Last updated: 11/03/2018 08:35:16
Immunogenicity, safety of measles-mumps-rubella-varicella vaccine (MeMuRu-OKA) compared to Priorix™ given with Varilrix™
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Comparative study evaluating the immunogenicity and safety of MeMuRu-OKA vaccine and measles-mumps-rubella vaccine (Priorix™) co-administered with varicella vaccine (Varilrix™) in children primed with measles-mumps-rubella vaccine
Trial description: As measles-mumps-rubella (MMR) vaccination is established as routine childhood practice in most industrialised countries and varicella vaccination is now being introduced in many countries during the second year of life, a combined measles-mumps-rubella-varicella vaccine was developed for administration convenience and improved compliance to vaccination. To account for situations where children have received a first dose of MMR vaccine without varicella, this study will evaluate the effect of the combined measles-mumps-rubella-varicella vaccine given in place of the second dose of MMR vaccine. A second dose of the monovalent varicella vaccine will be given to all children participating to this trial since there is a current debate on the need of a second dose to induce a full protection against varicella.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: MeMuRu-OKA (study vacc)
Biological/vaccine: MMR, Varicella vacc (control)
Enrollment:
446
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Gillet Y et al. (2009) Immunogenicity and safety of measles-mumps-rubella-varicella (MMRV) vaccine followed by one dose of varicella vaccine in children aged 15 months-2 years or 2-6 years primed with measles-mumps-rubella (MMR) vaccine. Vaccine. 27 (3): 446-453.
Medical condition
Varicella, Rubella, Measles, Mumps
Product
SB208133, SB208136, SB209762
Collaborators
Not applicable
Study date(s)
March 2006 to November 2006
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
15 months - 6 years
Accepts healthy volunteers
Yes
- Children must be healthy to participate
- Immunosuppressive (including HIV) conditions, allergic diseases, neurological disorders, known anaphylactic reaction to MMR vaccine, and fever (axillary temperature ³ 37.5°C at the time of vaccination) are excluding factors.
- Children must have received one dose (but not more) of MMR at least 6 weeks before entering the study.
Inclusion and exclusion criteria
Inclusion criteria:
- Children must be healthy to participate
Exclusion criteria:
- Immunosuppressive (including HIV) conditions, allergic diseases, neurological disorders, known anaphylactic reaction to MMR vaccine, and fever (axillary temperature ³ 37.5°C at the time of vaccination) are excluding factors.
- Children must have received one dose (but not more) of MMR at least 6 weeks before entering the study.
- They must not receive or have received other non-registered drug or vaccine within 30 days prior to study start, or immunosuppressants for more than 14 days.
- Immunoglobulins or any blood products are prohibited during the 6 months before and during the study, as well as vaccine other than that foreseen by the protocol, 30 days before until 56 days after vaccination.
- Children must not have been vaccinated against varicella.
- They must not have had measles, mumps, rubella or varicella, or have been exposed to those diseases within 30 days prior to study start.
- New-born infants (< 5 weeks of age), pregnant women without previous exposure to chickenpox, and immunodeficient persons cannot live in the same household as the vaccinated child.
Trial location(s)
Location
GSK Investigational Site
Kehl, Baden-Wuerttemberg, Germany, 77694
Status
Study Complete
Location
GSK Investigational Site
Bad Saulgau, Baden-Wuerttemberg, Germany, 88348
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Krefeld, Nordrhein-Westfalen, Germany, 47798
Status
Study Complete
Location
GSK Investigational Site
Herford, Nordrhein-Westfalen, Germany, 32049
Status
Study Complete
Location
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24943
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Kirchzarten, Baden-Wuerttemberg, Germany, 79199
Status
Study Complete
Location
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24937
Status
Study Complete
Location
GSK Investigational Site
Bad Oeynhausen, Nordrhein-Westfalen, Germany, 32549
Status
Study Complete
Location
GSK Investigational Site
Villeneuve les Avignons, France, 30400
Status
Study Complete
Location
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24944
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Boennigheim, Baden-Wuerttemberg, Germany, 74357
Status
Study Complete
Location
GSK Investigational Site
Detmold, Nordrhein-Westfalen, Germany, 32756
Status
Study Complete
Location
GSK Investigational Site
Loehne, Nordrhein-Westfalen, Germany, 32584
Status
Study Complete
Location
GSK Investigational Site
Tettnang, Baden-Wuerttemberg, Germany, 88069
Status
Study Complete
Location
GSK Investigational Site
Stuttgart, Baden-Wuerttemberg, Germany, 70469
Status
Study Complete
Location
GSK Investigational Site
Schwaebisch-Hall, Baden-Wuerttemberg, Germany, 74523
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Neumuenster, Schleswig-Holstein, Germany, 24534
Status
Study Complete
Location
GSK Investigational Site
Schwieberdingen, Baden-Wuerttemberg, Germany, 71701
Status
Terminated/Withdrawn
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
Completed
Actual primary completion date
Not applicable
Actual study completion date
2006-24-11
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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