A Phase 3 interventional study of MMRV and MMR (Priorix®) in Rubella, Varicella and Mumps, sponsored by GlaxoSmithKline. Completed at 41 sites in 2 countries. Open to participants aged 12 Months to 18 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-15.
Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention
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.
85 studies on the registry are indexed under Rubella; 11 are open to participants now.
This study's enrollment of 398 is below the median of 801 across 71 interventional studies indexed under Rubella.
Browse Rubella studies →GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
The record gives a start of Jul 2004, a primary completion of Dec 2004 and a completion of Dec 2004. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Measles-Mumps-Rubella Vaccine