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. - MeMuRu-OKA 046
- Conditions
- Healthy male and female children between 15 months and 6 years of age who previously received an MMR vaccine will receive one dose of MMR + V or MMRV. A second dose of varicella vaccine will be given to all subjects.
- Registration Number
- EUCTR2005-006065-14-DE
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 446
All subjects must satisfy the following criteria at study entry:
• Subjects who the investigator believes that they and 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 MMR 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
• Subjects who already received a second dose of MMR vaccine.
• 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, greater than or equal to 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.
• Previous vaccination against varicella.
• Known history of a measles, mumps, rubella and/or varicella infection.
• Known exposure to measles, mumps, rubella and/or varicella within 30 days prior to the study start.
• 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 MMR-containing vaccine. 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 neurological 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 diarrhea, 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 greater than or equal to 38°C or axillary temperature greater than or equal to 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
- Secondary Outcome Measures
Name Time Method