Long-term Follow-up on Immunogenicity & Safety of Measles-Mumps-Rubella-Varicella (MMRV) Combined Vaccine
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®.
3 other identifiers
interventional
398
2 countries
41
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2004
Shorter than P25 for phase_3
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
December 1, 2006
CompletedFirst Posted
Study publicly available on registry
December 4, 2006
CompletedSeptember 15, 2016
September 1, 2016
5 months
December 1, 2006
September 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Subjects must not have received an additional dose of measles, mumps, rubella or varicella containing vaccines.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (41)
GSK Investigational Site
Klagenfurt, A-9020, Austria
GSK Investigational Site
Neufeld/Leitha, A 2491, Austria
GSK Investigational Site
Salzburg, A-5020, Austria
GSK Investigational Site
Villach, A-9500, Austria
GSK Investigational Site
Bindlach, Bavaria, 95463, Germany
GSK Investigational Site
Marktredwitz, Bavaria, 95615, Germany
GSK Investigational Site
Olching, Bavaria, 82140, Germany
GSK Investigational Site
Tegernsee, Bavaria, 83684, Germany
GSK Investigational Site
Tutzing, Bavaria, 82327, Germany
GSK Investigational Site
Hamburg, Hamburg, 22089, Germany
GSK Investigational Site
Bad Camberg, Hesse, 65520, Germany
GSK Investigational Site
Fulda, Hesse, 36037, Germany
GSK Investigational Site
Hochheim am Main, Hesse, 65239, Germany
GSK Investigational Site
Marburg/Lahn, Hesse, 35039, Germany
GSK Investigational Site
Nidderau, Hesse, 61130, Germany
GSK Investigational Site
Rüsselsheim am Main, Hesse, 65428, Germany
GSK Investigational Site
Wiesbaden, Hesse, 65205, Germany
GSK Investigational Site
Salzgitter, Lower Saxony, 38226, Germany
GSK Investigational Site
Wolfenbüttel, Lower Saxony, 38302, Germany
GSK Investigational Site
Bochum, North Rhine-Westphalia, 44791, Germany
GSK Investigational Site
Detmold, North Rhine-Westphalia, 32756, Germany
GSK Investigational Site
Gütersloh, North Rhine-Westphalia, 33332, Germany
GSK Investigational Site
Kirchlengern, North Rhine-Westphalia, 32278, Germany
GSK Investigational Site
Löhne, North Rhine-Westphalia, 32584, Germany
GSK Investigational Site
Münster, North Rhine-Westphalia, 48159, Germany
GSK Investigational Site
Bad Kreuznach, Rhineland-Palatinate, 55543, Germany
GSK Investigational Site
Bad Sobernheim, Rhineland-Palatinate, 55566, Germany
GSK Investigational Site
Frankenthal, Rhineland-Palatinate, 67227, Germany
GSK Investigational Site
Gau-Algesheim, Rhineland-Palatinate, 55435, Germany
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55116, Germany
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55131, Germany
GSK Investigational Site
Schoeneberg - Kuebelberg, Rhineland-Palatinate, 66901, Germany
GSK Investigational Site
Trier, Rhineland-Palatinate, 54290, Germany
GSK Investigational Site
Worms, Rhineland-Palatinate, 67547, Germany
GSK Investigational Site
Altenholz, Schleswig-Holstein, 24161, Germany
GSK Investigational Site
Bredstedt, Schleswig-Holstein, 25821, Germany
GSK Investigational Site
Brunsbüttel, Schleswig-Holstein, 25541, Germany
GSK Investigational Site
Flensburg, Schleswig-Holstein, 24937, Germany
GSK Investigational Site
Flensburg, Schleswig-Holstein, 24943, Germany
GSK Investigational Site
Husum, Schleswig-Holstein, 25813, Germany
GSK Investigational Site
Neumünster, Schleswig-Holstein, 24534, Germany
Related Publications (4)
Habermehl P, Zepp F, Sänger R, Otto W, Helm K, Meister N, Knuf M, Kindler K, Willems P. Assessment of Varicella Breakthrough Cases One Year after Administration of Two Doses of a Measles, Mumps, Rubella, Varicella Vaccine in the Second Year of Life. Abstract presented at the 24th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID), Basel, Switzerland, 03-05 May 2006.
BACKGROUNDKnuf M, Faber J, Barth I, Habermehl P. A combination vaccine against measles, mumps, rubella and varicella. Drugs Today (Barc). 2008 Apr;44(4):279-92. doi: 10.1358/dot.2008.44.4.1210755.
PMID: 18536786BACKGROUNDKnuf M, Zepp F, Helm K, Maurer H, Prieler A, Kieninger-Baum D, Douha M, Willems P. Antibody persistence for 3 years following two doses of tetravalent measles-mumps-rubella-varicella vaccine in healthy children. Eur J Pediatr. 2012 Mar;171(3):463-70. doi: 10.1007/s00431-011-1569-4. Epub 2011 Sep 21.
PMID: 21935584BACKGROUNDZepp F et al. Persistence of Functional Antibodies against Mumps Remains High One Year after Administration of Two Doses of a Measles, Mumps, Rubella, Varicella (MMRV) Vaccine in the Second Year of Life. Presented at 24th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID), Basel, Switzerland, 03-05 May 2006.
BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2006
First Posted
December 4, 2006
Study Start
July 1, 2004
Primary Completion
December 1, 2004
Study Completion
December 1, 2004
Last Updated
September 15, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.