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

Condition(s) targeted: Measles; Mumps; Rubella; Varicella

Intervention: MMRV (Biological); MMR (Priorix®) (Biological); Varicella (Varilrix®) (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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.

Official title: Follow-up to Evaluate the the Immunogenicity & Safety of GSK Biologicals' MMRV Vaccine Given as a Two-Dose Schedule in the Second Year of Life, as Compared to Separate Administration of GSK Biologicals' Priorix® & Varilrix®.

Study design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Seropositivity rate & antibody titers for MMRV at 1, 2 & 3 year

Occurrence of breakthrough cases & contacts with MMRV disease(s) for 3 years after vaccination

Minimum age: 12 Months. Maximum age: 18 Months. Gender(s): Both.

Criteria:

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.

GSK Clinical Trials Call Center, Salzburg, Austria

GSK Clinical Trials Call Center, München, Germany

Starting date: July 2003
Ending date: December 2006
Last updated: February 5, 2008