxoSmithKline s GSK Biologicals measles-mumps-rubella-varicella candidate vaccine MeMuRu-OKA and GSK Biologicals measles-mumps-rubella vaccine Priorix co-administered in separate injections with GSK Biologicals varicella vaccine Varilrix when given in healthy children who previously received a first dose of an MMR vaccine and one dose of a varicella vaccine. - MeMuRu OKA 047
- Conditions
- Active immunisation against mumps, measles, rubella and varicellaMedDRA version: 6.1Level: PTClassification code 10046980
- Registration Number
- EUCTR2005-005825-75-IT
- Lead Sponsor
- GLAXO SMITHKLINE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
- 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 child between and including 15 months and 6 years of age at the time of the vaccination. - Children who previously received one dose of an MMR vaccine and one dose of a varicella vaccine at least 6 weeks before entering the study. - Written informed consent obtained from the parent or guardian of the subject after they have been advised on the risks and benefits of the study in a language they clearly understand, and before performance of any study procedure. - 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
The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study Subjects who already received a second dose of MMR and/or varicella vaccine. Known history of measles, mumps, rubella or varicella disease. Known exposure to measles, mumps, rubella and varicella within 30 days prior to the study start. 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, 61619; 0.5 mg/kg/day. Inhaled and topical steroids are allowed. Administration of immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period. Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the study vaccine dose, until 42-56 days after vaccination. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus HIV infection. A family history of congenital or hereditary immunodeficiency. Any known anaphylactic reaction from previous administration of an MMR- and/or varicella-containing vaccines. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, including obvious allergic reactions to neomycin, egg proteins. Major congenital defects or serious chronic illness. History of any neurologic disorders or seizures. 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 99.5 F / Rectal temperature 38 C 100.4 F . Rectal temperature 61619; 38 C or axillary temperature 61619; 37.5 C at the time of vaccination. Residence in the same household as a high risk person during the study period e.g. - New-born infants 0-4 weeks of age - Pregnant women who have a negative history of chickenpox - Persons with known immunodeficiency
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate the non-inferiority of MeMuRu-OKA vaccine to Priorix and Varilrix vaccines administered as separate injections in terms of measles, mumps, rubella and varicella geometric mean titres GMTs 42-56 days after vaccination.;Secondary Objective: - To assess the reactogenicity and safety of the study vaccines - To assess measles, mumps, rubella and varicella seropositivity rates 42-56 days after vaccination;Primary end point(s): Measles, mumps, rubella and varicella geometric mean titre GMT ratios, 42-56 days after vaccination
- Secondary Outcome Measures
Name Time Method