Measles, Mumps, Rubella, Varicella
Conditions
Brief summary
This study will compare the immunogenicity and safety of the MeMuRu-OKA vaccine administered subcutaneously or using an alternative administration route.
Interventions
BIOLOGICALMeMuRu-OKA (study vaccine)
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
11 Months to 22 Months
Healthy volunteers
Yes
Inclusion criteria
* Children must be healthy and have a birth weight \> 2000 g to participate
Exclusion criteria
* confirmed or suspected tuberculosis, immunosuppressive (including HIV) conditions, neurological disorders, history of allergic disease or reaction, major congenital defects, chronical administration of salicylates, and fever (axillary temperature ³ 37.5°C at the time of vaccination) are excluding factors. * Children from pregnant mothers who have a negative history of chickenpox are also excluded from the study. * Children must have received one dose (but not more) of MMR and of varicella at least 6 weeks before entering the study. They must not receive or have received other non-registered drug or vaccine within 30 days prior to study start, or immunosuppressants for more than 14 days. * Immunoglobulins or any blood products are prohibited during the 6 months before and during the study, as well as vaccine other than that foreseen by the protocol within 30 days before vaccination. * Children must not have had measles, mumps, rubella or varicella/zoster, or have been exposed to those diseases within 30 days prior to study start. * New-born infants (\< 5 weeks of age), pregnant women without previous exposure to chickenpox, and immunodeficient persons cannot live in the same household as the vaccinated child
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seroconversion rates after vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Antibody titres; safety: solicited local/ general, unsolicited AEs (42 days), SAEs (whole study) | — |
Countries
Germany
Outcome results
None listed