A phase IIIB, partially blind, randomized study to evaluate the immunogenicity and safety of GlaxoSmithKline Biologicals’ measles-mumps-rubella-varicella vaccine (MeMuRu-OKA) given to healthy children during the second year of life following a 4-week and a 12-month interval between two doses - MMRV-042 & MMRV-045

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 540

Inclusion Criteria

All subjects must satisfy the following criteria at study entry:
? 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 subject between 11-13 months of age (i.e. from 11-month birthday until the day before the 14-month birthday) at the time of the first vaccination.
Note: Subjects to be enrolled in Germany should receive two doses of the vaccine during the second year of life according to the local recommendation. To comply with this recommendation, the age of subjects at the time of the first vaccination in Germany is suggested to be from 11-month to 12.5-month of age.
? Written informed consent obtained from the parent or guardian of the subject (or from both parents as required in The Netherlands).
? 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

The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:
- 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 each vaccination until 42-56 days after each vaccination.
N. meningitidis type C conjugate vaccine is allowed to be given up to seven days - Previous vaccination against 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.
- 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°C.
- Rectal temperature =38.0ºC or axillary temperature =37.5ºC at the time of vaccination.
- Administration of immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period.

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

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