Clinical trial NCT00406211: Long-term Follow-up on Immunogenicity & Safety of Measles-Mumps-Rubella-Varicella (MMRV) Combined Vaccine
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rubella
Varicella
Mumps
Measles
Keywords: Rubella
Varicella
Measles
Mumps
Germany
Austria
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-12-04
Enrollment: 398
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Seropositivity rate & antibody titers for MMRV at 1, 2 & 3 year
measure: Occurrence of breakthrough cases & contacts with MMRV disease(s) for 3 years after vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Klagenfurt
country: Austria
facility: GSK Investigational Site
city: Neufeld/Leitha
country: Austria
facility: GSK Investigational Site
city: Salzburg
country: Austria
facility: GSK Investigational Site
city: Villach
country: Austria
facility: GSK Investigational Site
city: Bindlach
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Marktredwitz
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Olching
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Tegernsee
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Tutzing
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Bad Camberg
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Fulda
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Hochheim
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Marburg/Lahn
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Nidderau
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Ruesselsheim
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Wiesbaden
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Salzgitter
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Wolfenbuettel
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Bochum
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Detmold
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Guetersloh
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Kirchlengern
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Loehne
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Muenster
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Bad Kreuznach
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Bad Sobernheim
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Frankenthal
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Gau-Algesheim
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Mainz
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Mainz
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Schoeneberg - Kuebelberg
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Trier
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Worms
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Altenholz
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Bredstedt
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Brunsbuettel
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Flensburg
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Flensburg
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Husum
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Neumuenster
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Hamburg
country: Germany
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Knuf 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.
citation: Knuf 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.
citation: Zepp 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.