Measles, Mumps, Rubella, Varicella
Conditions
Brief summary
As measles-mumps-rubella (MMR) vaccination is established as routine childhood practice in most industrialised countries and varicella vaccination is now being introduced in many countries during the second year of life, a combined measles-mumps-rubella-varicella vaccine was developed for administration convenience and improved compliance to vaccination. To account for situations where children have received a first dose of MMR vaccine without varicella, this study will evaluate the effect of the combined measles-mumps-rubella-varicella vaccine given in place of the second dose of MMR vaccine. A second dose of the monovalent varicella vaccine will be given to all children participating to this trial since there is a current debate on the need of a second dose to induce a full protection against varicella.
Interventions
BIOLOGICALMeMuRu-OKA (study vacc)
BIOLOGICALMMR, Varicella vacc (control)
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Months to 6 Years
Healthy volunteers
Yes
Inclusion criteria
* Children must be healthy to participate
Exclusion criteria
* Immunosuppressive (including HIV) conditions, allergic diseases, neurological disorders, known anaphylactic reaction to MMR vaccine, and fever (axillary temperature ³ 37.5°C at the time of vaccination) are excluding factors. * Children must have received one dose (but not more) of MMR 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, 30 days before until 56 days after vaccination. * Children must not have been vaccinated against varicella. * They must not have had measles, mumps, rubella or varicella, 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 |
|---|---|
| Varicella seroconversion and MMR titres at 42-56 days after first vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety: solicited local/general, unsolicited AEs (42 days), SAEs (whole study) | — |
Countries
France, Germany, Italy
Outcome results
None listed