Last updated: 11/04/2018 00:40:34
Long-term follow-up on immunogenicity & safety of Measles-Mumps-Rubella-Varicella (MMRV) combined vaccine
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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®.
Trial 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
398
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
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.
Knuf M et al. (2008) A combination vaccine against measles, mumps, rubella and varicella. Drugs Today (Barc). 44(4):279-292.
Knuf M et al. (2011) Antibody persistence for 3 years following two doses of tetravalent measles-mumps-rubella-varicella vaccine in healthy children. Eur J Pediatr. [Epub ahead of print].
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.
Medical condition
Rubella, Varicella, Mumps, Measles
Product
SB208133, SB208136, SB209762
Collaborators
Not applicable
Study date(s)
July 2004 to December 2004
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
12 - 18 months
Accepts healthy volunteers
Yes
- 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 must not have received an additional dose of measles, mumps, rubella or varicella containing vaccines.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24937
Status
Study Complete
Location
GSK Investigational Site
Frankenthal, Rheinland-Pfalz, Germany, 67227
Status
Study Complete
Location
GSK Investigational Site
Guetersloh, Nordrhein-Westfalen, Germany, 33332
Status
Study Complete
Location
GSK Investigational Site
Hamburg, Hamburg, Germany, 22089
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
Status
Study Complete
Location
GSK Investigational Site
Trier, Rheinland-Pfalz, Germany, 54290
Status
Study Complete
Location
GSK Investigational Site
Bredstedt, Schleswig-Holstein, Germany, 25821
Status
Study Complete
Location
GSK Investigational Site
Loehne, Nordrhein-Westfalen, Germany, 32584
Status
Study Complete
Location
GSK Investigational Site
Worms, Rheinland-Pfalz, Germany, 67547
Status
Study Complete
Location
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44791
Status
Study Complete
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55116
Status
Study Complete
Location
GSK Investigational Site
Brunsbuettel, Schleswig-Holstein, Germany, 25541
Status
Study Complete
Location
GSK Investigational Site
Kirchlengern, Nordrhein-Westfalen, Germany, 32278
Status
Study Complete
Location
GSK Investigational Site
Gau-Algesheim, Rheinland-Pfalz, Germany, 55435
Status
Study Complete
Location
GSK Investigational Site
Bad Sobernheim, Rheinland-Pfalz, Germany, 55566
Status
Study Complete
Location
GSK Investigational Site
Wolfenbuettel, Niedersachsen, Germany, 38302
Status
Study Complete
Location
GSK Investigational Site
Altenholz, Schleswig-Holstein, Germany, 24161
Status
Study Complete
Location
GSK Investigational Site
Schoeneberg - Kuebelberg, Rheinland-Pfalz, Germany, 66901
Status
Study Complete
Location
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24943
Status
Study Complete
Location
GSK Investigational Site
Detmold, Nordrhein-Westfalen, Germany, 32756
Status
Study Complete
Location
GSK Investigational Site
Husum, Schleswig-Holstein, Germany, 25813
Status
Study Complete
Location
GSK Investigational Site
Salzgitter, Niedersachsen, Germany, 38226
Status
Study Complete
Location
GSK Investigational Site
Bad Kreuznach, Rheinland-Pfalz, Germany, 55543
Status
Study Complete
Location
GSK Investigational Site
Neumuenster, Schleswig-Holstein, Germany, 24534
Status
Study Complete
Location
GSK Investigational Site
Muenster, Nordrhein-Westfalen, Germany, 48159
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2004-09-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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