Measles, Mumps, Rubella, Varicella
Conditions
Brief summary
Since measles-mumps-rubella (MMR) and varicella vaccinations are established as routine childhood practice and often co-administered during the second year of life, a combined measles-mumps-rubella-varicella (MeMuRu-OKA) vaccine is fully justified. Such a combined vaccine was developed and extensively studied in susceptible children. In countries where varicella mass-vaccination is already implemented, a transition period is necessary as children who started with separate first-dose vaccinations of MMR and varicella will receive a single shot of the combined vaccine as the second dose. To account for those situations, this study will evaluate the effect of the combined measles-mumps-rubella-varicella vaccine given in place of separate MMR and varicella vaccines as a second dose.
Interventions
BIOLOGICALMeMuRu-OKA (study vac)
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 and of varicella vaccine 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. 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, MMR titres at 42-56 days after first vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Seropositivity rates. Safety: solicited local/general, unsolicited AEs (42 days), SAEs (whole study) | — |
Countries
Canada, Italy
Outcome results
None listed