Long-term Follow-up on Immunogenicity & Safety of Measles-Mumps-Rubella-Varicella (MMRV) Combined Vaccine

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Rubella

Varicella

Mumps

Measles

Treatments

Biological: MMR (Priorix®)

Biological: Varicella (Varilrix®)

Biological: MMRV

Study type

Interventional

Funder types

Industry

Identifiers

NCT00406211

208136/041

208136/040

208136/039

Details and patient eligibility

About

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.

Enrollment

398 patients

Sex

All

Ages

12 to 18 months old

Volunteers

Accepts Healthy Volunteers

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