Rubella, Varicella, Mumps, Measles
Conditions
Keywords
Rubella, Varicella, Measles, Mumps, Germany, Austria
Brief summary
Follow-up to evaluate the immunogenicity and safety of three production lots of GSK Biologicals' MMRV vaccine given as a two-dose schedule to healthy children in their second year of life, as compared to separate administration of GSK Biologicals' measles-mumps-rubella (MMR) vaccine (Priorix®) and varicella vaccine (Varilrix®) in Germany & Austria. Blood samples were collected at three time points during the follow-up period (Year 1, 2 & 3). No new subjects will be enrolled in these follow-up phases of the study.
Interventions
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Months to 18 Months
Healthy volunteers
Yes
Inclusion criteria
* Written informed consent from the parents/guardians of the child before participating in the long-term follow-up. * Subjects must have received their complete vaccination course according to the group allocation (i.e. subjects must have received either two doses of MMRV combined vaccine, or two doses of Priorix vaccine and one dose of Varilrix vaccine as separate injections in the primary vaccination study. * Subjects were aged between 12 to 18 months of age at the time of the first vaccination in the primary study.
Exclusion criteria
* Subjects must not have received an additional dose of measles, mumps, rubella or varicella containing vaccines.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of breakthrough cases & contacts with MMRV disease(s) for 3 years after vaccination | — |
| Seropositivity rate & antibody titers for MMRV at 1, 2 & 3 year | — |
Countries
Austria, Germany
Outcome results
None listed