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NCT00406211

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®.

Completed Phase 3 Last updated 14 September 2016
What this trial tests

Phase 3 trial testing MMRV in Rubella in 398 participants. Completed in 1 December 2004.

Timeline
1 July 2004
Primary endpoint
1 December 2004
1 December 2004

Quick facts

Lead sponsorGlaxoSmithKline
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment398
Start date1 July 2004
Primary completion1 December 2004
Estimated completion1 December 2004
Sites41 locations across Austria, Germany

Drugs / interventions tested

Conditions studied

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 12 Months to 18 Months, any sex, with Rubella or Varicella. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Antibody persistence for 3 years following two doses of tetravalent measles-mumps-rubella-varicella vaccine in healthy children.
    Knuf M, Zepp F, Helm K, Maurer H, et al · · 2012 · cited 14× · PMID 21935584 · DOI 10.1007/s00431-011-1569-4

Verify or expand the search:

Other trials of MMRV

Trials testing the same drug.

Other recruiting trials for Rubella

Currently open trials in the same condition.

Other GlaxoSmithKline trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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